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stringlengths 11
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stringlengths 34
385
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stringclasses 2
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listlengths 1
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16.3k
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36
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Single
|
Adverse Events
|
NCT00670982
|
Neutropenia was the most prevalent adverse event in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT00670982', 'Intervention': ['INTERVENTION 1: ', ' First Line Treatment', ' Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week', 'INTERVENTION 2: ', ' Second Line Treatment', ' Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, with metastatic disease.', ' HER2-positive tumor', ' Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan', ' 18 years of age or older', ' Life expectancy of more than 12 weeks', ' ECOG Performance Status of 0 or 1', ' Normal organ and marrow function as outlined in the protocol', ' Left ventricular ejection fraction 50% or greater as determined by RVG or echocardiogram within 30 days prior to initiation of protocol therapy', ' Patients with stable or previously treated CNS metastases are eligible for study participation, provided there is no history of clinically significant CNS bleeding', ' Men and women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation', ' COHORT A:', ' No prior chemotherapy for treatment of metastatic breast cancer', ' May NOT have received prior treatment with trastuzumab for recurrent or metastatic breast cancer', ' No prior vinorelbine for treatment of breast cancer', ' No prior bevacizumab for treatment of breast cancer', ' May have received prior radiation therapy and/or any number of lines of hormonal therapy', ' Prior trastuzumab therapy in the adjuvant setting is also allowed, providing that relapse occured at least 12 months following the last dose', ' Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment', ' COHORT B:', ' One prior line of chemotherapy for treatment of metastatic breast cancer or recurrence of breast cancer within 12 months of completion of adjuvant trastuzumab', ' No prior vinorelbine for treatment of breast cancer', ' No prior bevacizumab for treatment of breast cancer', ' May have received prior radiation therapy and/or any number of lines of hormonal therapy', ' Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment', 'Exclusion Criteria:', ' Patients who have had chemotherapy within 14 days prior to entering the study, ot those who have not recovered adequately from adverse events due to agents administered earlier', ' Concurrent radiation therapy', ' History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in this study', ' Prior therapy with bevacizumab or vinorelbine', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study', ' Inadequately controlled hypertension', ' Prior history of hypertensive crisis of hypertensive encephalopathy', ' NHYA Grade II or greater congestive heart failure', ' History of myocardial infarction of unstable angina within 6 months prior to study enrollment', ' History of stroke or transient ischemic attack within 6 months prior to study enrollment', ' Progressive or untreated CNS metastases', ' Significant vascular disease within 6 months prior to study enrollment', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study', ' Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious non-healing wound, active ulcer, or untreated bone fracture', ' Proteinuria at screening', ' Pregnant or lactating', ' Current and ongoing treatment with full-dose warfarin or its equivalent'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.', ' Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: First Line Treatment', ' Arm/Group Description: Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: percentage of participants 36 (17 to 59)', 'Results 2: ', ' Arm/Group Title: Second Line Treatment', ' Arm/Group Description: Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: percentage of participants 29 (4 to 71)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/29 (31.03%)', ' Neutropenia 5/29 (17.24%)', ' Cataracts 1/29 (3.45%)', ' Abdominal Pain 1/29 (3.45%)', ' Perforated Appendix 1/29 (3.45%)', ' Surgical Intervention 1/29 (3.45%)', ' Deep Vein Thrombosis 1/29 (3.45%)', ' Cerebrovascular Ischemia 1/29 (3.45%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f40c8d92-2921-45fd-8389-15048b08e229
|
|
Comparison
|
Intervention
|
NCT00256698
|
NCT03573804
|
the primary trial and the secondary trial use completely different drugs and techniques for their interventions.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00256698', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Anastrozole', ' Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg', 'INTERVENTION 2: ', ' Anastrozole', 'Anastrozole 1 mg'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis', 'Exclusion Criteria:', ' Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy', ' Premenopausal women'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP)', ' RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen \'progression\' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.', ' Time frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Anastrozole', ' Arm/Group Description: Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg', ' Overall Number of Participants Analyzed: 258', ' Median (Full Range)', ' Unit of Measure: months 10.8 (0 to 49.31)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: Anastrozole 1 mg', ' Overall Number of Participants Analyzed: 256', ' Median (Full Range)', ' Unit of Measure: months 10.2 (0 to 54.34)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 40/256 (15.63%)', ' Anaemia 1/256 (0.39%)', ' Cardiac Failure 3/256 (1.17%)', ' Pericardial Effusion 0/256 (0.00%)', ' Angina Pectoris 0/256 (0.00%)', ' Arrhythmia 0/256 (0.00%)', ' Atrial Flutter 0/256 (0.00%)', ' Cardiac Arrest 0/256 (0.00%)', ' Atrial Fibrillation 1/256 (0.39%)', ' Bradycardia 1/256 (0.39%)', ' Cardiomyopathy 1/256 (0.39%)', ' Myocardial Infarction 1/256 (0.39%)', 'Adverse Events 2:', ' Total: 45/254 (17.72%)', ' Anaemia 1/254 (0.39%)', ' Cardiac Failure 1/254 (0.39%)', ' Pericardial Effusion 2/254 (0.79%)', ' Angina Pectoris 1/254 (0.39%)', ' Arrhythmia 1/254 (0.39%)', ' Atrial Flutter 1/254 (0.39%)', ' Cardiac Arrest 1/254 (0.39%)', ' Atrial Fibrillation 0/254 (0.00%)', ' Bradycardia 0/254 (0.00%)', ' Cardiomyopathy 0/254 (0.00%)', ' Myocardial Infarction 0/254 (0.00%)']}
|
{'Clinical Trial ID': 'NCT03573804', 'Intervention': ['INTERVENTION 1: ', ' Prone to Supine MRI Evaluated by Radiologist A', ' Radiologist A, number of participants successfully segmented', 'INTERVENTION 2: ', ' Prone to Supine MRI Evaluated by Radiologist B', ' Radiologist B, number of participants successfully segmented'], 'Eligibility': ['Inclusion Criteria:', ' Age > 18 years.', ' Female gender.', ' Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ', ' Tumor size at least 1 cm in diameter as visualized on mammogram or US.', ' A diagnostic breast MRI is considered to be clinically indicated.', ' Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.', 'Exclusion Criteria:', ' Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.', ' Severe claustrophobia.', ' Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).', ' History of median sternotomy.', ' Pregnancy. Patient attestation that they are not pregnant will be acceptable.', ' Patients who have received neoadjuvant chemotherapy.'], 'Results': ['Outcome Measurement: ', ' Number of Successful Segmentation of Supine MRI Images', ' Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.', ' Time frame: 30 minutes', 'Results 1: ', ' Arm/Group Title: Prone to Supine MRI Evaluated by Radiologist A', ' Arm/Group Description: Radiologist A, number of participants successfully segmented', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 54 87.1%', 'Results 2: ', ' Arm/Group Title: Prone to Supine MRI Evaluated by Radiologist B', ' Arm/Group Description: Radiologist B, number of participants successfully segmented', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 61 98.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/62 (0.00%)', 'Adverse Events 2:', ' ']}
|
31387af4-aad1-4f3c-bd81-641340ad4096
|
Single
|
Results
|
NCT00534417
|
The median TTP in cohort one of the primary trial is just under 27 months.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00534417', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine and Fulvestrant', ' Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of 80 kg.', ' Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.', ' At least 18 years of age.', ' Post-menopausal female (ie, amenorrheic for at least 12 months prior to study entry). Post-menopausal status will be confirmed by drawing follicle stimulating hormone (FSH) and estradiol levels if < 2 years since last menses.', ' Ambulatory outpatient with Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 2 at study entry.', ' Primary tumor human epidermal growth factor receptor 2 (HER-2) negative at study entry.(Investigator discretion will be used in instances of immuno-histochemistry [IHC] 2+.)', ' Histologically or cytologically confirmed MBC.', ' Primary tumor and/or metastatic lesion estrogen receptor + and/or progesterone receptor + by IHC.', ' At least one measurable or evaluable(non-measurable) lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (see Appendix 11.6) which has not been irradiated (i.e., newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable but are considered evaluable (non-measurable). Minimum indicator lesion size for measurable disease: 10 mm measured by spiral computed tomography (CT) or 20 mm measured by conventional techniques.', ' Adequate hematologic, renal, and hepatic function.', 'Hematologic values: Neutrophils (ANC) > 1.5 x 109/L; Platelet count > 100 x 109/L.', ' Renal function: estimated creatinine clearance > 30 mL/min as calculated with Cockcroft-Gault equation.', ' Note: In patients with moderate renal impairment (calculated creatinine clearance 30 to 50 mL/min) at baseline, a dose reduction to (-1) of the capecitabine starting dose is required.', ' Serum bilirubin < 1.5 x upper limit normal (ULN).', ' Alanine transaminase (ALT) or aspartate transaminase (AST) < 2.5 x ULN (or < 5 x ULN in the case of liver metastases).', ' Alkaline phosphatase < 2.5 x ULN (or < 5 x ULN in the case of liver metastases or < 10 x ULN in the case of bone disease).', ' International normalization ratio (INR) < 1.6.', ' Must have 1 prior regimen of endocrine therapy for metastatic breast cancer. This would include patients who have a recurrence while on adjuvant hormone therapy OR have first recurrence after adjuvant hormone therapy OR progressed after first line hormone therapy for metastatic breast cancer OR treatment naïve patients who present with metastatic breast cancer.', 'Exclusion Criteria:', ' Prior administration of capecitabine.', ' Prior administration of fulvestrant.', ' Prior chemotherapy for metastatic breast cancer.', ' Radiotherapy 2 weeks prior to registration, except if to a non-target lesion only or single-dose radiation for palliation. NOTE: Prior radiation to a target lesion(s) is permitted only if there has been clear progression of the lesion since radiation was completed.', ' Life expectancy <3 months.', ' Serious, uncontrolled, concurrent infection(s).', ' Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency.', ' Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cervical cancer or superficial bladder tumors (stage Ta or Tis).', ' Participation in any investigational drug study within 4 weeks preceding the start of study treatment.', ' Clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication)or myocardial infarction within the last 12 months prior to study entry.', ' Active brain metastases. Patients with neurological symptoms must undergo a CT scan or magnetic resonance imaging (MRI) of the brain to exclude active brain metastasis. NOTE: Patients with treated brain metastases are eligible provided they have no evidence of disease and are off definitive therapy (including steroids) 3 months prior to study entry.', ' Central nervous system (CNS) disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.', ' Known human immunodeficiency virus or chronic hepatitis B or C.', ' Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.', ' Major surgery within 4 weeks of the start of study treatment, without complete recovery.', ' Lack of physical integrity of the upper GI tract or malabsorption syndrome.', ' Known, existing uncontrolled coagulopathy.', ' Any of the following laboratory values:', ' Abnormal hematologic values (neutrophils [ANC]: <1.5 × 109/L, platelet count: <100 × 109/L)', ' Impaired renal function (estimated creatinine clearance: <30 mL/min as calculated with Cockcroft-Gault equation). Note: In patients with moderate renal impairment (calculated creatinine clearance: 30 to 50 mL/min) at baseline, a dose reduction to (-1) of the capecitabine starting dose is required.', ' Serum bilirubin >1.5 × upper normal limit (ULN).', ' Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 × ULN (or >5 × ULN in the case of liver metastases).', ' Alkaline phosphatase > 2.5 × ULN (or >5 × ULN in the case of liver metastases or >10 × ULN in the case of bone disease).', ' International normalization ratio (INR) >1.6.', ' History of:', ' Bleeding diathesis,(ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or', ' Long-term anticoagulant therapy,(other than antiplatelet therapy and warfarin 1 mg qd for port prophylaxis).', ' History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol).', ' Unwillingness to give written informed consent.', ' Unwillingness to participate or inability to comply with the protocol for the duration of the study.'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP)', ' Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.', ' Time frame: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.', 'Results 1: ', ' Arm/Group Title: Capecitabine and Fulvestrant', ' Arm/Group Description: Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of 80 kg.', ' Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.', ' Overall Number of Participants Analyzed: 41', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 26.94 [1] (7.26 to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/41 (21.95%)', ' Neutropenia * 1/41 (2.44%)', ' Cardiac Tamponade * 1/41 (2.44%)', ' Pericardial Effusion * 1/41 (2.44%)', ' Abdominal Pain Upper * 1/41 (2.44%)', ' Colitis * 1/41 (2.44%)', ' Diarrhoea * 1/41 (2.44%)', ' Enteritis * 1/41 (2.44%)', ' Nausea * 1/41 (2.44%)', ' Vomiting * 1/41 (2.44%)', ' Adverse Drug Reaction * 1/41 (2.44%)', ' Pneumonia * 2/41 (4.88%)', ' Overdose * 1/41 (2.44%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
eabe9a78-965e-4984-82c2-25598b6b35da
|
|
Single
|
Results
|
NCT01328249
|
The Percentage of Participants With Feasibility was 10% higher in cohort 1 of the primary trial than in cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01328249', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Eribulin Mesylate With Filgrastim as Needed', " Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade 2.", 'INTERVENTION 2: ', ' Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim', ' Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants 60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.'], 'Eligibility': ['Inclusion Criteria', ' Male and female subjects aged greater than or equal to (>=) 18 years', ' Histologically confirmed Stage I to III invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.', ' HER-2 normal as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemistry (IHC) staining.', ' Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.', ' Adequate cardiac function, defined by baseline LVEF >=50 percent (%) by Multiple Gated Acquisition (MUGA) scan or echocardiogram.', ' ECOG performance status of 0 or 1.', ' Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 mg/dL or calculated creatinine clearance >=40 mL/min per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by ANC >=1.5 x 10^9/L, hemoglobin >=10.0 g/dL, and platelet count >=100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 x ULN.', ' Females of childbearing potential must have a negative urine or beta-human chorionic gonadotropin serum pregnancy test within 2 weeks prior to Cycle 1, Day 1. A urine pregnancy test should be repeated prior to chemotherapy if not conducted within 72 hours of start of treatment. Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male subjects who are not abstinent or who have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).', ' Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice.', ' Exclusion Criteria', ' Stage IV breast cancer.', ' Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.', ' Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.', ' Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer.', ' Subjects with known positive human immunodeficiency virus (HIV) status.', ' Pregnancy or breast feeding at the time of study enrollment. Eligible subjects of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy.', ' Subjects with known allergy or hypersensitivity to doxorubicin, cyclophosphamide, or eribulin mesylate.', ' Inability to comply with the study and/or follow-up procedures.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Feasibility', ' The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.', ' Time frame: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months', 'Results 1: ', ' Arm/Group Title: Cohort 1: Eribulin Mesylate With Filgrastim as Needed', " Arm/Group Description: Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade 2.", ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 70.4 (58.5 to 80.4)', 'Results 2: ', ' Arm/Group Title: Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim', ' Arm/Group Description: Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants 60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 60.0 (41.7 to 76.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/55 (10.91%)', ' Febrile neutropenia 2/55 (3.64%)', ' Nausea 2/55 (3.64%)', ' Oesophagitis 2/55 (3.64%)', ' Vomiting 2/55 (3.64%)', ' Mucosal inflammation 0/55 (0.00%)', ' Pyrexia 2/55 (3.64%)', ' Breast abscess 0/55 (0.00%)', ' Catheter site cellulitis 0/55 (0.00%)', ' Genital herpes 1/55 (1.82%)', ' Lung infection 0/55 (0.00%)', ' Upper respiratory tract infection 1/55 (1.82%)', 'Adverse Events 2:', ' Total: 4/26 (15.38%)', ' Febrile neutropenia 1/26 (3.85%)', ' Nausea 0/26 (0.00%)', ' Oesophagitis 0/26 (0.00%)', ' Vomiting 0/26 (0.00%)', ' Mucosal inflammation 1/26 (3.85%)', ' Pyrexia 1/26 (3.85%)', ' Breast abscess 1/26 (3.85%)', ' Catheter site cellulitis 1/26 (3.85%)', ' Genital herpes 0/26 (0.00%)', ' Lung infection 1/26 (3.85%)', ' Upper respiratory tract infection 0/26 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
006f6b4e-6245-4f09-9786-327bbed3d766
|
|
Single
|
Results
|
NCT00699491
|
3/4 participants in the primary trial suffered from Dose-limiting toxicities.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22
] |
[] |
{'Clinical Trial ID': 'NCT00699491', 'Intervention': ['INTERVENTION 1: ', ' Dose Level 1', ' 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Dose Level -1', ' 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22', ' Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of breast cancer with diagnosis of metastatic or locally recurrent disease (locally recurrent disease should be stage IV e.g. chest wall involvement)', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (Karnofsky >= 80%)', ' Life expectancy of > 12 weeks', ' Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent', ' Negative serum pregnancy test =< 7 days of registration for women of childbearing potential:', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of IMC-A12 and CCI-779 (temsirolimus)', ' Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Nursing women must be willing to discontinue nursing; NOTE: breastfeeding should be discontinued if the mother is treated with CCI-779 and IMC-A12', ' Absolute neutrophil count >= 1,500/mcL', ' Hemoglobin >= 8.5 g/dL', ' Platelets >= 100,000/mcL', ' Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)', ' Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 X institutional ULN if liver function test [LFT] elevations due to liver metastases)', ' Creatinine =< 1.5 X institutional ULN OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine > institutional ULN', ' Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)', ' Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)', ' Albumin >= 3.4 mg/dL', ' Fasting or non fasting serum glucose < 120 mg/dL', ' Hemoglobin A1c (HbA1c) (for all patients with a history of diabetes mellitus) < 8%', ' Phase I only: Any number of prior therapy regimens is allowed', ' Phase II only: Measurable disease is required for the Phase II portion of the study; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], x-ray) or as >= 10 mm with spiral CT scan', ' Phase II only: =< two and at least one prior chemotherapy regimens in the setting of metastatic or locally recurrent (stage IV chest wall involvement) disease are required', 'Exclusion Criteria:', ' Phase I patients only: Patients with base line diabetes requiring oral hypoglycemics or insulin', ' Phase II patients only: Poorly controlled diabetes mellitus; NOTE: patients with a history of diabetes mellitus on oral hypoglycemics or insulin are allowed to participate, provided that their fasting blood glucose is < 120 mg/dL and that they are on a stable dietary or therapeutic regimen for this condition', ' Any of the following:', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (hormonal agents are not allowed and oral contraceptives are not acceptable for contraception)', ' Receiving hormonal agents used for the treatment of breast cancer with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist', ' Any of the following prior therapies:', ' Systemic anti-cancer therapy =< 3 weeks prior to registration', ' Radiation therapy =< 2 weeks prior to registration', ' Prior invasive non-breast malignancy, except for adequately treated basal or squamous cell carcinoma of the skin or other cancer from which the patient has been disease free for >= 5 years', ' Known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin); allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12, or temsirolimus', ' Prior treatment with agents targeting the insulin-like growth factor-I receptor (IGF-IR)/insulin-like growth factors (IGFs) or phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (Akt)/mechanistic target of rapamycin (mTOR) pathway', ' Receiving any other investigational agents or herbal preparations', ' Patients may not be taking oral corticosteroids except for replacement for adrenal insufficiency', ' Uncontrolled brain metastases; Note: brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for >= 12 weeks', ' Known human immunodeficiency virus (HIV)-positive patients who have cluster of differentiation (CD)4 counts below the normal range or who are on anti-retroviral therapy that may interfere with the metabolism of temsirolimus', ' Uncontrolled intercurrent illness including, but not limited to:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Uncontrolled symptomatic cardiac arrhythmia', ' Psychiatric illness/social situations that would limit compliance with study requirements', " Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) or any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort"], 'Results': ['Outcome Measurement: ', ' Recommended Dose Level for Phase II Testing (RPTD) (Phase I)', ' The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.', ' Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:', ' Any grade 4 hematologic toxicity', ' Hyperglycemia that cannot be stably controlled with diabetic medication', ' Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)', ' Time frame: During first course', 'Results 1: ', ' Arm/Group Title: Dose Level 1', ' Arm/Group Description: 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: DLTs 2', 'Results 2: ', ' Arm/Group Title: Dose Level -1', ' Arm/Group Description: 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22', ' Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: DLTs 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Hemoglobin decreased 0/3 (0.00%)', ' Mucositis oral 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Vomiting 0/3 (0.00%)', ' Death 0/3 (0.00%)', ' Edema limbs 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Pain 0/3 (0.00%)', ' Skin infection 0/3 (0.00%)', ' Alanine aminotransferase increased 0/3 (0.00%)', ' Alkaline phosphatase increased 0/3 (0.00%)', ' Creatinine increased 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/2 (50.00%)', ' Hemoglobin decreased 0/2 (0.00%)', ' Mucositis oral 1/2 (50.00%)', ' Nausea 0/2 (0.00%)', ' Vomiting 0/2 (0.00%)', ' Death 0/2 (0.00%)', ' Edema limbs 0/2 (0.00%)', ' Fatigue 1/2 (50.00%)', ' Pain 1/2 (50.00%)', ' Skin infection 0/2 (0.00%)', ' Alanine aminotransferase increased 0/2 (0.00%)', ' Alkaline phosphatase increased 0/2 (0.00%)', ' Creatinine increased 1/2 (50.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
88b13330-b937-4bbc-80ea-4bf8ccc17bd1
|
|
Comparison
|
Eligibility
|
NCT01009918
|
NCT01688609
|
There are no racial criteria for entry into the primary trial, but there are for the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20
] |
[
17
] |
{'Clinical Trial ID': 'NCT01009918', 'Intervention': ['INTERVENTION 1: ', ' Arm I Lisinopril', ' Patients receive oral lisinopril once daily.', ' lisinopril: Given orally', 'INTERVENTION 2: ', ' Arm II Coreg CR®', ' Patients receive oral Coreg CR® once daily.', ' Coreg CR®: Given orally'], 'Eligibility': ['INCLUSION CRITERIA', ' Males and Females 18 years old diagnosed with HER2 positive breast cancer', ' Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab.', ' Left Ventricular Ejection Fraction (LVEF) 50% by MUGA scan or echocardiogram', ' Adequate renal function for administration of trastuzumab-containing chemotherapy regimen.', ' Sitting systolic blood pressure of > 90 mm Hg', ' Pulse 60 beats/minute', ' Not pregnant or breastfeeding', ' Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study', ' Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents', ' Able to swallow capsules', 'EXCLUSION CRITERIA:', ' Patients with metastatic disease', ' Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen', ' Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin', ' Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction', ' Known allergy to either ACE inhibitors or β-blockers', ' History of bronchial asthma or related bronchospastic conditions', ' Hereditary or idiopathic angioedema', ' History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings', ' This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment', ' Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Arm I Lisinopril', ' Arm/Group Description: Patients receive oral lisinopril once daily.', ' lisinopril: Given orally', ' Overall Number of Participants Analyzed: 152', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 45 29.6%', 'Results 2: ', ' Arm/Group Title: Arm II Coreg CR ', ' Arm/Group Description: Patients receive oral Coreg CR once daily.', ' Coreg CR : Given orally', ' Overall Number of Participants Analyzed: 147', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 43 29.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/158 (3.16%)', ' Anemia 1/158 (0.63%)', ' Febrile Neutropenia 0/158 (0.00%)', ' Spleen Disorder 0/158 (0.00%)', ' Palpitations 0/158 (0.00%)', ' Chest pain - cardiac 0/158 (0.00%)', ' Pericardial Effusion 1/158 (0.63%)', ' Colitis 0/158 (0.00%)', ' Diarrhea 1/158 (0.63%)', ' Fatigue 0/158 (0.00%)', ' Skin Infection 0/158 (0.00%)', ' Neutrophil Count Decreased 0/158 (0.00%)', 'Adverse Events 2:', ' Total: 4/156 (2.56%)', ' Anemia 0/156 (0.00%)', ' Febrile Neutropenia 1/156 (0.64%)', ' Spleen Disorder 0/156 (0.00%)', ' Palpitations 0/156 (0.00%)', ' Chest pain - cardiac 0/156 (0.00%)', ' Pericardial Effusion 0/156 (0.00%)', ' Colitis 1/156 (0.64%)', ' Diarrhea 0/156 (0.00%)', ' Fatigue 1/156 (0.64%)', ' Skin Infection 0/156 (0.00%)', ' Neutrophil Count Decreased 1/156 (0.64%)']}
|
{'Clinical Trial ID': 'NCT01688609', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)', ' Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.', ' Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.', ' lapatinib ditosylate: Given PO', ' paclitaxel: Given IV', ' trastuzumab: Given IV', ' therapeutic conventional surgery: Undergo lumpectomy or mastectomy', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed primary invasive breast cancer', ' Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound', ' Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+', ' Patients have not received prior therapies for breast cancer', ' Patients have Karnofsky >= 70%', ' Leukocytes >= 3,000/mcL', ' Absolute neutrophil count >= 1,500/mcL', ' Hemoglobin >= 9.0 g/dL', ' Platelets >= 75,000/mcL', ' Total bilirubin =< 1.5 times institutional upper limit of normal', ' Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase[SGPT]) =< 2.5 times institutional ULN', ' Creatinine =< 1.5 times institutional upper limit of normal (ULN)', ' Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi-gated acquisition (MUGA) or echocardiography', ' Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)', ' Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab', ' Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document', ' Only Japanese women are eligible for the trial', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy', ' Patients who are receiving any other investigational agents', ' Patients have distal metastasis (stage IV disease)', ' Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study', ' Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible', ' Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women', ' Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes', ' Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)', ' Patients who have neuropathy >= grade 2 of any cause', ' Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer'], 'Results': ['Outcome Measurement: ', ' Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks', " For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar's test in all patients and separately in patients with and without pCR.", ' Time frame: From baseline to 18 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)', ' Arm/Group Description: Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.', ' Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.', ' lapatinib ditosylate: Given PO', ' paclitaxel: Given IV', ' trastuzumab: Given IV', ' therapeutic conventional surgery: Undergo lumpectomy or mastectomy', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Count of Participants', ' Unit of Measure: Participants baseline CD44v expression : pCR: 5 27.8%', ' baseline CD44v expression : non-pCR: 3 16.7%', ' CD44v expression at 6 weeks : pCR: 0 0.0%', ' CD44v expression at 6 weeks : non-pCR: 4 22.2%', ' CD44v expression at 18 weeks : pCR: 0 0.0%', ' CD44v expression at 18 weeks : non-pCR: 5 27.8%', ' baseline ALDH1 expression : pCR: 8 44.4%', ' baseline ALDH1 expression : non-pCR: 10 55.6%', ' ALDH1 expression at 6 weeks : pCR: 7 38.9%', ' ALDH1 expression at 6 weeks : non-pCR: 10 55.6%', ' ALDH1 expression at 18 weeks : pCR: 8 44.4%', ' ALDH1 expression at 18 weeks : non-pCR: 9 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)']}
|
e90e2368-808d-454d-8080-30427235b89d
|
Single
|
Eligibility
|
NCT00723398
|
Patients with both type 1 and 2 Diabetes are not suitable for the primary trial.
|
Entailment
|
[
5,
9
] |
[] |
{'Clinical Trial ID': 'NCT00723398', 'Intervention': ['INTERVENTION 1: ', ' Group 1: Control', ' Control, no intervention', 'INTERVENTION 2: ', ' Group 2: Raloxifene 60 mg', ' Raloxifene 60 mg Orally Daily'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy', ' Breast density greater than 25%', ' No hormone replacement therapy for at least six months prior to entry into this study', ' Non-smokers.', 'Exclusion Criteria:', ' History of stroke, pulmonary embolism or deep vein thrombosis', ' History of atherosclerotic heart disease', ' Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)', ' Diabetes mellitus', ' Uncontrolled hypertension (BP 140/90)', ' Presence of a psychiatric condition that would interfere with adherence to the protocol.'], 'Results': ['Outcome Measurement: ', ' Change in Absolute Breast Density', ' Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Group 1: Control', ' Arm/Group Description: Control, no intervention', ' Overall Number of Participants Analyzed: 53', ' Mean (Standard Deviation)', ' Unit of Measure: cm squared Absolute density at baseline: 53 participants', ' 65.53 (59.43)', ' Absolute density at 1 year: 48 participants', ' 59.29 (40.72)', ' Absolute density at 2 years: 46 participants', ' 54.34 (20.11)', 'Results 2: ', ' Arm/Group Title: Group 2: Raloxifene 60 mg', ' Arm/Group Description: Raloxifene 60 mg Orally Daily', ' Overall Number of Participants Analyzed: 53', ' Mean (Standard Deviation)', ' Unit of Measure: cm squared Absolute density at baseline: 53 participants', ' 64.39 (39.95)', ' Absolute density at 1 year: 41 participants', ' 60.48 (38.89)', ' Absolute density at 2 years: 38 participants', ' 60.57 (35.10)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/53 (0.00%)', ' Endometrial Cancer [1]0/53 (0.00%)', 'Adverse Events 2:', ' Total: 1/53 (1.89%)', ' Endometrial Cancer [1]1/53 (1.89%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d375ef3f-8b35-40eb-b9c0-3fc9592d9bec
|
|
Comparison
|
Intervention
|
NCT00245219
|
NCT00038103
|
the primary trial and the secondary trial only have test groups, so all patients are receiving novel (FDA approved) interventions.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00245219', 'Intervention': ['INTERVENTION 1: ', ' Health Tracking (Control)', ' Participants assigned to the health-tracking condition received usual care and did not attend any meetings.', 'INTERVENTION 2: ', ' Peer Support', ' The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.'], 'Eligibility': ['Eligible participants were:', ' English speaking women,', ' 25 years of age or older,', ' Living within a 60 mile radius of Pittsburgh, Pennsylvania,', ' either: a first time diagnosis of stage I or II breast cancer or if they had received an initial diagnosis of stage IV cancer or a distant recurrence of breast cancer,', ' Patients with early stage cancer must have been diagnosed within the past 6 months,', ' There was no window for enrollment for patients with late stage cancer.'], 'Results': ['Outcome Measurement: ', ' Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)', ' The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).', ' Time frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)', 'Results 1: ', ' Arm/Group Title: Health Tracking (Control)', ' Arm/Group Description: Participants assigned to the health-tracking condition received usual care and did not attend any meetings.', ' Overall Number of Participants Analyzed: 85', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 46.55 (11.61)', ' Time 2: 47.03 (10.40)', ' Time 3: 50.28 (9.88)', 'Results 2: ', ' Arm/Group Title: Peer Support', ' Arm/Group Description: The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.', ' Overall Number of Participants Analyzed: 62', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 47.63 (11.25)', ' Time 2: 49.25 (10.64)', ' Time 3: 50.03 (11.18)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/91 (0.00%)', 'Adverse Events 2:', ' Total: 0/94 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00038103', 'Intervention': ['INTERVENTION 1: ', ' Exemestane (Exemestane Alone)', ' oral dose exemestane taken with food (25 mg tablet once daily)', 'INTERVENTION 2: ', ' Combination (Exemestane + Celecoxib)', ' oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.', ' Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.', ' at least one measurable lesion', 'Exclusion Criteria:', ' More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.', ' Previous hormonotherapy for advanced disease other than Tamoxifen.', ' Myocardial infarction within previous 6 mo'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Clinical Benefit', ' Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.', ' Time frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)', 'Results 1: ', ' Arm/Group Title: Exemestane (Exemestane Alone)', ' Arm/Group Description: oral dose exemestane taken with food (25 mg tablet once daily)', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants 24', 'Results 2: ', ' Arm/Group Title: Combination (Exemestane + Celecoxib)', ' Arm/Group Description: oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: participants 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9', ' Cardiac Failure Congestive 0/53 (0.00%)', ' Ascites 1/53 (1.89%)', ' Nausea 1/53 (1.89%)', ' Vomiting 2/53 (3.77%)', ' Intestinal Obstruction 1/53 (1.89%)', ' Diarrhoea 0/53 (0.00%)', ' Pain 1/53 (1.89%)', ' Death 1/53 (1.89%)', ' General physical health deterioration 1/53 (1.89%)', ' Gait Disturbance 1/53 (1.89%)', ' Asthenia 2/53 (3.77%)', ' Fatigue 0/53 (0.00%)', 'Adverse Events 2:', ' Total: 14', ' Cardiac Failure Congestive 1/56 (1.79%)', ' Ascites 0/56 (0.00%)', ' Nausea 0/56 (0.00%)', ' Vomiting 0/56 (0.00%)', ' Intestinal Obstruction 0/56 (0.00%)', ' Diarrhoea 1/56 (1.79%)', ' Pain 1/56 (1.79%)', ' Death 1/56 (1.79%)', ' General physical health deterioration 1/56 (1.79%)', ' Gait Disturbance 1/56 (1.79%)', ' Asthenia 0/56 (0.00%)', ' Fatigue 1/56 (1.79%)']}
|
2f2301cd-b8fa-47cc-94cc-e31150ce8f9e
|
Comparison
|
Eligibility
|
NCT00248170
|
NCT01299038
|
Ae-Cha is a 32 year old Korean woman with an inoperable breast cancer, she is too old to participate in both the secondary trial and the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
{'Clinical Trial ID': 'NCT00248170', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' 2.5 mg by mouth (p.o.) once daily', 'INTERVENTION 2: ', ' Anastrozole', ' 1 mg p.o. once daily'], 'Eligibility': ['Inclusion Criteria:', ' Recent primary surgery for breast cancer', ' Early stage breast cancer', ' Postmenopausal', ' Hormone receptor positive', ' Positive lymph node involvement', 'Exclusion Criteria:', ' Metastatic disease', ' Presence of contralateral breast cancer including DCIS', ' Progression', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival', ' Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.', ' Time frame: 84 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: 2.5 mg by mouth (p.o.) once daily', ' Overall Number of Participants Analyzed: 2061', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (84.14 to NA)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: 1 mg p.o. once daily', ' Overall Number of Participants Analyzed: 2075', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 486/2049 (23.72%)', ' Anaemia 4/2049 (0.20%)', ' Autoimmune haemolytic anaemia 0/2049 (0.00%)', ' Haemorrhagic anaemia 1/2049 (0.05%)', ' Lymphadenopathy 0/2049 (0.00%)', ' Pancytopenia 0/2049 (0.00%)', ' Acute coronary syndrome 1/2049 (0.05%)', ' Acute myocardial infarction 3/2049 (0.15%)', ' Adams-Stokes syndrome 1/2049 (0.05%)', ' Angina pectoris 8/2049 (0.39%)', ' Angina unstable 1/2049 (0.05%)', 'Adverse Events 2:', ' Total: 520/2062 (25.22%)', ' Anaemia 3/2062 (0.15%)', ' Autoimmune haemolytic anaemia 1/2062 (0.05%)', ' Haemorrhagic anaemia 0/2062 (0.00%)', ' Lymphadenopathy 2/2062 (0.10%)', ' Pancytopenia 1/2062 (0.05%)', ' Acute coronary syndrome 1/2062 (0.05%)', ' Acute myocardial infarction 4/2062 (0.19%)', ' Adams-Stokes syndrome 0/2062 (0.00%)', ' Angina pectoris 8/2062 (0.39%)', ' Angina unstable 2/2062 (0.10%)']}
|
{'Clinical Trial ID': 'NCT01299038', 'Intervention': ['INTERVENTION 1: ', ' Rosuvastatin 20mg', ' Rosuvastatin 20mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', 'INTERVENTION 2: ', ' Rosuvastatin 40mg', ' Rosuvastatin 40mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Metastatic adenocarcinoma of the breast (Stage IV)', ' Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)', ' Minimum age 18 years', ' ECOG Performance status of 0, 1 or 2', ' Normal organ and marrow function as defined in the protocol', 'Exclusion Criteria:', ' Participants may not be receiving any other study agents', ' Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks', ' Any statin therapy within the last 3 weeks', ' Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)', ' Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors', ' Conditions predisposing to renal failure secondary to rhabdomyolysis', ' Recent history of heavy alcohol use as judged by the treating physician', ' Known to be pregnant (testing not required) or nursing', ' History of rhabdomyolysis on statin therapy', ' Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'], 'Results': ['Outcome Measurement: ', ' Mean Change of Tissue Factor Bearing Microparticles', ' Comparison of plasma microparticle concentration between baseline and week 4', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: Rosuvastatin 20mg', ' Arm/Group Description: Rosuvastatin 20mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', ' Overall Number of Participants Analyzed: 8', ' Mean (Standard Deviation)', ' Unit of Measure: microparticles per microliter 102 (586)', 'Results 2: ', ' Arm/Group Title: Rosuvastatin 40mg', ' Arm/Group Description: Rosuvastatin 40mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: microparticles per microliter -618 (624)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}
|
eea73ae4-0985-4f74-957d-e2aad7ab453c
|
Single
|
Results
|
NCT00313170
|
Patients in the primary trial treated with Fulvestrant 250 mg had a higher Objective response rate than those treated with Fulvestrant 250 mg + Loading Dose.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00313170', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 250 mg', 'Fulvestrant 250 mg', 'INTERVENTION 2: ', ' Fulvestrant 250 mg + Loading Dose', ' Fulvestrant 250 mg + Loading Dose'], 'Eligibility': ['Inclusion Criteria:', ' Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor.', ' Requiring hormonal treatment.', ' Postmenopausal women (woman who has stopped having menstrual periods)', 'Exclusion Criteria:', ' Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced BC.', ' Treatment with more than one previous regimen of endocrine therapy for advanced BC.', ' An existing condition that prevents compliance.'], 'Results': ['Outcome Measurement: ', ' Objective Response (ORR)', ' Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).', ' Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg', ' Arm/Group Description: Fulvestrant 250 mg', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 8.5 (2.4 to 20.4)', 'Results 2: ', ' Arm/Group Title: Fulvestrant 250 mg + Loading Dose', ' Arm/Group Description: Fulvestrant 250 mg + Loading Dose', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 5.9 (1.2 to 16.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/47 (8.51%)', ' Anaemia 0/47 (0.00%)', ' Myocardial Infarction 0/47 (0.00%)', ' Macular Hole 1/47 (2.13%)', ' Diverticulum Intestinal Haemorrhagic 0/47 (0.00%)', ' Melaena 0/47 (0.00%)', ' Pain 0/47 (0.00%)', ' Pneumonia 0/47 (0.00%)', ' Hip Fracture 0/47 (0.00%)', ' Meniscus Lesion 1/47 (2.13%)', ' Amnesia 0/47 (0.00%)', ' Ischaemic Stroke 1/47 (2.13%)', ' Depression 0/47 (0.00%)', 'Adverse Events 2:', ' Total: 9/50 (18.00%)', ' Anaemia 1/50 (2.00%)', ' Myocardial Infarction 1/50 (2.00%)', ' Macular Hole 0/50 (0.00%)', ' Diverticulum Intestinal Haemorrhagic 1/50 (2.00%)', ' Melaena 1/50 (2.00%)', ' Pain 0/50 (0.00%)', ' Pneumonia 0/50 (0.00%)', ' Hip Fracture 0/50 (0.00%)', ' Meniscus Lesion 0/50 (0.00%)', ' Amnesia 0/50 (0.00%)', ' Ischaemic Stroke 0/50 (0.00%)', ' Depression 1/50 (2.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6550c068-14e6-4e93-8f98-756338c91e35
|
|
Comparison
|
Intervention
|
NCT01293032
|
NCT00849472
|
None of the patients in the primary trial or the secondary trial are required to undergo radiotherapy or a support group course.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01293032', 'Intervention': ['INTERVENTION 1: ', ' Group 2 (RS 11-25)', ' Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy', ' The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines', ' The patient must be female', ' The patient must be greater than or equal to 18 years old', ' The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1', ' The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy', ' The primary breast tumor must be >= 2 cm by physical exam or imaging', ' Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.', ' The tumor must have been determined to be HER2-negative as follows:', ' Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or', ' Chromogenic in situ hybridization (CISH) is performed, the result must indicate a HER2 gene copy number of < 6 per nucleus; or', ' Immunohistochemistry (IHC) 0-1+; or', ' IHC 2+ and FISH-negative or CISH-negative', ' The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as > 10% tumor staining by immunohistochemistry', ' The patient must have been evaluated by a treating physician, reviewed and discussed by the multi-disciplinary breast team, and considered to be a candidate for chemotherapy', 'Exclusion Criteria:', ' FNA alone to diagnose the primary tumor', ' Excisional biopsy or lumpectomy performed prior to randomization', ' Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration', ' Tumors clinically staged as including inflammatory breast cancer', ' Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible)', ' Definitive clinical or radiologic evidence of metastatic disease (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization)', ' Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are eligible)', ' HER2 test result of IHC 3+, regardless of FISH results, if performed', ' Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)', ' History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization', ' Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to registration', ' Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy', ' Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)', ' Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements', ' Use of any investigational product within 30 days prior to registration'], 'Results': ['Outcome Measurement: ', ' The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment', ' The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.', ' Time frame: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Group 2 (RS 11-25)', ' Arm/Group Description: Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.15 (0.051 to 0.319)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT00849472', 'Intervention': ['INTERVENTION 1: ', ' AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib', ' Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of tumor and blood samples required for the FB-6 correlative science studies', ' The ECOG performance status must be 0 or 1', ' Patients must have the ability to swallow oral medication.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Patients must have clinical stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla measuring at least 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' Adequate organ function', " LVEF assessment by 2-D echocardiogram or MUGA scan performed within 3 months prior to study entry must be greater or equal to 50% regardless of the facility's LLN.", ' ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.', ' The TSH level must be within normal limits for the laboratory.', 'Exclusion Criteria:', ' Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by FISH or CISH (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.', ' FNA alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to study entry.', ' Surgical axillary staging procedure prior to study entry.', ' Definitive clinical or radiologic evidence of metastatic disease.', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.', ' Contralateral invasive breast cancer at any time.', ' Non-breast malignancies unless the patient is considered to be disease-free for 5 or more years prior to study entry and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Requirement for chronic use of any of the prohibited medications or substances', ' Previous therapy with anthracyclines, taxanes, or pazopanib for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.', ' Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM.', ' Any sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy', ' History of hepatitis B or C.', ' Symptomatic pancreatitis or asymptomatic greater or equal to grade 2 elevation of amylase or lipase as per NCI CTCAE v3.0.', ' History of documented pancreatitis.', ' Uncontrolled hypertension defined as systolic BP greater than 140 mmHg or diastolic BP greater greater than 90 mmHg, with or without anti-hypertensive medication.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' Cardiac disease that would preclude the use of any of the drugs included in the FB-6 treatment regimen.', ' History of TIA or CVA.', ' History of any arterial thrombotic event within 12 months prior to study entry.', ' Pulmonary embolism or DVT within 6 months prior to study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months prior to study entry, exclusive of menorrhagia in premenopausal women.', ' Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' History of GI perforation, abdominal fistulae, or intra-abdominal abscess.', ' Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function.', " Sensory/motor neuropathy greater or equal to grade 2, as defined by the NCI's CTCAE v3.0.", ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of study therapy and for at least 3 months following the last dose of pazopanib.', ' Pregnancy or lactation at the time of study entry.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Known immediate or delayed hypersensitivity reaction to doxorubicin, cyclophosphamide, paclitaxel, pazopanib, or drugs chemically related to pazopanib.', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes', ' pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.', ' Time frame: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)', 'Results 1: ', ' Arm/Group Title: AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib', ' Arm/Group Description: Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.', ' Overall Number of Participants Analyzed: 93', ' Measure Type: Number', ' Unit of Measure: Participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/101 (14.85%)', ' Anaemia 1/101 (0.99%)', ' Febrile neutropenia 1/101 (0.99%)', ' Myocardial ischaemia 1/101 (0.99%)', ' Nausea 1/101 (0.99%)', ' Vomiting 1/101 (0.99%)', ' Pyrexia 2/101 (1.98%)', ' Herpes zoster 1/101 (0.99%)', ' Infection 2/101 (1.98%)', ' Perineal abscess 1/101 (0.99%)', ' Cellulitis 1/101 (0.99%)', ' Thermal burn 1/101 (0.99%)', ' Alanine aminotransferase increased 1/101 (0.99%)']}
|
0f5b81f0-b422-4000-8e0e-9f09c612ebc3
|
Comparison
|
Adverse Events
|
NCT00645333
|
NCT00006110
|
the primary trial records several immune system related adverse events in its patients, whereas the secondary trial does not.
|
Entailment
|
[
7,
8
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'Clinical Trial ID': 'NCT00645333', 'Intervention': ['INTERVENTION 1: ', ' MK-0752 and Docetaxel', ' MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Men or women with metastatic (Stage IV) breast cancer, or with locally advanced breast cancer (Stages IIIA > 10 cm, or Stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy', ' Presence of measurable or evaluable disease', ' Adequate organ function', ' Ability to swallow intact study drug capsules', ' Zubrod Performance Status of 0-1 with at least a 3 month life expectancy', ' Appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity', 'Exclusion Criteria:', ' Concurrent treatment with hormonal therapy intended to treat cancer', ' Radiotherapy within 7 days prior to first dose', ' Symptomatic central nervous system, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks', ' Serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment', ' Patients who are pregnant or nursing', ' Confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT)', ' The number of DLTs experienced by participants within the first 21 days.', ' DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:', ' Non-hematologic toxicity Grade 3 by the NCI CTCAE version 3.0.', ' ANC<1000 for more than 7 days despite use of pegfilgrastim.', ' Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time.', ' Time frame: first 21 days', 'Results 1: ', ' Arm/Group Title: MK-0752 and Docetaxel', ' Arm/Group Description: MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: Dose Limiting Toxicities 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/30 (53.33%)', ' Chest pain *1/30 (3.33%)', ' Abdominal pain *1/30 (3.33%)', ' Diarrhea *2/30 (6.67%)', ' Edema limbs *1/30 (3.33%)', ' Hypersensitivity *2/30 (6.67%)', ' Autoimmune disorder *1/30 (3.33%)', ' Immune system disorder *1/30 (3.33%)', ' Device related infection *2/30 (6.67%)', ' Upper respiratory infection *1/30 (3.33%)', ' Fracture *1/30 (3.33%)']}
|
{'Clinical Trial ID': 'NCT00006110', 'Intervention': ['INTERVENTION 1: ', ' Herceptin Regimen After AC', ' Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).', 'INTERVENTION 2: ', ' Herceptin Regimen After TP', ' Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.'], 'Eligibility': ['Inclusion Criteria', ' Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast', ' Fine needle aspiration, core needle biopsy, or incisional biopsy allowed', ' No excisional biopsy', ' Any of the following:', ' Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)', ' Any T with N2 (including axillary lymph nodes matted to one another) or N3', ' Any T4, including inflammatory breast cancer', ' Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor', ' Supraclavicular or infraclavicular positive lymph nodes without distant metastases', ' Distant metastases with measurable disease in breast or lymph nodes', ' Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria', ' Measurable or evaluable disease', ' PATIENT CHARACTERISTICS:', ' Age: Not specified', ' Sex: Female', ' Menopausal status: Not specified', 'Performance status: Not specified', ' Life expectancy: Not specified', ' Hematopoietic:', ' White cell count > 3000 / mm3 Platelet count > 100,000 / mm3', ' Hemoglobin > 9 mg / dl Bilirubin < 1.5 x normal Creatinine < 1.5 x normal left ventricular ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception', ' Exclusions', ' Prior malignancies except:', ' Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix that has been curatively treated by surgery alone Nonbreast malignancy from which patient has been disease-free for 5 years and is at low risk of recurrence'], 'Results': ['Outcome Measurement: ', ' Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.', ' Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.', ' Time frame: 78 weeks (1.5 years)', 'Results 1: ', ' Arm/Group Title: Herceptin Regimen After AC', ' Arm/Group Description: Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Asymptomatic LVEF < 50%: 1 1.9%', ' Congestive Heart Failure: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Herceptin Regimen After TP', ' Arm/Group Description: Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Asymptomatic LVEF < 50%: 8 16.0%', ' Congestive Heart Failure: 1 2.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/52 (13.46%)', ' Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 0/52 (0.00%)', ' Atrial Fibrillation * 1/52 (1.92%)', ' Sepsis * 1/52 (1.92%)', ' Muscle weakness upper limb * 1/52 (1.92%)', ' Dizziness * 1/52 (1.92%)', ' Seizure * 1/52 (1.92%)', ' Nervous system disorders - Other, specify * [1]1/52 (1.92%)', 'Adverse Events 2:', ' Total: 1/30 (3.33%)', ' Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1/30 (3.33%)', ' Atrial Fibrillation * 0/30 (0.00%)', ' Sepsis * 0/30 (0.00%)', ' Muscle weakness upper limb * 0/30 (0.00%)', ' Dizziness * 0/30 (0.00%)', ' Seizure * 0/30 (0.00%)', ' Nervous system disorders - Other, specify * [1]0/30 (0.00%)']}
|
f6bba549-3d18-4a53-8685-96b4e321b1a7
|
Comparison
|
Intervention
|
NCT00602043
|
NCT01720602
|
Several treatments in the secondary trial and the primary trial are administered by mouth.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'Clinical Trial ID': 'NCT00602043', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites', ' Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.', ' laboratory biomarker analysis: Correlative studies', 'INTERVENTION 2: ', ' Diagnostic FES: Patients With FES Negative Sites of Disease', ' Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.'], 'Eligibility': ['Inclusion Criteria:', ' Patients will have pathologically confirmed invasive breast cancer with clinical, radiographic and/or pathologic evidence of stage IV disease; patients must have tissue blocks available from biopsy of at least one site of metastatic disease and/or from diagnosis of their primary breast cancer', ' Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or non-measurable but must be present in at least one non-liver site and imageable on FDG PET scan; in patients with non-measurable disease by RECIST criteria, one of the following may be used to assess and follow disease: MUC-1 antigen level (either cancer antigen [CA] 27.29 or carcinoembryonic antigen [CEA]) > 2 x upper limit of normal (ULN), Circulating tumor cell assay > 5, or FDG-PET SUV > 2.5 in purely lytic lesions; elevated tumor markers alone are insufficient', ' No prior endocrine therapy for breast cancer or', ' Off adjuvant endocrine therapy for > 6 months or', ' Greater than 2 years of a single adjuvant endocrine therapy at the time of first recurrence and plan to change to alternate endocrine therapy; use of tamoxifen must be discontinued 6-8 weeks prior to entrance into the study', ' Prior chemotherapy regimens in the adjuvant or neoadjuvant setting are allowed', ' Women treated with adjuvant LHRH (luteinizing hormone-releasing hormone) analog are eligible', ' Be assessed for menopausal status; for study purposes, postmenopausal is defined as:', ' A prior documented bilateral oophorectomy, or', ' A history of at least 12 months without spontaneous menstrual bleeding, or', ' Age 60 or older with a prior hysterectomy without oophorectomy, or', ' Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented follicle stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab', ' Premenopausal patients must have a baseline FSH, and estradiol levels to determine menopausal status; measures will be repeated at 3-6 months to confirm menopausal status', ' Patients must be positive for estrogen receptor (ER) and may or may not be positive for progesterone receptor (PgR) by IHC in the primary tumor and/or metastatic site; the pathology report for assay of ER will be reviewed by one of the investigators prior to enrollment, the study pathologist will review the pathology report if necessary for determination of study eligibility', ' Tumor HER2/neu expression must be determined prior to study enrollment; assessment may be by fluorescence in situ hybridization (FISH) assay or by immunohistochemistry (ICC); if determination is intermediate by ICC, FISH must be performed', ' Life expectancy > 16 weeks', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Absolute neutrophil count (ANC) >= 1,000', ' Platelet count >= 50,000', ' Hemoglobin within normal limits (WNL) for the institution', ' Serum creatinine =< 1.5 x institutional ULN (IULN) and estimated creatinine clearance > 50 mL/min using the Cockroft-Gault formula', ' Bilirubin =< 1.5 x ULN', ' Serum glutamic oxaloacetic transaminase (SGOT)/ serum glutamic pyruvate transaminase (SGPT) =< 1.5 x ULN', ' Alkaline phosphatase =< 2.5 x ULN', ' Patients must be planning a course of endocrine therapy with one of the following: tamoxifen +/- ovarian suppression, aromatase inhibitor +/- fulvestrant (with ovarian suppression in pre-menopausal patients) or fulvestrant alone', ' After entry into the study, patients are expected to be followed for at least 6 months after the injection of [^18F] FES', ' Have a negative pregnancy test within 7 days prior to registration if of childbearing potential', ' No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures', ' Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', 'Exclusion Criteria:', ' Patients with a history of prior endocrine therapy for metastatic disease are NOT eligible; adjuvant endocrine therapy for < 2 years total or discontinued less than 6 months before first disease recurrence also excludes the patient', ' Patients with disease in the liver only are NOT eligible for the study', ' Patients who are HER2/neu positive disease and planning to undergo HER2-directed therapy (trastuzumab or lapatinib) are NOT eligible for the study', ' Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded', ' Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases', ' History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent', ' Any other life-threatening illness (e.g., serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)', ' Unwillingness to give informed consent', " Medically unstable as judged by the patient's physician", ' Psychological, familial, sociological, or geographical conditions which do not permit compliance with the study protocol', " Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion", ' Patient weight greater than 400 lbs (exceeds weight limit for tomograph table)', ' Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)', ' Adult patients who require monitored anesthesia for PET scanning'], 'Results': ['Outcome Measurement: ', ' Best Overall Response', ' Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease [per response evaluation criteria in solid tumors (RECIST, version 1.1)], size-based response criteria were used to assess response.', ' For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).', ' The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).', ' Time frame: Up to 6 months', 'Results 1: ', ' Arm/Group Title: Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites', ' Arm/Group Description: Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: patients with progressive disease 5', 'Results 2: ', ' Arm/Group Title: Diagnostic FES: Patients With FES Negative Sites of Disease', ' Arm/Group Description: Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: patients with progressive disease 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT01720602', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Vorinostat, AI Therapy)', ' Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.', ' vorinostat: Given PO', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' positron emission tomography: Correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' fludeoxyglucose F 18: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven diagnosis of breast cancer', ' Stage IV disease', ' Patient has previously derived clinical benefit from endocrine therapy, but is no longer deriving benefit to endocrine therapy in the opinion of the treating investigator', ' At least one site of measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Female patient is post menopausal as defined by one of the following; free from menses for >= 2 years, surgically sterilized, FSH and estradiol in post-menopausal range AND surgical absence of uterus OR chemotherapy induced amenorrhea lasting > 1 year OR currently on ovarian suppression', ' Female patient of childbearing potential has a negative urine or serum (beta human chorionic gonadotropin [B-hCG]) pregnancy test within 14 days prior to receiving the first dose of vorinostat', ' Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study', ' Absolute neutrophil count (ANC) >= 1,500/mcL', ' Platelets >= 50,000/mcL', ' Hemoglobin >= 9 g/dL', ' Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation', ' Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation', ' Potassium (K) levels normal limits', ' Magnesium (Mg) levels normal limits', ' Calculated creatinine clearance >= 30 mL/min', ' Creatinine clearance should be calculated per institutional standard', ' Serum total bilirubin =< 1.5 x ULN', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x ULN', ' Alkaline phosphatase =< 2.5 x ULN', " Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent", ' Patient has a life expectancy of at least 12 weeks in the opinion of the treating investigator', ' Patient is willing to continue on same AI therapy', ' Patient agrees to participate in imaging protocol 7184 and is separately consented', 'Exclusion Criteria:', ' Patient has not derived clinical benefit from prior endocrine therapy', ' Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184', ' Patient has received an ER blocking therapy (selective estrogen receptor modulating or downregulating selective estrogen receptor modulator [SERM] or selective estrogen receptor degrader [SERD] i.e. tamoxifen or fulvestrant) within the past 6 weeks', ' Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidepsin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period', ' Patient is on any systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone during the 30 days prior to the start of the study drugs', ' Patient has known hypersensitivity to the components of study drug or its analogs', ' Patients with uncontrolled brain metastases', ' New York Heart Association (NYHA) class III or IV congestive heart failure, myocardial infarction within the previous 6 months, QTc > 0.47 seconds, or uncontrolled arrhythmia', ' Type I diabetes mellitus; patients with type II diabetes mellitus will be included as long as their glucose can be controlled to under 200 mg/dL', ' Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study', ' Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse', ' Patients with known active viral hepatitis', " Patient has a history or current evidence of any condition, therapy, or laboratory (lab) abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate"], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST', ' A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.', ' Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).', ' Time frame: 8 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Vorinostat, AI Therapy)', ' Arm/Group Description: Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.', ' vorinostat: Given PO', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' positron emission tomography: Correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' fludeoxyglucose F 18: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of patients 60 (35 to 81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Liver failure [1]1/15 (6.67%)', ' Fever [1]1/15 (6.67%)']}
|
1fe36432-40f8-4c53-ac2b-0f8e50e5743f
|
Comparison
|
Adverse Events
|
NCT01091454
|
NCT00054275
|
There were more cases of Anemia and vomiting in the primary trial than the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
{'Clinical Trial ID': 'NCT01091454', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cisplatin and Brostallicin)', ' Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria', ' Histologically or cytologically confirmed adenocarcinoma of the breast with clinical evidence of metastatic disease', ' Triple negative breast cancer defined as HER2-(according to current American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER- (defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)', ' 0 to 4 prior chemotherapy regimens in the metastatic setting', ' Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only', ' Hemoglobin >= 10.0 g/dL', ' Absolute neutrophil count (ANC) >= 1500/mm^3', ' Platelet count >= 100,000/mL', ' Total bilirubin =< 1.5 x upper limit of normal (ULN)', ' Serum creatinine =< 1.5 mg/dL', ' Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases', ' Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are due to liver metastases', ' Electrocardiogram (EKG) completed =< 15 days prior to registration', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2', ' Life expectancy > 3 months', ' Has written informed consent', ' Willingness to return to NCCTG enrolling institution for treatment and follow-up', ' Patient willing to provide blood samples for research purposes', ' Exclusion Criteria', ' HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified) breast cancer by ASCO/CAP guidelines', ' Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as > 1% of either receptor by IHC)', ' Any of the following', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs', ' Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration', ' Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the CTCAE)', ' Major surgery =< 4 weeks prior to registration', ' Chemotherapy or immunologic therapy =< 3 weeks prior to registration', ' Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only', ' * NOTES:', ' Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed', ' If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 2 weeks', ' Acute adverse events from radiation must have resolved to =< grade 1 (according to the CTEP active version of the CTCAE)', ' Evidence of active brain metastasis including leptomeningeal involvement', ' * NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed; to be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued', ' History of allergy or hypersensitivity to the drugs used in this study (or their excipients) including platinum compounds (cisplatin, carboplatin)', ' Active, unresolved infection', ' Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations or co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or would interfere significantly with the proper assessment of safety of the prescribed regimens or would limit compliance with study requirements or would make it undesirable for patient to participate in the trial', ' Clinically significant cardiovascular or cerebrovascular disease, including any history of the following =< 6 months prior to registration:', ' Myocardial infarction', ' Unstable angina', ' New York Heart Association (NYHA) class II or greater congestive heart failure', ' Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' * NOTE: Patient may not enroll in such clinical trials while participating in this study; exception may be granted for trials related to symptom management (cancer control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial', ' Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD)4 count within institutional normal range and no history of an AIDS-defining illness are eligible'], 'Results': ['Outcome Measurement: ', ' 3-month Progression-free Survival (3-mo PFS) Rate', ' A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Treatment (Cisplatin and Brostallicin)', ' Arm/Group Description: Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.511 (0.386 to 0.676)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/48 (60.42%)', ' Anemia 4/48 (8.33%)', ' Febrile neutropenia 7/48 (14.58%)', ' Atrial fibrillation 1/48 (2.08%)', ' Pericardial effusion 1/48 (2.08%)', ' Sinus bradycardia 1/48 (2.08%)', ' Nausea 2/48 (4.17%)', ' Vomiting 2/48 (4.17%)', ' Death NOS 1/48 (2.08%)', ' Fatigue 3/48 (6.25%)', ' Allergic reaction 1/48 (2.08%)', ' Lung infection 1/48 (2.08%)', ' Mucosal infection 1/48 (2.08%)']}
|
{'Clinical Trial ID': 'NCT00054275', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and OSI-774', ' docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed stage IV or recurrent adenocarcinoma of the breast', ' Measurable disease', ' Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel', ' Stable brain metastases allowed', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Male or female', ' Menopausal status', ' Not specified', ' Performance status', ' ECOG (Eastern Cooperative Oncology Group) 0-2 OR', ' Karnofsky 60-100%', ' Life expectancy', ' More than 6 months', ' Hematopoietic', ' WBC(White Blood Count) at least 3,000/mm^3', ' Platelet count at least 100,000/mm^3', ' Absolute neutrophil count at least 1,500/mm^3', ' Hemoglobin at least 8 g/dL', ' Hepatic', ' Bilirubin normal', ' AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal', ' Renal', ' Creatinine normal OR', ' Creatinine clearance at least 60 mL/min', ' No clinically significant proteinuria', ' No significant impairment of renal function', ' Cardiovascular', ' No New York Heart Association class III or IV heart disease', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' No inadequately controlled hypertension', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception', ' No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80', ' No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer', ' No ongoing or active infection', ' No peripheral neuropathy greater than grade 1', ' No other concurrent uncontrolled medical condition that would preclude study participation', ' No psychiatric illness or social situation that would preclude study compliance', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior trastuzumab (Herceptin) allowed', ' Chemotherapy', ' See Disease Characteristics', ' No prior chemotherapy for recurrent or metastatic disease', ' Prior adjuvant chemotherapy allowed', ' Endocrine therapy', ' Prior hormonal therapy allowed', ' Radiotherapy', ' Not specified', ' Surgery', ' Not specified', ' Other', ' No other concurrent investigational agents'], 'Results': ['Outcome Measurement: ', ' Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000', ' Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.', ' Time frame: after 6 course (6 months) of combination therapy', 'Results 1: ', ' Arm/Group Title: Docetaxel and OSI-774', ' Arm/Group Description: docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants Partial response: 11', ' Disease progression: 14', 'Stable disease: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/39 (71.79%)', ' Anemia 1/39 (2.56%)', ' Leukopenia 4/39 (10.26%)', ' Neutropenia 4/39 (10.26%)', ' Chest Pain 1/39 (2.56%)', ' Pericarditis 1/39 (2.56%)', ' Sinus Tach. 1/39 (2.56%)', ' Sinus Tachycardia 1/39 (2.56%)', ' Eye tearing 1/39 (2.56%)', ' Diarrhea 7/39 (17.95%)', ' Mucositis 3/39 (7.69%)', ' Nausea 2/39 (5.13%)', ' Vomiting [1]1/39 (2.56%)', ' Fatigue 6/39 (15.38%)']}
|
3576f3e7-a1b9-4a75-934a-1ad2165b69dd
|
Single
|
Adverse Events
|
NCT01446159
|
the primary trial only had a total of 66 patients in across both its cohorts.
|
Contradiction
|
[
0,
1,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT01446159', 'Intervention': ['INTERVENTION 1: ', ' MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'INTERVENTION 2: ', ' MEDI-573 30 mg/kg + AI', ' Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy', ' Tumors are positive for ER, PgR, or both', ' Tumors must be negative for HER2 (by FISH, CISH or IHC)', ' Female gender and age 18 years at time of study entry', ' Postmenopausal', ' Karnofsky Performance Status 70', ' Life expectancy of 6 months', 'Exclusion Criteria:', ' Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:', ' Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573', ' Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed', ' Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)', ' Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573', ' Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis', ' Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to Grade 1 at the time of starting study treatment', ' Previous treatment with agents that target the IGF receptor', ' History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI', ' History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix', ' Poorly controlled diabetes mellitus'], 'Results': ['Outcome Measurement: ', ' Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', ' An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', ' Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'Results 1: ', ' Arm/Group Title: MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Arm/Group Description: Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 2 66.7%', 'Results 2: ', ' Arm/Group Title: MEDI-573 30 mg/kg + AI', ' Arm/Group Description: Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Febrile neutropenia 1/3 (33.33%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 1/3 (33.33%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/3 (0.00%)', ' Febrile neutropenia 0/3 (0.00%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 0/3 (0.00%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
de71f285-4382-465f-9e7e-d163662f6d9c
|
|
Single
|
Adverse Events
|
NCT00281697
|
the primary trial does not record any pain related adverse events.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT00281697', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy + Bevacizumab', ' Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.', 'INTERVENTION 2: ', ' Standard Chemotherapy + Placebo', ' Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent form.', ' 18 years of age.', ' Histologically confirmed carcinoma of the breast with measurable or non-measurable metastatic disease that has progressed (patients with a history of brain metastasis are eligible for study participation [USA only], as long as their brain metastases have been treated and they have no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone).', ' Progression of disease during or following administration of one (non-investigational) chemotherapy regimen administered in the first-line setting.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' For women of childbearing potential, use of an effective means of non-hormonal contraception.', ' Life expectancy 3 months.', ' Willingness and capacity to comply with study and follow-up procedures.', 'Exclusion Criteria:', ' Prior hormonal therapy only as treatment for metastatic disease without chemotherapy. Patients must have received chemotherapy for their metastatic disease in the first-line setting. Hormone therapy alone is not allowed.', ' For subjects who have received prior anthracycline-based therapy, documentation of left ventricular ejection fraction < 50% by either multiple gated acquisition (MUGA) or echocardiogram (ECHO).', ' Treatment with more than one prior cytotoxic regimen for metastatic breast cancer (MBC).', ' HER2-positive status (patients who have unknown HER2 status, and for whom determination of HER2 status is not possible, are eligible for this study).', ' Unknown estrogen receptor (ER) and progesterone receptor (PR) status.', ' Radiation therapy other than for palliation or brain metastasis, biologic therapy, or chemotherapy for MBC within 21 days prior to Day 0 (Day 1 of Cycle 1 of treatment).', ' Prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) pathway-targeted therapy.', ' Untreated brain metastasis.', ' Inadequately controlled hypertension.', ' Unstable angina.', ' New York Heart Association Grade II or greater congestive heart failure (CHF).', ' History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab/placebo infusion).', ' History of stroke or transient ischemic attack within 6 months prior to Day 0.', ' Clinically significant peripheral vascular disease.', ' Evidence of bleeding diathesis or coagulopathy.', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the study.', ' Minor surgical procedures, fine-needle aspirations, or core biopsies within 7 days prior to Day 0.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.', ' Serious, non-healing wound, ulcer, or bone fracture.', ' History of anaphylactic reaction to monoclonal antibody therapy not controlled with treatment premedication.', ' History of other malignancies within 5 years of Day 0, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.', ' inadequate organ function.', ' Pregnancy (positive serum pregnancy test) or lactation.', ' Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subject at high risk from treatment complications.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.', ' Time frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy + Bevacizumab', ' Arm/Group Description: Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.', ' Overall Number of Participants Analyzed: 459', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.2 (6.5 to 7.6)', 'Results 2: ', ' Arm/Group Title: Standard Chemotherapy + Placebo', ' Arm/Group Description: Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.', ' Overall Number of Participants Analyzed: 225', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.1 (4.1 to 6.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 112/458 (24.45%)', ' Febrile neutropenia 8/458 (1.75%)', ' Neutropenia 6/458 (1.31%)', ' Anaemia 3/458 (0.66%)', ' Thrombocytopenia 3/458 (0.66%)', ' Pancytopenia 2/458 (0.44%)', ' Myocardial infarction 0/458 (0.00%)', ' Pericardial effusion 0/458 (0.00%)', ' Tachycardia 0/458 (0.00%)', ' Acute myocardial infarction 1/458 (0.22%)', ' Atrial fibrillation 0/458 (0.00%)', 'Adverse Events 2:', ' Total: 39/221 (17.65%)', ' Febrile neutropenia 5/221 (2.26%)', ' Neutropenia 1/221 (0.45%)', ' Anaemia 2/221 (0.90%)', ' Thrombocytopenia 0/221 (0.00%)', ' Pancytopenia 0/221 (0.00%)', ' Myocardial infarction 2/221 (0.90%)', ' Pericardial effusion 2/221 (0.90%)', ' Tachycardia 2/221 (0.90%)', ' Acute myocardial infarction 0/221 (0.00%)', ' Atrial fibrillation 1/221 (0.45%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
406247fb-003a-47b7-8fe4-b6b963b98f08
|
|
Comparison
|
Results
|
NCT02441946
|
NCT00325598
|
the secondary trial does not have a defined end date, whereas the primary trial lasted 2 weeks.
|
Contradiction
|
[
0,
3
] |
[
0,
3
] |
{'Clinical Trial ID': 'NCT02441946', 'Intervention': ['INTERVENTION 1: ', ' Abemaciclib + Anastrozole', ' Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.', ' All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.', ' Total treatment duration was 16 weeks.', 'INTERVENTION 2: ', ' Abemaciclib', ' Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.', ' All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.', ' Total treatment duration was 16 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Have postmenopausal status.', ' Adenocarcinoma of the breast.', ' Breast tumor 1 centimeter (cm) in diameter, HR+, HER2-.', ' Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.', ' Primary breast cancer that is suitable for baseline core biopsy.', ' Have adequate organ function.', 'Exclusion Criteria:', ' Bilateral invasive breast cancer.', ' Metastatic breast cancer (local spread to axillary lymph nodes is permitted).', ' Inflammatory breast cancer.', ' Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.', ' Prior radiotherapy to the ipsilateral chest wall for any malignancy.', ' Prior anti-estrogen therapy.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline to 2 Weeks in Ki67 Expression', ' Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.', ' Time frame: Baseline, 2 Weeks', 'Results 1: ', ' Arm/Group Title: Abemaciclib + Anastrozole', ' Arm/Group Description: Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.', ' All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.', ' Total treatment duration was 16 weeks.', ' Overall Number of Participants Analyzed: 59', ' Geometric Mean (90% Confidence Interval)', ' Unit of Measure: Percent Change -92.86 (-94.82 to -90.16)', 'Results 2: ', ' Arm/Group Title: Abemaciclib', ' Arm/Group Description: Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.', ' All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.', ' Total treatment duration was 16 weeks.', ' Overall Number of Participants Analyzed: 52', ' Geometric Mean (90% Confidence Interval)', ' Unit of Measure: Percent Change -90.52 (-93.12 to -86.93)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/74 (1.35%)', ' Neutropenia 0/74 (0.00%)', ' Acute coronary syndrome 0/74 (0.00%)', ' Angina pectoris 0/74 (0.00%)', ' Myocardial infarction 0/74 (0.00%)', ' Abdominal pain 1/74 (1.35%)', ' Pancreatitis 0/74 (0.00%)', ' Mastitis 0/74 (0.00%)', ' Fracture 0/74 (0.00%)', ' Alanine aminotransferase increased 1/74 (1.35%)', ' Aspartate aminotransferase increased 1/74 (1.35%)', 'Adverse Events 2:', ' Total: 1/75 (1.33%)', ' Neutropenia 0/75 (0.00%)', ' Acute coronary syndrome 0/75 (0.00%)', ' Angina pectoris 0/75 (0.00%)', ' Myocardial infarction 0/75 (0.00%)', ' Abdominal pain 0/75 (0.00%)', ' Pancreatitis 0/75 (0.00%)', ' Mastitis 0/75 (0.00%)', ' Fracture 0/75 (0.00%)', ' Alanine aminotransferase increased 0/75 (0.00%)', ' Aspartate aminotransferase increased 0/75 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00325598', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1 (36 Gy)', ' 36 Gy in 9 fractions BID x 4 1/2 treatment days', ' Partial Breast Irradiation (PBI)', 'INTERVENTION 2: ', ' Cohort 2 (40 Gy)', ' 40 Gy in 10 fractions BID over 5 treatment days', ' Partial Breast Irradiation (PBI)'], 'Eligibility': ['Inclusion Criteria', ' Histologic Documentation:', ' Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer.', ' Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen.', ' Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted.', ' Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted.', ' Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy.', ' Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status.', " In the case where invasive cancer is present, the invasive cancer's pathology will be used regardless if DCIS is also present.", ' Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist.', ' Radiation therapy should begin within:', ' 4-12 weeks from definitive surgical procedure', ' 2-6 weeks after chemotherapy, if chemotherapy given first', ' Radiation cannot be delivered concurrently with chemotherapy.', ' Age >= 18 years of age', ' ECOG Performance Status 0-2.', ' Signed Informed Consent', ' Exclusion Criteria', ' The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following criteria should not be entered in this study:', ' 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region.', ' b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region.', ' Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement', ' Histological evidence of:', ' Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible.', ' EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion 7, 55.', ' Invasive Lobular Carcinoma', ' Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible 56, 57.', ' Infiltrating papillary carcinoma', ' Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin.', ' History of cosmetic or reconstructive breast surgery', ' Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.', ' Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.', ' Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications', ' Women who are pregnant.'], 'Results': ['Outcome Measurement: ', ' Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan', ' -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.', ' Time frame: Within 1 year of protocol registration', 'Results 1: ', ' Arm/Group Title: Cohort 1 (36 Gy)', ' Arm/Group Description: 36 Gy in 9 fractions BID x 4 1/2 treatment days', ' Partial Breast Irradiation (PBI)', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 100', 'Results 2: ', ' Arm/Group Title: Cohort 2 (40 Gy)', ' Arm/Group Description: 40 Gy in 10 fractions BID over 5 treatment days', ' Partial Breast Irradiation (PBI)', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/50 (6.00%)', ' Fever 1/50 (2.00%)', ' Rigors/chills 1/50 (2.00%)', ' Chest pain 1/50 (2.00%)', ' Costochondritis 1/50 (2.00%)', ' Infection (mastitis) 1/50 (2.00%)', ' Breast pain 1/50 (2.00%)', ' Breast edema 1/50 (2.00%)', ' Pelvic pain 1/50 (2.00%)', ' Dyspnea 1/50 (2.00%)', ' Erythema 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 0/50 (0.00%)', ' Fever 0/50 (0.00%)', ' Rigors/chills 0/50 (0.00%)', ' Chest pain 0/50 (0.00%)', ' Costochondritis 0/50 (0.00%)', ' Infection (mastitis) 0/50 (0.00%)', ' Breast pain 0/50 (0.00%)', ' Breast edema 0/50 (0.00%)', ' Pelvic pain 0/50 (0.00%)', ' Dyspnea 0/50 (0.00%)', ' Erythema 0/50 (0.00%)']}
|
47553222-0aff-4394-bcfc-9f19c0863835
|
Single
|
Adverse Events
|
NCT00201864
|
One patient in the primary trial had blood calcium levels far above normal.
|
Entailment
|
[
5
] |
[] |
{'Clinical Trial ID': 'NCT00201864', 'Intervention': ['INTERVENTION 1: ', ' Exemestane and Fulvestrant', ' Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Proven breast cancer', ' Metastatic or locally advanced breast cancer', ' Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)', ' Postmenopausal status', ' No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed', ' ECOG (Eastern Cooperative Oncology Group) performance status 0-2', ' Adequate organ function', 'Exclusion Criteria:', ' No prior Exemestane or Fulvestrant', ' Uncontrolled intercurrent illness including but not limited to:', ' ongoing or active infection', ' symptomatic congestive heart failure', ' unstable angina pectoris', ' cardiac arrhythmia', ' myocardial infarction within the last 3 months', ' psychiatric illness/social situations that would limit compliance with study', ' Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.', ' Presence of bleeding diathesis or coagulopathy, patients requiring coumadin'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.', ' TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: Every 2 cycles up to 2 years', 'Results 1: ', ' Arm/Group Title: Exemestane and Fulvestrant', ' Arm/Group Description: Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.9 (3.9 to 13.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/40 (15.00%)', ' Nausea 1/40 (2.50%)', ' Vomiting 1/40 (2.50%)', ' Chest pain 1/40 (2.50%)', ' Hypercalcemia 1/40 (2.50%)', ' Thromboembolism 2/40 (5.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e4756896-55c2-46e1-be19-14697ad3b39f
|
|
Comparison
|
Adverse Events
|
NCT02447003
|
NCT00917735
|
The difference in cohort size between cohort 2 of the secondary trial and cohort 2 of the primary trial makes it impossible to make meaningful comparisons.
|
Entailment
|
[
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26
] |
[
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21
] |
{'Clinical Trial ID': 'NCT02447003', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Pembrolizumab', ' Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', 'INTERVENTION 2: ', ' Cohort B: Pembrolizumab', ' Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).'], 'Eligibility': ['Inclusion Criteria:', ' For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.', ' For second line plus monotherapy (Parts 1 and 2):', ' Has received at least one systemic treatment for metastatic breast cancer', ' Has documented disease progression on or after the most recent therapy', ' Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting', ' For first line monotherapy (Part 1):', ' Has received no prior systemic treatment for metastatic breast cancer', ' Has PD-L1-positive mTNBC.', ' For second line plus monotherapy (Part 2):', ' - Has PD-L1 strong positive mTNBC', ' For all parts:', ' Has mTNBC confirmed by a central laboratory', ' For biomarker analysis, adequate newly obtained core or excisional biopsy of a not-previously-irradiated metastatic tumor lesion (mandatory)', ' Has measurable metastatic disease', ' Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment', ' Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment', ' Has adequate organ function', 'Exclusion Criteria:', ' Is currently participating and receiving study treatment, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to study Day 1', ' Has received prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic treatment within 4 weeks prior to study Day 1', ' Has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1', ' Has not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents administered within at least 2 weeks prior to study Day 1', ' Has an active autoimmune disease requiring systemic treatment in past 2 years', ' Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment', ' Has known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer', ' Has radiographically-detectable central nervous system (CNS) metastases and/or carcinomatous meningitis', ' Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis or a history of interstitial lung disease', ' Has an active infection requiring systemic therapy', ' Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study', ' Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment', ' Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137) or has participated in Merck MK-3475 (pembrolizumab) study', ' Has a known history of human immunodeficiency virus (HIV)', ' Has known active Hepatitis B or C', ' Has received a live vaccine within 30 days of planned start of study treatment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Central Imaging Vendor (CIV) in All Cohort A Participants', ' ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: 30% decrease in sum of diameters [SOD] of target lesions) per RECIST 1.1 by CIV. ORR was estimated by Agresti-Coull (A-C) method. The percentage of participants who had CR or PR is reported here as the protocol-specified ORR, for the first pembrolizumab course, assessed from enrolment/treatment initiation and analyzed by Cohort, for all participants in Cohort A. Per protocol final ORR analysis in all Cohort A participants was done at the time of final statistical efficacy analysis, with a 10-November (Nov)-2017 cutoff. Per protocol ORR per RECIST 1.1 by CIV in all Cohort A participants was planned and conducted as a pre-specified primary outcome analysis. Per protocol ORR per RECIST 1.1 by CIV in all Cohort B participants was analyzed separately as a pre-specified secondary outcome analysis and reported later in the record.', ' Time frame: Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)', 'Results 1: ', ' Arm/Group Title: Cohort A: Pembrolizumab', ' Arm/Group Description: Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', ' Overall Number of Participants Analyzed: 170', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 5.3 (2.7 to 9.9)', 'Results 2: ', ' Arm/Group Title: Cohort B: Pembrolizumab', ' Arm/Group Description: Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 46/170 (27.06%)', ' Anaemia 1/170 (0.59%)', ' Febrile neutropenia 1/170 (0.59%)', ' Cardiac tamponade 1/170 (0.59%)', ' Myocarditis 1/170 (0.59%)', ' Pericardial effusion 2/170 (1.18%)', ' Pericarditis 1/170 (0.59%)', ' Colitis 1/170 (0.59%)', ' Constipation 1/170 (0.59%)', ' Diarrhoea 0/170 (0.00%)', ' Gastroenteritis eosinophilic 0/170 (0.00%)', ' Intestinal obstruction 0/170 (0.00%)', 'Adverse Events 2:', ' Total: 0/1 (0.00%)', ' Anaemia 0/1 (0.00%)', ' Febrile neutropenia 0/1 (0.00%)', ' Cardiac tamponade 0/1 (0.00%)', ' Myocarditis 0/1 (0.00%)', ' Pericardial effusion 0/1 (0.00%)', ' Pericarditis 0/1 (0.00%)', ' Colitis 0/1 (0.00%)', ' Constipation 0/1 (0.00%)', ' Diarrhoea 0/1 (0.00%)', ' Gastroenteritis eosinophilic 0/1 (0.00%)', ' Intestinal obstruction 0/1 (0.00%)', ' Nausea 0/1 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00917735', 'Intervention': ['INTERVENTION 1: ', ' Green Tea Extract', ' Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.', 'INTERVENTION 2: ', ' Sugar Pill', ' Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Healthy postmenopausal women aged 50-70 years', ' "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts', ' Willing to avoid consumption of green tea for 1 year', 'Exclusion Criteria:', ' Positive serological markers of hepatitis B or hepatitis C infections', ' Elevated levels of liver enzymes', ' Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors', ' Current smoker of cigarettes or other tobacco products', ' BMI <19 or >40 kg/m2', ' Weight change > 10 lbs during the previous year', ' History of breast cancer or proliferative breast disease', ' Regular consumption of > 7 alcoholic drinks/wk', ' Regular consumption of green tea (>1 cup/wk)', ' Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors', ' Participation in any weight loss or weight gain studies', ' Currently taking Methotrexate or Enbrel', ' History of ovarian cancer', ' Any form of cancer in the last 5 years', ' Presence of implants'], 'Results': ['Outcome Measurement: ', ' Mammographic Density', ' Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.', ' Time frame: Baseline and month 12', 'Results 1: ', ' Arm/Group Title: Green Tea Extract', ' Arm/Group Description: Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 28.9 mg catechins including 210.7 11.0 mg of EGCG.', ' Overall Number of Participants Analyzed: 462', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 22.71 (21.39 to 24.10)', ' Percent mammographic density at month 12: 22.09 (20.77 to 23.50)', 'Results 2: ', ' Arm/Group Title: Sugar Pill', ' Arm/Group Description: Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.', ' Overall Number of Participants Analyzed: 470', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 21.84 (20.59 to 23.17)', ' Percent mammographic density at month 12: 21.13 (19.88 to 22.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/538 (2.23%)', ' Hypertension 0/538 (0.00%)', ' Acoustic Neuroma 1/538 (0.19%)', ' Diarrhea 0/538 (0.00%)', ' Colitis 1/538 (0.19%)', ' Elevated ALT or AST enzyme 7/538 (1.30%)', ' Diagnosis of Uterine Cancer 0/538 (0.00%)', ' Motorcycle accident 0/538 (0.00%)', ' Fall 0/538 (0.00%)', ' Surgery 3/538 (0.56%)', 'Adverse Events 2:', ' Total: 8/537 (1.49%)', ' Hypertension 1/537 (0.19%)', ' Acoustic Neuroma 0/537 (0.00%)', ' Diarrhea 1/537 (0.19%)', ' Colitis 0/537 (0.00%)', ' Elevated ALT or AST enzyme 0/537 (0.00%)', ' Diagnosis of Uterine Cancer 2/537 (0.37%)', ' Motorcycle accident 1/537 (0.19%)', ' Fall 1/537 (0.19%)', ' Surgery 2/537 (0.37%)']}
|
594c9a79-d601-46b4-ae30-0b48a1117693
|
Comparison
|
Adverse Events
|
NCT02447003
|
NCT00917735
|
It is appropriate to make clinical conclusions comparing cohort 2 of the secondary trial and cohort 2 the primary trial, despite the difference in cohort size.
|
Contradiction
|
[
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26
] |
[
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21
] |
{'Clinical Trial ID': 'NCT02447003', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Pembrolizumab', ' Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', 'INTERVENTION 2: ', ' Cohort B: Pembrolizumab', ' Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).'], 'Eligibility': ['Inclusion Criteria:', ' For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.', ' For second line plus monotherapy (Parts 1 and 2):', ' Has received at least one systemic treatment for metastatic breast cancer', ' Has documented disease progression on or after the most recent therapy', ' Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting', ' For first line monotherapy (Part 1):', ' Has received no prior systemic treatment for metastatic breast cancer', ' Has PD-L1-positive mTNBC.', ' For second line plus monotherapy (Part 2):', ' - Has PD-L1 strong positive mTNBC', ' For all parts:', ' Has mTNBC confirmed by a central laboratory', ' For biomarker analysis, adequate newly obtained core or excisional biopsy of a not-previously-irradiated metastatic tumor lesion (mandatory)', ' Has measurable metastatic disease', ' Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment', ' Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment', ' Has adequate organ function', 'Exclusion Criteria:', ' Is currently participating and receiving study treatment, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to study Day 1', ' Has received prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic treatment within 4 weeks prior to study Day 1', ' Has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1', ' Has not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents administered within at least 2 weeks prior to study Day 1', ' Has an active autoimmune disease requiring systemic treatment in past 2 years', ' Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment', ' Has known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer', ' Has radiographically-detectable central nervous system (CNS) metastases and/or carcinomatous meningitis', ' Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis or a history of interstitial lung disease', ' Has an active infection requiring systemic therapy', ' Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study', ' Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment', ' Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137) or has participated in Merck MK-3475 (pembrolizumab) study', ' Has a known history of human immunodeficiency virus (HIV)', ' Has known active Hepatitis B or C', ' Has received a live vaccine within 30 days of planned start of study treatment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Central Imaging Vendor (CIV) in All Cohort A Participants', ' ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: 30% decrease in sum of diameters [SOD] of target lesions) per RECIST 1.1 by CIV. ORR was estimated by Agresti-Coull (A-C) method. The percentage of participants who had CR or PR is reported here as the protocol-specified ORR, for the first pembrolizumab course, assessed from enrolment/treatment initiation and analyzed by Cohort, for all participants in Cohort A. Per protocol final ORR analysis in all Cohort A participants was done at the time of final statistical efficacy analysis, with a 10-November (Nov)-2017 cutoff. Per protocol ORR per RECIST 1.1 by CIV in all Cohort A participants was planned and conducted as a pre-specified primary outcome analysis. Per protocol ORR per RECIST 1.1 by CIV in all Cohort B participants was analyzed separately as a pre-specified secondary outcome analysis and reported later in the record.', ' Time frame: Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)', 'Results 1: ', ' Arm/Group Title: Cohort A: Pembrolizumab', ' Arm/Group Description: Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', ' Overall Number of Participants Analyzed: 170', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 5.3 (2.7 to 9.9)', 'Results 2: ', ' Arm/Group Title: Cohort B: Pembrolizumab', ' Arm/Group Description: Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 46/170 (27.06%)', ' Anaemia 1/170 (0.59%)', ' Febrile neutropenia 1/170 (0.59%)', ' Cardiac tamponade 1/170 (0.59%)', ' Myocarditis 1/170 (0.59%)', ' Pericardial effusion 2/170 (1.18%)', ' Pericarditis 1/170 (0.59%)', ' Colitis 1/170 (0.59%)', ' Constipation 1/170 (0.59%)', ' Diarrhoea 0/170 (0.00%)', ' Gastroenteritis eosinophilic 0/170 (0.00%)', ' Intestinal obstruction 0/170 (0.00%)', 'Adverse Events 2:', ' Total: 0/1 (0.00%)', ' Anaemia 0/1 (0.00%)', ' Febrile neutropenia 0/1 (0.00%)', ' Cardiac tamponade 0/1 (0.00%)', ' Myocarditis 0/1 (0.00%)', ' Pericardial effusion 0/1 (0.00%)', ' Pericarditis 0/1 (0.00%)', ' Colitis 0/1 (0.00%)', ' Constipation 0/1 (0.00%)', ' Diarrhoea 0/1 (0.00%)', ' Gastroenteritis eosinophilic 0/1 (0.00%)', ' Intestinal obstruction 0/1 (0.00%)', ' Nausea 0/1 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00917735', 'Intervention': ['INTERVENTION 1: ', ' Green Tea Extract', ' Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.', 'INTERVENTION 2: ', ' Sugar Pill', ' Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Healthy postmenopausal women aged 50-70 years', ' "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts', ' Willing to avoid consumption of green tea for 1 year', 'Exclusion Criteria:', ' Positive serological markers of hepatitis B or hepatitis C infections', ' Elevated levels of liver enzymes', ' Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors', ' Current smoker of cigarettes or other tobacco products', ' BMI <19 or >40 kg/m2', ' Weight change > 10 lbs during the previous year', ' History of breast cancer or proliferative breast disease', ' Regular consumption of > 7 alcoholic drinks/wk', ' Regular consumption of green tea (>1 cup/wk)', ' Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors', ' Participation in any weight loss or weight gain studies', ' Currently taking Methotrexate or Enbrel', ' History of ovarian cancer', ' Any form of cancer in the last 5 years', ' Presence of implants'], 'Results': ['Outcome Measurement: ', ' Mammographic Density', ' Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.', ' Time frame: Baseline and month 12', 'Results 1: ', ' Arm/Group Title: Green Tea Extract', ' Arm/Group Description: Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 28.9 mg catechins including 210.7 11.0 mg of EGCG.', ' Overall Number of Participants Analyzed: 462', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 22.71 (21.39 to 24.10)', ' Percent mammographic density at month 12: 22.09 (20.77 to 23.50)', 'Results 2: ', ' Arm/Group Title: Sugar Pill', ' Arm/Group Description: Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.', ' Overall Number of Participants Analyzed: 470', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 21.84 (20.59 to 23.17)', ' Percent mammographic density at month 12: 21.13 (19.88 to 22.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/538 (2.23%)', ' Hypertension 0/538 (0.00%)', ' Acoustic Neuroma 1/538 (0.19%)', ' Diarrhea 0/538 (0.00%)', ' Colitis 1/538 (0.19%)', ' Elevated ALT or AST enzyme 7/538 (1.30%)', ' Diagnosis of Uterine Cancer 0/538 (0.00%)', ' Motorcycle accident 0/538 (0.00%)', ' Fall 0/538 (0.00%)', ' Surgery 3/538 (0.56%)', 'Adverse Events 2:', ' Total: 8/537 (1.49%)', ' Hypertension 1/537 (0.19%)', ' Acoustic Neuroma 0/537 (0.00%)', ' Diarrhea 1/537 (0.19%)', ' Colitis 0/537 (0.00%)', ' Elevated ALT or AST enzyme 0/537 (0.00%)', ' Diagnosis of Uterine Cancer 2/537 (0.37%)', ' Motorcycle accident 1/537 (0.19%)', ' Fall 1/537 (0.19%)', ' Surgery 2/537 (0.37%)']}
|
99e8ee0e-d72d-4e19-9424-20e5891bb2b6
|
Single
|
Adverse Events
|
NCT01273896
|
There was twice as many cases of Dyspnea as Cardiac adverse events in cohort 1 of the primary trial.
|
Entailment
|
[
0,
2,
8
] |
[] |
{'Clinical Trial ID': 'NCT01273896', 'Intervention': ['INTERVENTION 1: ', ' STA-9090', ' This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.', ' STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' Male and Female patients must be at least 18 years of age', ' Pathologically confirmed diagnosis of breast cancer', ' Metastatic or advanced stage breast cancer', ' Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy)', ' Patients with HER2+ disease must have received prior treatment with Trastuzumab', ' Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy', ' Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) 3 weeks', ' Measurable disease by RECIST 1.1', ' Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1', ' Life expectancy of at least 3 months', ' Adequate hematologic function as defined by:', ' Absolute neutrophil count 1,500 cells/μL', ' Platelets 100,000/μL', ' Hemoglobin 9.0g/dL', ' Adequate hepatic function as defined by:', ' Serum bilirubin 1.5 X upper limit of normal (ULN);', ' Adequate renal function as defined by a serum creatinine 1.5 x ULN', ' AST, ALT, and alkaline phosphatase 3 × ULN except for:', ' Patients with hepatic metastases: ALT and AST 5 × ULN', ' Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN', " Patients with Gilbert's disease: serum bilirubin < 5 mg/dL", ' Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures', ' Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment', ' Female subjects of childbearing age must have a negative serum pregnancy test at study entry.', 'Exclusion Criteria:', ' Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease', ' Major surgery within 4 weeks prior to first dose of STA-9090', ' Poor peripheral venous access for study drug administration. Study drug administration via indwelling catheters allowed only if the catheter is made of silicone material.', ' History of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80)', ' Baseline QTc > 470 msec', ' Ventricular ejection fraction (EF) <50% at baseline', ' Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)', ' Women who are pregnant or lactating', ' Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator', ' Seizure disorder or requirement for seizure medication', ' Prior treatment with an HSP90 inhibitor', ' persistent adverse events of prior therapies that are > 1 grade 1 in severity', ' history of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery', ' history of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block', ' New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers or diuretics'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate', ' To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response', ' Time frame: Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle', 'Results 1: ', ' Arm/Group Title: STA-9090', ' Arm/Group Description: This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.', ' STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: participants 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' Cardiac General, other1/22 (4.55%)', ' Pain - Abdomen NOS1/22 (4.55%)', ' Death not assoc w CTCAE term- Death NOS1/22 (4.55%)', ' Death not assoc w CTCAE term-Disease prog NOS1/22 (4.55%)', ' Liver dysfunction/failure1/22 (4.55%)', ' Sodium, low (hyponatremia)1/22 (4.55%)', ' Dyspnea (shortness of breath)2/22 (9.09%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f1b0653f-b5ce-4558-b325-56244940c0cd
|
|
Single
|
Adverse Events
|
NCT01234402
|
the primary trial at least 8 different types of cardiac related adverse events.
|
Contradiction
|
[
0,
4,
5,
6,
7,
8,
9,
10,
13,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT01234402', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab + Capecitabine', ' Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.', 'INTERVENTION 2: ', ' Icrucumab + Capecitabine', ' Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.'], 'Eligibility': ['Inclusion Criteria:', ' The participant has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease', ' Has measurable or nonmeasurable disease', ' Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Has received prior anthracycline therapy', ' Has received prior taxane therapy', ' Participants with human epidermal growth factor receptor-2 (HER2) positive disease must have progressed on or following trastuzumab', ' Participants with hormone receptor-positive disease must have progressed on or following hormone therapy', ' Has received 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)', ' Has completed any prior radiotherapy 4 weeks prior to randomization', ' Has completed any prior hormonal therapy 2 weeks prior to randomization', ' Has adverse events (AEs) that have resolved to Grade 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy', ' Has adequate hematologic, coagulation, hepatic and renal function', ' Does not have:', ' cirrhosis at a level of Child-Pugh B (or worse) or', ' cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis', ' Has urinary protein is 1+ on dipstick or routine urinalysis; if urine protein 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study', ' Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication', 'Exclusion Criteria:', ' Has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that there has been a disease-free interval for > 3 years', ' Has a known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80', ' Has a known sensitivity to 5-fluorouracil (5-FU)', ' Has a known dihydropyrimidine dehydrogenase deficiency', ' Has received prior capecitabine treatment for advanced breast cancer', ' Has received investigational therapy within 2 weeks prior to randomization', ' Has received bevacizumab within 4 weeks prior to randomization', ' Has received more than 1 prior antiangiogenic agent for breast cancer', ' Has a known sensitivity to agents of similar biologic composition as ramucirumab DP or Icrucumab (IMC-18F1), or other agents that specifically target vascular endothelial growth factor (VEGF)', ' Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention', ' Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' Has experienced a Grade 3 bleeding event within 3 months prior to randomization', ' Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other oral anticoagulant', ' Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorder in the opinion of the investigator', ' Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization', ' Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease', ' Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy', ' Has received a prior allogeneic organ or tissue transplantation', ' Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization', ' Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization', ' Has known HIV or AIDS infection', ' Has an elective or planned major surgery to be performed during the course of the trial', ' Participant is pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of 5 millimeter (mm) and the appearance of 1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.', ' Time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)', 'Results 1: ', ' Arm/Group Title: Ramucirumab + Capecitabine', ' Arm/Group Description: Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.', ' Overall Number of Participants Analyzed: 52', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 22.1 (12.1 to 36.1)', 'Results 2: ', ' Arm/Group Title: Icrucumab + Capecitabine', ' Arm/Group Description: Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.', ' Overall Number of Participants Analyzed: 49', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 7.3 (6.3 to 13.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/52 (38.46%)', ' Anaemia 0/52 (0.00%)', ' Pancytopenia 1/52 (1.92%)', ' Acute myocardial infarction 0/52 (0.00%)', ' Atrial fibrillation 0/52 (0.00%)', ' Cardiac failure 1/52 (1.92%)', ' Cardiogenic shock 1/52 (1.92%)', ' Palpitations 0/52 (0.00%)', ' Pericardial effusion 0/52 (0.00%)', ' Right ventricular failure 1/52 (1.92%)', ' Abdominal pain 0/52 (0.00%)', ' Ascites 3/52 (5.77%)', 'Adverse Events 2:', ' Total: 25/49 (51.02%)', ' Anaemia 2/49 (4.08%)', ' Pancytopenia 0/49 (0.00%)', ' Acute myocardial infarction 1/49 (2.04%)', ' Atrial fibrillation 1/49 (2.04%)', ' Cardiac failure 0/49 (0.00%)', ' Cardiogenic shock 0/49 (0.00%)', ' Palpitations 1/49 (2.04%)', ' Pericardial effusion 4/49 (8.16%)', ' Right ventricular failure 0/49 (0.00%)', ' Abdominal pain 1/49 (2.04%)', ' Ascites 0/49 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
24b24d36-2500-4841-99a3-13cba905d77d
|
|
Single
|
Adverse Events
|
NCT00546104
|
1 patient in the primary trial suffered from a blood clot blocking their trachea.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00546104', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib', '50mg-100mg po BID'], 'Eligibility': ['Inclusion Criteria:', ' Measurable Stage IV or inoperable Stage III advanced breast cancer.', ' There is no limit on the number of prior therapies.', ' At least 3 weeks since prior chemotherapy, biological or hormonal therapy.', ' At least 2 weeks since surgical biopsy.', ' At least 3 weeks since major (open thoracic/abdominal/cardiac) surgery.', ' No central nervous system (CNS) metastases except solitary brain metastasis', ' No cardiac dysfunction', ' left ventricular ejection fraction (LVEF) 50% as determined by multiple gated acquisition scan (MUGA)/echocardiogram', ' Adequate blood counts', ' Normal liver and kidney function', ' Negative serum pregnancy test.', ' Able to provide informed consent', 'Exclusion Criteria:', ' Pregnant or breast feeding.', ' Prior treatment with dasatinib.', ' Bone as the only site of disease.', ' Significant gastrointestinal bleeding', ' Septicemia, infection, acute hepatitis, hypokalemia, or hypomagnesemia'], 'Results': ['Outcome Measurement: ', ' Estimation of the Proportion of Progression-free Patients at 16 Wks.', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate.', ' Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first.', ' Time frame: 16 weeks', 'Results 1: ', ' Arm/Group Title: Dasatinib', ' Arm/Group Description: 50mg-100mg po BID', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0 (0 to 20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/31 (32.26%)', ' Edema, limb 1/31 (3.23%)', ' Thrombosis1/31 (3.23%)', ' diarrhea1/31 (3.23%)', ' Pain 2/31 (6.45%)', ' Pain, back1/31 (3.23%)', ' Pain, extrimity limb 1/31 (3.23%)', ' Syncope 1/31 (3.23%)', ' Pain, chest/thorax1/31 (3.23%)', ' hyponatremia 1/31 (3.23%)', ' fever1/31 (3.23%)', ' AST 1/31 (3.23%)', ' infection1/31 (3.23%)', ' Anorexia 1/31 (3.23%)', ' Dyspnea 2/31 (6.45%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0797ff90-f847-4442-92fd-017c539bb38f
|
|
Single
|
Intervention
|
NCT00606931
|
the primary trial tests positron emission tomography as a technique for guiding a medical procedure.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00606931', 'Intervention': ['INTERVENTION 1: ', ' PET Guided Biopsy', ' No comparison group. All enrolled participants were expected to undergo PET guided biopsy.'], 'Eligibility': ['Inclusion Criteria:', ' Individuals aged 25 years or older', ' Individuals who have at least one breast imaging finding requiring biopsy, specifically:', ' Individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or MRI (as per ACR BIRADS™ 4C or 5) and requiring biopsy confirmation OR o Individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution FDG PET scan', ' Individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.', ' Individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or MRI if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or MRI if not detectable on mammography) is more than 1 cm. (Note: The study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, CT, or MRI, if the lesion is not detectable or measurable on mammography.)', ' Individuals who have agreed to participate in the study and who have signed study-specific informed consent', 'Exclusion Criteria:', ' Women who are or may be pregnant', ' Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study', ' Age less than 25 years', ' Individuals with breast implant(s) in the breast containing the lesion of interest', ' Individuals who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PET-guided biopsy', ' Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure', ' Individuals with Type I or poorly controlled Type II diabetes mellitus', ' Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging', ' Inability to provide informed consent', ' Individuals who have had surgery on the study breast(s) within the past 12 months'], 'Results': ['Outcome Measurement: ', ' Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.', ' Success in completion of the PET guided biopsy of a suspicious lesion was determined by', ' Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR', ' Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).', ' Time frame: within two days of obtaining histopathology of the lesion biopsied', 'Results 1: ', ' Arm/Group Title: PET Guided Biopsy', ' Arm/Group Description: No comparison group. All enrolled participants were expected to undergo PET guided biopsy.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: Number of lesions 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6b595151-7e51-4062-b587-3207ea251677
|
|
Comparison
|
Intervention
|
NCT04080297
|
NCT02780713
|
Both cohorts of the primary trial receive higher doses of Q-122 than either of the secondary trial cohorts receive of AZD9496 variants.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT04080297', 'Intervention': ['INTERVENTION 1: ', ' 100 mg Q-122', ' Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.', 'INTERVENTION 2: ', ' 200 mg Q-122', ' Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Be a female of any race between the ages of 30-70 years.', ' History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.', ' Naturally menopausal: 12 months spontaneous amenorrhea or > 6 but < 12 months amenorrhea with a serum follicle stimulating hormone (FSH) level of > 40 mIU/mL (Milli-international Units Per Milliliter).', ' Surgically menopausal with an FSH level > 40 mIU/mL.', ' Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot flushes per week, as verified for both weeks during the 14-day Screening Phase, prior to enrollment into the treatment phase of the study.', ' Able to read, understand and complete the required subject diary.', ' Willing and able to complete the daily subject diary, attend all study visits, and participate in all study procedures, including PK blood draws.', 'Exclusion Criteria:', ' Childbearing potential, including pregnancy, or lactation.', ' Undiagnosed abnormal genital bleeding.', ' Significant day-to-day variability in hot flushes.', ' Participation in another clinical trial within 30 days prior to screening or during the study.', ' Legal incapacity or limited legal capacity.', ' Chronic renal (serum creatinine > 2.0 mg/dL) or hepatic disease [SGPT (ALT) or SGOT (AST) > 2X normal limits].', ' Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122.', ' Untreated overt hyperthyroidism.', ' Use of thyroid medication of less than 12 weeks on a stable dose.', ' Any clinically important systemic disease in the judgement of the investigator.', ' Inability to complete all study visits and study assessments for scheduling or other reasons.', " Any other reason which in the investigator's opinion makes the subject unsuitable for a clinical trial.", ' Abnormal laboratory findings including:', ' Hematocrit < 30% or hemoglobin < 9.5 gm/dL', ' Fasting blood sugar > 140 mg/dL', ' Fasting serum triglycerides > 300 mg/dL', ' Fasting SGOT, SGPT, GGT, or bilirubin greater than twice the upper limit of normal (a subject will not be excluded if a second measurement is less than twice the upper limit of normal)', ' Creatinine > 2.0 mg/dL'], 'Results': ['Outcome Measurement: ', ' Adverse Event (AE) Reporting of Q-122', ' Number of participants with indicated AE receiving Q-122', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: 100 mg Q-122', ' Arm/Group Description: Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 70.0%', 'Results 2: ', ' Arm/Group Title: 200 mg Q-122', ' Arm/Group Description: Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 63.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', ' Breast pain 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 1/11 (9.09%)', ' Breast pain 1/11 (9.09%)']}
|
{'Clinical Trial ID': 'NCT02780713', 'Intervention': ['INTERVENTION 1: ', ' Treatment Period 1', ' Participants received AZD9496 - Variant A (100 mg).', 'INTERVENTION 2: ', ' Treatment Period 2', ' Participants received AZD9496 - Reference (100 mg).'], 'Eligibility': ['Inclusion Criteria:', ' Provision of signed and dated, written informed consent prior to any study specific procedures.', ' Healthy male and/or female subjects aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.', ' Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria: Post-menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the post-menopausal range (OR) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation', ' Male subjects aged 18 to 39 years must be vasectomized. Male subjects aged 40 to 65 years must either be vasectomized or have no intention of fathering a child for a period of 6 months after receiving the last dose of IMP.', ' Have a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive.', ' Values for AST, ALT, TBL, GGT and ALP must be at or below the upper limit of normal ranges at screening.', 'Exclusion Criteria:', " History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.", ' History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.', ' Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.', ' Previous history of venous or arterial thromboembolism or thrombophilia.', ' History of endometrial polyps, endometrial cancer, atypical endometrial hyperplasia, or other endometrial disorders unless subjects have undergone total hysterectomy and there is no evidence of active disease (females only).', ' Any clinically significant abnormalities in clinical chemistry (other than Inclusion no.6), hematology, or urinalysis results at screening, as judged by the investigator.', ' Any clinically significant abnormal findings in supine vital signs, after 10 minutes of supine rest, at screening and/or admission to the unit, defined as: (a) Systolic blood pressure < 90 mmHg or 150 mmHg (b) Diastolic blood pressure < 50 mmHg or 95 mmHg and (c) Heart rate < 45 or > 90 beats per minute', ' Any clinically important abnormalities in rhythm, conduction or morphology of the resting 12-lead ECG that, as judged by the investigator, that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or pronounced left ventricular hypertrophy.', ' Prolonged QTcF > 460 ms for females and QTcF > 450 ms for males or family history of long QT syndrome.', ' PR (PQ) interval shortening < 110 ms or evidence of ventricular pre-excitation).', ' PR (PQ) interval prolongation > 240 ms, intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block.', ' Persistent or intermittent complete bundle branch block with QRS > 120 ms or evidence of pronounced ventricular hypertrophy or pre-excitation.', ' Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody.', ' Known or suspected history of drug abuse, as judged by the investigator.', ' Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.', ' Known or suspected history of alcohol or drug abuse or excessive intake of alcohol, as judged by the investigator.', ' Positive screen for drugs of abuse, alcohol or cotinine at screening or on each admission to the unit.', ' History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9496.', ' Excessive intake of caffeine/xanthine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.', " Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.", ' Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life Note: Hormonal replacement therapy is not allowed for females.', ' Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening', ' Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion is 3 months after the final dose from previous study or 1 month after the last visit of previous study, whichever is the longest. ote: Subjects consented and screened, but not dosed in this study or a previous phase I study, are not excluded.', ' Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives', ' Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.', ' Subjects who are vegans or have medical dietary restrictions.', ' Subjects who cannot communicate reliably with the investigator.', ' Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.'], 'Results': ['Outcome Measurement: ', ' Pharmacokinetics: Maximum Plasma Concentration (Cmax) for AZD9496 and Its Metabolites at Each Treatment Period.', ' To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.', ' Time frame: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment period', 'Results 1: ', ' Arm/Group Title: Treatment Period 1', ' Arm/Group Description: Participants received AZD9496 - Variant A (100 mg).', ' Overall Number of Participants Analyzed: 14', ' Geometric Mean (Geometric Coefficient of Variation)', ' Unit of Measure: ng/mL AZD9496: 64.85 (73.54%)', ' M3: 10.30 (98.93%)', ' M5: 1.102 (85.27%)', 'Results 2: ', ' Arm/Group Title: Treatment Period 2', ' Arm/Group Description: Participants received AZD9496 - Reference (100 mg).', ' Overall Number of Participants Analyzed: 14', ' Geometric Mean (Geometric Coefficient of Variation)', ' Unit of Measure: ng/mL AZD9496: 381.0 (55.83%)', ' M3: 62.98 (76.91%)', ' M5: 7.409 (75.18%)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
e802b1f6-62fb-4759-b261-c69dbdc1d7ef
|
Comparison
|
Intervention
|
NCT00593346
|
NCT00902330
|
the primary trial treament last for a shorter period of time than the secondary trial treatment.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT00593346', 'Intervention': ['INTERVENTION 1: ', ' Accelerated Partial Breast Brachytherapy', ' Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.', ' Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.'], 'Eligibility': ['Inclusion Criteria:', ' AJCC stage 0, I, or II (TisN0, T1N0, T2N0 = 3 cm) histologically confirmed carcinoma of the breast, treated with tylectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate.', ' Signed study-specific informed consent for participation in the study.', ' Negative, or close but negative, inked histologic margins of tylectomy or reexcision specimen to be confirmed prior to placing the brachytherapy catheters. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.', ' Negative post-tylectomy or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy.', ' For patients with invasive cancer, no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.', ' Invasive ductal, lobular, medullary, papillary, colloid (mucinous),or tubular histologies. Noninvasive ductal carcinoma in situ.', " Chemotherapy or hormonal therapy planned for = 2 weeks after removal of brachytherapy catheters is permitted. Hormonal therapy is allowed during brachytherapy at treating radiation oncologist's decision.", ' Negative pregnancy test for premenopausal patients with an intact uterus', 'Exclusion Criteria:', ' Patients with distant metastases.', ' Patients with in-situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.', ' Patients with proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.', ' Patients who are pregnant or lactating.', ' Patients with histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.', ' Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.', ' Patients with systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash.', ' Patients with coexisting medical conditions in whom life expectancy is < 2 years.', ' Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or completing the full series of high dose rate brachytherapy treatments on an outpatient basis.', " Patients with Paget's disease of the nipple.", ' Patients with skin involvement, regardless of tumor size.', ' Patients with a breast unsatisfactory for brachytherapy. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, placement of catheters is technically problematic.', ' Patients with tylectomies so extensive that the cosmetic result is fair or poor prior to brachytherapy.', ' Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.', ' Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma.', ' Other malignancy, except non-melanoma skin cancer, 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous.', ' Time between final definitive breast procedure to radioactive source loading of the brachytherapy catheters is greater than 8 weeks.', ' Patients with diffuse (> 1 quadrant or >5 cm in diameter) suspicious microcalcifications.', ' Patients with suspicious microcalcifications remaining on the post-tylectomy mammogram'], 'Results': ['Outcome Measurement: ', ' Local Control Using Ipsilateral Breast Tumor Recurrence Rates', ' [Not Specified]', ' Time frame: 2 years after treatment completion', 'Results 1: ', ' Arm/Group Title: Accelerated Partial Breast Brachytherapy', ' Arm/Group Description: Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.', ' Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.', ' Overall Number of Participants Analyzed: 151', ' Measure Type: Number', ' Unit of Measure: percentage of participants .7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/151 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00902330', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Cranial Microcurrent Electrical Stimulation [CES])', ' Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.', ' energy-based therapy: Given once a day for 18 weeks', 'INTERVENTION 2: ', ' Arm II (Sham CES)', ' Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.', ' sham intervention: Given once a day for 18 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of stage I-IIIA breast cancer', ' Scheduled to receive adjuvant chemotherapy', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Pre, peri, or post-menopausal', ' ECOG performance status 0-1', ' No dementia', ' No active psychosis', ' No history of seizure disorder', ' No implanted electrical device', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy', ' No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days'], 'Results': ['Outcome Measurement: ', ' Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer', " Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire", ' Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months', 'Results 1: ', ' Arm/Group Title: Arm I (Cranial Microcurrent Electrical Stimulation [CES])', ' Arm/Group Description: Patients receive a CES unit (Alpha-Stim 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.', ' energy-based therapy: Given once a day for 18 weeks', ' Overall Number of Participants Analyzed: 77', ' Least Squares Mean (Standard Deviation)', ' Unit of Measure: units on a scale Anxiety: 4.040 (0.419)', ' Depression: 4.520 (0.398)', ' Fatigue: 3.349 (0.294)', ' Pain: 1.174 (0.197)', ' Sleep: 38.235 (2.376)', 'Results 2: ', ' Arm/Group Title: Arm II (Sham CES)', ' Arm/Group Description: Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.', ' sham intervention: Given once a day for 18 weeks', ' Overall Number of Participants Analyzed: 75', ' Least Squares Mean (Standard Deviation)', ' Unit of Measure: units on a scale Anxiety: 4.529 (0.431)', ' Depression: 4.565 (0.407)', ' Fatigue: 3.191 (0.301)', ' Pain: 1.272 (0.202)', ' Sleep: 40.474 (2.443)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/77 (1.30%)', ' Seizure * [1]1/77 (1.30%)', 'Adverse Events 2:', ' Total: 0/75 (0.00%)', ' Seizure * [1]0/75 (0.00%)']}
|
0a24a07e-2cb4-4591-aea4-a370f462cc49
|
Comparison
|
Eligibility
|
NCT02322814
|
NCT00356148
|
A patient with Histologically confirmed estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor 2 positive breast cancer, with no known Brain metastases and no prior history of cardiac dysfunction, could be eligible for both the secondary trial and the primary trial.
|
Contradiction
|
[
0,
2,
22,
15,
33
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'Clinical Trial ID': 'NCT02322814', 'Intervention': ['INTERVENTION 1: ', ' Cohort I: Cobimetinib, Paclitaxel', ' Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.', 'INTERVENTION 2: ', ' Cohort I: Placebo, Paclitaxel', ' Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor 2 (HER2)-negative adenocarcinoma of the breast with measurable metastatic or locally advanced disease', ' Locally advanced disease must not be amenable to resection with curative intent', ' Measurable disease, according to RECIST, v1.1', ' Adequate hematologic and end organ function', ' Agreement to use highly effective contraceptive methods as stated in protocol', 'Exclusion Criteria:', ' Disease-Specific Exclusion Criteria', ' Known HER2-, ER-positive, or PR-positive breast cancer by local laboratory assessment', ' Any prior chemotherapy, hormonal, or targeted therapy, for inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC)', ' Any systemic anticancer therapy within 3 weeks prior to Cycle 1, Day 1', ' Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1', ' Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for major surgical procedure during the course of the study', ' Prior exposure to experimental treatment targeting rapidly accelerated fibrosarcoma (Raf), MAP kinase/ERK kinase (MEK), or the mitogen-activated protein kinase (MAPK) pathway', ' Brain metastases (symptomatic or nonsymptomatic) that have not been treated previously, are progressive, or require any type of therapy (e.g., radiation, surgery, or steroids) to control symptoms from brain metastases within 30 days prior to first study treatment dose', ' Cobimetinib-Specific Exclusion Criteria', ' History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration', ' Cobimetinib is metabolized by the hepatic cytochrome P3A4 (CYP3A4) enzyme. Drugs CYP3A4/5 inhibitors and inducers should be avoided', ' Atezolizumab-Specific Exclusion Criteria (Cohorts II and III Only)', ' History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins', ' Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation', ' History of autoimmune disease', ' Prior allogenic stem cell or solid organ transplantation', ' History of idiopathic pulmonary fibrosis (including pneumonitis), drug induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan', ' Positive test for Human Immunodeficiency Virus (HIV)', ' Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] or positive hepatitis B virus [HBV] deoxyribonucleic acid [DNA] test at screening) or hepatitis C', ' Active tuberculosis', ' Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study', ' Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death ligand-1 (anti-PD-L1) therapeutic antibodies', ' Treatment with systemic immunostimulatory agents (including but not limited to interferons or Interlukin-2 [IL-2]) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization', ' Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial', ' Cardiac Exclusion Criteria', ' History of clinically significant cardiac dysfunction', ' Corrected QT interval at screening greater than (>) 480 milliseconds (ms) (average of triplicate screening measurements)', ' Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50 percent (%), whichever is lower', ' General Exclusion Criteria', ' No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay', ' Pregnancy (positive serum pregnancy test) or lactation', ' Uncontrolled serious medical or psychiatric illness', ' Active infection requiring IV antibiotics on Cycle 1, Day 1', ' Participants who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil) or to nab-paclitaxel and any of the excipients'], 'Results': ['Outcome Measurement: ', ' Cohort I: Progression-Free Survival, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', ' PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1.', ' Time frame: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Cohort I: Cobimetinib, Paclitaxel', ' Arm/Group Description: Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.', ' Overall Number of Participants Analyzed: 43', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 16.43 (8.14 to 31.14)', 'Results 2: ', ' Arm/Group Title: Cohort I: Placebo, Paclitaxel', ' Arm/Group Description: Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.', ' Overall Number of Participants Analyzed: 47', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 23.71 (18.14 to 32.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/16 (37.50%)', ' Febrile neutropenia * 0/16 (0.00%)', ' Neutropenia * 0/16 (0.00%)', ' Mitral valve incompetence * 1/16 (6.25%)', ' Cardiac failure * 0/16 (0.00%)', ' Cardiac Arrest * 0/16 (0.00%)', ' Papilloedema * 0/16 (0.00%)', ' Diarrhoea * 0/16 (0.00%)', ' Intestinal obstruction * 0/16 (0.00%)', ' Nausea * 0/16 (0.00%)', ' Vomiting * 0/16 (0.00%)', ' Pyrexia * 2/16 (12.50%)', 'Adverse Events 2:', ' Total: 9/43 (20.93%)', ' Febrile neutropenia * 1/43 (2.33%)', ' Neutropenia * 0/43 (0.00%)', ' Mitral valve incompetence * 0/43 (0.00%)', ' Cardiac failure * 1/43 (2.33%)', ' Cardiac Arrest * 0/43 (0.00%)', ' Papilloedema * 0/43 (0.00%)', ' Diarrhoea * 0/43 (0.00%)', ' Intestinal obstruction * 0/43 (0.00%)', ' Nausea * 0/43 (0.00%)', ' Vomiting * 0/43 (0.00%)', ' Pyrexia * 0/43 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00356148', 'Intervention': ['INTERVENTION 1: ', ' Prophylaxis Group', ' patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis', 'INTERVENTION 2: ', ' No Prophylaxis Group', ' Patients who are BMI over 25 and not receive antibiotic prophylaxis'], 'Eligibility': ['Inclusion Criteria:', ' Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.', 'Exclusion Criteria:', ' Ductal carcinoma in situ (DCIS; stage 0 cancer),', ' Advanced or distant metastatic stage,', ' Receiving any neoadjuvant therapy,', ' History of receiving any antibiotics within prior 3 months,', ' History of immunodeficiency,', ' Having a remote infection,', ' History of reaction to study antibiotics,', ' Denial of signing the consent form.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).', ' [Not Specified]', ' Time frame: 1 month', 'Results 1: ', ' Arm/Group Title: Prophylaxis Group', ' Arm/Group Description: patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis', ' Overall Number of Participants Analyzed: 187', ' Measure Type: Number', ' Unit of Measure: participants 9', 'Results 2: ', ' Arm/Group Title: No Prophylaxis Group', ' Arm/Group Description: Patients who are BMI over 25 and not receive antibiotic prophylaxis', ' Overall Number of Participants Analyzed: 182', ' Measure Type: Number', ' Unit of Measure: participants 25'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/189 (0.00%)', 'Adverse Events 2:', ' Total: 0/183 (0.00%)']}
|
97d0bbf0-c2c5-409b-820b-6e14a6326b06
|
Single
|
Eligibility
|
NCT00859651
|
Helen had stage III ovarian cancer 7 years prior, but has been disease-free for 5 years., she is excluded from the primary trial.
|
Contradiction
|
[
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT00859651', 'Intervention': ['INTERVENTION 1: ', ' Cholecalciferol 20,000 IU Group', ' Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.', 'INTERVENTION 2: ', ' Cholecalciferol 30,000 IU Group', ' Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.'], 'Eligibility': ['Inclusion Criteria:', ' Elevated risk of breast cancer defined as having at least one of the following: (1) Predicted 5-year modified Gail model risk of 1.67% or greater, (2) Lobular carcinoma in situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.', ' Age 21 years or older.', ' Postmenopausal defined as > 6 months since the last menstrual period, prior bilateral oophorectomy, or serum follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values consistent with institutional normal values for the postmenopausal state.', ' Baseline mammographic density 25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense breasts"; >75% = "extremely dense breasts").', ' Baseline serum 25-hydroxyvitamin D <32 ng/ml.', ' Normal breast exam and mammogram (Breast Imaging Reporting and Data System (BIRADS) score of 1 or 2) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. Normal baseline breast magnetic resonance imaging (MRI) (BIRADS score of 1, 2, or 3).', ' Prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at least 28 days prior to enrollment.', ' At least one breast available for imaging. No bilateral breast implants.', ' Willingness to not take vitamin D supplements during the one year intervention, but up to 1000mg of calcium supplementation is allowed.', ' Normal serum calcium.', ' Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).', ' Performance status of 0 or 1.', 'Exclusion Criteria:', ' Other prior malignancy. The following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.', ' History of kidney stones.', ' Hypersensitivity reactions to vitamin D.', ' On estrogen replacement therapy.', ' Significant medical or psychiatric condition that would preclude study completion.'], 'Results': ['Outcome Measurement: ', ' Change in Serum 25(OH)D', ' 25(OH)D level at the end of one year intervention', ' Time frame: Baseline to 1 year', 'Results 1: ', ' Arm/Group Title: Cholecalciferol 20,000 IU Group', ' Arm/Group Description: Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.', ' Overall Number of Participants Analyzed: 18', ' Mean (Standard Deviation)', ' Unit of Measure: ng/ml 25 (5)', 'Results 2: ', ' Arm/Group Title: Cholecalciferol 30,000 IU Group', ' Arm/Group Description: Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: ng/ml 33 (9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)', 'Adverse Events 2:', ' Total: 0/22 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
bbb5ebc0-83c8-46cb-89b4-e1c67e042350
|
|
Single
|
Results
|
NCT00699491
|
the primary trial results show that the Recommended Dose Level for Phase II Testing (RPTD) (Phase I) is 3 mg/ks cixutumumab.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22
] |
[] |
{'Clinical Trial ID': 'NCT00699491', 'Intervention': ['INTERVENTION 1: ', ' Dose Level 1', ' 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Dose Level -1', ' 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22', ' Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of breast cancer with diagnosis of metastatic or locally recurrent disease (locally recurrent disease should be stage IV e.g. chest wall involvement)', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (Karnofsky >= 80%)', ' Life expectancy of > 12 weeks', ' Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent', ' Negative serum pregnancy test =< 7 days of registration for women of childbearing potential:', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of IMC-A12 and CCI-779 (temsirolimus)', ' Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Nursing women must be willing to discontinue nursing; NOTE: breastfeeding should be discontinued if the mother is treated with CCI-779 and IMC-A12', ' Absolute neutrophil count >= 1,500/mcL', ' Hemoglobin >= 8.5 g/dL', ' Platelets >= 100,000/mcL', ' Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)', ' Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 X institutional ULN if liver function test [LFT] elevations due to liver metastases)', ' Creatinine =< 1.5 X institutional ULN OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine > institutional ULN', ' Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)', ' Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)', ' Albumin >= 3.4 mg/dL', ' Fasting or non fasting serum glucose < 120 mg/dL', ' Hemoglobin A1c (HbA1c) (for all patients with a history of diabetes mellitus) < 8%', ' Phase I only: Any number of prior therapy regimens is allowed', ' Phase II only: Measurable disease is required for the Phase II portion of the study; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], x-ray) or as >= 10 mm with spiral CT scan', ' Phase II only: =< two and at least one prior chemotherapy regimens in the setting of metastatic or locally recurrent (stage IV chest wall involvement) disease are required', 'Exclusion Criteria:', ' Phase I patients only: Patients with base line diabetes requiring oral hypoglycemics or insulin', ' Phase II patients only: Poorly controlled diabetes mellitus; NOTE: patients with a history of diabetes mellitus on oral hypoglycemics or insulin are allowed to participate, provided that their fasting blood glucose is < 120 mg/dL and that they are on a stable dietary or therapeutic regimen for this condition', ' Any of the following:', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (hormonal agents are not allowed and oral contraceptives are not acceptable for contraception)', ' Receiving hormonal agents used for the treatment of breast cancer with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist', ' Any of the following prior therapies:', ' Systemic anti-cancer therapy =< 3 weeks prior to registration', ' Radiation therapy =< 2 weeks prior to registration', ' Prior invasive non-breast malignancy, except for adequately treated basal or squamous cell carcinoma of the skin or other cancer from which the patient has been disease free for >= 5 years', ' Known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin); allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12, or temsirolimus', ' Prior treatment with agents targeting the insulin-like growth factor-I receptor (IGF-IR)/insulin-like growth factors (IGFs) or phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (Akt)/mechanistic target of rapamycin (mTOR) pathway', ' Receiving any other investigational agents or herbal preparations', ' Patients may not be taking oral corticosteroids except for replacement for adrenal insufficiency', ' Uncontrolled brain metastases; Note: brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for >= 12 weeks', ' Known human immunodeficiency virus (HIV)-positive patients who have cluster of differentiation (CD)4 counts below the normal range or who are on anti-retroviral therapy that may interfere with the metabolism of temsirolimus', ' Uncontrolled intercurrent illness including, but not limited to:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Uncontrolled symptomatic cardiac arrhythmia', ' Psychiatric illness/social situations that would limit compliance with study requirements', " Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) or any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort"], 'Results': ['Outcome Measurement: ', ' Recommended Dose Level for Phase II Testing (RPTD) (Phase I)', ' The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.', ' Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:', ' Any grade 4 hematologic toxicity', ' Hyperglycemia that cannot be stably controlled with diabetic medication', ' Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)', ' Time frame: During first course', 'Results 1: ', ' Arm/Group Title: Dose Level 1', ' Arm/Group Description: 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: DLTs 2', 'Results 2: ', ' Arm/Group Title: Dose Level -1', ' Arm/Group Description: 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22', ' 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22', ' Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: DLTs 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Hemoglobin decreased 0/3 (0.00%)', ' Mucositis oral 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Vomiting 0/3 (0.00%)', ' Death 0/3 (0.00%)', ' Edema limbs 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Pain 0/3 (0.00%)', ' Skin infection 0/3 (0.00%)', ' Alanine aminotransferase increased 0/3 (0.00%)', ' Alkaline phosphatase increased 0/3 (0.00%)', ' Creatinine increased 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/2 (50.00%)', ' Hemoglobin decreased 0/2 (0.00%)', ' Mucositis oral 1/2 (50.00%)', ' Nausea 0/2 (0.00%)', ' Vomiting 0/2 (0.00%)', ' Death 0/2 (0.00%)', ' Edema limbs 0/2 (0.00%)', ' Fatigue 1/2 (50.00%)', ' Pain 1/2 (50.00%)', ' Skin infection 0/2 (0.00%)', ' Alanine aminotransferase increased 0/2 (0.00%)', ' Alkaline phosphatase increased 0/2 (0.00%)', ' Creatinine increased 1/2 (50.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
620106e8-2a7f-4078-80b6-d5f1840c66e1
|
|
Single
|
Results
|
NCT00513292
|
In the primary trial the FEC-75 Then Paclitaxel/Trastuzumab group had more Invasive Tumor Remaining in the Breast than the Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 group.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00513292', 'Intervention': ['INTERVENTION 1: ', ' FEC-75 Then Paclitaxel/Trastuzumab', ' Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', 'INTERVENTION 2: ', ' Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', ' Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of invasive adenocarcinoma by core needle biopsy', ' Fine needle aspiration allowed provided primary tumor size < 2 cm and lymph node metastases are present', ' Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present', ' Primary tumor 2 cm and/or 1 biopsy-positive lymph node', ' HER2-positive disease', ' Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification', ' Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score', ' Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed', ' Synchronous invasive breast cancer not allowed', ' Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed', ' Those treated with radiation therapy are not allowed', ' No definitive clinical or radiologic evidence of metastatic disease', ' No history of invasive breast cancer', ' Hormone receptor status known', ' Menopausal status not specified', ' ECOG performance status of 0 -1', ' Absolute neutrophil count 1,200/mm³', ' Platelet count 100,000/mm³', ' Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal [ULN]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin', ' Alkaline phosphatase 2.5 times ULN', ' AST 1.5 times ULN', ' Creatinine normal', ' Left ventricular ejection fraction (LVEF) 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months', ' Patients with either skeletal pain or alkaline phosphatase that is > ULN but 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease', ' Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy', ' Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence', ' Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:', ' Carcinoma in situ of the cervix', ' Colon carcinoma in situ', ' Melanoma in situ', ' Basal cell and squamous cell carcinoma of the skin', ' No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:', ' Active cardiac disease', ' Angina pectoris that requires the use of antianginal medication', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Clinically significant valvular disease', ' Cardiomegaly on chest x-ray', ' Ventricular hypertrophy on EKG', " Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)", ' Patients with hypertension that is well controlled on medication are eligible', ' History of cardiac disease', ' Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests', ' Documented congestive heart failure', ' Documented cardiomyopathy', " No sensory or motor neuropathy grade 2, as defined by the NCI's CTCAE v3.0", ' Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy', ' Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration', ' Not pregnant or nursing', ' No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements', ' No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens', ' No prior surgical axillary staging procedure', ' Prior non-excisional biopsy of an axillary node allowed', ' No prior treatment for this breast cancer', ' Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry', ' Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery', ' No prior therapy with anthracyclines or taxanes for any malignancy', ' No other investigational agents within the past 30 days', ' No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)', ' No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention'], 'Results': ['Outcome Measurement: ', ' pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy', ' Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: FEC-75 Then Paclitaxel/Trastuzumab', ' Arm/Group Description: Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 138', ' Measure Type: Number', ' Unit of Measure: percentage of participants 56.5 (47.8 to 64.9)', 'Results 2: ', ' Arm/Group Title: Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', ' Arm/Group Description: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 142', ' Measure Type: Number', ' Unit of Measure: percentage of participants 54.2 (45.7 to 62.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/138 (13.77%)', ' Blood disorder 1/138 (0.72%)', ' Febrile neutropenia 1/138 (0.72%)', ' Hemoglobin decreased 8/138 (5.80%)', ' Hemolysis 0/138 (0.00%)', ' Atrial fibrillation 0/138 (0.00%)', ' Left ventricular failure 3/138 (2.17%)', ' Myocardial ischemia 0/138 (0.00%)', ' Sinus tachycardia 1/138 (0.72%)', ' Supraventricular tachycardia 0/138 (0.00%)', ' Extraocular muscle paresis 0/138 (0.00%)', 'Adverse Events 2:', ' Total: 26/142 (18.31%)', ' Blood disorder 1/142 (0.70%)', ' Febrile neutropenia 3/142 (2.11%)', ' Hemoglobin decreased 11/142 (7.75%)', ' Hemolysis 1/142 (0.70%)', ' Atrial fibrillation 1/142 (0.70%)', ' Left ventricular failure 5/142 (3.52%)', ' Myocardial ischemia 1/142 (0.70%)', ' Sinus tachycardia 1/142 (0.70%)', ' Supraventricular tachycardia 1/142 (0.70%)', ' Extraocular muscle paresis 1/142 (0.70%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
94a7b007-0332-4d01-979e-9677e5da4316
|
|
Single
|
Adverse Events
|
NCT00127205
|
More patients in the primary trial suffer from dysfunctions with ventricular contractions than ventricular systole.
|
Contradiction
|
[
10,
17,
18
] |
[] |
{'Clinical Trial ID': 'NCT00127205', 'Intervention': ['INTERVENTION 1: ', ' Arm I Zoledronate', ' Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', ' zoledronic acid: Given IV', 'INTERVENTION 2: ', ' Arm II Clodronate', ' Patients receive oral clodronate once daily for 35 months.', ' clodronate disodium: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed primary adenocarcinoma of the breast', ' Stage I-III disease', ' No evidence of metastatic disease', ' Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks', ' Axillary evaluation per institutional standards', ' Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer', ' Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible', ' Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible', ' Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab [Herceptin^®], bevacizumab, or hematopoietic growth factors)', ' Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs 12 weeks after completion of surgery', ' Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease', ' Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Creatinine 2 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No renal failure', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of esophageal stricture or motility disorders', ' Gastroesophageal reflux disorder allowed', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior or concurrent hematopoietic growth factors allowed', ' HER-2-targeted therapies allowed', ' Antiangiogenics allowed', ' Chemotherapy', ' See Disease Characteristics', ' Endocrine therapy', ' See Disease Characteristics', ' Radiotherapy', ' Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician', ' Surgery', ' See Disease Characteristics', ' Other', ' Prior neoadjuvant therapy allowed', ' Prior bisphosphonates for bone density allowed', ' No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis', ' No concurrent enrollment in clinical trials with bone density as an endpoint', ' Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.', ' Time frame: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'Results 1: ', ' Arm/Group Title: Arm I Zoledronate', ' Arm/Group Description: Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', ' zoledronic acid: Given IV', ' Overall Number of Participants Analyzed: 2231', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 88 (87 to 90)', 'Results 2: ', ' Arm/Group Title: Arm II Clodronate', ' Arm/Group Description: Patients receive oral clodronate once daily for 35 months.', ' clodronate disodium: Given orally', ' Overall Number of Participants Analyzed: 2235', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 88 (86 to 89)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/2125 (0.99%)', ' Febrile neutropenia 0/2125 (0.00%)', ' Hemoglobin 0/2125 (0.00%)', ' Cardiac General-Other 0/2125 (0.00%)', ' Cardiac-ischemia/infarction 1/2125 (0.05%)', ' Conduction abnorm/AV block - Sick sinus syndrome 0/2125 (0.00%)', ' Left ventricular diastolic dysfunction 0/2125 (0.00%)', ' Left ventricular systolic dysfunction 0/2125 (0.00%)', ' Pain - Cardiac/heart 0/2125 (0.00%)', 'Adverse Events 2:', ' Total: 190/2186 (8.69%)', ' Febrile neutropenia 3/2186 (0.14%)', ' Hemoglobin 3/2186 (0.14%)', ' Cardiac General-Other 2/2186 (0.09%)', ' Cardiac-ischemia/infarction 1/2186 (0.05%)', ' Conduction abnorm/AV block - Sick sinus syndrome 1/2186 (0.05%)', ' Left ventricular diastolic dysfunction 3/2186 (0.14%)', ' Left ventricular systolic dysfunction 1/2186 (0.05%)', ' Pain - Cardiac/heart 3/2186 (0.14%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2849d0ce-fed2-4c49-bec1-777c440caaeb
|
|
Single
|
Adverse Events
|
NCT00992225
|
Only 2 of the 12 adverse event types recorded in the primary trial, occurred more than once.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00992225', 'Intervention': ['INTERVENTION 1: ', ' LY573636-sodium', ' Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met'], 'Eligibility': ['Inclusion Criteria:', ' Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.', ' Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.', 'Exclusion Criteria:', ' Serious pre-existing medical condition.', ' Have active central nervous system or leptomeningeal metastasis.', ' Current hematologic malignancies, acute or chronic leukemia.', ' Receiving Warfarin (Coumadin).', ' Have a history of radiation therapy involving more than 25% of the bone marrow.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With an Objective Overall Response', ' Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is 30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.', ' Time frame: Baseline to measured progressive disease or death from any cause up to 12 months', 'Results 1: ', ' Arm/Group Title: LY573636-sodium', ' Arm/Group Description: Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: percentage of participants 6.1 (1.1 to 17.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/33 (30.30%)', ' Constipation 1/33 (3.03%)', ' Dysphagia 1/33 (3.03%)', ' Ileus 1/33 (3.03%)', ' Nausea 1/33 (3.03%)', ' Vomiting 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', ' Pain 1/33 (3.03%)', ' Sepsis 2/33 (6.06%)', ' Urinary tract infection 1/33 (3.03%)', ' Alanine aminotransferase increased 1/33 (3.03%)', ' Aspartate aminotransferase increased 1/33 (3.03%)', ' Dehydration 2/33 (6.06%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
aa6a20f8-ee49-42b7-9b9b-64caa8b22e35
|
|
Comparison
|
Adverse Events
|
NCT01332630
|
NCT00121134
|
There were more patients with significantly elevated blood pressure in cohort 1 of the primary trial, than in cohort 1 of the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'Clinical Trial ID': 'NCT01332630', 'Intervention': ['INTERVENTION 1: ', ' TPI 287', ' TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically proven breast cancer with metastatic disease to the brain.', ' Patients must have measurable disease on MRI that has progressed after prior therapy. PD will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on Gd-MRI, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.', ' Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease', ' Patients must be >/=18 years of age.', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.', ' Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dL, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dL, AST/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </= 3X the upper limit of normal (ULN).', ' Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of white blood cell count (WBC) and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame.', ' Women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. If in doubt, check FSH, LH and estradiol level) must have a negative urine or serum pregnancy test at screening.', ' Sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study .', ' Patients or their legal representative must be able to read, understand and sign an informed consent form (ICF).', ' TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and international normalized ratio (INR).', 'Exclusion Criteria:', ' Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug.', ' Patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management).', ' Patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment', ' Patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases', ' Patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°C within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in CORE).', ' Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure.', ' Patients with known HIV or Hepatitis B or C', ' Patients who are pregnant or lactating or not practicing adequate contraception', " Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.", ' Patients who are receiving concomitant systemic therapy for breast cancer.', ' Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."', ' Time frame: 8-24 weeks', 'Results 1: ', ' Arm/Group Title: TPI 287', ' Arm/Group Description: TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 21 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/21 (28.57%)', ' Hypertension 3/21 (14.29%)', ' Edema 3/21 (14.29%)', ' Nausea 2/21 (9.52%)', ' Fracture 1/21 (4.76%)', ' Dizziness 3/21 (14.29%)', ' Syncope 2/21 (9.52%)', ' Headache 2/21 (9.52%)', ' Dyspnea 2/21 (9.52%)', ' Hypoxia 3/21 (14.29%)']}
|
{'Clinical Trial ID': 'NCT00121134', 'Intervention': ['INTERVENTION 1: ', ' Group A- Bevacizumab Alone', ' Bevacizumab 15 mg/kg every 3 wks for 1 year', 'INTERVENTION 2: ', ' Group B-Bevacizumab+Cyclophosphamide+Methotrexate', ' Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging', ' Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.', ' Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.', ' For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.', ' Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.', ' LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.', ' ECOG performance status 0-1', 'Exclusion Criteria:', ' Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment', ' Patients with metastatic disease are ineligible.', ' Known HIV infection', ' Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding', ' Uncontrolled intercurrent illness', ' Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment', ' History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab', ' Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded', ' History of bleeding diathesis or coagulopathy', ' History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)', ' Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer', ' Patients with large or rapidly accumulating pleural or abdominal effusions', ' Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR', ' Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed', ' Patients may not receive other investigational agents while on study'], 'Results': ['Outcome Measurement: ', ' The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Group A- Bevacizumab Alone', ' Arm/Group Description: Bevacizumab 15 mg/kg every 3 wks for 1 year', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60', 'Results 2: ', ' Arm/Group Title: Group B-Bevacizumab+Cyclophosphamide+Methotrexate', ' Arm/Group Description: Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/40 (2.50%)', ' Hypertension 0/40 (0.00%)', ' Lower GI bleed 1/40 (2.50%)', ' Death 0/40 (0.00%)', ' Headache 0/40 (0.00%)', ' Dyspnea 0/40 (0.00%)', ' Sinusitis 0/40 (0.00%)', ' Wound Dehiscence 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 3/41 (7.32%)', ' Hypertension 1/41 (2.44%)', ' Lower GI bleed 0/41 (0.00%)', ' Death 0/41 (0.00%)', ' Headache 0/41 (0.00%)', ' Dyspnea 0/41 (0.00%)', ' Sinusitis 1/41 (2.44%)', ' Wound Dehiscence 1/41 (2.44%)']}
|
01a57096-0278-4c70-be43-acd57010cd6f
|
Single
|
Intervention
|
NCT02953860
|
Patients in the primary trial receive more mg of Enzalutamide than Fulvestrant over the course of the study.
|
Entailment
|
[
3
] |
[] |
{'Clinical Trial ID': 'NCT02953860', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant With Enzalutamide', ' 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.', ' Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.'], 'Eligibility': ['Inclusion Criteria:', ' ER+ Her2- breast cancer', ' Metastatic', ' Female, at least 18 years of age', ' Candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant', ' Measurable or evaluable by RECIST 1.1', ' ECOG PS 0-2', ' Able to swallow study drug and comply with study requirements', ' Tumor available for fresh biopsy (two biopsies - pretreatment as regards enzalutamide, and during treatment at 4 weeks). The patient will be also be asked if they would be willing to provide a third biopsy at time of progression.', ' If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression. Patients may have already gotten the loading dose of ovarian suppression. Pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screening.', ' ANC >1000/uL and platelets >75,000/uL at screening visit', " Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)", ' Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or < 5 times ULN if patient has documented liver metastases', ' Creatinine < 1.5 times ULN', ' INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy', ' Willing to donate blood for research at 4 time points', ' Written informed consent obtained prior to biopsies and blood samples', ' Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued.', 'Exclusion Criteria:', ' Current or previously treated brain or leptomeningeal metastases', ' History of seizures', ' Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464)', ' Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant', ' To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.', ' Time frame: 24 Weeks', 'Results 1: ', ' Arm/Group Title: Fulvestrant With Enzalutamide', ' Arm/Group Description: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.', ' Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 21.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/32 (6.25%)', ' myocardial infarction [1]1/32 (3.13%)', ' cholecystitis [2]1/32 (3.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
49213077-0a5b-4368-a48a-282d2ca9d77a
|
|
Single
|
Results
|
NCT00263588
|
All the primary trial subjects either had Progressive disease, Complete CNS objective response rate or partial response rate.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26
] |
[] |
{'Clinical Trial ID': 'NCT00263588', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings', 'INTERVENTION 2: ', ' Cohort B', ' 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.'], 'Eligibility': ['Inclusion criteria:', ' Signed Informed Consent', ' ErbB2(HER2)overexpressing breast cancer.', ' Brain lesion(s) which are progressing.', ' Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).', ' Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.', ' Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.', ' Able to swallow an oral medication.', ' Adequate kidney and liver function.', ' Adequate bone marrow function.', 'Exclusion criteria:', ' Pregnant or lactating females.', ' Conditions that would effect the absorption of an oral drug.', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.', ' Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.', " Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent."], 'Results': ['Outcome Measurement: ', ' The Number of Participants With Central Nervous System (CNS) Best Overall Response', ' Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)', ' Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.', ' The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)', ' A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms', ' Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings', ' Overall Number of Participants Analyzed: 94', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response (CR): 0 0.0%', ' Partial response (PR): 6 6.4%', ' Stable disease (SD): 40 42.6%', ' Progressive disease (PD): 40 42.6%', 'Unknown: 8 8.5%', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response (CR): 0 0.0%', ' Partial response (PR): 9 6.3%', ' Stable disease (SD): 46 32.2%', ' Progressive disease (PD): 70 49.0%', ' Unknown: 18 12.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 36/95 (37.89%)', ' Atrial fibrillation 0/95 (0.00%)', ' Cardio-respiratory arrest 1/95 (1.05%)', ' Left ventricular dysfunction 0/95 (0.00%)', ' Pericardial effusion 0/95 (0.00%)', ' Vertigo 0/95 (0.00%)', ' Constipation 1/95 (1.05%)', ' Diarrhoea 6/95 (6.32%)', ' Duodenal ulcer 0/95 (0.00%)', ' Duodenal ulcer haemorrhage 0/95 (0.00%)', ' Gastrointestinal haemorrhage 0/95 (0.00%)', 'Adverse Events 2:', ' Total: 52/147 (35.37%)', ' Atrial fibrillation 1/147 (0.68%)', ' Cardio-respiratory arrest 0/147 (0.00%)', ' Left ventricular dysfunction 1/147 (0.68%)', ' Pericardial effusion 1/147 (0.68%)', ' Vertigo 1/147 (0.68%)', ' Constipation 0/147 (0.00%)', ' Diarrhoea 4/147 (2.72%)', ' Duodenal ulcer 1/147 (0.68%)', ' Duodenal ulcer haemorrhage 1/147 (0.68%)', ' Gastrointestinal haemorrhage 2/147 (1.36%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
426d3ecd-73e3-4226-83c6-cfcb9212ed62
|
|
Single
|
Results
|
NCT00696072
|
20 patients treated with Dasatinib and Letrozole in the primary trial had a Disease Free Interval (DFI) Greater Than 2 Years.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00696072', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib Plus Letrozole', ' Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years', ' Dasatinib 100 mg + Letrozole 2.5 mg', ' Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days', 'INTERVENTION 2: ', ' Letrozole', ' Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years', ' Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days'], 'Eligibility': ['For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.', 'Inclusion Criteria:', ' Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease', ' Has measurable or evaluable-only disease', ' Is female, 18 yrs of age, post menopausal or surgically sterile', ' HER2 negative, HR+, ER+ and/or PgR+ breast cancer', ' 0-1 prior chemotherapy regimen for metastatic disease.', ' Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior', ' Prior tamoxifen therapy is allowed', ' No AI therapy for >1 year without recurrence', 'Exclusion Criteria:', ' Pregnant or breast feeding', ' Prior hormonal therapy for metastatic or locally recurrent disease', ' >1 chemotherapy regimen for metastatic disease', ' Pleural or pericardial effusion', ' Serious cardiac condition'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population', ' CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.', ' Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)', 'Results 1: ', ' Arm/Group Title: Dasatinib Plus Letrozole', ' Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years', ' Dasatinib 100 mg + Letrozole 2.5 mg', ' Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: participants CBR (CR+PR+SD): 40', ' CBR, DFI <= 2 Years: 20', 'CBR, DFI > 2 Years: 20', 'Results 2: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years', ' Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants CBR (CR+PR+SD): 40', ' CBR, DFI <= 2 Years: 20', 'CBR, DFI > 2 Years: 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/57 (24.56%)', ' Anemia * 0/57 (0.00%)', ' CVA * 2/57 (3.51%)', ' Cardiac Insufficiency * 0/57 (0.00%)', ' Congestive Heart Failure * 0/57 (0.00%)', ' Coronary Insufficiency * 1/57 (1.75%)', ' Effusion Pericardial * 0/57 (0.00%)', ' Cholelithiasis * 1/57 (1.75%)', ' Colitis * 0/57 (0.00%)', ' Dehydration * 1/57 (1.75%)', ' Diverticulitis * 0/57 (0.00%)', ' Nausea * 2/57 (3.51%)', 'Adverse Events 2:', ' Total: 2/63 (3.17%)', ' Anemia * 1/63 (1.59%)', ' CVA * 0/63 (0.00%)', ' Cardiac Insufficiency * 1/63 (1.59%)', ' Congestive Heart Failure * 1/63 (1.59%)', ' Coronary Insufficiency * 0/63 (0.00%)', ' Effusion Pericardial * 1/63 (1.59%)', ' Cholelithiasis * 0/63 (0.00%)', ' Colitis * 1/63 (1.59%)', ' Dehydration * 1/63 (1.59%)', ' Diverticulitis * 1/63 (1.59%)', ' Nausea * 0/63 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7c12676c-7973-4e9d-b1fc-3b14d241d0c8
|
|
Comparison
|
Adverse Events
|
NCT01466972
|
NCT01446159
|
the primary trial recorded one patient with congestive Cardiac failure, the secondary trial recorded more.
|
Contradiction
|
[
0,
2
] |
[
0,
5,
13,
18
] |
{'Clinical Trial ID': 'NCT01466972', 'Intervention': ['INTERVENTION 1: ', ' Pazopanib in Combination With a NSAI', ' Non-randomized, open label', ' Pazopanib: Oral, 800mg tablet daily per cycle'], 'Eligibility': ['Inclusion Criteria:', ' Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up.', ' - Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for Screening or Baseline purposes provided these tests are obtained as specified in the protocol).', ' Subjects must have measurable or evaluable disease. Disease sites that are evaluable for progression but not measurable per RECIST guidelines include:', ' Bone lesions', ' Previously irradiated lesions', ' Cutaneous manifestations (non-discreet lesions only)', ' Age 18 years.', ' Postmenopausal women defined by one of the criteria:', ' No spontaneous menses for at least 12 months if the subject is 50 years old;', ' Amenorrheic for at least 12 months if the subject is < 50 years old, with serum estradiol within the institutional postmenopausal range;', ' Bilateral oophorectomy;', ' If prior hysterectomy but intact ovaries, must be 55 years old, or have serum estradiol within the postmenopausal range;', ' If premenopausal, must be on a GnRH agonist (leuprolide or goserelin) with serum estradiol levels within the institutional postmenopausal range.', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.', ' Histologically or cytologically confirmed estrogen receptor (ER) and/or progesterone receptor (PgR) positive carcinoma of the breast with unresectable, locally advanced and/or metastatic (AJCC Stage IV) disease.', ' Subjects must have received prior hormonal therapy for the treatment of breast cancer as follows:', ' Progression must be documented while taking a nonsteroidal aromatase inhibitor including anastrozole or letrozole.', ' No more than 2 prior hormonal therapies for metastatic disease.', ' If hormonal therapy was administered in the adjuvant setting, subjects must have received therapy for at least 6 months prior to developing metastatic disease.', ' Note: A regimen of sequential tamoxifen/AI in the adjuvant setting is considered to be one therapy', ' - If hormonal therapy was administered in the metastatic setting, subjects must have received therapy for at least 3 months prior to progression', ' Subjects whose tumors overexpress ErbB2 are eligible provided that they have progressed following therapy which included trastuzumab and/or lapatinib.', ' Note for prior lapatinib: Subjects must have completed therapy with lapatinib at least 7 days prior to the first dose of study drug.', ' Note for prior trastuzumab: Subjects who received Q3 weekly, Q2 weekly or Q1 weekly must have completed therapy with trastuzumab at least 3 weeks, 2 weeks or 1 week, respectively, prior to the first dose of study drug.', ' Adequate hematologic and hepatic function as defined in Protocol Table 1', ' Subjects must have discontinued hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP or premarin), at least 28 days prior to receiving the first dose of randomized therapy.', ' Radiotherapy prior to initiation of therapy is allowed to a limited area (e.g., palliative treatment for painful bone metastases), if it is not the sole site of disease. Subjects must have completed treatment at least one week prior to starting study drugs, and must have recovered from all treatment-related toxicities.', ' Bisphosphonate or RANK ligand inhibitor therapy for bone metastases is allowed. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted;', ' Ability to swallow and retain oral medication.', 'Exclusion Criteria:', ' Prior use of pazopanib', ' Premenopausal levels of estradiol, or ongoing menses (see definitions of menopause above).', ' Known central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if the subject has clinical findings suggestive of CNS metastasis.', ' History of another active malignancy. Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.', ' Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including, but not limited to:', ' Malabsorption syndrome', ' Major resection of the stomach or small bowel that could affect the absorption of study drug', ' Inflammatory bowel disease', ' Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation', ' History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment', ' Presence of uncontrolled infection.', ' Prolongation of corrected QT interval (QTc) >480msecs.', ' History of any one or more of the following cardiovascular conditions within the past 6 months:', ' Angioplasty or stenting', ' Myocardial infarction', ' Unstable angina', ' Coronary artery by-pass graft surgery', ' Symptomatic peripheral vascular disease', ' Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).', ' Use of an investigational agent, including an investigational anti-cancer agent, within 14 days prior to the first dose of study drug.', ' Prior use of an investigational drug that targets VEGF or VEGF receptors.', ' Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.', ' Poorly controlled hypertension (defined as systolic blood pressure (SBP) of 140mmHg or diastolic blood pressure (DBP) of 90mmHg).', ' Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed prior to start of study therapy. The mean SBP/DBP values must be <140/90mmHg (OR 150/90mmHg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study.', ' History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.', ' Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible.', ' Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer not related to cancer (procedures such as catheter placement not considered to be major).', ' Evidence of active bleeding or bleeding diathesis.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures"], 'Results': ['Outcome Measurement: ', ' Number of Participants With Clinical Benefit (CB)', ' For the purpose of this study, participants who obtained a complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 were defined as having a clinical benefit from the treatment. An overall response rate of 20% was considered to be clinically meaningful. All participants who take at least two weeks of study drug and the non-steroidal aromatase inhibitor were evaluated for toxicity and efficacy', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Pazopanib in Combination With a NSAI', ' Arm/Group Description: Non-randomized, open label', ' Pazopanib: Oral, 800mg tablet daily per cycle', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 13 46.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/30 (26.67%)', ' Heart Failure 1/30 (3.33%)', ' Vertigo 1/30 (3.33%)', ' Small intestinal obstruction 1/30 (3.33%)', ' Fever 1/30 (3.33%)', ' Aspartate aminotransferase increased 1/30 (3.33%)', ' Alanine aminotransferase increased 1/30 (3.33%)', ' Back Pain 1/30 (3.33%)', ' Pleural effusion 1/30 (3.33%)', ' Rash maculo-papular 1/30 (3.33%)', ' Hypotension 1/30 (3.33%)']}
|
{'Clinical Trial ID': 'NCT01446159', 'Intervention': ['INTERVENTION 1: ', ' MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'INTERVENTION 2: ', ' MEDI-573 30 mg/kg + AI', ' Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy', ' Tumors are positive for ER, PgR, or both', ' Tumors must be negative for HER2 (by FISH, CISH or IHC)', ' Female gender and age 18 years at time of study entry', ' Postmenopausal', ' Karnofsky Performance Status 70', ' Life expectancy of 6 months', 'Exclusion Criteria:', ' Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:', ' Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573', ' Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed', ' Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)', ' Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573', ' Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis', ' Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to Grade 1 at the time of starting study treatment', ' Previous treatment with agents that target the IGF receptor', ' History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI', ' History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix', ' Poorly controlled diabetes mellitus'], 'Results': ['Outcome Measurement: ', ' Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', ' An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', ' Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'Results 1: ', ' Arm/Group Title: MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Arm/Group Description: Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 2 66.7%', 'Results 2: ', ' Arm/Group Title: MEDI-573 30 mg/kg + AI', ' Arm/Group Description: Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Febrile neutropenia 1/3 (33.33%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 1/3 (33.33%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/3 (0.00%)', ' Febrile neutropenia 0/3 (0.00%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 0/3 (0.00%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)']}
|
3419e901-5880-488d-912c-023e8d1b51c7
|
Single
|
Intervention
|
NCT00748553
|
Patients in the primary trial receive 50mg/m2, 75mg/m2 and 80mg/m2 daily every 5 days for each 4-week cycle
|
Contradiction
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00748553', 'Intervention': ['INTERVENTION 1: ', ' Phase 1', ' Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle', ' Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle'], 'Eligibility': ['Inclusion Criteria:', ' For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.', ' For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.', ' Her-2/neu negative (Phase II)', ' Negative pregnancy test for female subjects', ' Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.', ' Male or female for phase I and female for phase II, >19 years of age and any race.', 'Exclusion Criteria:', ' Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1', ' Known brain metastases', ' Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)', ' Active infection requiring antibiotic therapy', ' History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane', ' Grade 2 or greater motor or sensory neuropathy', ' Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)', ' Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.', ' Known or suspected hypersensitivity to azacitidine or mannitol', ' Pregnant or breast feeding', ' Patients with advanced malignant hepatic tumors', ' Malignancy other than breast carcinoma (phase II)', ' Known HIV infection or chronic hepatitis B or C'], 'Results': ['Outcome Measurement: ', ' Phase I: Percentage of Participants Responding to Treatment', ' Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Phase 1', ' Arm/Group Description: Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle', ' Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: percent of participants with response 61.5 (35 to 87.95)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
cd645637-0a31-4f54-bc75-4a52349cf100
|
|
Single
|
Adverse Events
|
NCT02115984
|
A total of 3 patients in the primary trial experience a Herpes related adverse event.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT02115984', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy & Panagen', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', 'INTERVENTION 2: ', ' Chemotherapy & Placebo', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).'], 'Eligibility': ['Inclusion Criteria:', ' Signed and dated written informed consent', ' Women at an age of 18 years', ' Stage II-IV breast cancer (with distant metastases)', ' The patients will be subject to chemotherapy with cyclophosphan/doxorubicin/ fluorouracil as a standard chemotherapy for treating breast cancer', ' The patients have not been earlier subject to chemotherapy', ' Functional status according to the Eastern Cooperative Oncology Group (ECOG) 2', ' Leukocyte counts of 3 × 109/L before the treatment course', ' Neutrophil counts of 1.5 × 109/L before the treatment course', ' Platelet counts of 100 × 109/L before the treatment course', ' Adequate heart function', ' Adequate liver function, that is, alanine aminotransferase / aspartate aminotransferase (ALT / AST) activity < 2.5 × upper limit of normal (ULN); acid phosphatase activity < 5 × ULN; and bilirubin concentration < 5 × ULN; and', ' Adequate renal function, that is, the creatinine concentration in the blood serum < 1.5 × ULN; urea concentration < ULN; and endogenous creatinine clearance', 'Exclusion Criteria:', ' Participation in clinical trials less than 30 days before sequential randomization', ' Previous exposure to Panagen or any other leukostimulatory drugs at a stage of clinical development', ' Known hypersensitivity to cyclophosphan, doxorubicin, or fluorouracil', ' Therapy with systemically active antibiotics less than 72 h before the beginning of chemotherapy', ' Long-term oral intake of corticosteroids', ' Previous X-ray therapy performed less than 4 weeks before randomization', ' Previous transplantation of hematopoietic stem cells', ' Other malignant neoplasms during the last 5 years except for basal cell or flat cell carcinoma or intraepithelial carcinoma of the uterine cervix', " Any disease or state that according to the opinion of researcher can influence patient's safety or the estimation of a final trial point; and", ' Pregnant and nursing women; the fertile patients should use chemical or barrier contraceptives during the period of trials'], 'Results': ['Outcome Measurement: ', ' The Quantity of Leukocytes and Neutrophils in the Blood of Patients', ' [Not Specified]', ' Time frame: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)', 'Results 1: ', ' Arm/Group Title: Chemotherapy & Panagen', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 51', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 8.1 (6.5 to 8.8)', ' Leukocytes after the 2nd chemotherapy: 6.6 (5.9 to 7.2)', ' Leukocytes after the 3rd chemotherapy: 5 (4.6 to 5.5)', ' Neutrophils baseline: 5.33 (4.42 to 6.36)', ' Neutrophils after the 2nd chemotherapy: 4.62 (3.43 to 4.82)', ' Neutrophils after the 3rd chemotherapy: 3.19 (1.81 to 3.58)', 'Results 2: ', ' Arm/Group Title: Chemotherapy & Placebo', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 7.2 (6.5 to 7.9)', ' Leukocytes after the 2nd chemotherapy: 4.8 (4.1 to 5.6)', ' Leukocytes after the 3rd chemotherapy: 4.1 (3.8 to 4.4)', ' Neutrophils baseline: 5.2 (4.2 to 6.05)', ' Neutrophils after the 2nd chemotherapy: 2.76 (2.22 to 3.27)', ' Neutrophils after the 3rd chemotherapy: 2.44 (2.31 to 2.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 57/57 (100.00%)', ' Dry eyes 13/33 (39.39%)', ' Heartburn 9/33 (27.27%)', ' Nausea after the CT (before day 7) 57/57 (100.00%)', ' Herpetic eruption 0/33 (0.00%)', ' Dry skin 15/33 (45.45%)', ' Alopecia 57/57 (100.00%)', 'Adverse Events 2:', ' Total: 23/23 (100.00%)', ' Dry eyes 2/11 (18.18%)', ' Heartburn 2/11 (18.18%)', ' Nausea after the CT (before day 7) 23/23 (100.00%)', ' Herpetic eruption 3/11 (27.27%)', ' Dry skin 9/11 (81.82%)', ' Alopecia 23/23 (100.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
adfc79ba-2996-47ce-9986-7d287931df89
|
|
Comparison
|
Results
|
NCT01129336
|
NCT01945775
|
16 participants of the primary trial are considered to be censored. the secondary trial used the same outcome measurement, but had no censored patients.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[
0,
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9,
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11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT01129336', 'Intervention': ['INTERVENTION 1: ', ' Patients Without Bone Metastases', ' Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.', 'INTERVENTION 2: ', ' Patients With Bone Metastases', ' Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Female patients (age 18 years)', ' HER2-negative metastatic breast cancer (stage IV)', ' Patients will be receiving chemotherapy or hormonal therapy', ' Patients with no bone metastasis and 1 prior treatments for metastatic breast cancer. Patients with newly diagnosed metastatic breast cancer may have received adjuvant or neoadjuvant chemotherapy as long as treatment was completed 12 months prior to relapse.', ' Asymptomatic brain metastasis is permitted if all of the following criteria are met:', ' no sign of clinical progression or known progression of brain metastasis', ' off steroids for at least 2 weeks prior to study enrollment', ' Stable renal function: two serum creatinine determinations of <3 mg/dL, obtained no less than 7 days apart (one value may be obtained within 6 weeks prior to Screening; the second must be obtained during Screening)', ' ECOG performance status of 0 or 1', ' Life expectancy of 6 months', ' Negative serum pregnancy test', ' Ability and willingness to comply with all study requirements', 'Exclusion Criteria:', ' Known hypersensitivity to zoledronic acid or other bisphosphonates', ' Patients with history of another malignancy within the last two years prior to study enrollment, except cured basal cell carcinoma of the skin or excised carcinoma in site of the cervix', ' Use of concurrent investigational agents is prohibited. Prior use of investigational agents is permitted if discontinued 30 days prior to Screening.', ' No prior therapy with an antiresorptive agent', ' Patients with active brain metastases or meningeal metastases', ' Current or recent (in the six months prior to initial study drug treatment) severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or poorly controlled Type I/II diabetes mellitus', ' Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw', ' Patients who have received radiotherapy 4 weeks prior to study enrollment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions 2 weeks prior to study enrollment is allowed', ' Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) 4 weeks prior to study enrollment or who have not recovered from side effects of such therapy', ' Diminished renal capacity: calculated creatinine clearance (CrCl) <30 mL/min (based on Cockcroft-Gault formula)', ' Corrected (i.e., adjusted for serum albumin) serum calcium of <8.0 mg/dL (2.00 mmol/L) or 12 mg/dL (3.00 mmol/L)', ' Pregnant or breast-feeding females', ' Women of child-bearing potential who are not willing/able to use effective methods of birth control (e.g., abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)', ' History of non-compliance to medical regimens and/or patients who are considered unreliable', ' History of bone metabolism diseases'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Progression Free Survival (PFS)', ' Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.', ' Time frame: up to 18 months', 'Results 1: ', ' Arm/Group Title: Patients Without Bone Metastases', ' Arm/Group Description: Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: Participants Event: 9', 'Censor: 6', 'Results 2: ', ' Arm/Group Title: Patients With Bone Metastases', ' Arm/Group Description: Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: Participants Event: 19', 'Censor: 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Anaemia 1/15 (6.67%)', ' Rectal haemorrhage 1/15 (6.67%)', ' Chest discomfort 0/15 (0.00%)', ' Hepatic failure 0/15 (0.00%)', ' Extradural abscess 0/15 (0.00%)', ' Osteomyelitis 0/15 (0.00%)', ' Pharyngitis 0/15 (0.00%)', ' Pneumonia 0/15 (0.00%)', ' Sepsis 0/15 (0.00%)', ' Diabetes mellitus 0/15 (0.00%)', ' Hyperkalaemia 0/15 (0.00%)', ' Hyponatraemia 1/15 (6.67%)', 'Adverse Events 2:', ' Total: 7/29 (24.14%)', ' Anaemia 0/29 (0.00%)', ' Rectal haemorrhage 0/29 (0.00%)', ' Chest discomfort 1/29 (3.45%)', ' Hepatic failure 1/29 (3.45%)', ' Extradural abscess 1/29 (3.45%)', ' Osteomyelitis 1/29 (3.45%)', ' Pharyngitis 1/29 (3.45%)', ' Pneumonia 1/29 (3.45%)', ' Sepsis 1/29 (3.45%)', ' Diabetes mellitus 1/29 (3.45%)', ' Hyperkalaemia 1/29 (3.45%)', ' Hyponatraemia 0/29 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01945775', 'Intervention': ['INTERVENTION 1: ', ' Talazoparib', " Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", 'INTERVENTION 2: ', " Physician's Choice Treatment", " Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days."], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy', ' Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor', ' No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)', ' Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated', ' Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', 'Exclusion Criteria:', ' First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject', ' Prior treatment with a PARP inhibitor (not including iniparib)', " Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)", ' Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded', ' Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy', ' Cytotoxic chemotherapy within 14 days before randomization', ' Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization', ' HER2 positive breast cancer', ' Active inflammatory breast cancer', ' CNS metastases', ' Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.', ' Subjects with leptomeningeal carcinomatosis are not permitted', ' Prior malignancy except for any of the following:', ' Prior BRCA-associated cancer as long as there is no current evidence of the cancer', ' Carcinoma in situ or non-melanoma skin cancer', ' A cancer diagnosed and definitively treated 5 years before randomization with no subsequent evidence of recurrence', ' Known to be human immunodeficiency virus positive', ' Known active hepatitis C virus, or known active hepatitis B virus', ' Known hypersensitivity to any of the components of talazoparib'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment', ' IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.', ' Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)', 'Results 1: ', ' Arm/Group Title: Talazoparib', " Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 287', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.6 (7.2 to 9.3)', 'Results 2: ', " Arm/Group Title: Physician's Choice Treatment", " Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 144', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.2 to 6.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/286 (36.01%)', ' Anaemia * 18/286 (6.29%)', ' Neutropenia * 3/286 (1.05%)', ' Thrombocytopenia * 2/286 (0.70%)', ' Febrile neutropenia * 1/286 (0.35%)', ' Leukopenia * 1/286 (0.35%)', ' Pancytopenia * 2/286 (0.70%)', ' Pericardial effusion * 3/286 (1.05%)', ' Atrial flutter * 1/286 (0.35%)', ' Cardiac tamponade * 1/286 (0.35%)', ' Diplopia * 2/286 (0.70%)', ' Vomiting * 5/286 (1.75%)', 'Adverse Events 2:', ' Total: 39/126 (30.95%)', ' Anaemia * 0/126 (0.00%)', ' Neutropenia * 4/126 (3.17%)', ' Thrombocytopenia * 0/126 (0.00%)', ' Febrile neutropenia * 1/126 (0.79%)', ' Leukopenia * 0/126 (0.00%)', ' Pancytopenia * 0/126 (0.00%)', ' Pericardial effusion * 0/126 (0.00%)', ' Atrial flutter * 0/126 (0.00%)', ' Cardiac tamponade * 0/126 (0.00%)', ' Diplopia * 0/126 (0.00%)', ' Vomiting * 2/126 (1.59%)']}
|
414ae027-b420-4f01-afd5-164cd8146a30
|
Single
|
Intervention
|
NCT00470847
|
the primary trial participants will not receive any Lapatinib post WBRT.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00470847', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib,Whole Brain Radiation,Herceptin', ' Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically-confirmed invasive breast cancer', ' HER2 overexpressing breast cancer defined as 3+ staining by immunohistochemistry, or HER2 gene amplification by FISH', ' At least one parenchymal brain metastasis', ' Disease progression in the CNS as assessed by at least one of the following; new neurological signs or symptoms; new lesion(s) in the CNS on an imaging study; progressive lesions on an imaging study', ' At least two weeks since prior radiotherapy, last chemotherapy, immunotherapy, biologic therapy, or major surgery for cancer', ' 18 years of age or older', ' Life expectancy of greater than 12 weeks', ' ECOG performance status 0-2', ' Normal organ and marrow function as described in the protocol', ' Left ventricular ejection fraction > 50%', ' Able to swallow and retain oral medications', 'Exclusion Criteria:', ' Prior WBRT', ' Receiving any other investigational agents', ' Concurrent chemotherapy, immunotherapy, biologic therapy or hormonal therapy for treatment of their cancer', ' History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to herceptin or lapatinib', ' Leptomeningeal carcinomatosis as the only site of CNS involvement', ' Concurrent treatment with medications that are either inducers of inhibitors of CYP3A4', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents', ' Other known contraindication to MRI', ' Uncontrolled intercurrent illness', ' History of other active malignancy except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix', ' Pregnant or breastfeeding women'], 'Results': ['Outcome Measurement: ', ' The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.', ' The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects.', ' Time frame: 5 Years', 'Results 1: ', ' Arm/Group Title: Lapatinib,Whole Brain Radiation,Herceptin', ' Arm/Group Description: Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: milligrams 1250'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/27 (29.63%)', ' Diarrhea 2/27 (7.41%)', ' Vomiting 2/27 (7.41%)', ' Hypoxia 1/27 (3.70%)', ' Sinusitis 1/27 (3.70%)', ' Pulmonary Embolus 2/27 (7.41%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45b2b9ec-ba58-4323-810a-4baed9c84a0e
|
|
Single
|
Eligibility
|
NCT00971945
|
Patients must have already participated in a specific clinical study to participate in the primary trial.
|
Entailment
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT00971945', 'Intervention': ['INTERVENTION 1: ', ' Treatment Arm', ' Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).'], 'Eligibility': ['Inclusion Criteria:', ' Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing Adverse Events', ' This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)', ' Time frame: From first dose to end of follow-up period (up to approximately 33 months)', 'Results 1: ', ' Arm/Group Title: Treatment Arm', ' Arm/Group Description: Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' Nausea 1/6 (16.67%)', ' Vomiting 1/6 (16.67%)', ' Femur fracture 1/6 (16.67%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
72ffdfbf-aa72-4d44-814a-1d6ab8883898
|
|
Single
|
Adverse Events
|
NCT00403130
|
There were no cases of Leukopenia or Arrhythmia observed in patients participating in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00403130', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab + Gemcitabine + Paclitaxel', ' Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles', ' Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles', ' Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles'], 'Eligibility': ['INCLUSION CRITERIA', ' Previously-untreated metastatic breast cancer. May have had prior chest wall irradiation or palliative radiation to bony sites for control of pain or fracture. These sites of disease, however, will not be considered as sites of measurable disease.', ' Use of bisphosphonates will be permitted.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Granulocyte count 1500/mm³', ' Platelet count 100,000/mm³', ' Hemoglobin 8.0 g/dL.', ' Serum glutamic oxaloacetic transaminase (SGOT) / serum glutamic pyruvic transaminase (SGPT) 2.5 x the institutional upper limit of normal (ULN) if alkaline phosphatase is ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are ULN.', ' Total bilirubin within institutional limits of normal.', ' Calculated creatinine clearance 30 mL/min using the formula: Ccr(mL/min) = [(140-age in years) X (wt in kg) X 0.85 (females)]/(72 x serum creatinine in mg/dL)', ' 18 years of age.', ' Prior anthracycline treatment in the adjuvant setting or prior chest wall radiation must have left ventricular ejection fraction (LVEF) within the institutional range of normal as assessed by pre-treatment multigated acquisition (MUGA) scan or echocardiogram (ECHO).', ' All patients must give signed written informed consent.', ' May have received adjuvant therapy as long as therapy complete > 12 months from study entry.', ' Females of childbearing potential must have a negative pregnancy test taken 2 weeks prior to study enrollment, and must consent to the use of effective contraception during the study period and for 6months thereafter.', ' EXCLUSION CRITERIA', ' Receiving hormonal therapy', ' Prior treatment for metastatic disease with cytotoxic agents or inhibitors of epidermal growth factor receptor (EGFR)', ' Her2NEU-positive breast cancers, by either immunohistochemistry (IHC) score 3+ or fluorescence in situ hybridization (FISH)', ' Pregnant or lactating.', ' Patients have had active malignancies other than breast cancer in the past 5 years with the exception of in situ carcinoma of the cervix or nonmelanomatous skin cancer.', ' Active or unresolved infection.', ' Pre-existing peripheral neuropathy > Grade 1.', ' Prior history of severe hypersensitivity reaction to paclitaxel, gemcitabine, bevacizumab or drugs formulated with polysorbate 80.', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.', ' Blood pressure of >150/100 mmHg', ' Unstable angina', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infarction within 6 months', ' History of stroke within 6 months', ' Clinically-significant peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Presence of central nervous system or brain metastases', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study', ' Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0', ' Urine protein:creatinine ratio 1.0 at screening', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0', ' Serious, non-healing wound, ulcer, or bone fracture', ' Inability to comply with study and/or follow-up procedures'], 'Results': ['Outcome Measurement: ', ' Time-to-Progression (TTP)', ' Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab + Gemcitabine + Paclitaxel', ' Arm/Group Description: Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles', ' Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles', ' Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles', ' Overall Number of Participants Analyzed: 9', ' Median (Standard Deviation)', ' Unit of Measure: months 8.9 (5.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/26 (69.23%)', ' Thrombocytopenia * 4/26 (15.38%)', ' Neutropenia * 3/26 (11.54%)', ' Epitasis * 1/26 (3.85%)', ' Peripheral arterial ischemia * 1/26 (3.85%)', ' Thrombosis * [1]1/26 (3.85%)', ' Weakness * 1/26 (3.85%)', ' Pain * [2]2/26 (7.69%)', ' Febrile neutropenia * 1/26 (3.85%)', ' Aspartate Aminotransferase * [3]1/26 (3.85%)', ' Syncope * 1/26 (3.85%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
db613a72-e300-41a7-987f-788c306d94a4
|
|
Single
|
Intervention
|
NCT02202252
|
The difference between cohort 1 and 2 of the primary trial is the insertion of an additional negative pressure drain for patients in cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
5,
10,
5
] |
[] |
{'Clinical Trial ID': 'NCT02202252', 'Intervention': ['INTERVENTION 1: ', ' Single Drain', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', 'INTERVENTION 2: ', ' Double Drain', ' Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer', ' Modified radical mastectomy', 'Exclusion Criteria:', ' Distant metastasis', ' Male breast cancer', 'Bleeding diathesis'], 'Results': ['Outcome Measurement: ', ' Patient Comfort Scale', ' Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).', ' Time frame: Postoperative 5 days', 'Results 1: ', ' Arm/Group Title: Single Drain', ' Arm/Group Description: Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 8)', 'Results 2: ', ' Arm/Group Title: Double Drain', ' Arm/Group Description: Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' Total: 0/30 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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2667d301-2efb-4d92-bc12-ccfc869e4835
|
|
Single
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Adverse Events
|
NCT00934856
|
In total, across both cohorts of the primary trial, there was at least 2 fatigued patients.
|
Contradiction
|
[
0,
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4,
5,
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8,
9,
10,
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13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
[] |
{'Clinical Trial ID': 'NCT00934856', 'Intervention': ['INTERVENTION 1: ', ' MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', 'INTERVENTION 2: ', ' MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)', ' HER2-positive metastatic or locally advanced breast cancer', ' For MBC participants:', ' Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel', ' History of disease progression within 3 months prior to study entry', ' For LABC participants:', ' Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)', 'Exclusion Criteria:', ' Significant cardiac disease', ' Inadequate bone marrow, liver or renal function', ' For MBC participants:', ' Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases', ' Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.', ' For LABC participants:', ' Clinically or radiologically detectable metastasis (M1 disease)', ' Participants for whom surgery as primary intent procedure is the best option to treat their disease', ' Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population', ' DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.', ' Time frame: Cycle 1 (up to 21 days)', 'Results 1: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 2', 'Results 2: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 0/6 (0.00%)', ' Thrombocytopenia * 1/6 (16.67%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 1/6 (16.67%)', ' Cholecystitis * 1/6 (16.67%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 1/6 (16.67%)', ' Thrombocytopenia * 0/6 (0.00%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 0/6 (0.00%)', ' Cholecystitis * 0/6 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
60bff573-0251-4f05-b2b7-dec74c7363cc
|
|
Comparison
|
Eligibility
|
NCT01581619
|
NCT01008150
|
histologically confirmed extensive intraductal component of primary breast carcinoma would result in exclusion from the primary trial, but not from the secondary trial.
|
Entailment
|
[
4,
10
] |
[
0,
1,
2,
3,
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5,
6,
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20,
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22,
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25,
26,
27,
28,
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33,
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42,
43
] |
{'Clinical Trial ID': 'NCT01581619', 'Intervention': ['INTERVENTION 1: ', ' Partial Breast Irradiation', ' Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks', ' External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks'], 'Eligibility': ['Inclusion Criteria:', ' Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography', ' Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen', ' Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery', 'Exclusion Criteria:', ' No distant metastasis', ' Not pregnant or breastfeeding', ' No diffuse suspicious microcalcifications', ' No prior radiation therapy to the ipsilateral or contralateral breast or thorax', ' No histologic evidence of lymphovascular invasion (LVI)', ' No histologic evidence of EIC', ' No history of cosmetic or reconstructive breast surgery', ' No psychiatric illness that would prevent the patient from giving informed consent', ' No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient', ' No other currently active second malignancy other than non-melanoma skin cancers'], 'Results': ['Outcome Measurement: ', ' Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks', ' The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.', ' Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.', ' The development of clinical fat necrosis.', ' The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.', ' The data is shown as the number of participants that experienced each of the specific toxicities.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Partial Breast Irradiation', ' Arm/Group Description: Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks', ' External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 3 or 4 Skin/ Subcutaneous toxicity: 0 0.0%', ' Grade 3 or 4 Pulmonary Toxicity: 0 0.0%', ' Fat Necrosis: 0 0.0%', ' Rib fractures on ipsilateral treated side: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/53 (3.77%)', ' Seroma 1/53 (1.89%)', ' Skin Infection [1]1/53 (1.89%)']}
|
{'Clinical Trial ID': 'NCT01008150', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Paclitaxel + Trastuzumab Then A C', ' 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Trastuzumab', ' Doxorubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm 2: Paclitaxel + Neratinib Then A C', ' 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Neratinib', ' Doxorubicin', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer.', ' Submission of a block from the diagnostic biopsy sample and from the surgical sample, if gross residual disease greater than or equal to 1.0 cm was removed at the time of surgery, is required for all patients', ' Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.', ' The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.', ' Patients must have the ability to swallow oral medication.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Breast cancer must be determined to be HER2-positive prior to randomization. Assays using FISH or CISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.', ' Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1; cT3 and cN0 or cN1; Any cT and cN2 or cN3; or cT4', ' The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL', " The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and aspartate aminotransferase (AST) and ALT must be less than or equal to 1.5 x ULN for the lab.", ' Patients with alkaline phosphatase greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements for adequate hepatic function are met.', ' Patients with either unexplained skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.', ' Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.', " The left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multiple gated acquisition(MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's LLN.", 'Exclusion Criteria:', ' fine-needle aspiration (FNA) alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to randomization.', ' Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.)', ' Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 90 days prior to randomization.)', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiation therapy (RT). (Patients with a history of LCIS are eligible.)', ' Contralateral invasive breast cancer at any time. (Patients with contralateral DCIS or lobular carcinoma in situ (LCIS) are eligible.)', ' History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.', ' Known metastatic disease from any malignancy (solid tumor or hematologic).', ' Previous therapy with anthracyclines, taxanes, cyclophosphamide, trastuzumab, or neratinib for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.', ' Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)', ' Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.', ' Active hepatitis B or hepatitis C with abnormal liver function tests.', ' Intrinsic lung disease resulting in dyspnea.', ' Active infection or chronic infection requiring chronic suppressive antibiotics.', ' Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function.', ' Persistent greater than or equal to grade 2 diarrhea regardless of etiology.', ' Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.', ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).', ' Uncontrolled hypertension defined as a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)', ' Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; history of documented congestive heart failure (CHF); and documented cardiomyopathy.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Pregnancy or lactation at the time of randomization.', ' The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.', ' Use of any investigational agent within 4 weeks prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response in Breast and Axillary Lymph Nodes.', ' Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy', ' Time frame: At time of surgery, approximately 7 months', 'Results 1: ', ' Arm/Group Title: Arm 1: Paclitaxel + Trastuzumab Then A C', ' Arm/Group Description: 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Trastuzumab', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 16 38.1%', 'Results 2: ', ' Arm/Group Title: Arm 2: Paclitaxel + Neratinib Then A C', ' Arm/Group Description: 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Neratinib', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 14 33.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/42 (16.67%)', ' Febrile neutropenia 1/42 (2.38%)', ' Left venrticular dysfunction 1/42 (2.38%)', ' Cardiac valve disease 1/42 (2.38%)', ' Diarrhoea 0/42 (0.00%)', ' Abdominal pain 1/42 (2.38%)', ' Colitis 0/42 (0.00%)', ' Nausea 0/42 (0.00%)', ' Vomiting 0/42 (0.00%)', ' Pyrexia 0/42 (0.00%)', ' Influenza like illness 1/42 (2.38%)', ' Oedema peripheral 1/42 (2.38%)', ' Fatigue 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 7/42 (16.67%)', ' Febrile neutropenia 0/42 (0.00%)', ' Left venrticular dysfunction 1/42 (2.38%)', ' Cardiac valve disease 0/42 (0.00%)', ' Diarrhoea 0/42 (0.00%)', ' Abdominal pain 0/42 (0.00%)', ' Colitis 0/42 (0.00%)', ' Nausea 0/42 (0.00%)', ' Vomiting 0/42 (0.00%)', ' Pyrexia 2/42 (4.76%)', ' Influenza like illness 0/42 (0.00%)', ' Oedema peripheral 0/42 (0.00%)', ' Fatigue 0/42 (0.00%)']}
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f6f8a0d3-6288-44cf-9b34-27444110dd10
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Comparison
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Intervention
|
NCT00572728
|
NCT02472964
|
Patients in the primary trial and the secondary trial will take Herceptin© (trastuzumab) or paclitaxel intravenously.
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Contradiction
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[
0,
1,
2,
3,
4,
5,
6
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[
0,
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{'Clinical Trial ID': 'NCT00572728', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic (18F-FLT)', ' Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.', ' Fluorothymidine F-18: Undergo 18F-FLT PET/CT', ' Positron Emission Tomography: Undergo 18F-FLT PET/CT', ' Computed Tomography: Undergo 18F-FLT PET/CT', ' Laboratory Biomarker Analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy', ' Locally advanced breast cancer, not stage IV, and with a tumor size >= 2 cm (as measured on imaging or estimated by physical exam)', ' No obvious contraindications for primary chemotherapy', ' Residual tumor planned to be removed surgically following completion of neoadjuvant therapy', ' Able to lie still for 1.5 hours for PET scanning', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Leukocytes >= 3,000/ul', ' Absolute neutrophil count >= 1,500/ul', ' Platelets >= 100,000/ul', ' Total bilirubin within normal institutional limits', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times the institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal', ' If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation', ' Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines', 'Exclusion Criteria:', ' Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Medically unstable', ' Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine', ' Pregnant or nursing', ' Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years', ' Currently on hormone therapy as the primary systemic neoadjuvant therapy'], 'Results': ['Outcome Measurement: ', ' %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response', ' The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies', ' Time frame: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)', 'Results 1: ', ' Arm/Group Title: Diagnostic (18F-FLT)', ' Arm/Group Description: Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.', ' Fluorothymidine F-18: Undergo 18F-FLT PET/CT', ' Positron Emission Tomography: Undergo 18F-FLT PET/CT', ' Computed Tomography: Undergo 18F-FLT PET/CT', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: percentage change of SUVmax 38.78 (26.07)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/90 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02472964', 'Intervention': ['INTERVENTION 1: ', ' Herceptin© + Taxane', ' Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .', 'INTERVENTION 2: ', ' MYL-1401O Trastuzumab + Taxane', ' Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Locally recurrent or MBC that is not amenable to curative surgery and/or radiation.', ' Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization. Archival tumor tissue samples can be used.', ' Pathologically confirmed breast cancer with at least one measurable metastatic target lesion (based on RECIST criteria, version 1.1). Bone, central nervous system (CNS), and skin lesions, as well as lesions that were irradiated, biopsied or had any form of local intervention or surgical manipulation are only to be assessed as non-target lesions.', ' Patients previously treated with trastuzumab or lapatinib in the adjuvant setting are allowed if metastatic disease was diagnosed at least one year after the last dose of treatment.', ' Prior treatment with hormonal agents or bisphosphonates/denosumab is allowed. Bisphosphonates/denosumab can be given simultaneously with study treatment but cannot start after randomization and is considered an indication of progressive disease (PD). Hormonal agents must be discontinued prior to beginning study therapy.', ' Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 2', ' Serum creatinine 1.5 x ULN (upper limit of normal),', " Total bilirubin 1.0 x ULN (>1.0 x ULN if documented Gilbert's disease),", ' Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 2.5 x ULN,', ' AST and/or ALT <1.5 x ULN if alkaline phosphatase >2.5 x ULN,', ' Alkaline phosphatase >2.5 x ULN;if bone metastases present and no liver dysfunction present.', ' Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by multiple gated acquisition scan or echocardiogram.', 'Exclusion Criteria:', ' Prior systemic therapy in the metastatic disease setting. This includes: chemotherapy, signal transduction inhibitors (e.g., lapatinib), HER2 targeted therapy (e.g., trastuzumab), or other investigational anticancer therapy.', ' Prior treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2.', ' Patients with bone or skin as the only site of disease. Patients with skin lesions measurable by CT scans or MRI as only site of measurable disease are allowed.', ' Surgery or radiotherapy 2 weeks preceding Day 1. Target lesions have to be outside the irradiated fields and the patient has fully recovered from surgery or radiotherapy.', ' Presence of unstable angina or a history of congestive heart failure according to the New York Heart Association criteria, history of myocardial infarction <1 year from randomization, clinically significant valvular disease, serious cardiac arrhythmia requiring treatment, uncontrolled hypertension or known pulmonary hypertension.', ' Peripheral sensory or motor neuropathy Grade 2 or higher according to the National Cancer Institute-Common Terminology Criteria (NCI-CTC) Version 4.03 [19].', ' Any other cancer, including contralateral breast cancer, within 5 years prior to screening with the exception of adequately treated ductal carcinoma in situ, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.', ' Immunocompromized patients, including known seropositivity for human immunodeficiency virus, or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen or antibody to hepatitis C virus with confirmatory testing).', ' Complete listing of Inc/Excl. within protocol'], 'Results': ['Outcome Measurement: ', ' Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population', ' Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.', ' Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.', ' Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.', ' Time frame: from time of First treatment to week 24', 'Results 1: ', ' Arm/Group Title: Herceptin + Taxane', ' Arm/Group Description: Part 1: Herceptin (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .', ' Overall Number of Participants Analyzed: 228', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 0 0.0%', ' Partial Response: 146 64.0%', ' Stable Disease: 49 21.5%', ' Progressive Disease: 20 8.8%', ' Not Evaluable: 13 5.7%', 'Results 2: ', ' Arm/Group Title: MYL-1401O Trastuzumab + Taxane', ' Arm/Group Description: Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.', ' Overall Number of Participants Analyzed: 230', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 3 1.3%', ' Partial Response: 157 68.3%', ' Stable Disease: 48 20.9%', ' Progressive Disease: 9 3.9%', ' Not Evaluable: 13 5.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 91/246 (36.99%)', ' Febrile Neutropenia 10/246 (4.07%)', ' Leukopenia 12/246 (4.88%)', ' Neutropenia 62/246 (25.20%)', ' Pancytopenia 0/246 (0.00%)', ' Thrombocytopenia 1/246 (0.41%)', ' Acute Myocardial Infarction 0/246 (0.00%)', ' Cardiac Failure 0/246 (0.00%)', ' Carditis 0/246 (0.00%)', ' Abdominal Pain 0/246 (0.00%)', ' Anal Fissure 0/246 (0.00%)', ' Diarrhoea 4/246 (1.63%)', 'Adverse Events 2:', ' Total: 97/247 (39.27%)', ' Febrile Neutropenia 11/247 (4.45%)', ' Leukopenia 5/247 (2.02%)', ' Neutropenia 68/247 (27.53%)', ' Pancytopenia 1/247 (0.40%)', ' Thrombocytopenia 0/247 (0.00%)', ' Acute Myocardial Infarction 1/247 (0.40%)', ' Cardiac Failure 2/247 (0.81%)', ' Carditis 1/247 (0.40%)', ' Abdominal Pain 1/247 (0.40%)', ' Anal Fissure 1/247 (0.40%)', ' Diarrhoea 3/247 (1.21%)']}
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8b0482c1-74d4-48ae-96bc-d80f8f1a0f50
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Single
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Eligibility
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NCT00836186
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Patients cannot be excluded from the primary trial on the basis of race or ethnicity.
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Entailment
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[
0,
6
] |
[] |
{'Clinical Trial ID': 'NCT00836186', 'Intervention': ['INTERVENTION 1: ', ' Radiation Therapy', ' Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.', ' Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.'], 'Eligibility': ['INCLUSION CRITERIA:', ' Patient must be 18 years of age or older', ' Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T, any N, M0 disease', ' Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved.', ' Patients must be registered such that radiation therapy begins within 10 weeks of last surgery', ' Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult', ' Women of all races and ethnic groups are eligible for this trial', 'EXCLUSION CRITERIA:', ' Patients must not have received prior radiation therapy to the breast at any time for any reason', ' Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible', ' Patients treated with a mastectomy are NOT eligible', ' Any patient with active local-regional disease prior to registration is not eligible', ' No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years', ' Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy', ' Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment'], 'Results': ['Outcome Measurement: ', ' Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy', ' Number of proteins that are expressed differently in response to receiving radiation therapy for breast cancer. The data reflect the total number of proteins pooled across all participants.', ' Time frame: 2 - 4 weeks post radiation therapy', 'Results 1: ', ' Arm/Group Title: Radiation Therapy', ' Arm/Group Description: Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.', ' Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.', ' Overall Number of Participants Analyzed: 65', ' Measure Type: Number', ' Unit of Measure: Proteins 31'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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878dcfeb-c3db-4077-9a3e-8098efa80a99
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Comparison
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Eligibility
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NCT04396665
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NCT00493636
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Any patient can enter into the primary trial or the secondary trial; as long as they are willing to provide Informed consent and are capable of using the internet.
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Contradiction
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[
0,
1,
2,
3,
4
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[
0,
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17,
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19,
20,
21,
22,
23,
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25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38
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{'Clinical Trial ID': 'NCT04396665', 'Intervention': ['INTERVENTION 1: ', ' Intervention Group', ' Women in the intervention group', 'INTERVENTION 2: ', ' Control Group', ' Women in the control group'], 'Eligibility': ['Inclusion Criteria:', ' Informed consent signed', ' Capability to use internet', 'Exclusion Criteria:', ' Breast cancer diagnosis duting the intervention'], 'Results': ['Outcome Measurement: ', ' Feasibility of an Educational Intervention: Adherence to the Intervention', ' Participants that finish the intervention', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Intervention Group', ' Arm/Group Description: Women in the intervention group', ' Overall Number of Participants Analyzed: 134', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 99 73.9%', 'Results 2: ', ' Arm/Group Title: Control Group', ' Arm/Group Description: Women in the control group', ' Overall Number of Participants Analyzed: 90', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 83 92.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
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{'Clinical Trial ID': 'NCT00493636', 'Intervention': ['INTERVENTION 1: ', ' A (Sorafenib + Gemcitabine or Capecitabine)', ' Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', 'INTERVENTION 2: ', ' B (Placebo + Gemcitabine or Capecitabine)', ' Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast.', ' Measurable or evaluable locally advanced or metastatic disease.', ' Age 18 years.', ' Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.', ' Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.', ' No more than one prior chemotherapy regimen for locally advanced or metastatic disease.', ' Prior hormonal therapy allowed provided it has been discontinued prior to randomization.', ' Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.', ' ECOG Performance Status of 0 or 1.', ' Adequate bone marrow, liver, and renal function', ' Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.', ' Patients must be able and willing to sign a written informed consent.', ' Patients must be able to swallow and retain oral medication.', 'Exclusion Criteria:', ' Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.', ' Patients with active brain metastases.', ' Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.', ' Prior use of gemcitabine/capecitabine or sorafenib.', ' Evidence or history of bleeding diathesis or coagulopathy.', ' Serious, non-healing wound, ulcer, or bone fracture.', " Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.", ' Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.', ' Clinically significant cardiac disease', ' Uncontrolled hypertension', ' Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.', ' Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks of randomization.', ' Any other hemorrhage/bleeding event NCI-CTCAE Grade 3 within 4 weeks of randomization.', ' Active clinically serious infection > NCI-CTCAE Grade 2.', ' Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).', ' Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years prior to randomization.', ' Known or suspected allergy to sorafenib or gemcitabine/capecitabine.', " Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.", ' Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.', ' Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.', ' Women who are pregnant or breast-feeding.', ' Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.', ' Inability to comply with protocol and/or not willing or not available for follow-up assessments.', " Any condition which in the investigator's opinion makes the patient unsuitable for the study participation."], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' [Not Specified]', ' Time frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.', 'Results 1: ', ' Arm/Group Title: A (Sorafenib + Gemcitabine or Capecitabine)', ' Arm/Group Description: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', ' Overall Number of Participants Analyzed: 81', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 103 (83 to 128)', 'Results 2: ', ' Arm/Group Title: B (Placebo + Gemcitabine or Capecitabine)', ' Arm/Group Description: Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', ' Overall Number of Participants Analyzed: 79', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 81 (48 to 95)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/79 (40.51%)', ' Febrile neutropenia * 2/79 (2.53%)', ' Neutropenia * 0/79 (0.00%)', ' Vomiting * 3/79 (3.80%)', ' Abdominal pain * 1/79 (1.27%)', ' Nausea * 2/79 (2.53%)', ' Diarrhea * 2/79 (2.53%)', ' Constipation * 0/79 (0.00%)', ' Stomatitis * 2/79 (2.53%)', ' Disease progression * 2/79 (2.53%)', ' Pyrexia * 1/79 (1.27%)', ' Fatigue * 3/79 (3.80%)', ' Mucosal inflammation * 2/79 (2.53%)', 'Adverse Events 2:', ' Total: 28/77 (36.36%)', ' Febrile neutropenia * 0/77 (0.00%)', ' Neutropenia * 2/77 (2.60%)', ' Vomiting * 2/77 (2.60%)', ' Abdominal pain * 3/77 (3.90%)', ' Nausea * 2/77 (2.60%)', ' Diarrhea * 1/77 (1.30%)', ' Constipation * 2/77 (2.60%)', ' Stomatitis * 0/77 (0.00%)', ' Disease progression * 2/77 (2.60%)', ' Pyrexia * 3/77 (3.90%)', ' Fatigue * 0/77 (0.00%)', ' Mucosal inflammation * 0/77 (0.00%)']}
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fc5dbfec-ba79-4c5d-9e38-3c97d0397570
|
Comparison
|
Adverse Events
|
NCT01234337
|
NCT00217672
|
No cases of Anaphylaxis occurred in either the primary trial or the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
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17,
18,
19,
20,
21,
22,
23
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[
0,
1,
2,
3,
4,
5,
6,
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8,
9,
10,
11
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{'Clinical Trial ID': 'NCT01234337', 'Intervention': ['INTERVENTION 1: ', ' Sorafenib (Nexavar, BAY43-9006) + Capecitabine', ' Sorafenib tablets were administered orally continuously at a total daily dose of 600 mg (200 mg in the morning, 400 mg in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and sorafenib dose to a total daily dose of 800 mg for that participant.', 'INTERVENTION 2: ', ' Placebo + Capecitabine', ' Placebo tablets matching with sorafenib were administered orally continuously (1 tablet in the morning, 2 tablets in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that participant.'], 'Eligibility': ['Inclusion Criteria:', ' Age is >=18 years', ' Subject has histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast. HER2 status should be determined by an accredited laboratory', ' Subject has locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. Must have measurable or non-measurable disease (according to RECIST [Response Evaluation Criteria for Solid Tumors] 1.1)', ' All computer tomography (CT; with contrast) and magnetic resonance imaging (MRI) used to document disease must have been done <= 4 weeks before randomization. Bone scans (if clinically indicated) must have been done <= 12 weeks prior to randomization', ' Subject must have received up to two prior chemotherapy regimens (adjuvant/neo-adjuvant treatments are considered one regimen), and no more than one prior regimen for advanced and/or metastatic disease. Chemotherapy regimens include both targeted and biologic therapy', ' Prior regimens must have included an anthracycline (eg, doxorubicin, epirubicin) and a taxane (eg, paclitaxel, docetaxel), either in combination or in separate regimens, in either the neo-adjuvant/adjuvant or the metastatic setting or both, as either monotherapy or as part of a combination with another agent. Sequential regimens will count as a single regimen; multiple neo-adjuvant / adjuvant regimens will count as a single regimen', ' Subjects are either resistant to or have failed prior taxane and anthracycline OR Resistant to or have failed prior taxane AND for whom further anthracycline therapy is not indicated (for example, intolerance or cumulative doses of doxorubicin or doxorubicin equivalents [for example, epirubicin)', ' Subjects who relapse beyond 12 months after the last taxane or anthracycline dose given in the adjuvant, neo-adjuvant, or metastatic setting are eligible. Further therapy with the agent(s) for a subsequent regimen must have been considered and ruled out, for example due to prior toxicity or intolerance, or based on the local standard of practice', ' Prior experimental chemotherapy treatment is allowed, provided it is given in combination with at least one drug approved for the treatment of breast cancer (excluding drugs that target VEGF [Vascular Endothelial Growth Factor] or VEGFR [Vascular Endothelial Growth Factor Receptor], eg, bevacizumab, brivanib, sunitinib, vatalinib).', ' Prior hormonal therapy for locally advanced or metastatic breast cancer is allowed. Subjects who are refractory to hormonal therapy are allowed.', ' Prior neo-adjuvant or adjuvant chemotherapy is allowed.', ' Subject must have discontinued prior chemotherapy (including both targeted and biologic therapies), prior therapeutic radiation therapy, or prior hormonal therapy for locally advanced or metastatic disease >= 4 weeks (28 days) before randomization. Start of study treatment is allowed within less than 28 days of the prior therapy provided that 5 half-lives of the prior treatment drug(s) have elapsed', ' ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1', ' Adequate bone marrow, liver and renal function within 7 days prior to randomization', ' All acute toxic effects of any prior treatment have resolved to NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) v4.0 Grade 1 or less', ' Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization', ' Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF (Informed Consent Form) until at least 30 days after the last dose of study drug.', ' Subject must be able to swallow and retain oral medication', 'Exclusion Criteria:', ' HER2 positive breast cancer', ' Unknown hormone receptor status (estrogen and progesterone receptor).', ' Subjects with bilateral breast cancer or a history of two distinct breast cancers.', ' Subjects with inflammatory breast carcinoma.', ' Subjects who have received no prior taxane and anthracycline for the treatment of breast cancer (either in adjuvant, neo-adjuvant or metastatic setting).', ' Prior use of sorafenib or capecitabine', ' Subjects considered by the treating investigator to be appropriate candidates for hormonal therapy as current treatment for locally advanced/metastatic breast cancer', ' Subjects with locally advanced disease who are considered by the treating investigator to be appropriate candidates for radiation therapy as current treatment for locally advanced breast cancer', ' Subjects with active brain metastases or leptomeningeal disease.', ' Subjects with seizure disorder requiring medication.', ' Radiation to any lesions <= 4 weeks prior to randomization. Palliative radiation to bone metastasis for pain control is permitted with provisions', ' Major surgery, open biopsy, or significant traumatic injury <= 4 weeks', ' Evidence or history of bleeding diathesis or coagulopathy. Uncontrolled hypertension, active or clinically significant cardiac disease. Subject with thrombotic, embolic, venus or arterial events', ' Subjects with any hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks before randomization', ' Subjects with an infection of NCI-CTCAE v4.0 > Grade 2', ' Subjects with a history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection.', " Subjects who have used strong CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, St. John's Wort [Hypericum perforatum], dexamethasone at a dose of greater than 16 mg daily, or rifampin [rifampicin], and/or rifabutin) within 28 days before randomization.", ' Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer', ' Subjects with a history DHPD (Dihydropyrimidine dehydrogenase) reaction to fluropyrimidine or history of known or suspected allergy or hypersensitivity to any of the study drugs', ' Presence of a non-healing wound, non-healing ulcer, or bone fracture', ' Women pregnant or breast feeding', " Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation"], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1', ' PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.', ' Time frame: From randomization of the first participant until approximately 3 years or until disease radiological progression', 'Results 1: ', ' Arm/Group Title: Sorafenib (Nexavar, BAY43-9006) + Capecitabine', ' Arm/Group Description: Sorafenib tablets were administered orally continuously at a total daily dose of 600 mg (200 mg in the morning, 400 mg in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and sorafenib dose to a total daily dose of 800 mg for that participant.', ' Overall Number of Participants Analyzed: 266', ' Median (95% Confidence Interval)', ' Unit of Measure: days 166 (131 to 206)', 'Results 2: ', ' Arm/Group Title: Placebo + Capecitabine', ' Arm/Group Description: Placebo tablets matching with sorafenib were administered orally continuously (1 tablet in the morning, 2 tablets in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that participant.', ' Overall Number of Participants Analyzed: 271', ' Median (95% Confidence Interval)', ' Unit of Measure: days 165 (126 to 204)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 80/260 (30.77%)', ' Anaemia * 2/260 (0.77%)', ' Febrile neutropenia * 0/260 (0.00%)', ' Neutropenia * 2/260 (0.77%)', ' Thrombocytopenia * 0/260 (0.00%)', ' Bundle branch block right * 0/260 (0.00%)', ' Pericardial effusion * 0/260 (0.00%)', ' Cardiopulmonary failure * 0/260 (0.00%)', ' Aplasia * 0/260 (0.00%)', ' Eye symptom * 1/260 (0.38%)', ' Abdominal discomfort * 0/260 (0.00%)', 'Adverse Events 2:', ' Total: 71/267 (26.59%)', ' Anaemia * 2/267 (0.75%)', ' Febrile neutropenia * 1/267 (0.37%)', ' Neutropenia * 0/267 (0.00%)', ' Thrombocytopenia * 1/267 (0.37%)', ' Bundle branch block right * 1/267 (0.37%)', ' Pericardial effusion * 5/267 (1.87%)', ' Cardiopulmonary failure * 1/267 (0.37%)', ' Aplasia * 1/267 (0.37%)', ' Eye symptom * 0/267 (0.00%)', ' Abdominal discomfort * 1/267 (0.37%)']}
|
{'Clinical Trial ID': 'NCT00217672', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel + Bevacizumab', ' docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.'], 'Eligibility': ['Inclusion Criteria', ' Female 18 and over', ' Histologically or cytologically confirmed adenocarcinoma of the breast at first diagnosis', ' Stage IV disease, with at least one measurable lesion according to the RECIST criteria.', ' HER2-negative disease, by fluorescence in situ hybridization', ' ECOG performance status 0-1', ' Life expectancy of at least 24 weeks', ' No prior chemotherapy for metastatic breast cancer (prior endocrine therapy is permitted).', ' Prior adjuvant chemotherapy is permitted. If patients received a taxane in the adjuvant setting, at least 12 months must have elapsed since the completion of adjuvant therapy.', ' At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy, with complete recovery from the effects of these interventions', ' If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment for at least 3 months thereafter.', ' Patient is accessible and willing to comply with treatment and follow-up.', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures.', ' Required laboratory values', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hemoglobin 9.0 g/dL', ' Creatinine 2.0 mg/dL', " Total bilirubin < 1.0 x upper limit of normal (ULN) (patients with documents Gilbert's syndrome are eligible).", ' Alkaline phosphatase (AP) normal AND Angiotensin Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) 2.5 times upper limit of normal (ULN) or AP 2.5 times ULN AND AST or ALT 1.5 times ULN or AP 5 times ULN AND AST or ALT normal.', ' Exclusion Criteria', ' Prior chemotherapy for metastatic breast cancer', ' Prior treatment with an anti-angiogenic agent', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Current or prior history of central nervous system or brain metastases', ' Presence of neuropathy > grade 2 (NCI- Common Toxicity Criteria (CTC) version 3.0) at baseline', ' Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [BP > 150/100]), myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications.', ' Inability to comply with the study protocol or follow-up procedures', ' Pregnancy or lactation', ' A history of a severe hypersensitivity reaction to Bevacizumab, or Docetaxel or other drugs formulated with polysorbate 80.', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to beginning therapy', ' Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24 hour urine collection, which must be an adequate collection and must demonstrate <1 gm of protein/24 hour to allow participation in the study.'], 'Results': ['Outcome Measurement: ', ' Antitumor Activity Based on Time to Tumor Progression (TTP).', ' [Not Specified]', ' Time frame: From randomization until tumor progression', 'Results 1: ', ' Arm/Group Title: Docetaxel + Bevacizumab', ' Arm/Group Description: docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.', ' Overall Number of Participants Analyzed: 67', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.3 (8.2 to 12.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/74 (17.57%)', ' neutropenia 1/74 (1.35%)', ' left ventricular dysfunction 1/74 (1.35%)', ' fistula enterovesical 1/74 (1.35%)', ' constipation and hypokalemia 1/74 (1.35%)', ' nausea, vomiting and burning abdominal pain 2/74 (2.70%)', ' Infection 1/74 (1.35%)', ' febrile neutropenia 3/74 (4.05%)', ' speech impairment 1/74 (1.35%)', ' dyspnea, pain 1/74 (1.35%)', ' hemorrhage/bleeding 2/74 (2.70%)']}
|
a8514489-cb31-4c8a-abca-e1f7b3a8d4ce
|
Comparison
|
Intervention
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NCT03210220
|
NCT00290745
|
Unlike the primary trial, the secondary trial has no control group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6
] |
{'Clinical Trial ID': 'NCT03210220', 'Intervention': ['INTERVENTION 1: ', ' Pecs Group', ' Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .', 'INTERVENTION 2: ', ' Control Group', 'There is no block.'], 'Eligibility': ['Inclusion Criteria:', ' American Society of Anesthesiologists( ASA) I or II Scheduled for breast cancer surgery', 'Exclusion Criteria:', ' Sensitivity to local anesthetic, Bleeding disorders , Receiving anticoagulant, Body mass index (BMI) > 35/kg/m2 , Spine or chest wall deformity , Pregnancy'], 'Results': ['Outcome Measurement: ', ' Intraoperative Remifentanil Consumption', ' Intraoperative remifentanil consumption during surgery(whole intraoperative period)', ' Time frame: whole intraoperative period', 'Results 1: ', ' Arm/Group Title: Pecs Group', ' Arm/Group Description: Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: μg/kg/h 6.75 (2.18)', 'Results 2: ', ' Arm/Group Title: Control Group', ' Arm/Group Description: There is no block.', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: μg/kg/h 10.12 (3.68)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/19 (0.00%)', 'Adverse Events 2:', ' Total: 0/20 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00290745', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen or Letrozole', ' tamoxifen or letrozole work in treating women with ductal carcinoma in situ', ' letrozole', ' tamoxifen citrate', ' conventional surgery', ' neoadjuvant therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy', ' No evidence of contralateral breast disease or palpable masses on breast examination', ' No presence or suspicion of invasive cancer, including contralateral invasive cancer, on core biopsy and MRI', ' No documented ipsilateral axillary adenopathy', ' Planning to undergo lumpectomy or mastectomy', ' Estrogen receptor (ER)-positive tumor by immunohistochemistry', ' PATIENT CHARACTERISTICS:', ' Female patient', ' Premenopausal or postmenopausal', ' Postmenopausal is defined by any of the following:', ' No spontaneous menses for >= 1 year', ' Bilateral oophorectomy', ' Radiation castration and amenorrheic for >= 3 months', ' Follicle-stimulating hormone (FSH) > 20 IU/L AND off all hormonal therapy (e.g., hormone replacement therapy or birth control pills) for >= 1 month', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No co-morbidities contraindicating the use of tamoxifen, including any of the following:', ' Prior history of thrombotic events', ' History of hypercoagulable state', ' History of endometrial hyperplasia', ' Abnormal vaginal bleeding', ' No history of contrast dye-related allergies/reactions', ' No history of metal-containing prostheses or implants', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography', ' Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes', ' Time frame: Baseline and 6 months', 'Results 1: ', ' Arm/Group Title: Tamoxifen or Letrozole', ' Arm/Group Description: tamoxifen or letrozole work in treating women with ductal carcinoma in situ', ' letrozole', ' tamoxifen citrate', ' conventional surgery', ' neoadjuvant therapy', ' Overall Number of Participants Analyzed: 54', ' Median (Inter-Quartile Range)', ' Unit of Measure: change in tumor volume (mm) -5.0 (-10.4 to 0.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}
|
64411610-090b-42d2-a176-d2b13ffef591
|
Comparison
|
Intervention
|
NCT02364388
|
NCT01425268
|
warm saline solution is used in both the primary trial and the secondary trial.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT02364388', 'Intervention': ['INTERVENTION 1: ', ' MAESTRO', 'Baseline'], 'Eligibility': ['Inclusion Criteria', ' Female', ' 18 years of age or older', ' Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan', 'Exclusion Criteria:', ' Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos)', ' Pregnant or lactating', ' Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU'], 'Results': ['Outcome Measurement: ', ' OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses', ' Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation.', ' Time frame: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.', 'Results 1: ', ' Arm/Group Title: MAESTRO', ' Arm/Group Description: Baseline', ' Overall Number of Participants Analyzed: 143', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Masses Mean (96% Confidence Interval)Unit of Measure: percentage of masses: 41.1 (33.1 to 49.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/217 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01425268', 'Intervention': ['INTERVENTION 1: ', ' AeroForm Tissue Expansion', ' AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', 'INTERVENTION 2: ', ' Saline Tissue Expansion', ' Saline Tissue Expansion inflated by needle injections of saline', ' Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'], 'Eligibility': ['Inclusion Criteria:', ' Subject is a woman between the ages of 18-70.', ' Subject needs to have tissue expansion as part of her breast reconstruction.', ' Subject is able to provide written informed consent.', ' Subject is able and willing to comply with all of the study requirements.', ' Subject is able to understand and manage at home dosing regimen.', 'Exclusion Criteria:', ' Subjects skin is not suitable for tissue expansion.', ' Subject has remaining tumor cells following her mastectomy.', ' Subject has a current or prior infection at the intended expansion site.', ' Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.', ' 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.', ' 5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.', ' 6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).', ' 7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).', ' 8. Subject is currently participating in a concurrent investigational drug or device study.', ' 9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.', ' 12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.', ' 13. Subject is pregnant or planning on becoming pregnant during the study period.', ' 14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.'], 'Results': ['Outcome Measurement: ', ' Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event', ' The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: AeroForm Tissue Expansion', ' Arm/Group Description: AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', ' Overall Number of Participants Analyzed: 98', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: Breasts: 149 96.1%', 'Results 2: ', ' Arm/Group Title: Saline Tissue Expansion', ' Arm/Group Description: Saline Tissue Expansion inflated by needle injections of saline', ' Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.', ' Overall Number of Participants Analyzed: 52', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: Breasts: 82 98.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/99 (21.21%)', ' Neutropenic Fever [1]1/99 (1.01%)', ' Extrusion [2]1/99 (1.01%)', ' Deflation [3]1/99 (1.01%)', ' Under-Expansion [4]1/99 (1.01%)', ' Exposure [5]1/99 (1.01%)', ' Cellulitis [6]5/99 (5.05%)', ' Wound Infection [7]1/99 (1.01%)', ' Hematoma, Breast [8]1/99 (1.01%)', ' Seroma [9]1/99 (1.01%)', ' Hematoma, Chest VAP Site [10]1/99 (1.01%)', 'Adverse Events 2:', ' Total: 7/52 (13.46%)', ' Neutropenic Fever [1]0/52 (0.00%)', ' Extrusion [2]1/52 (1.92%)', ' Deflation [3]1/52 (1.92%)', ' Under-Expansion [4]0/52 (0.00%)', ' Exposure [5]0/52 (0.00%)', ' Cellulitis [6]2/52 (3.85%)', ' Wound Infection [7]2/52 (3.85%)', ' Hematoma, Breast [8]1/52 (1.92%)', ' Seroma [9]0/52 (0.00%)', ' Hematoma, Chest VAP Site [10]0/52 (0.00%)']}
|
82bd50ac-9407-413b-9eb8-653cef49706c
|
Comparison
|
Intervention
|
NCT02122796
|
NCT01575522
|
The intervention section for the primary trial does not detail the type or duration of the intervention, unlike the secondary trial.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4
] |
{'Clinical Trial ID': 'NCT02122796', 'Intervention': ['INTERVENTION 1: ', ' Patients Undergoing Mastectomy Surgery', ' Number of individuals having mastectomy surgery who were approached for participation in the trial'], 'Eligibility': ['Inclusion Criteria:', ' Women', ' 18 years or older', ' Undergoing mastectomy surgery', 'Exclusion Criteria:', ' Non-English speaking', ' Pregnant', ' Also undergoing an oophorectomy, TRAM or Latissimus flap surgery'], 'Results': ['Outcome Measurement: ', ' Number of Patients Eligible Compared to the Number Approached and Enrolled', ' Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.', ' Time frame: One year', 'Results 1: ', ' Arm/Group Title: Patients Undergoing Mastectomy Surgery', ' Arm/Group Description: Number of individuals having mastectomy surgery who were approached for participation in the trial', ' Overall Number of Participants Analyzed: 252', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Elligible: 61 24.2%', ' Approached: 252 100.0%', ' Consented: 30 11.9%', ' Declined: 31 12.3%', ' Final Sample with complete data: 26 10.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01575522', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Tivantinib)', ' Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically or cytologically confirmed invasive breast cancer, with recurrent or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation', ' Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' Participants must have recent evidence of progressive disease', ' Participants must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days before enrollment in the study', ' Participants must have discontinued all biologic therapy (including vaccines) at least 14 days before enrollment in the study', ' Participants must have discontinued any investigational therapy at least 14 days before enrollment in the study', ' Participants may have received prior radiation therapy in either the metastatic or early-stage setting', ' Radiation therapy must be completed at least 14 days before enrollment in the study', ' Participant must not have received radiation to > 25% of his or her bone marrow within 30 days of starting study treatment', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Hemoglobin >= 9.0 g/dL', ' Absolute neutrophil count >= 1,500/mcL', ' Platelets >= 100,000/mcL', ' Total bilirubin =< 1.5 times upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN; for participants with documented liver metastases, AST/ALT =< 5.0 times ULN', ' Serum creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal', ' Either the primary tumor and/or the metastasis must be triple-negative; the invasive tumor must be hormone-receptor poor, defined as estrogen-receptor negative (ER-) and progesterone-receptor negative (PR-), or staining < 10% by immunohistochemistry (IHC)', ' Human epidermal growth factor receptor 2 (HER2) status: the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC, or FISH < 2.0', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the study and for 90 days after the last investigational drug dose received', ' Female subjects of childbearing potential must have a negative serum pregnancy test within 21 days of cycle 1 day 1', ' Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment; bisphosphonate therapy may also be initiated on study treatment if needed', ' Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Participants who have received chemotherapy, biologic, investigational, or radiotherapy within 14 days prior to entering the study', ' Participants who are receiving any other investigational agents', ' Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms', ' Participants with a history of treated central nervous system (CNS) metastases are eligible', ' Treated brain metastases are defined as those having no evidence of progression or hemorrhage for >= 2 months after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) during the screening period', ' Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician', ' Participants may be taking anti-convulsant medications, which must be non-enzyme-inducing anti-epileptic drugs', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197', ' History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study', ' Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible'], 'Results': ['Outcome Measurement: ', ' PFS Status', ' Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Time from start of treatment to time of progression or death, assessed up to 6 months', 'Results 1: ', ' Arm/Group Title: Treatment (Tivantinib)', ' Arm/Group Description: Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO', ' Overall Number of Participants Analyzed: 22', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.2 (1.0 to 1.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/22 (59.09%)', ' Constipation 1/22 (4.55%)', ' Death [1]3/22 (13.64%)', ' Neutropenia 1/22 (4.55%)', ' Anxiety 1/22 (4.55%)', ' Pleural effusion 1/22 (4.55%)', ' Cough 1/22 (4.55%)', ' Dyspnea 3/22 (13.64%)', ' Cellulitis 1/22 (4.55%)', ' Thromboembolic event 1/22 (4.55%)']}
|
470611af-16b2-4094-ae2a-c9c6155e2672
|
Single
|
Adverse Events
|
NCT00693719
|
the primary trial recorded less than 3 different Adverse Events .
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00693719', 'Intervention': ['INTERVENTION 1: ', ' Etoposide/Irinotecan', ' Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle', ' Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of locally advanced or metastatic breast cancer', ' Recurrent, refractory or progressive disease after receiving prior anthracycline, taxane, and capecitabine therapy', ' Prior anthracycline and taxane therapy may have been as neoadjuvant, or adjuvant therapy if disease progression is documented within a year of completing that agent', ' Received prior capecitabine therapy for metastatic or recurrent disease', ' Measurable disease', ' Bone metastases requires other disease present that can be measured', ' No brain metastases, unless documented to be controlled post-completion of local therapy (surgery and/or radiation therapy) for at least 4 weeks', ' No meningeal carcinomatosis', ' No malignant effusion as the only site of disease recurrence', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Performance status of 0-2', ' Creatinine 1.5 mg/dL OR creatinine clearance 40 mL/min', ' Hemoglobin 10 g/dL', ' ANC 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Bilirubin normal or hyperbilirubinemia < grade 1 (unless due to Gilbert syndrome with elevated total but normal levels of conjugated bilirubin)', ' Not pregnant or nursing', ' Fertile patients must use effective contraception', ' No other non-breast malignancy, except nonmelanoma skin cancer', " No other serious underlying medical condition, that in the opinion of the treating physician, would make study protocol unreasonably hazardous for the patient or would preclude the patient's ability to comply with the study protocol", ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristic', ' Recovered from all prior chemotherapy or radiotherapy to NCI CTC grade 1', ' Unlimited documented prior chemotherapy regimens allowed', ' No prior irinotecan hydrochloride or etoposide', " No Hypericum perforatum (St. John's wort) 14 days prior to, during, or 7 days after completion of study therapy", ' At least 7 days since prior and no concurrent phenytoin, carbamazepine, phenobarbital, or any other enzyme-inducing anticonvulsant drug (EIACD)', ' No concurrent aprepitant'], 'Results': ['Outcome Measurement: ', ' Median Time to Progression', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months', 'Results 1: ', ' Arm/Group Title: Etoposide/Irinotecan', ' Arm/Group Description: Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle', ' Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle', ' Overall Number of Participants Analyzed: 31', ' Median (Standard Error)', ' Unit of Measure: Days 149 (33.83)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/31 (12.90%)', ' Bleeding 1/31 (3.23%)', ' Pain 2/31 (6.45%)', ' Dehydration 1/31 (3.23%)', ' Dyspnea 1/31 (3.23%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f3a03aec-194d-4538-9be3-cea8281d995c
|
|
Comparison
|
Intervention
|
NCT00911898
|
NCT02352779
|
the primary trial and the secondary trial do not explain their interventions in the intervention section.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT00911898', 'Intervention': ['INTERVENTION 1: ', ' MM-111', 'All participants'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed advanced cancer that is:', ' HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation', ' Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory', ' Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining', " Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.", ' Patients must be >= 18 years of age', ' Patients or their legal representatives must be able to understand and sign an informed consent', ' Patients may have measurable or non-measurable tumor(s)', ' Patients should have ECOG Performance Score (PS) 0 or 1', ' Patients must have adequate bone marrow reserves as evidenced by:', ' Absolute neutrophil count (ANC) >= 1,500/uL and', ' Platelet count >= 100,000/uL', ' Hemoglobin >= 9 g/dL', ' Patients must have tumor tissue amenable to biopsy', ' Patients must be willing to undergo biopsy prior to treatment to MM-111', 'Exclusion Criteria:', ' Patients for whom potentially curative antineoplastic therapy is available', ' Patients who are pregnant or lactating', ' Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)', ' Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial', ' Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)', ' Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD) or Maximum Feasible Dose', ' The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.', ' Time frame: 28 days', 'Results 1: ', ' Arm/Group Title: MM-111', ' Arm/Group Description: All participants', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: mg/kg NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/20 (15.00%)', ' Disease Progression1/20 (5.00%)', ' Acute viral myocarditis1/20 (5.00%)']}
|
{'Clinical Trial ID': 'NCT02352779', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Low-dose Omega-3 Fatty Acid)', ' Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Placebo: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies', 'INTERVENTION 2: ', ' Arm II (High-dose Omega-3 Fatty Acid)', ' Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past', ' Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer', ' Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)', ' Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine', ' Be able to read English', ' Able to swallow medication', ' Give written informed consent', 'Exclusion Criteria:', ' Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)', ' Be taking anticoagulant medication (does not include aspirin)', ' Have sensitivity or allergy to fish and/or shellfish', ' Have sensitivity or allergy to soy and/or soybeans', ' Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue'], 'Results': ['Outcome Measurement: ', ' Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value', ' BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).', ' MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).', ' Time frame: Baseline to 6 weeks', 'Results 1: ', ' Arm/Group Title: Arm I (Low-dose Omega-3 Fatty Acid)', ' Arm/Group Description: Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Placebo: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 24', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: units on a scale BFI-SF Mean Post - Pre: -3.66 (-4.37 to -2.96)', ' MFSI-SF Mean Post - Pre: -11.03 (-16.55 to -5.50)', 'Results 2: ', ' Arm/Group Title: Arm II (High-dose Omega-3 Fatty Acid)', ' Arm/Group Description: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 30', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: units on a scale BFI-SF Mean Post - Pre: -3.68 (-4.31 to -3.05)', ' MFSI-SF Mean Post - Pre: -13.93 (-18.82 to -9.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
14a5e557-b223-4649-9867-0ff0e9001f5e
|
Single
|
Intervention
|
NCT03329937
|
the primary trial Participants received niraparib 200 milligrams (mg) PO once daily for a 28 day cycle, for 3 cycles, after which all participants undergo neoadjuvant chemotherapy.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT03329937', 'Intervention': ['INTERVENTION 1: ', ' Niraparib 200 mg', " Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed."], 'Eligibility': ['Inclusion Criteria:', ' Participants age >= 18 years old.', ' Participants with a deleterious or suspected deleterious breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation (germline or somatic) may be enrolled into the study based on either local or central laboratory testing of BRCA status.', ' Histologically-confirmed HER2-negative localized breast cancer by core biopsy.', ' Primary operable, non-metastatic invasive carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. In participants with multifocal and/or multicentric, the largest lesion should be measured. Both unilateral and bilateral breast cancer are allowed.', ' Primary tumor size >=1cm.', ' Measurable disease by breast ultrasound and MRI.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate organ function defined as:', ' Absolute neutrophil count (ANC) >=1500 per microliters (/μL).', ' Platelets >=100,000/μL.', ' Hemoglobin >=9 grams per deciliter (g/dL).', ' Serum creatinine <=1.5*upper limit of normal (ULN) or calculated creatinine clearance >=50 milliliters per minute (mL/min) using Cockcroft-Gault equation.', " Total bilirubin <=1.5*ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.", ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5*ULN.', ' Participants must have recovered to Grade 1 toxicity from prior cancer therapy (a participant with Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may qualify for this study).', ' Participant able to take oral medications.', ' Participant meets the following criteria:', ' Female participant (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug, or is of non-childbearing potential.', ' Female participant is of non-childbearing potential (other than medical reasons) as defined:', ' i) >=45 years of age and has not had menses for >1 year. ii) Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon the screening evaluation.', " iii) Has undergone post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy, oophorectomy or tubal ligation must be confirmed in the medical records, otherwise the participant must be willing to use 2 adequate barrier methods throughout the study starting from the screening visit through 180 days after the last dose of study drug. Information must be captured appropriately within the site's source documents.", ' c) Male participant agrees to use an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.', ' Able to understand the study procedures and agree to participate in the study by providing written informed consent.', 'Exclusion Criteria:', ' Prior anti-cancer therapies for current malignancy.', " Known evidence of distant metastasis. Staging studies are not required. The decision to pursue staging studies is at the discretion of the treating clinician, based on the participant's clinical and pathological findings consistent with standard guidelines.", ' Known hypersensitivity to the components of niraparib components or their formulation excipients.', ' Major surgery within 3 weeks of starting the study or participant has not recovered from any effects of any major surgery.', ' Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.', " History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study drug, or is not in the best interest of the participant to participate.", ' Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study drug or within the 180-day period after the last dose of study drug.', ' Immunocompromised participants.', ' Known active hepatic disease (Hepatitis B or C).', ' Prior treatment with a known PARP inhibitor.', ' Other active malignancy that warrants systemic therapy.', ' Known history of myelodysplastic syndromes (MDS) or Acute myeloid leukemia (AML).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Tumor Response Measured by Breast MRI', ' Tumor response measured by breast MRI is defined as >=30 percent (%) reduction of tumor volume from Baseline based on primary lesion after niraparib treatment without any new lesion development. Tumor volume was calculated as (length × width × height × pi [π])/6. Responses were assessed as Clinical complete response (CR): A complete disappearance of all tumor signs in the breast as assessed by imaging test. Clinical partial response (PR): A reduction in the tumor volume of the primary tumor size by >=30% assessed by palpation or imaging test. Clinical stable disease (SD): No significant change in tumor volume during treatment. Clinical progressive disease (cPD): The development of new, previously undetected lesions, or an estimated increase in the size of the primary lesion by greater than 20%. Percentage of participants with tumor response and its 95 percent confidence interval (CI) has been presented. The 95% CI was the binomial exact CI based on Clopper-Pearson method.', ' Time frame: At 2 months', 'Results 1: ', ' Arm/Group Title: Niraparib 200 mg', " Arm/Group Description: Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed.", ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 90.5 (69.6 to 98.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/21 (9.52%)', ' Thrombocytopenia 1/21 (4.76%)', ' Ventricular septal defect 1/21 (4.76%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c8df3461-4063-4fb0-ae48-f57062eb0a68
|
|
Comparison
|
Intervention
|
NCT01539317
|
NCT01323530
|
the primary trial uses a topical intervention and the secondary trial exclusively uses intravenous treatments.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01539317', 'Intervention': ['INTERVENTION 1: ', ' Topical Saline', ' Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule', ' Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness', 'INTERVENTION 2: ', ' Topical Liquid Lidocaine', ' Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule', ' Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness'], 'Eligibility': ['Eligibility Criteria', ' Women aged 18 to 70 years old.', ' Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).', ' 1 year from diagnosis of breast cancer.', ' Stable heterosexual partnership =/>5 years or by investigator discretion.', ' More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).', ' Menopausal, demonstrated by at least one of the following:', " i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. Follicle Stimulating Hormone (FSH) level >25 in women below age 50 with an ovary and scarred or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist monitors FSH during aromatase inhibitor therapy).", ' Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.', ' Willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain.', ' 3.2 Exclusion Criteria', ' Diagnosis of benign or malignant phyllodes tumor of the breast.', ' Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).', ' Has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam).', ' Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.', ' The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.', ' Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).', ' Potential subject has used topical or systemic estrogen within the last 4 months.', ' Has continued tenderness of vestibule mucosa immediately after application of both test liquids.', ' Allergy to lidocaine or other numbing agents.'], 'Results': ['Outcome Measurement: ', ' Prevention of Entry Dyspareunia With Non-hormonal Therapy', ' Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being "no pain" and 10 being "worst possible pain"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.', ' Time frame: During Phase II (0-4 weeks) and during Phase III (5-12 weeks)', 'Results 1: ', ' Arm/Group Title: Topical Saline', ' Arm/Group Description: Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule', ' Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness', ' Overall Number of Participants Analyzed: 21', ' Mean (Inter-Quartile Range)', ' Unit of Measure: Units on a scale Phase II: 5.3 (3 to 7)', ' Phase III: 0.57 (0.07 to 1.80)', 'Results 2: ', ' Arm/Group Title: Topical Liquid Lidocaine', ' Arm/Group Description: Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule', ' Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness', ' Overall Number of Participants Analyzed: 22', ' Mean (Inter-Quartile Range)', ' Unit of Measure: Units on a scale Phase II: 1.04 (0.65 to 1.92)', ' Phase III: 0.45 (0 to 1.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/25 (0.00%)', 'Adverse Events 2:', ' Total: 0/25 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01323530', 'Intervention': ['INTERVENTION 1: ', ' Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)', ' Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).', 'INTERVENTION 2: ', ' Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)', ' Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).'], 'Eligibility': ['Inclusion Criteria', ' Subjects who meet all of the following criteria will be included in the study:', ' Dose-escalation cohorts (Phase 1b):', ' Histologically or cytologically confirmed cancer that is advanced and/or metastatic', ' Resistant/refractory to approved therapies (defined as progressive disease during or within 6 months after the last anti-cancer therapy) or for whom single agent capecitabine at this dose level and schedule would be a reasonable treatment option in the opinion of the investigator', ' For subjects that previously received capecitabine, all capecitabine related toxicities must have completely resolved', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement.', ' Females of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin (hCG) at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.', ' Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly affective method of contraception (e.g. condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously)', ' Life expectancy of greater than 3 months', ' Willing and able to comply with all aspects of the protocol', ' Provide written informed consent', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2', ' Males and females, age greater than or equal to18 years', ' Dose-confirmation cohorts (Phase 2):', ' Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic', ' Received up to three prior chemotherapy regimens in any setting (sequential neoadjuvant/ adjuvant treatment counting as one regimen)', ' Chemotherapy regimens must have included an anthracycline (unless anthracycline containing chemotherapy is inappropriate) and a taxane, either in combination or in separate regimens', ' No prior treatment with capecitabine in any setting', ' At least one lesion of greater than or equal to 1.5cm in longest diameter for non-lymph nodes and greater than or equal to 1.5cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 7', ' Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement.', ' Females of childbearing potential must have a negative urine or serum beta hCG at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD, or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential', ' Life expectancy of greater than 3 months', ' Willing and able to comply with all aspects of the protocol', ' ECOG-PS 0 or 1', ' Females, age greater than or equal to 18 years', ' Exclusion Criteria', ' Subjects who meet any of the following criteria will be excluded from participation in the study:', ' Radiotherapy, chemotherapy, biological therapy or investigational agents within 4 weeks prior to the start of study treatment; subjects must have recovered from any previous therapy related toxicity to less than Grade 1 at study entry (except for stable sensory neuropathy less than or equal to Grade 2 and alopecia)', ' Treatment with mitomycin C or nitrosourea within 6 weeks prior to commencing on study treatment', ' Hormonal treatment within 2 weeks prior to start of study treatment (continued use of antiandrogens and/or gonadorelin analogues for treatment of prostate cancer permitted)', ' Prior participation in an eribulin clinical study, even if not assigned to eribulin treatment', ' Subject with hypersensitivity to halochondrin B and /or halochondrin B chemical derivates or capecitabine or any of the excipients', ' Suspected dihydropyrimidine dehydrogenase (DPD) deficiency', ' Previous radiotherapy encompassing greater than 30% of marrow', ' Previous organ allograft requiring immunosuppression', ' Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier', ' Meningeal carcinomatosis', ' Significant cardiovascular impairment (history of congestive heart failure greater than New York Heart Association [NYHA] grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia)', " Electrocardiogram (ECG) with QT interval corrected for heart rate (QTc) interval greater than 470 msec (as measured either by Bazett's or Fredericia's formula)", ' Pre-existing neuropathy greater than Grade 2', ' Anti-coagulant therapy with warfarin or related compounds, other than for line patency, that cannot be changed to heparin-based therapy for the duration of the study', ' Subjects with known positive serology for Human Immunodeficiency Virus (HIV), or Hepatitis B or C', " Subjects with other significant disease or disorder that, in the Investigator's opinion, would exclude the subject from the study", ' Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study', ' Unable to swallow tablets'], 'Results': ['Outcome Measurement: ', ' Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)', ' DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count [ANC] less than 1.0*10^9/liter [L], fever of at least 38.5 degree celsius [°C]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline.', ' Time frame: Cycle 1 (21 days)', 'Results 1: ', ' Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)', ' Arm/Group Description: Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 12.5%', 'Results 2: ', ' Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)', ' Arm/Group Description: Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/8 (25.00%)', ' Febrile neutropenia 1/8 (12.50%)', ' Heparin-induced Thrombocytopenia 0/8 (0.00%)', ' Neutropenia 0/8 (0.00%)', ' Constipation 0/8 (0.00%)', ' Dysphagia 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', ' Vomiting 0/8 (0.00%)', ' Abdominal Pain 0/8 (0.00%)', ' Diarrhoea 0/8 (0.00%)', ' Intestinal Ischaemia 0/8 (0.00%)', ' Small intestine obstruction 0/8 (0.00%)', ' Fatigue 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 4/6 (66.67%)', ' Febrile neutropenia 0/6 (0.00%)', ' Heparin-induced Thrombocytopenia 0/6 (0.00%)', ' Neutropenia 2/6 (33.33%)', ' Constipation 0/6 (0.00%)', ' Dysphagia 1/6 (16.67%)', ' Nausea 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Abdominal Pain 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Intestinal Ischaemia 0/6 (0.00%)', ' Small intestine obstruction 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)']}
|
1cd7cf90-bf66-480b-9227-2f7d2eccd647
|
Single
|
Results
|
NCT00370552
|
There over 20% difference in the Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) between the 2 cohorts of the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
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15
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{'Clinical Trial ID': 'NCT00370552', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg', ' Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg', ' Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion criteria:', ' Locally recurrent or metastatic breast cancer, previously untreated with chemotherapy for advanced disease.', ' At least 1 target lesion per RECIST criteria. Locally recurrent disease must not be amenable to resection with curative intent.', ' No previous cytotoxic chemotherapy for locally recurrent/metastatic disease.', ' Relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane therapy.', ' No previous breast cancer known to overexpress or amplify the human epidermal growth factor receptor 2 gene.', ' Prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must have been discontinued at least 2 weeks before randomization.', ' Karnofsky performance status of 80 to 100 or Eastern Cooperative Oncology Group performance status of 0 to 1.', ' Estimated life expectancy of at least 12 weeks.', ' Recovery from recent therapy (except for alopecia), including chemotherapy, immunotherapy, biologic therapy, or investigational product. Any such therapy must have been completed at least 3 weeks before randomization and at least 6 weeks from use of nitrosourea, or mitomycin.', ' Recovery from recent surgery and radiation therapy. At least 1 week since minor surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation; at least 4 weeks from major surgery; and at least 8 weeks from liver resection, thoracotomy, or neurosurgery.', ' Absolute neutrophil count 1500/mm^3.', ' Hemoglobin 9 g/dL.', ' Platelets 100,000/mm^3.', ' Total bilirubin 1.5 times the upper limit of normal (ULN).', ' Aspartate aminotransferase or alanine aminotransferase 2.5*ULN.', ' Normal partial thromboplastin time and either international normalized ratio or prothrombin time <1.5*ULN.', ' Serum creatinine 1.5*ULN or 24-hour creatinine clearance >60 mL/min.', ' Urine dipstick for proteinuria <2+ (negative, trace, or +1). Participants with 2+ proteinuria at baseline were to undergo 24-hour urine collection and demonstrate 1g of protein in 24 hours to be eligible.', 'Exclusion criteria:', ' Women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months after treatment with bevacizumab.', ' Women who were pregnant or breastfeeding.', ' Women with a positive pregnancy test on enrollment or prior to study drug administration.', ' Sexually active fertile men, whose partners were WOCBP, not using an adequate method of birth control.', ' Evidence of baseline sensory or motor neuropathy.', ' Serious infection or nonmalignant medical illnesses uncontrolled or the control of which could be jeopardized by this therapy.', ' History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious gastric ulcer, or bone fracture within 6 months of study entry.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' Significant vascular disease.', ' Clinically significant cardiovascular disease.', ' Baseline left ventricular ejection fraction by multiple-gated acquisition scan or echocardiogram for subjects with prior exposure to anthracyclines not within institutional normal limits.', ' Symptomatic peripheral vascular disease.', ' History of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell transplant within the previous 2 years.', ' Evidence of bleeding diathesis or coagulopathy.', ' Prior treatment with an epothilone or any antiangiogenic agent.', ' Concurrent nonhealing wound, ulcer, or fracture.', ' Any current or history of brain and/or leptomeningeal metastases. Psychiatric disorders or other conditions rendering the participant incapable of complying with the requirements of the protocol.', ' Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix.', ' Known allergy to any of the study drugs or their excipients.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study', ' CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.', ' Time frame: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression', 'Results 1: ', ' Arm/Group Title: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg', ' Arm/Group Description: Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 47.8 (32.9 to 63.1)', 'Results 2: ', ' Arm/Group Title: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg', ' Arm/Group Description: Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 71.1 (55.7 to 83.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/45 (33.33%)', ' Anemia 1/45 (2.22%)', ' Leukopenia 0/45 (0.00%)', ' Neutropenia 0/45 (0.00%)', ' Thrombocytopenia 1/45 (2.22%)', ' Febrile neutropenia 0/45 (0.00%)', ' Angina pectoris 0/45 (0.00%)', ' Atrial fibrillation 0/45 (0.00%)', ' Vomiting 1/45 (2.22%)', ' Diarrhea 1/45 (2.22%)', ' Abdominal pain 1/45 (2.22%)', ' Diverticular perforation 0/45 (0.00%)', 'Adverse Events 2:', ' Total: 16/45 (35.56%)', ' Anemia 0/45 (0.00%)', ' Leukopenia 2/45 (4.44%)', ' Neutropenia 3/45 (6.67%)', ' Thrombocytopenia 0/45 (0.00%)', ' Febrile neutropenia 1/45 (2.22%)', ' Angina pectoris 0/45 (0.00%)', ' Atrial fibrillation 1/45 (2.22%)', ' Vomiting 0/45 (0.00%)', ' Diarrhea 0/45 (0.00%)', ' Abdominal pain 0/45 (0.00%)', ' Diverticular perforation 1/45 (2.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
15f9d033-ebf7-44b3-94e2-3b8ee90b862b
|
|
Single
|
Adverse Events
|
NCT00266799
|
None of the patients in cohort 1 of the primary trial had Acute coronary syndrome.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT00266799', 'Intervention': ['INTERVENTION 1: ', ' Pegylated Liposomal Doxorubicin (PLD)', ' PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be female.', ' Patients must have metastatic disease of a cytological or histological confirmed breast cancer.', ' Patients must be 18 years or older.', ' Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable/evaluable disease are not excluded. Also patients with only bone metastasis are not excluded.', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) 0-2.', ' Patients must have a sufficient life expectancy to be treated with chemotherapy.', ' Patients must be willing and able to complete study questionnaires.', ' Patients must have adequate renal function as evidenced by serum creatinine <=1.5 mg/dL, or a creatinine clearance of >=45 mL/min (if serum creatinine is > 1.5 mg/dL but <= 1.8 mg/dL).', ' Patients must have adequate bone marrow function as evidenced by leukocyte count greater than 3.5 g/L, hemoglobin >=9.0 g/dL, and platelet count >=100x10^9/L.', ' Patients must have adequate liver function as evidenced by bilirubin of <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase <=3 times, ULN unless related to liver metastasis.', ' Patients must have Sodium and Potassium values within normal limits.', ' Patients whose clinical condition (co-morbidity) allows a treatment with monotherapy or who expressed their wish to be treated with monotherapy.', ' Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.', 'Exclusion Criteria:', ' History of receiving prior chemotherapy in the metastatic setting (Note: patients may have had', ' hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy).', ' Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded.', ' Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients.', ' Patients with known DPD (dihydro pyrimidine dehydrogenase) deficiency.', ' Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine.', ' Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy, trastuzumab, or biologicals are also not permitted.', ' Patients with Human epidermal growth factor receptor 2 (Her-2/neu) overexpressing tumors with the most recent evaluation as the relevant result', ' immunologically Her2neu 3+ positive', ' Her2neu-2+ positive and ´Fluorescent in-situ hybridization (FISH)´ positive', ' History of treatment with capecitabine', ' History of treatment with anthracyclines in the adjuvant setting exceeding cumulative doses of anthracyclines by more than 360 mg/m^2 doxorubicin (or equivalents, i.e. 600mg/m^2 epirubicine).', ' Patients with anthracycline resistant disease are not permitted. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 12 months after completion of anthracycline therapy.', ' Strong remission pressure that requires polychemotherapy with the exception of patients who are not suitable for a treatment with polychemotherapy or not accepting polychemotherapy.', ' Evidence of primary or metastatic malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater.', ' Patients with reduced liver functions (evidenced by bilirubin of above 1.5 times the upper limits of normal (ULN); alkaline phosphatase above 3 times ULN (except related to liver metastasis, in which case <=5 x ULN).', ' Dyspnea on exertion.', ' History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure or myocardial infarct within less than six months or an left ventricular ejection fraction (LVEF) below 50%.', ' Woman with childbearing potential with insufficient contraception [e.g. intra-uterine device (IUD) are regarded as sufficient] during the study period and the six months following the last study drug application. All methods based on hormonal contraception are not permitted.', ' Existing pregnancy or lactation (note on pregnancy test). A negative pregnancy test for women of childbearing potential has to be in place prior randomization (Note: A pregnancy test has to be done for patients who are not postmenopausal. Postmenopausal is defined as those not having a menstrual period for 12 months in a row).', ' Existing doubts on ability and willingness of the subject for cooperation.', ' Participation of the subject at a clinical study within the last 30 days.', ' Participation of the subject in the same clinical study at an earlier date.', ' Concomitant participation in another study than the one described here.', ' Abuse of drugs, alcohol, or pharmaceuticals.', ' Any condition, whether medical or non-medical, that may interfere, in the opinion of the investigator, with aim of this study.'], 'Results': ['Outcome Measurement: ', ' Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.', ' Time frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death', 'Results 1: ', ' Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD)', ' Arm/Group Description: PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: Months By Investigator Assessment (ITT): 6.02 (5.10 to 8.19)', ' By RECIST Criteria (ITT): 6.58 (5.29 to 8.19)', ' By Investigator Assessment (TTP N = 63, N = 59): 5.85 (4.37 to 7.86)', ' By RECIST Criteria (TTP N = 63, N = 59): 6.02 (4.37 to 7.86)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 102', ' Median (95% Confidence Interval)', ' Unit of Measure: Months By Investigator Assessment (ITT): 6.05 (4.27 to 9.07)', ' By RECIST Criteria (ITT): 7.10 (4.77 to 9.53)', ' By Investigator Assessment (TTP N = 63, N = 59): 5.88 (2.99 to 8.98)', ' By RECIST Criteria (TTP N = 63, N = 59): 6.05 (4.08 to 9.27)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/98 (30.61%)', ' NEUTROPENIA 1/98 (1.02%)', ' ATRIAL FIBRILLATION 1/98 (1.02%)', ' CARDIAC FAILURE 1/98 (1.02%)', ' TACHYCARDIA 0/98 (0.00%)', ' ACUTE VESTIBULAR SYNDROME 1/98 (1.02%)', ' VERTIGO 0/98 (0.00%)', ' ABDOMINAL PAIN 0/98 (0.00%)', ' COLITIS 0/98 (0.00%)', ' DIARRHOEA 2/98 (2.04%)', ' FEMORAL HERNIA 0/98 (0.00%)', ' HAEMATEMESIS 0/98 (0.00%)', ' ILEUS 0/98 (0.00%)', ' NAUSEA 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 46/102 (45.10%)', ' NEUTROPENIA 0/102 (0.00%)', ' ATRIAL FIBRILLATION 0/102 (0.00%)', ' CARDIAC FAILURE 0/102 (0.00%)', ' TACHYCARDIA 2/102 (1.96%)', ' ACUTE VESTIBULAR SYNDROME 0/102 (0.00%)', ' VERTIGO 1/102 (0.98%)', ' ABDOMINAL PAIN 2/102 (1.96%)', ' COLITIS 1/102 (0.98%)', ' DIARRHOEA 8/102 (7.84%)', ' FEMORAL HERNIA 1/102 (0.98%)', ' HAEMATEMESIS 1/102 (0.98%)', ' ILEUS 1/102 (0.98%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ab6a9d30-eb92-4503-a69c-bdf3f3e6c38d
|
|
Single
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Eligibility
|
NCT02995980
|
A patient presenting Glomerular filtration rate of 63, a severe iodinated contrast allergy and with BI-RADS category c breast tissue would be eligilbe for the primary trial.
|
Contradiction
|
[
0,
3,
4,
5,
6
] |
[] |
{'Clinical Trial ID': 'NCT02995980', 'Intervention': ['INTERVENTION 1: ', ' Contrast Enhanced Mammography', ' Contrast-enhanced spectral mammography for the detection breast cancer .', ' DECE mammography: Contrast mammography', 'INTERVENTION 2: ', ' Standard Digital Mammogram', ' Full field digital mammography for the detection breast cancer', ' digital mammography: routine digital mammography'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' At least 19 years old', ' Glomerular filtration rate> 60', ' Heterogeneously or extremely dense breasts (BI-RADS category c or d).', 'Exclusion Criteria:', ' History of iodinated contrast allergy', ' Pregnant or lactating as determined by routine standard practice', ' Personal history of breast cancer', ' History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)', ' History of prior breast reduction mammoplasty surgery', ' History of prior breast augmentation surgery', ' Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.'], 'Results': ['Outcome Measurement: ', ' Percent Accuracy of Contrast Mammography', 'The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Contrast Enhanced Mammography', ' Arm/Group Description: Contrast-enhanced spectral mammography for the detection breast cancer .', ' DECE mammography: Contrast mammography', ' Overall Number of Participants Analyzed: 114', ' Measure Type: Number', ' Unit of Measure: percentage of accuracy 100 (29 to 100)', 'Results 2: ', ' Arm/Group Title: Standard Digital Mammogram', ' Arm/Group Description: Full field digital mammography for the detection breast cancer', ' digital mammography: routine digital mammography', ' Overall Number of Participants Analyzed: 114', ' Measure Type: Number', ' Unit of Measure: percentage of accuracy 67 (9 to 99)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/128 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
51cf1333-78b1-410a-82fe-aabfaa00a840
|
|
Single
|
Results
|
NCT00662025
|
on assessment 0 the primary trial Participants had a confirmed disappearance of all target and non-target lesions.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00662025', 'Intervention': ['INTERVENTION 1: ', ' SUNITINIB+CAPECITABINE', ' Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent', ' Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.', ' Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.', 'Exclusion Criteria:', ' Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.', ' Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.', " Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting"], 'Results': ['Outcome Measurement: ', " Number of Participants With Objective Response Based on Data Review Committee's Assessment", ' Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as 30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation 4 weeks after initial documentation of response.', ' Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.', 'Results 1: ', ' Arm/Group Title: SUNITINIB+CAPECITABINE', ' Arm/Group Description: Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.', ' Overall Number of Participants Analyzed: 63', ' Measure Type: Number', ' Unit of Measure: participants Total Number of Participants with CR+PR: 19', ' Complete Response (CR): 0', ' Partial Response (PR): 19'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/63 (26.98%)', ' Febrile neutropenia 1/63 (1.59%)', ' Leukopenia 1/63 (1.59%)', ' Thrombocytopenia 3/63 (4.76%)', ' Anemia 1/63 (1.59%)', ' Ascites 1/63 (1.59%)', ' Diarrhoea 1/63 (1.59%)', ' Gingival bleeding 1/63 (1.59%)', ' Vomiting 1/63 (1.59%)', ' Gastrointestinal haemorrhage 1/63 (1.59%)', ' Fatigue 2/63 (3.17%)', ' Malaise 2/63 (3.17%)', ' Pyrexia 2/63 (3.17%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d2e957c3-1e20-4ccd-9cf7-4cc2da63f74d
|
|
Comparison
|
Adverse Events
|
NCT00570921
|
NCT00274456
|
There is one case of Cardiopulmonary failure in cohort 2 of the secondary trial, but none in cohort 1 of the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
13,
14,
15,
3,
4,
5,
19,
20,
21,
22,
10,
11,
25
] |
{'Clinical Trial ID': 'NCT00570921', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Everolimus', ' Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal status, defined as any one of the following criteria: Documented history of bilateral oophorectomy, Age 60 years or more, OR Age 45 to 59 and satisfying one or more of the following criteria: Amenorrhea for at least 12 months and intact uterus OR Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration - within postmenopausal range including: Patients who have had a hysterectomy or Patients who have received hormone replacement', ' Patients must have histologically confirmed invasive breast cancer', ' Metastatic or locally advanced disease', ' Patients must have estrogen receptor and/or progesterone receptor positive disease', ' Measurable or evaluable disease', ' Failure of aromatase inhibitor therapy within the previous 6 months. Patients who received prior tamoxifen are eligible to enroll', ' Prior aromatase inhibitor therapy or other endocrine therapy must be discontinued at least 1 week prior to enrollment and any toxicity from such therapy must have reverted to grade I or less at the time of enrollment', ' Patients must not have received chemotherapy, radiation therapy, or had surgery within 4 weeks prior to enrollment and any toxicity from such therapy must have recovered to grade 1 or less prior to enrollment', ' Patients must not have received either of the study medications previously', ' WHO performance status of 0, 1, or 2', ' Adequate organ function defined as follows: Adequate renal function, defined by a serum creatinine within the upper limits of normal, Adequate liver function, defined by a bilirubin of < 1.5 the upper limit of normal (ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) of 2.5 times the ULN, Adequate bone marrow function, defined as an absolute neutrophil count (ANC) 1.5 x 109/L, platelet count (PLT) >100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) <1.3, and because fulvestrant is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia or in patients on anticoagulants', ' Patients will be asked to provide a tumor paraffin block if available', ' Ability to understand and sign a written informed consent for participation in the trial', 'Exclusion Criteria:', ' Known severe hypersensitivity to everolimus (or similar drugs) or any of the excipients of this product', ' Premenopausal status', ' Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ', ' Patients with brain metastasis or leptomeningeal involvement', ' Patients with malignant pleural effusion or ascites only disease', ' Rapidly progressive visceral disease', ' WHO performance status of 3 or 4', ' As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris or significant cardiac arrhythmia, Psychiatric illness/social situations that would limit compliance with study requirements, Severely impaired lung function such as severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease, a known forced expiratory volume at one second (FEV1) of < 1.5 liters, or dyspnea of grade III or greater, Uncontrolled diabetes as defined by a fasting blood sugar (FBS) of > 1.5 ULM, Known liver disease such as cirrhosis or chronic hepatitis, Known HIV positivity, OR known condition causing malabsorption', ' Chronic treatment with systemic steroids or other immunosuppressive agents', ' Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period', ' Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial', ' Prior treatment with an mTOR inhibitor', ' Treatment with a non-approved or investigational drug within 30 days or 5 half-lives of the drug, whichever is greater, before Day 1 of study treatment', ' In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections', ' History of hypersensitivity to castor oil'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' [Not Specified]', ' Time frame: Duration of time start of treatment to time of documented progression or death', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Everolimus', ' Arm/Group Description: Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.4 (1.9 to 12.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/33 (15.15%)', ' Left Ventricular Thrombus * 1/33 (3.03%)', ' Nausea * 1/33 (3.03%)', ' Acute Cholecystitis * 1/33 (3.03%)', ' Renal Failure * 1/33 (3.03%)', ' Pneumonia * 1/33 (3.03%)']}
|
{'Clinical Trial ID': 'NCT00274456', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 300 mg/m^2 q3w', ' ABI-007 300 mg/m^2 administered once every third week (q3w).', 'INTERVENTION 2: ', ' ABI-007 100 mg/m^2 Weekly', ' ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest'], 'Eligibility': ['Inclusion Criteria:', ' Patients had to meet the following criteria to be eligible for the study:', ' Pathologically confirmed adenocarcinoma of the breast.', ' No prior chemotherapy for metastatic breast cancer.', ' Stage IV disease.', ' Measurable disease (must have been 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were 1.0 cm).', ' At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.', ' At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.', ' At least 4 weeks since major surgery, with full recovery.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Age 18 years.', ' Patient had the following blood counts at Baseline:', ' Absolute neutrophil count (ANC) 1.5*10^9 cells/L', ' Platelets 100*10^9 cells/L', ' Hemoglobin (Hgb) 9 g/dL.', ' Patient had the following baseline blood chemistry levels:', ' Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) 2.5x upper limit of normal (ULN) range', ' Total bilirubin normal', ' Alkaline phosphatase 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL.', ' Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).', ' If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).', ' If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.', ' Informed consent had been obtained.', 'Exclusion Criteria:', ' Patients who met any of the following criteria were excluded from the study:', ' Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.', ' Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.', ' Concurrent immunotherapy or hormonal therapy for breast cancer.', ' Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.', ' Serious intercurrent medical or psychiatric illness, including serious active infection.', ' History of class II-IV congestive heart failure.', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.', ' Patients who had received an investigational drug within the previous 3 weeks.', ' Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.', ' Pregnant or nursing women', ' Patients with prior hypersensitivity to either Taxol or Taxotere.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator', ' Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.', ' Time frame: Day 1 up to 95 weeks', 'Results 1: ', ' Arm/Group Title: ABI-007 300 mg/m^2 q3w', ' Arm/Group Description: ABI-007 300 mg/m^2 administered once every third week (q3w).', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 37 (26.0 to 47.7)', ' Investigator assessed ORR: 46 (34.8 to 57.3)', 'Results 2: ', ' Arm/Group Title: ABI-007 100 mg/m^2 Weekly', ' Arm/Group Description: ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 45 (33.6 to 55.9)', ' Investigator assessed ORR: 63 (52.3 to 74.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/76 (18.42%)', ' Neutropenia 10/76 (13.16%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 0/76 (0.00%)', ' Optic ischaemic neuropathy 0/76 (0.00%)', ' Bowel peristalsis increased 1/76 (1.32%)', ' Colitis 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 12/76 (15.79%)', ' Neutropenia 2/76 (2.63%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 1/76 (1.32%)', ' Optic ischaemic neuropathy 1/76 (1.32%)', ' Bowel peristalsis increased 0/76 (0.00%)', ' Colitis 1/76 (1.32%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 1/76 (1.32%)']}
|
aef2367d-78a5-4dc7-a6f7-d96415082362
|
Single
|
Adverse Events
|
NCT00201851
|
There were no cases of Oesophageal spasming, Diastolic dysfunction or thrombosis observed in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00201851', 'Intervention': ['INTERVENTION 1: ', ' A - Scheduled Surgery', ' Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'INTERVENTION 2: ', ' B - Immediate Surgery', ' Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'], 'Eligibility': ['Inclusion Criteria:', ' Open for accrual in Asia only', ' Female age 18-50,', ' premenopausal with regular cycles (>25-35 in length)', ' fine-needle aspiration diagnosis', ' Stage II-IIIA hormone receptor positive invasive breast cancer', ' No prior radiation or chemotherapy', ' Must be surgical candidate for bilateral oophorectomy'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' 5-year disease-free survival', ' Time frame: two- to three-year accrual and initial two or more years of follow-up period', 'Results 1: ', ' Arm/Group Title: A - Scheduled Surgery', ' Arm/Group Description: Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 244', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64', 'Results 2: ', ' Arm/Group Title: B - Immediate Surgery', ' Arm/Group Description: Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 255', ' Measure Type: Number', ' Unit of Measure: percentage of participants 71'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/244 (0.00%)', ' Pregnancy *0/244 (0.00%)', ' Endocervical cancer *0/244 (0.00%)', ' Nosocomial pneumonia *0/244 (0.00%)', ' Venous thrombosis *0/244 (0.00%)', 'Adverse Events 2:', ' Total: 5/255 (1.96%)', ' Pregnancy *1/255 (0.39%)', ' Endocervical cancer *1/255 (0.39%)', ' Nosocomial pneumonia *2/255 (0.78%)', ' Venous thrombosis *1/255 (0.39%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
29ae75a2-d8d2-4427-bba3-ab2c411d5718
|
|
Single
|
Adverse Events
|
NCT00475670
|
compared to cohort 1 of the primary trial, other than sudden death, there are more cases of every observed adverse event in cohort 2.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00475670', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Monotherapy', ' Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.', 'INTERVENTION 2: ', ' Trastuzumab, Taxane', " Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks."], 'Eligibility': ['Inclusion Criteria:', ' at least 10 months of Herceptin treatment for HER2-positive early breast cancer;', ' metastatic breast cancer >=12 months after discontinuation of Herceptin;', ' measurable disease.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic breast cancer;', ' brain metastases;', ' invasive malignancy other than metastatic breast cancer.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines', ' CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.', ' Time frame: Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited', 'Results 1: ', ' Arm/Group Title: Trastuzumab Monotherapy', ' Arm/Group Description: Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: percentage of participants ', 'Results 2: ', ' Arm/Group Title: Trastuzumab, Taxane', " Arm/Group Description: Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.", ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 61.0 (48.7 to 80.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Febrile Neutropenia * 0/3 (0.00%)', ' Neutropenia * 0/3 (0.00%)', ' Sudden Death * 0/3 (0.00%)', ' Bacterial Infection * 0/3 (0.00%)', ' Bronchitis * 0/3 (0.00%)', ' Sepsis * 0/3 (0.00%)', ' Lymphoedema * 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 6/41 (14.63%)', ' Febrile Neutropenia * 1/41 (2.44%)', ' Neutropenia * 1/41 (2.44%)', ' Sudden Death * 1/41 (2.44%)', ' Bacterial Infection * 1/41 (2.44%)', ' Bronchitis * 1/41 (2.44%)', ' Sepsis * 1/41 (2.44%)', ' Lymphoedema * 1/41 (2.44%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
985c4cb3-2684-4a67-a479-998602044a0d
|
|
Comparison
|
Adverse Events
|
NCT00107276
|
NCT00232505
|
Less than 5% of patients undergoing the intervention in the primary trial had adverse events, in comparison almost 10% patients in cohort 1 of the secondary trial experienced an adverse event, and less than a 1/3 of those in cohort 2 of the secondary trial had adverse events.
|
Contradiction
|
[
0,
1
] |
[
0,
1,
8,
9
] |
{'Clinical Trial ID': 'NCT00107276', 'Intervention': ['INTERVENTION 1: ', ' Cyclophosphamide and Capecitabine', ' cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed stage IV breast cancer', ' Metastatic disease (M1) OR multiple sites of new disease that is clinically obvious metastatic disease (i.e., multiple sites of new osseous disease)', ' Meets 1 of the following criteria:', ' Measurable disease', ' Non-measurable disease', ' MUC-1 antigen level > 2 times upper limit of normal AND level has increased by 1.5 times', ' Must have documented MUC-1 antigen level', ' Either cancer antigen (CA) 15-3 or CA 27-29 allowed', ' Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)', ' No symptomatic brain or CNS metastases', ' Previously treated brain or CNS metastasis allowed provided radiotherapy was completed 8 weeks before study entry', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' No known existing uncontrolled coagulopathy', ' Hepatic', ' Not specified', ' Renal', ' Creatinine clearance > 40 mL/min', ' Cardiovascular', ' No congestive heart failure', ' No symptomatic coronary artery disease', ' No cardiac arrhythmia not well controlled with medication', ' No myocardial infarction within the past 12 months', ' No other clinically significant cardiac disease', ' Gastrointestinal', ' Able to take oral medication', ' No uncontrolled nausea, vomiting, or diarrhea', ' No lack of physical integrity of the upper gastrointestinal tract', ' No malabsorption syndrome', ' Other', ' Not pregnant or nursing', ' Fertile patients must use effective contraception', ' No active infection requiring systemic therapy', ' No prior severe reaction to fluoropyrimidines', ' No known sensitivity to fluorouracil', ' No known dihydropyrimidine dehydrogenase deficiency', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' No concurrent immunotherapy or biologic therapy for breast cancer', ' No concurrent gene therapy for breast cancer', ' No concurrent filgrastim (G-CSF)', ' Chemotherapy', ' At least 14 days since prior chemotherapy and recovered', ' No more than 2 prior chemotherapy regimens for metastatic disease', ' No prior capecitabine for metastatic disease', ' No prior oral cyclophosphamide for metastatic disease', ' Prior IV cyclophosphamide allowed', ' No other concurrent chemotherapy for breast cancer', ' Endocrine therapy', ' See Disease Characteristics', ' No concurrent hormonal therapy for breast cancer', ' Radiotherapy', ' See Disease Characteristics', ' At least 14 days since prior radiotherapy to non-CNS disease sites and recovered', ' No concurrent radiotherapy for breast cancer', ' Surgery', ' Not specified', ' Other', ' Concurrent bisphosphonates allowed', ' No concurrent full-dose warfarin', ' Concurrent prophylactic warfarin ( 1 mg/day) to maintain port patency allowed', ' No other concurrent antineoplastic therapy for breast cancer'], 'Results': ['Outcome Measurement: ', ' Response Rate (Complete and Partial, Confirmed and Unconfirmed)', ' Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.', ' Time frame: Patients assessed at least every six weeks while on protocol treatment', 'Results 1: ', ' Arm/Group Title: Cyclophosphamide and Capecitabine', ' Arm/Group Description: cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each', ' Overall Number of Participants Analyzed: 80', ' Measure Type: Number', ' Unit of Measure: participants 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/95 (4.21%)', ' Death not associated with CTCAE term - Death NOS 1/95 (1.05%)', ' Death - Disease progression NOS 2/95 (2.11%)', ' CNS cerebrovascular ischemia 1/95 (1.05%)']}
|
{'Clinical Trial ID': 'NCT00232505', 'Intervention': ['INTERVENTION 1: ', ' Cetuximab', ' Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.', ' cetuximab: Given IV', 'INTERVENTION 2: ', ' Cetuximab and Carboplatin After Cetuximab Alone', ' Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Metastatic (stage IV) disease', ' Measurable disease by RECIST criteria', ' Irradiated lesions are not considered measurable disease', ' Central nervous system (CNS) metastases allowed if disease is stable (no evidence of progression) 3 months after local therapy', ' No lesions identifiable only by positron emission tomography (PET) scan', ' HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by Fluorescence In Situ Hybridization (FISH)', ' HER2 2+ by IHC allowed', ' Hormone receptor status:', ' Estrogen receptor-negative and progesterone receptor-negative tumor', ' Inclusion Criteria', ' At least 18 years of age', ' Metastatic breast cancer (Stage IV) with measurable disease by RECIST criteria', ' No more than three prior chemotherapy regimens either in the adjuvant or metastatic setting.', ' Histologically documented (either primary or metastatic site) breast cancer that is estrogen receptor- (ER-) negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplified by FISH performed upon the primary tumor or metastatic lesion. HER-2 2+ by immunohistochemistry is usually negative by FISH, and this confirmatory test should be performed when possible, however may participate if fulfill other criteria.', ' Completion of prior chemotherapy at least 3 weeks prior to study entry.', ' Patients may have received therapy (ies) in the adjuvant or metastatic setting, however must have discontinued prior to entry. Patients may receive concurrent bisphosphonates, however if taking bisphosphonates, bone lesions may not be used for progression or response.', ' Radiation therapy must be completed at least 2 weeks prior to study entry, and radiated lesions may not serve as measurable disease.', ' Patients may have CNS metastases if stable (no evidence of progression) > 3 months after local therapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and life expectancy of at least 6 months.', ' Adequate organ function defined as:absolute neutrophil count (ANC) > 1500/mm3, plts > 100,000/mm3, creatinine clearance >50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN) (or 5 x ULN in case of liver metastases); total bilirubin 1.5 mg/dL.', ' Tissue block available for EGFR studies is recommended, although will not exclude patients from participating.', ' Pregnant or lactating women will be excluded. Women of child bearing potential must have documented negative pregnancy test within two weeks of study entry and agree to acceptable birth control during the duration of the study therapy.', ' Signed written informed consent.', ' Exclusion Criteria', ' Lesions identifiable only by PET.', ' More than three prior chemotherapy regimens (including adjuvant). Sequential regimens such as doxorubicin and cyclophosphamide followed by paclitaxel (AC-paclitaxel) are considered one regimen.', ' Prior therapy which specifically and directly targets the EGFR pathway with therapeutic intent.', ' Prior platinum agent for metastatic disease. If platinum agent was used adjuvantly, the patient must have had at least 12 months disease-free interval prior to relapse.', ' Prior severe infusion reaction to a monoclonal antibody.', ' Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection).', ' Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction <45%', ' Other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study.', ' Inability to comply with the requirements of the study.'], 'Results': ['Outcome Measurement: ', ' Overall Disease Response Rate', ' Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Cetuximab', ' Arm/Group Description: Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.', ' cetuximab: Given IV', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 2 6.5%', ' Stable disease: 3 9.7%', ' Stable disease > 6 months: 1 3.2%', ' Progressive disease: 26 83.9%', ' Not evaluable: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cetuximab and Carboplatin After Cetuximab Alone', ' Arm/Group Description: Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 4 16.0%', ' Stable disease: 7 28.0%', ' Stable disease > 6 months: 3 12.0%', ' Progressive disease: 12 48.0%', ' Not evaluable: 2 8.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/31 (9.68%)', ' Edema: limb * 2/31 (6.45%)', ' Neutrophils/granulocytes (ANC/AGC) * 0/31 (0.00%)', ' Cardiac General - Other (Specify, __) * [1]0/31 (0.00%)', ' Cardiac General - Other (Specify, __) * [2]0/31 (0.00%)', ' Left ventricular diastolic dysfunction * 0/31 (0.00%)', ' Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/31 (0.00%)', 'Adverse Events 2:', ' Total: 8/25 (32.00%)', ' Edema: limb * 1/25 (4.00%)', ' Neutrophils/granulocytes (ANC/AGC) * 0/25 (0.00%)', ' Cardiac General - Other (Specify, __) * [1]1/25 (4.00%)', ' Cardiac General - Other (Specify, __) * [2]0/25 (0.00%)', ' Left ventricular diastolic dysfunction * 1/25 (4.00%)', ' Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/25 (0.00%)']}
|
39e8a353-4eb0-4cf6-b0c2-f36c4bf589f3
|
Single
|
Eligibility
|
NCT00617539
|
Patients with Extracranial metastases are still permited to enter in the primary trial.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00617539', 'Intervention': ['INTERVENTION 1: ', ' Irinotecan and Temozolomide', ' irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle', ' temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain', ' Extracranial metastases allowed', ' Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following:', ' External beam radiotherapy', ' Brachytherapy', ' Stereotactic radiosurgery', ' Surgery', ' Chemotherapy', ' Treatments with investigational drugs, biologics, or devices', ' Disease progression in the CNS must meet 1 of the following criteria:', ' New lesions in the CNS on an imaging study (contrast-enhanced CT scan or MRI)', ' Progressive lesions on an imaging study (contrast-enhanced CT scan or MRI)', ' New or progressive lesions that do not meet measurable disease definition allowed', ' Leptomeningeal disease allowed if concurrent progression or parenchymal brain metastases', ' Not a candidate for surgical resection and/or further stereotactic radiosurgery', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Life expectancy 1 month', ' Hemoglobin 10 g/dL (transfusion allowed)', ' ANC 1,500/mm³', ' Granulocyte count 1,500/mm³', ' Platelet count 100,000/mm³', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.5 times upper limit of normal (ULN)', ' AST and ALT 3 times ULN', ' Must be able to swallow and retain oral medications', ' No other active malignancy except for any of the following:', ' Curatively treated basal or squamous cell carcinoma of the skin', ' Carcinoma in situ of the cervix', ' Other malignancies considered disease-free', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast', ' No other known contraindication to MRI including, but not limited to, any of the following:', ' Cardiac pacemaker', ' Implanted cardiac defibrillator', ' Brain aneurysm clips', ' Cochlear implant', ' Ocular foreign body', ' Shrapnel', ' No active or uncontrolled infection', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from the side effects of prior chemotherapy, surgery, or radiotherapy for extracranial disease or brain metastases', ' Concurrent trastuzumab, bisphosphonate, and/or corticosteroid therapy allowed', ' At least 1 week since prior or on current stable dose of corticosteroid therapy', ' Patients on an enzyme-inducing anti-epileptic agent (EIAE) or valproic acid are eligible if they are switched to an alternate non-EIAE medication', ' Concurrent coumadin allowed', ' No prophylactic use of filgrastim (G-CSF) during first course of treatment'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS', ' Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.', ' Time frame: Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years', 'Results 1: ', ' Arm/Group Title: Irinotecan and Temozolomide', ' Arm/Group Description: irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle', ' temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 6.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/30 (53.33%)', ' Lymphopenia * 16/30 (53.33%)', ' Leukopenia * 5/30 (16.67%)', ' Neutropenia * 5/30 (16.67%)', ' Anemia * 3/30 (10.00%)', ' Thrombocytopenia * 3/30 (10.00%)', ' Vomiting * 2/30 (6.67%)', ' Nausea * 1/30 (3.33%)', ' Diarrhea * 1/30 (3.33%)', ' Dysphagia * 1/30 (3.33%)', ' Fatigue * 3/30 (10.00%)', ' Dehydration * 2/30 (6.67%)', ' Alkaline phosphatase increased * 1/30 (3.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d695120e-db68-481d-9023-881e48654e29
|
|
Single
|
Intervention
|
NCT00941330
|
Patients in cohort 1 of the primary trial receive Exemestane more often than cohort 2 patients receive Cytoxan.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT00941330', 'Intervention': ['INTERVENTION 1: ', ' A: Exemestane', ' ARM A: Patients will be treated with exemestane.', ' Exemestane: 25 mg daily by mouth for 6 to 12 months.', 'INTERVENTION 2: ', ' B: Docetaxel and Cytoxan', ' ARM B: Patients will be treated with docetaxel and cytoxan.', ' Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).', ' Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent.', ' Histologically or cytologically confirmed breast carcinoma.', ' Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], CM0).', ' Pre-treatment biopsy with the following characteristics:', ' Hormone receptor-positive cancer as defined as ER and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)', ' HER2-negative (HER2 2 by IHC; if HER2 2+ by IHC must be fluorescent in situ hybridization [FISH] non-amplified)', ' Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay', ' Patients must have measurable disease as defined by palpable lesion with both diameters 1 cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension 1 cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry.', ' Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study enrollment, defined as date of signed, informed consent. If clinically indicated, staging xrays and scans must be done within 28 days of study entry.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.', ' Adequate organ function within 14 days of study entry:', ' Bone marrow function: absolute neutrophil count (ANC) 1500/mm³, Hgb > 8.0 g/dl and platelet count 100,000/mm³.', ' Hepatic function: total bilirubin < upper limit of normal (ULN). Serum glutamic oxaloacetic transaminase (SGOT) (AST) or serum glutamic pyruvic transaminase (SGPT) (ALT) and alkaline phosphatase 1.5 x ULN).', ' Renal function: calculated creatinine clearance (CrCl) 30 mL/min using the Cockcroft Gault equation.', ' Patients must be at least 18 years of age.', 'Exclusion Criteria:', ' Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.', ' Pregnant or lactating women are not eligible. Women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period.', ' Medical, psychological or surgical condition which the investigator feels might compromise study participation.', ' Patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.', ' Evidence of peripheral or sensory neuropathy.', ' Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are excluded from participation.', ' Serious, uncontrolled, concurrent infection(s).', ' Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry.', ' Major surgery within 28 days of study entry.', ' Evidence of central nervous system (CNS) metastases.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response', ' Patients must have measurable disease by clinical examination.', ' Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.', ' If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.', ' Time frame: At time of definitive surgery', 'Results 1: ', ' Arm/Group Title: A: Exemestane', ' Arm/Group Description: ARM A: Patients will be treated with exemestane.', ' Exemestane: 25 mg daily by mouth for 6 to 12 months.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Downstaged: 5 35.7%', ' Stable: 4 28.6%', ' Upstaged: 5 35.7%', 'Results 2: ', ' Arm/Group Title: B: Docetaxel and Cytoxan', ' Arm/Group Description: ARM B: Patients will be treated with docetaxel and cytoxan.', ' Docetaxel: Docetaxel (75 mg/m ) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).', ' Cytoxan: Cytoxan (600 mg/m ) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Downstaged: 1 12.5%', ' Stable: 2 25.0%', ' Upstaged: 5 62.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', ' Gastroenteritis and Severe Diarrhea *0/15 (0.00%)', 'Adverse Events 2:', ' Total: 1/11 (9.09%)', ' Gastroenteritis and Severe Diarrhea *1/11 (9.09%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5319ac1a-07ae-4531-bf93-5fce83016c87
|
|
Single
|
Eligibility
|
NCT00388726
|
A 75 year old female patient, with an ECOG of 3 and an estimated life expectancy of more than a year would be eligible for the primary trial.
|
Contradiction
|
[
0,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00388726', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate 1.4 mg/kg^2', ' Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8', 'INTERVENTION 2: ', " Treatment of Physician's Choice", " Treatment of Physician's Choice"], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast.', ' Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.', ' Patients with locally recurrent or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent and/or metastatic disease.', ' Prior therapy must be documented by the following criteria prior to entry onto study:', ' Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and a taxane (e.g., paclitaxel, docetaxel) in any combination or order. Treatment with any of these agents is not required if they are contraindicated for a certain patient.', ' One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy, but at least 2 must have been given for relapsed or metastatic disease.', ' Patients must have proved refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy.', ' Patients with Human Epidermal Growth Factor 2 (HER2/neu) positive tumors may additionally have been treated with trastuzumab.', ' Patients may have additionally been treated with anti-hormonal therapy.', ' Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.', ' Life expectancy of >= 3 months.', ' Adequate renal function as evidenced by serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 x ULN (in absence of liver metastases) or > 5 x ULN (in presence of liver metastases) AND patient is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.', ' Patients willing and able to comply with the study protocol for the duration of the study.', ' Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.', ' EXCLUSION CRITERIA', ' Patients who have received any of the following treatments within the specified period before E7389 or TPC treatment start:', ' chemotherapy, radiation, trastuzumab or hormonal therapy within three weeks.', ' any investigational drug within four weeks.', ' Radiation therapy encompassing > 30% of marrow.', ' Prior treatment with mitomycin C or nitrosourea.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing a contrast-enhanced computed tomography or magnetic resonance imaging brain scan performed during screening to a prior scan performed at least 4 weeks earlier.', ' Patients with meningeal carcinomatosis.', ' Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy if randomized to E7389 are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.', ' Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Severe/uncontrolled intercurrent illness/infection.', ' Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).', ' Patients with organ allografts requiring immunosuppression.', ' Patients with known positive HIV status.', ' Patients who have had a prior malignancy, other than previous breast cancer, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence.', ' Patients with pre-existing neuropathy > Grade 2.', ' Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.', ' Patients who participated in a prior E7389 clinical trial whether or not E7389 was received.', " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study."], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Defined as the time from the date of randomization until the date of death from any cause.', ' Time frame: From date of randomization until death from any cause', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate 1.4 mg/kg^2', ' Arm/Group Description: Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8', ' Overall Number of Participants Analyzed: 508', ' Median (Full Range)', ' Unit of Measure: Days 399 (360 to 434)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice", " Arm/Group Description: Treatment of Physician's Choice", ' Overall Number of Participants Analyzed: 254', ' Median (Full Range)', ' Unit of Measure: Days 324 (282 to 380)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 130/503 (25.84%)', ' Febrile Neutropenia21/503 (4.17%)', ' Neutropenia9/503 (1.79%)', ' Anaemia1/503 (0.20%)', ' Pancytopenia1/503 (0.20%)', ' Pericardial Effusion2/503 (0.40%)', ' Cardiac Failure1/503 (0.20%)', ' Extrasystoles0/503 (0.00%)', ' Vertigo1/503 (0.20%)', ' Nausea7/503 (1.39%)', ' Vomiting5/503 (0.99%)', ' Diarrhoea1/503 (0.20%)', ' Abdominal Pain1/503 (0.20%)', ' Ascites1/503 (0.20%)', 'Adverse Events 2:', ' Total: 64/247 (25.91%)', ' Febrile Neutropenia3/247 (1.21%)', ' Neutropenia0/247 (0.00%)', ' Anaemia2/247 (0.81%)', ' Pancytopenia0/247 (0.00%)', ' Pericardial Effusion0/247 (0.00%)', ' Cardiac Failure0/247 (0.00%)', ' Extrasystoles1/247 (0.40%)', ' Vertigo0/247 (0.00%)', ' Nausea2/247 (0.81%)', ' Vomiting1/247 (0.40%)', ' Diarrhoea4/247 (1.62%)', ' Abdominal Pain3/247 (1.21%)', ' Ascites2/247 (0.81%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
087aba29-40c6-4453-a44b-e63c3867e5b4
|
|
Comparison
|
Eligibility
|
NCT03624972
|
NCT01216176
|
A 72 year old patient suffering from dementia would be excluded from both the secondary trial and the primary trial.
|
Entailment
|
[
4,
7
] |
[
56,
73
] |
{'Clinical Trial ID': 'NCT03624972', 'Intervention': ['INTERVENTION 1: ', ' Resources Only', ' Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.', 'INTERVENTION 2: ', ' Resources + Video', ' Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.', ' Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.'], 'Eligibility': ['Inclusion Criteria:', ' Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago', ' Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)', ' Willing to have clinic visit audio recorded', 'Exclusion Criteria:', ' Unable to speak English', ' Eastern Cooperative Oncology Group (ECOG) Performance score > 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member', ' Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.'], 'Results': ['Outcome Measurement: ', ' Self-Reported Self-Efficacy for Communicating About Sexual Health Issues', " Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.", ' Time frame: 2 weeks', 'Results 1: ', ' Arm/Group Title: Resources Only', ' Arm/Group Description: Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.', ' Overall Number of Participants Analyzed: 71', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale 8.5 (1.8)', 'Results 2: ', ' Arm/Group Title: Resources + Video', ' Arm/Group Description: Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.', ' Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.', ' Overall Number of Participants Analyzed: 71', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale 8.8 (2.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/71 (0.00%)', 'Adverse Events 2:', ' Total: 0/73 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01216176', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 - Cohort A', ' Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', 'AZD0530'], 'Eligibility': ['Inclusion Criteria - Phase 1 (Cohort A):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses > 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor', ' Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease', ' Measurable or evaluable disease according to RECIST criteria (see appendix VII)', ' Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab and/or lapatinib.', ' ECOG performance status 0-2 (see appendix VI)', ' Patients are suitable candidates for treatment with anastrozole (patients may have had any prior endocrine therapy or prior chemotherapy for treatment of their disease, either as adjuvant therapy, or as treatment for advanced disease). There is no restriction on the number of prior regimens in the phase I cohort A.', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count to 1.5 x 10^9/L', ' Hemoglobin to 9.0 g/dL', ' Platelet count to 100 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.0 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT within protocol parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.', ' Inclusion Criteria - Phase 2 (Cohort B):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor. Patients may have bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS in either breast but the DCIS will not be measured as part of the study endpoints.', ' Tumor size 2 cm', ' Tumor measurable either by clinical examination, mammography, MRI, or ultrasound', ' HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by IHC)', ' ECOG performance status 0-1 (see Appendix VI)', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count 1.5 x 10^9/L', ' Hemoglobin 9.0 g/dL', ' Platelet count 70 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.5 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT 1.5 x upper limit of normal (ULN)', ' Exclusion Criteria - Phase 1 (Cohort A):', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration.', ' Ongoing, chronic administration of bisphosphonate therapy is allowed so long as such treatment was ongoing at the time of study entry.', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their excipients', ' Evidence of bleeding diathesis or coagulopathy.', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication with drugs listed in Appendix XI should be excluded from study.', ' Any evidence of severe or uncontrolled systemic medical or psychiatric conditions (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.', ' Exclusion Criteria - Phase 2 (Cohort B):', ' Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast cancer is not an exclusion criterion.', ' Inflammatory breast cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast, or pathologically defined as dermal lymphatic invasion', ' Prior excisional biopsy or complete resection of the primary invasive tumor (prior sentinel node biopsy allowed)', ' Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer', ' Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular node involvement and/or direct invasion of the primary tumor into skin is allowed', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped for one week prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC AE version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g. history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 (saracatinib) or their excipients', ' Evidence of bleeding diathesis or coagulopathy', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' AZD0530 (saracatinib) is a substrate and inhibitor of CYP3A4. Since concurrent administration of AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted at MD discretion. Drugs listed in Appendix X that are known to strongly induce or inhibit CYP3A4 activity should be discontinued prior to study entry and should not be initiated during protocol treatment.', ' Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) disease.', ' Subjects unwilling or unable to undergo breast MRI as required by protocol will be excluded from study'], 'Results': ['Outcome Measurement: ', ' Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole', ' To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.', ' Time frame: Cycle 1: Days 1 - 28', 'Results 1: ', ' Arm/Group Title: Phase 1 - Cohort A', ' Arm/Group Description: Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', ' AZD0530', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: mg/day oral dose anastrozole: 1', 'saracatinib: 175'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/12 (25.00%)', ' Atrial fibrillation 0/12 (0.00%)', ' Cardiac ischemia/infarction [1]0/12 (0.00%)', ' Congestive Heart Failure [2]0/12 (0.00%)', ' Diverticulitis 0/12 (0.00%)', ' Cholecystitis 0/12 (0.00%)', ' Hyperbilirubinemia 0/12 (0.00%)', ' Urosepsis 2/12 (16.67%)', ' Brain hemorrhage complicating CNS metastasis 1/12 (8.33%)', ' Rash [3]0/12 (0.00%)']}
|
c66f3e9e-f232-4035-b705-2785946d1542
|
Comparison
|
Intervention
|
NCT01390064
|
NCT00485953
|
All Cohorts of the primary trial and the secondary trial receive their treatment via Subcutaneous administration.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01390064', 'Intervention': ['INTERVENTION 1: ', ' Initial Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', 'INTERVENTION 2: ', ' Escalation Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects of all races with histologically or cytologically confirmed stage IV breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed after primary or adjunctive therapy and must not have required a treatment change for 2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The chemotherapy regimen cannot contain steroids in the pre or post supportive care medications. If a subject is on an investigational drug, the drug must be cleared from the body over a period of 4 weeks.', ' Disease staging will be done according to the American Joint Commission on Cancer (AJCC), sixth edition.', ' Age 18 years and older of all races and ethnicity.', ' ECOG Performance Status 0 or 1.', ' Subjects must not have an active infection requiring treatment with antibiotics.', ' Subjects must not have other significant medical, surgical or psychiatric conditions, or require any medication or treatment, which may interfere with compliance of the treatment regimen.', ' Subjects must not have a diagnosis or evidence of organic brain syndrome, significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol.', ' Subjects must have no other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for 5 years prior to the time of registration.', ' Subjects must not have autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.', ' Women of childbearing potential must not be pregnant (negative serum pregnancy test must be done 48 hours prior to receiving the first dose of study drug) or breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or infant.', ' Women of childbearing potential must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods include oral contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.', ' Subjects must have obtained a white blood cell (WBC) count 3,000/mm3 and platelet count 100,000/mm3 within 2 weeks prior to registration.', ' Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase test (AST) and bilirubin 2 x institutional upper limit (IUL) of normal and serum creatinine 1.8 mg/dl, all obtained within 2 weeks prior to registration.', ' Subjects must be immunocompetent as measured by responsiveness to two recall antigens by skin testing.', ' All subjects who wish to participate in the study must sign an informed consent approved by the UAMS Institutional Review Board (IRB).', ' Laboratory tests must be completed within 2 weeks before the first dose.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Dose-limiting Toxicity (Defined as an Adverse Event of Grade 3 or Higher)', ' The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', ' Time frame: 9 weeks per subject', 'Results 1: ', ' Arm/Group Title: Initial Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Escalation Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00485953', 'Intervention': ['INTERVENTION 1: ', ' Active Medicine Group', ' risedronate 35 mg weekly', 'INTERVENTION 2: ', ' Placebo Group', ' Received placebo medication once weekly'], 'Eligibility': ['Inclusion Criteria:', ' elderly postmenopausal women (ages 55 and older)', ' osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.', ' with breast cancer on aromatase inhibitor therapy', ' with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)', ' type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients', ' Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits', 'Exclusion Criteria:', ' Women with stage 4 breast cancer (presence of distant metastases)', ' Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.', ' Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.', ' Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).', ' Those with untreated active peptic ulcer disease', ' Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.', ' Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)', ' Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor', ' Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study', ' Use of fluoride for more than 1 month ever (except for dental treatment)', ' Less than 2 evaluable vertebrae', ' Distant metastatic disease'], 'Results': ['Outcome Measurement: ', ' BMD of Spine by DXA', ' BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.', ' Time frame: at 24 months', 'Results 1: ', ' Arm/Group Title: Active Medicine Group', ' Arm/Group Description: risedronate 35 mg weekly', ' Overall Number of Participants Analyzed: 55', ' Mean (Standard Error)', ' Unit of Measure: percentage change 2.269 (0.583)', 'Results 2: ', ' Arm/Group Title: Placebo Group', ' Arm/Group Description: Received placebo medication once weekly', ' Overall Number of Participants Analyzed: 54', ' Mean (Standard Error)', ' Unit of Measure: percentage change -1.735 (0.611)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/55 (18.18%)', ' Cardiovascular related events5/55 (9.09%)', ' Gastrointestinal Events0/55 (0.00%)', ' Other events0/55 (0.00%)', ' Infection related events2/55 (3.64%)', ' Musculoskeletal related events2/55 (3.64%)', ' Other cancers0/55 (0.00%)', ' Urogenital related events0/55 (0.00%)', ' Breast related events1/55 (1.82%)', 'Adverse Events 2:', ' Total: 16/54 (29.63%)', ' Cardiovascular related events2/54 (3.70%)', ' Gastrointestinal Events1/54 (1.85%)', ' Other events4/54 (7.41%)', ' Infection related events3/54 (5.56%)', ' Musculoskeletal related events5/54 (9.26%)', ' Other cancers2/54 (3.70%)', ' Urogenital related events1/54 (1.85%)', ' Breast related events2/54 (3.70%)']}
|
c679f426-b235-4ae9-ad6c-4f1a46a494d2
|
Single
|
Adverse Events
|
NCT00879086
|
Cohort 1 and 2 of the primary trial had the same number of patients with anaemia and Neutropenia, but Cohort 1 had 8 more cases of Leukopenia than cohort 2.
|
Contradiction
|
[
0,
3,
4,
5,
14,
17,
18,
19
] |
[] |
{'Clinical Trial ID': 'NCT00879086', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).', 'INTERVENTION 2: ', ' Ixabepilone', ' Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).'], 'Eligibility': ['Inclusion criteria:', ' 1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.', 'Exclusion criteria:', ' Subjects who have received prior ixabepilone therapy.', ' Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.', ' Subjects with pre-existing neuropathy Grade greater than or equal to 2.', ' Subjects with a history of diabetes mellitus Type 1 or 2.', ' Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.', ' Subjects with missing digits required for vibration assessment.', ' Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)', ' Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA). Neuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia. If the post-baseline maximum CTCAE grade of the combined term "neuropathy" was greater than the baseline maximum CTCAE grade of the combined term, then the event was considered as treatment emergent neuropathy adverse events per CTCAE grade. For a single participant, 1) a neuropathy AE occurring more than once during the study, whether defined with the same or different MedDRA PTs, was counted only once, 2) a neuropathy AE with different CTCAE grades had only the highest grade AE counted.', ' Time frame: From administration of first dose up to approximately 5 years', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 33.3 (20.8 to 47.9)', 'Results 2: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 50.0 (35.5 to 64.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/51 (37.25%)', ' Febrile neutropenia 6/51 (11.76%)', ' Anaemia 1/51 (1.96%)', ' Leukopenia 1/51 (1.96%)', ' Neutropenia 1/51 (1.96%)', ' Thrombocytopenia 0/51 (0.00%)', ' Pericarditis 1/51 (1.96%)', ' Atrial flutter 0/51 (0.00%)', ' Cardiac failure congestive 0/51 (0.00%)', ' Visual impairment 0/51 (0.00%)', ' Dysphagia 1/51 (1.96%)', ' Abdominal pain 0/51 (0.00%)', ' Chills 1/51 (1.96%)', 'Adverse Events 2:', ' Total: 17/50 (34.00%)', ' Febrile neutropenia 0/50 (0.00%)', ' Anaemia 1/50 (2.00%)', ' Leukopenia 0/50 (0.00%)', ' Neutropenia 1/50 (2.00%)', ' Thrombocytopenia 1/50 (2.00%)', ' Pericarditis 0/50 (0.00%)', ' Atrial flutter 1/50 (2.00%)', ' Cardiac failure congestive 1/50 (2.00%)', ' Visual impairment 1/50 (2.00%)', ' Dysphagia 0/50 (0.00%)', ' Abdominal pain 1/50 (2.00%)', ' Chills 0/50 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
122b1aef-4506-464d-9852-47caa508b047
|
|
Comparison
|
Results
|
NCT00841828
|
NCT01959490
|
All cohorts in the primary trial had lower number of participants with pCR compared to cohort 1 of the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT00841828', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: EC -> D + Lapatinib', ' EC -> D + Lapatinib', ' Drugs plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)', 'INTERVENTION 2: ', ' Arm 2: EC -> D + Trastuzumab', ' EC -> D + Trastuzumab', ' Drug plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Signature of the written informed consent.', ' Histological documentation of breast cancer.', ' Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer.', ' HER2-positive breast cancer, defined as immunohistochemistry (IHQ) 3+ or positive FISH. When IHQ 2+ HER2 status must be assessed by FISH.', ' The patient granted her consent for taking a biopsy before treatment', ' The patient granted her consent for sending two tumor samples to central laboratory for molecular sub study.', ' Two weeks prior randomization pregnancy test negative for women of childbearing potential.', ' Women of childbearing potential must use adequate contraceptive measures during participation into study. Oral, injectable or implant hormonal contraceptives measure are not permitted.', ' A World Health Organization (WHO) performance status of 0 or 1 (Karnofsky 80)', ' Age > 18 years.', ' Absence of metastases disease', ' Baseline Electrocardiography (EKG) 12 weeks prior to randomization. Baseline left ventricular ejection fraction (LVEF) value within limit of normal value for the institution or > 50% of basal value', ' Normal laboratory test 2 weeks prior to randomization:', 'Haematology values: Neutrophil count 1,5 x109/l; Platelets 100 x 109/l; Haemoglobin 10mg/dl Biochemistry values: serum total bilirubin 1 x Upper Limit of Normal (ULN); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) 2,5 x ULN; alkaline phosphatase 5 x ULN. Patients which AST and/or ALT value are > 1,5 x ULN along with alkaline phosphatase value > 2,5 x ULN will be not included into the study.', ' Renal function: serum creatinine 175 µmol/l (2 mg/dl). If the value is borderline, clearance creatinine must be 60 ml/min', ' 12 weeks prior to randomization the following assessments and procedures must be fulfilled: Bilateral mammography; Magnetic resonance imaging (MRI) Breast and axillary; Chest X-Ray (posterioanterior and lateral); Abdominal ultrasound; Chest CT-Scan; Abdominal CT-Scan. Bone Scan (if applicable)', ' Patients must be accessible for treatment and follow up', 'Exclusion Criteria:', ' Patients with lumpectomy, partial mastectomy, modified radical mastectomy are not allowed to include into study.', ' Prior Immunotherapy, hormonal therapy and chemotherapy for breast cancer is not allowed.', ' Prior therapy with anthracycline and taxanes (paclitaxel and docetaxel) is not permitted for any neoplasia.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast carcinoma', ' Pregnant or nursing patients. Negative pregnant test (serum or urine) 14 days prior to randomization.', ' HER 2 negative breast cancer', ' Patients of childbearing potential must be use adequate contraceptive measures during study treatment. No hormonal contraceptive measure is permitted.', ' Any M1 breast cancer', ' Any motor or sensorial neurotoxicity grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.', ' Serious cardiac illness or medical conditions: Congestive heart failure, angina pectoris requiring specific treatment, myocardial infarction 1 year prior to enroll in the study; poorly controlled hypertension or high-risk uncontrolled arrhythmias.', ' History of significative neurological or psychiatric disease (psychotic, dementia or attack) what is unable to patient to grant her informed consent.', ' Uncontrolled severe Infection Uncontrolled diabetes mellitus, active peptic ulcer', ' Current malignancy or previous malignancy other that breast cancer. Exception cell carcinoma of the skin no melanoma, carcinoma in situ of the cervix or any other cancer in the past 10 years.', ' Long term treatment with corticoids except 6 months prior to inclusion in the study and low doses ( 20 mg methylprednisolone or equivalent)', ' Corticoid use contraindication', ' Concomitant hormonal replacement therapy. Previous treatment should be interrupted before inclusion into study.', ' Cardiopathy what stops patient taking Docetaxel and Trastuzumab: myocardial infarction recorded; angina pectoris requiring specific treatment; any congestive heart failure recorded; arrhythmia grade 3 or 4 according to NCI CTCAE version 3; any relevant valvular disease; chest X ray which shows cardiomegaly or EKG which shows ventricular hypertrophy unless LVEF value has been lower normal limit in the last 3 months.', ' Poorly controlled hypertension (systolic > 180 mm Hg or diastolic > 100 mm Hg). The patients with controlled hypertension under treatment can be included into study', ' Patients under treatment of arrhythmia, angina or congestive heart failure with drug which modifies cardiac conduction (after digital, beta blocker or inhibitors calcium channel) are excluded. However if these drugs are took for arterial tension the patient can be included into study.', ' The patient must interrupt concomitant treatment with hormonal therapy ej. raloxifene, tamoxifen and selective estrogen receptor modulators (SERM) prior to randomization.', ' Concomitant use of inhibitors and inductors of enzyme CYP3A4 complex (ketoconazole, itraconazole or grape juice; rifampicin, carbamazepin or fenitoin) are not permitted. Also, drug are substrate of enzyme CYP2C8 complex is not permitted along with lapatinib treatment.', ' Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial within 30 days prior to randomization into study.', ' Concomitant treatment with other anticancer therapy', ' Hypersensitivity reaction to drugs trastuzumab, lapatinib or their excipients.', 'Male'], 'Results': ['Outcome Measurement: ', ' Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).', ' Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.', ' Time frame: Up to 16 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1: EC -> D + Lapatinib', ' Arm/Group Description: EC -> D + Lapatinib', ' Drugs plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants with pCR 23.5 (11.9 to 35.1)', 'Results 2: ', ' Arm/Group Title: Arm 2: EC -> D + Trastuzumab', ' Arm/Group Description: EC -> D + Trastuzumab', ' Drug plus Biological', ' Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: percentage of participants with pCR 47.9 (33.8 to 62.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/52 (21.15%)', ' Neutrophils/granulocytes 3/52 (5.77%)', ' Diarrhea 2/52 (3.85%)', ' Mucositis 1/52 (1.92%)', ' Fever 1/52 (1.92%)', ' Infection 2/52 (3.85%)', ' Febrile Neutropenia 1/52 (1.92%)', ' Dyspnea 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 4/50 (8.00%)', ' Neutrophils/granulocytes 1/50 (2.00%)', ' Diarrhea 0/50 (0.00%)', ' Mucositis 0/50 (0.00%)', ' Fever 1/50 (2.00%)', ' Infection 1/50 (2.00%)', ' Febrile Neutropenia 1/50 (2.00%)', ' Dyspnea 0/50 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01959490', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1P (HER2 Positive)', ' Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Cohort 1T (HER2 Positive)', ' Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast, with sufficient tissue available for estrogen receptor (ER), progesterone receptor (PR), and HER 2 testing', ' HER2 must be positive by IHC or ISH testing by laboratory standard.', ' Needle biopsy or incisional biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1', ' Resectable disease-clinical stage I (T/0/N0miT1N0-N0mi), IIA-IIIA (T2 N0/T3N0 or T1-3 N1-N2a) or unresectable disease - clinical stage IIIB/IIIC (T4 or T1-3 N2b-3); no evidence of metastatic disease', ' No prior chemotherapy, hormonal therapy, or radiation therapy for this cancer', ' Absolute neutrophil count (ANC) 1000/ul', ' Platelet count 100,000/ul', ' Hemoglobin 9 g/dl', ' Serum creatinine 1.5 mg/dl or measured creatinine clearance of > 30 ml/min', ' Total bilirubin upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) 2.5 x ULN', " Patients with multiple foci of invasive cancer in the same breast are eligible if any single lesion meets the above size criteria and all sampled lesions are histologically similar (whether radiographically detected lesions separate from the target lesion are sampled for histologic evaluation is left to the discretion of the treating physicians); the presence of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) in either breast will not render a patient ineligible; patients with a small focus of invasive cancer detected the contralateral breast (clinical T1N0) are eligible, however only the histologic response in the breast containing the target lesions will be considered in determining the patient's pathologic response", ' Measurable disease in the breast or axilla that measures at least 1 cm by either clinical or radiographic measurement', 'Exclusion Criteria:', ' Excisional biopsy', ' Pregnant and lactating women are not eligible; all participants of reproductive age must have a negative serum pregnancy test at baseline and agree to use an effective barrier method of contraception during the entire period of treatment on the study', " Patients with New York Heart Association (NYHA) grade 2 or higher congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, or arterial thrombotic event with the past 12 months, uncontrolled hypertension (systolic blood pressure > 150 and/or diastolic blood pressure > 100 on antihypertensive medications; patients not on medication for high blood pressure who are found to have systolic blood pressure [SBP] > 150 and/or diastolic blood pressure [DBP] > 100 should have 3 documented episodes of elevated blood pressure before being considered 'uncontrolled', if they have 3 documented episodes of elevated blood pressure, then can be started on antihypertensive medications; patients currently on antihypertensive medications with elevated blood pressures as defined above may have their medications adjusted; if patients have persistent [3 episodes] of high blood pressure despite medication adjustment they will be considered ineligible for study participation; each measured episode should be 24 hours apart), prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled or clinically significant arrhythmia, grade II or greater peripheral vascular disease or prior history of stroke or transient ischemic attack (TIA); patient must have a pretreatment multi gated acquisition scan (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) above lower limit of normal", ' No non-breast malignancy within the past 5 years other than treated squamous or basal cell carcinoma of the skin or CIS of the cervix', ' Patients known to be human immunodeficiency virus (HIV) positive are not eligible for the study given their potentially compromised immune systems and increased risk of treatment-related toxicity', ' Advanced (T1N1-4/T2-3 N any) invasive cancer in the contralateral breast', ' Any known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage', ' Patients must not have a non-healing wound or fracture', ' Patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months', ' Patients must not have a bleeding diathesis, hereditary of acquired bleeding disorder or coagulopathy', ' Patients on therapeutic doses of Coumadin or Lovenox are ineligible to participate in study', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study; core biopsy or other minor surgical procedure, for example placement of a vascular access device, are excluded from this requirement', ' No known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.', ' Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.', ' Time frame: Up to 30 days after last cycle of treatment', 'Results 1: ', ' Arm/Group Title: Cohort 1P (HER2 Positive)', ' Arm/Group Description: Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 80.0%', 'Results 2: ', ' Arm/Group Title: Cohort 1T (HER2 Positive)', ' Arm/Group Description: Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/5 (20.00%)', ' Anemia * 0/5 (0.00%)', ' Febrile neutropenia * 0/5 (0.00%)', ' Diarrhea * 1/5 (20.00%)', ' Neutrophil count decreased * 0/5 (0.00%)', ' White blood cell decreased * 0/5 (0.00%)', ' Syncope * 1/5 (20.00%)', ' Hypotension * 1/5 (20.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Anemia * 0/6 (0.00%)', ' Febrile neutropenia * 0/6 (0.00%)', ' Diarrhea * 0/6 (0.00%)', ' Neutrophil count decreased * 0/6 (0.00%)', ' White blood cell decreased * 0/6 (0.00%)', ' Syncope * 0/6 (0.00%)', ' Hypotension * 0/6 (0.00%)']}
|
4a4f3e9e-6a29-4715-8000-2eec90e9bb5d
|
Comparison
|
Eligibility
|
NCT00297596
|
NCT00580333
|
Patients who completed a trastuzumab regiment, to treat the current breast cancer > 2 weeks before study entry are eligible for the primary trial but excluded from the secondary trial.
|
Entailment
|
[
0,
8,
10
] |
[
8,
9
] |
{'Clinical Trial ID': 'NCT00297596', 'Intervention': ['INTERVENTION 1: ', ' Oxaliplatin/Trastuzumab', ' Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Females 18 years of age', ' Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type', ' Measurable disease by RECIST and an ECOG 2', ' Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)', ' Baseline LVEF value within the institutional normal range', ' Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.', ' Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.', ' Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.', ' Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.', ' All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.', ' Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.', ' Patients must have recovered from toxicities due to prior therapy.', ' Lab values in accordance with the protocol', ' Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).', 'Exclusion Criteria:', ' Bone only disease are ineligible', ' Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.', ' Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.', ' Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.', ' Uncontrolled nervous system metastases', ' Dementia or significantly altered mental status that would interfere with proper consenting.', ' Receiving other investigational therapy.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Oxaliplatin/Trastuzumab', ' Arm/Group Description: Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 20 (4.3 to 35.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/25 (28.00%)', ' Perforated appendix 1/25 (4.00%)', ' Allergic reaction 1/25 (4.00%)', ' Pathologic fracture of let proximal humeral diaphysis 1/25 (4.00%)', ' Pathologic fracture of right proximal humeral diaphysis 1/25 (4.00%)', ' Respiratory failure secondary to metastatic disease 1/25 (4.00%)', ' Breast cancer 1/25 (4.00%)', ' Progressive disease 1/25 (4.00%)']}
|
{'Clinical Trial ID': 'NCT00580333', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin/Avastin', ' Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)', ' cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles', ' bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel', ' doxorubicin: Postoperative: Given intravenously for four 2-week cycles', ' cyclophosphamide: Postoperative: Given intravenously for four two-week cycles', ' paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week'], 'Eligibility': ['Inclusion Criteria:', ' All tumors must be ER-, PR- and HER2-negative', ' Clinical stage T2 or T3, N0-3, M0. Subjects with inflammatory breast cancer are not eligible', " For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes.", ' 18 years of age or older', ' Performance status (PS) of 0 or 1', ' Use of an effective means of contraception in subjects of child-bearing potential', ' Normal organ function as described in the protocol', 'Exclusion Criteria:', ' Any prior cytotoxic chemotherapy or radiation for the current breast cancer', ' HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer', ' Life expectancy of less than 12 weeks', ' Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study', ' Renal dysfunction for which exposure to cisplatin would require dose modifications', ' Steroid dependent asthma', ' Peripheral neuropathy of any etiology that exceeds grade 1', ' Uncontrolled diabetes', ' History of malignancy treated without curative intent', ' Any other pre-existing medical condition that would represent toxicity in excess of grade 1', ' Inadequately controlled hypertension', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) Grade II or greater congestive hear failure', ' History of myocardial infarction or unstable angina within 12 months prior to study enrollment', ' Any history of stroke or transient ischemic attack at any time', ' Known central nervous system (CNS) disease', ' Significant vascular disease', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious, non-healing wound, ulcer or bone fracture', ' Proteinuria at screening', ' Known hypersensitivity to any component of bevacizumab', ' Pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.', ' The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cisplatin/Avastin', ' Arm/Group Description: Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)', ' cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles', ' bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel', ' doxorubicin: Postoperative: Given intravenously for four 2-week cycles', ' cyclophosphamide: Postoperative: Given intravenously for four two-week cycles', ' paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (7 to 29)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/51 (0.00%)']}
|
9f7dc38b-1945-4035-a0ff-e08ead55145b
|
Single
|
Eligibility
|
NCT01525589
|
People who inherit undamaged variants of the BReast CAncer gene 1 or 2 are eligible for the primary trial.
|
Contradiction
|
[
0,
13
] |
[] |
{'Clinical Trial ID': 'NCT01525589', 'Intervention': ['INTERVENTION 1: ', ' Cohort A (BRCA+)', ' Patients with known deleterious BRCA1/2 mutation status at study entry', 'INTERVENTION 2: ', ' Cohort A1 (BRCA+/PARPi)', ' Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.'], 'Eligibility': ['Inclusion Criteria:', ' Women 18 and 75 years of age.', ' Voluntary signed informed consent form (ICF).', ' Proven diagnosis of metastatic breast cancer (MBC).', ' At least one, but no more than three, prior chemotherapy regimens for MBC.', ' Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.', ' Disease evaluable for response by specific appropriate criteria.', ' No or minimal disease-related symptoms not affecting patient daily activities.', ' Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)', ' Wash out periods prior to Day 1 of Cycle 1:', ' At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy', ' Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.', ' Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.', ' Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)', ' Prior treatment with PARP inhibitors (Patients in Cohort A1)', 'Exclusion Criteria:', ' Prior treatment with PM01183 or trabectedin.', ' Extensive prior RT.', ' Prior or concurrent malignant disease unless cured for more than five years.', ' Exceptions are breast cancer in the other breast.', ' Uncommon or rare subtypes of breast cancer.', ' Symptomatic or progressive brain metastases.', ' Bone-limited and exclusively metastases.', " Relevant diseases or clinical situations which may increase patient's risk:", ' History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).', ' Known muscular disease or functional alteration', ' Pregnant or breastfeeding women.', ' Impending need for immediate RT for symptomatic relief.', " Limitation of the patient's ability to comply with the treatment or to follow-up the protocol."], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.', ' Time frame: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment', 'Results 1: ', ' Arm/Group Title: Cohort A (BRCA+)', ' Arm/Group Description: Patients with known deleterious BRCA1/2 mutation status at study entry', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: percentage 40.7 (27.6 to 55.0)', 'Results 2: ', ' Arm/Group Title: Cohort A1 (BRCA+/PARPi)', ' Arm/Group Description: Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage 5.0 (0.1 to 24.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/54 (25.93%)', ' anaemia 2/54 (3.70%)', ' Febrile neutropenia 7/54 (12.96%)', ' Neutropenia 2/54 (3.70%)', ' Thrombocytopenia 6/54 (11.11%)', ' Atrial fibrillation 1/54 (1.85%)', ' Cardiac failure congestive 1/54 (1.85%)', ' Pericardial effusion 1/54 (1.85%)', ' Nausea 2/54 (3.70%)', ' Vomiting 3/54 (5.56%)', ' Catheter site erythema 1/54 (1.85%)', ' Chest discomfort 1/54 (1.85%)', 'Adverse Events 2:', ' Total: 5/20 (25.00%)', ' anaemia 0/20 (0.00%)', ' Febrile neutropenia 2/20 (10.00%)', ' Neutropenia 0/20 (0.00%)', ' Thrombocytopenia 0/20 (0.00%)', ' Atrial fibrillation 0/20 (0.00%)', ' Cardiac failure congestive 0/20 (0.00%)', ' Pericardial effusion 0/20 (0.00%)', ' Nausea 0/20 (0.00%)', ' Vomiting 0/20 (0.00%)', ' Catheter site erythema 0/20 (0.00%)', ' Chest discomfort 0/20 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b259774e-410a-49aa-b5d4-31b8d9505fc3
|
|
Comparison
|
Adverse Events
|
NCT01565499
|
NCT01234402
|
Some of the patients in the primary trial were recorded as having heart related adverse events, whereas many patients in the secondary trial experienced several different breathing related issues.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
{'Clinical Trial ID': 'NCT01565499', 'Intervention': ['INTERVENTION 1: ', ' Nab-Paclitaxel', ' The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.', 'Nab-paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically confirmed diagnosis of primary unilateral invasive early breast cancer with longest tumor size in breast 2cm, or < 2 cm with axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be 2cm (unless axillary involvement) and is designated as the "target" lesion for all subsequent tumor evaluations.', ' The breast tumors must be ER positive: more than 1% of stained tumor cells by immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative for HER2 amplification (defined as a ratio of HER2/neu copies to chromosome 17 centromere (CEP17) signals <1.8), according to the local laboratory).', ' Are clear candidates to receive chemotherapy by the investigator criteria.', ' Are at least 18 years of age.', ' Have at least one unidimensionally measurable lesion by RECIST [65] version 1.1, measured by mammogram.', ' Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2', ' Have adequate renal and liver function and bone marrow reserve as follows:', ' Bone marrow: absolute neutrophil count (ANC) > or = 1.500/mm3 (1.5 x 109/L); platelet count > or = 100.000/mm3 (100.0 x 109/L); and hemoglobin > or = 9 g/dL.', ' Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = 2.5 * ULN and Albumin 2.5 g/dL.', ' Renal: serum creatinine < 1.5 x ULN.', ' Exhibit patient compliance and geographic proximity that allow for adequate follow-up', ' Entry informed consent form signed by the patient.', 'Exclusion Criteria:', ' Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)', ' Synchronous contralateral or multicentric breast cancer.', ' Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis.', ' Second primary malignancy, except adequately treated carcinoma in situ of the cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was diagnosed and definitively treated more than 5 years ago with no subsequent evidence of recurrence.', ' Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).', ' Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.', ' Patients with known hypersensitivity to nab-paclitaxel or any of its components.', ' Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria', ' Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.', ' Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).', ' Patient is pregnant or breast feeding or planning to become pregnant within the six months after the end of treatment. Women with child-bearing potential must be performed a pregnancy serum or urine testing within 7 days prior to study entry according to institutional standards and should use an adequate non-hormonal contraceptive method (intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterilized) during treatment with study drugs and within the six months after the end of treatment.'], 'Results': ['Outcome Measurement: ', ' The Residual Cancer Burden Grade III (RCB-III).', ' The RCB-III was reported, including a 95% confidence interval. The estimate of the RCB-III was calculated as follows:', ' Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population', ' Time frame: After surgery, up to 4 months', 'Results 1: ', ' Arm/Group Title: Nab-Paclitaxel', ' Arm/Group Description: The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.', ' Nab-paclitaxel', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Count of Participants', ' Unit of Measure: Participants RCB III: Extensive residual disease (>3.28): 23 28.4%', ' RCB II: Moderate residual disease (1.36-3.28): 37 45.7%', ' RCB I: Minimal residual disease (>0-1.36): 14 17.3%', ' RCB 0: No residual disease (0): 6 7.4%', 'Unknown: 1 1.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/81 (7.41%)', ' Colitis [1]1/81 (1.23%)', ' Multiple Sclerosis Relapse 1/81 (1.23%)', ' Neurotoxicity [2]2/81 (2.47%)', ' Community-acquired pneumonia 1/81 (1.23%)', ' Local Infection Reservoir Area 1/81 (1.23%)']}
|
{'Clinical Trial ID': 'NCT01234402', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab + Capecitabine', ' Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.', 'INTERVENTION 2: ', ' Icrucumab + Capecitabine', ' Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.'], 'Eligibility': ['Inclusion Criteria:', ' The participant has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease', ' Has measurable or nonmeasurable disease', ' Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Has received prior anthracycline therapy', ' Has received prior taxane therapy', ' Participants with human epidermal growth factor receptor-2 (HER2) positive disease must have progressed on or following trastuzumab', ' Participants with hormone receptor-positive disease must have progressed on or following hormone therapy', ' Has received 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)', ' Has completed any prior radiotherapy 4 weeks prior to randomization', ' Has completed any prior hormonal therapy 2 weeks prior to randomization', ' Has adverse events (AEs) that have resolved to Grade 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy', ' Has adequate hematologic, coagulation, hepatic and renal function', ' Does not have:', ' cirrhosis at a level of Child-Pugh B (or worse) or', ' cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis', ' Has urinary protein is 1+ on dipstick or routine urinalysis; if urine protein 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study', ' Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication', 'Exclusion Criteria:', ' Has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that there has been a disease-free interval for > 3 years', ' Has a known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80', ' Has a known sensitivity to 5-fluorouracil (5-FU)', ' Has a known dihydropyrimidine dehydrogenase deficiency', ' Has received prior capecitabine treatment for advanced breast cancer', ' Has received investigational therapy within 2 weeks prior to randomization', ' Has received bevacizumab within 4 weeks prior to randomization', ' Has received more than 1 prior antiangiogenic agent for breast cancer', ' Has a known sensitivity to agents of similar biologic composition as ramucirumab DP or Icrucumab (IMC-18F1), or other agents that specifically target vascular endothelial growth factor (VEGF)', ' Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention', ' Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' Has experienced a Grade 3 bleeding event within 3 months prior to randomization', ' Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other oral anticoagulant', ' Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorder in the opinion of the investigator', ' Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization', ' Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease', ' Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy', ' Has received a prior allogeneic organ or tissue transplantation', ' Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization', ' Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization', ' Has known HIV or AIDS infection', ' Has an elective or planned major surgery to be performed during the course of the trial', ' Participant is pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of 5 millimeter (mm) and the appearance of 1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.', ' Time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)', 'Results 1: ', ' Arm/Group Title: Ramucirumab + Capecitabine', ' Arm/Group Description: Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.', ' Overall Number of Participants Analyzed: 52', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 22.1 (12.1 to 36.1)', 'Results 2: ', ' Arm/Group Title: Icrucumab + Capecitabine', ' Arm/Group Description: Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.', ' Overall Number of Participants Analyzed: 49', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 7.3 (6.3 to 13.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/52 (38.46%)', ' Anaemia 0/52 (0.00%)', ' Pancytopenia 1/52 (1.92%)', ' Acute myocardial infarction 0/52 (0.00%)', ' Atrial fibrillation 0/52 (0.00%)', ' Cardiac failure 1/52 (1.92%)', ' Cardiogenic shock 1/52 (1.92%)', ' Palpitations 0/52 (0.00%)', ' Pericardial effusion 0/52 (0.00%)', ' Right ventricular failure 1/52 (1.92%)', ' Abdominal pain 0/52 (0.00%)', ' Ascites 3/52 (5.77%)', 'Adverse Events 2:', ' Total: 25/49 (51.02%)', ' Anaemia 2/49 (4.08%)', ' Pancytopenia 0/49 (0.00%)', ' Acute myocardial infarction 1/49 (2.04%)', ' Atrial fibrillation 1/49 (2.04%)', ' Cardiac failure 0/49 (0.00%)', ' Cardiogenic shock 0/49 (0.00%)', ' Palpitations 1/49 (2.04%)', ' Pericardial effusion 4/49 (8.16%)', ' Right ventricular failure 0/49 (0.00%)', ' Abdominal pain 1/49 (2.04%)', ' Ascites 0/49 (0.00%)']}
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e09a11e4-afc8-4351-a5bc-d847424c79ce
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Comparison
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Intervention
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NCT01720602
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NCT00082810
|
the primary trial participants receive more anastrozole, Fulvestrant and exemestane than patients in the secondary trial.
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Contradiction
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[
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{'Clinical Trial ID': 'NCT01720602', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Vorinostat, AI Therapy)', ' Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.', ' vorinostat: Given PO', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' positron emission tomography: Correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' fludeoxyglucose F 18: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven diagnosis of breast cancer', ' Stage IV disease', ' Patient has previously derived clinical benefit from endocrine therapy, but is no longer deriving benefit to endocrine therapy in the opinion of the treating investigator', ' At least one site of measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Female patient is post menopausal as defined by one of the following; free from menses for >= 2 years, surgically sterilized, FSH and estradiol in post-menopausal range AND surgical absence of uterus OR chemotherapy induced amenorrhea lasting > 1 year OR currently on ovarian suppression', ' Female patient of childbearing potential has a negative urine or serum (beta human chorionic gonadotropin [B-hCG]) pregnancy test within 14 days prior to receiving the first dose of vorinostat', ' Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study', ' Absolute neutrophil count (ANC) >= 1,500/mcL', ' Platelets >= 50,000/mcL', ' Hemoglobin >= 9 g/dL', ' Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation', ' Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation', ' Potassium (K) levels normal limits', ' Magnesium (Mg) levels normal limits', ' Calculated creatinine clearance >= 30 mL/min', ' Creatinine clearance should be calculated per institutional standard', ' Serum total bilirubin =< 1.5 x ULN', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x ULN', ' Alkaline phosphatase =< 2.5 x ULN', " Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent", ' Patient has a life expectancy of at least 12 weeks in the opinion of the treating investigator', ' Patient is willing to continue on same AI therapy', ' Patient agrees to participate in imaging protocol 7184 and is separately consented', 'Exclusion Criteria:', ' Patient has not derived clinical benefit from prior endocrine therapy', ' Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184', ' Patient has received an ER blocking therapy (selective estrogen receptor modulating or downregulating selective estrogen receptor modulator [SERM] or selective estrogen receptor degrader [SERD] i.e. tamoxifen or fulvestrant) within the past 6 weeks', ' Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidepsin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period', ' Patient is on any systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone during the 30 days prior to the start of the study drugs', ' Patient has known hypersensitivity to the components of study drug or its analogs', ' Patients with uncontrolled brain metastases', ' New York Heart Association (NYHA) class III or IV congestive heart failure, myocardial infarction within the previous 6 months, QTc > 0.47 seconds, or uncontrolled arrhythmia', ' Type I diabetes mellitus; patients with type II diabetes mellitus will be included as long as their glucose can be controlled to under 200 mg/dL', ' Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study', ' Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse', ' Patients with known active viral hepatitis', " Patient has a history or current evidence of any condition, therapy, or laboratory (lab) abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate"], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST', ' A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.', ' Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).', ' Time frame: 8 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Vorinostat, AI Therapy)', ' Arm/Group Description: Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.', ' vorinostat: Given PO', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' positron emission tomography: Correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' fludeoxyglucose F 18: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of patients 60 (35 to 81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Liver failure [1]1/15 (6.67%)', ' Fever [1]1/15 (6.67%)']}
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{'Clinical Trial ID': 'NCT00082810', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 250 mg + Tipifarnib 300 mg', ' Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed adenocarcinoma of the breast', ' Patients must be postmenopausal', ' Patients must have stage IV disease or inoperable locally advanced disease', ' Patients must have ER- and/or PR-positive disease as determined by their local pathology laboratory', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; all sites of disease should be noted and followed', ' Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted; patients previously treated with two or more prior doses of fulvestrant are not eligible; patients who have received one prior dose of fulvestrant within 28 days are eligible so long as they meet other eligibility criteria', ' Patients must have ECOG performance status 0-2 (Karnofsky >= 60%)', ' Patients must have life expectancy of greater than 3 months', ' Leukocytes >= 3,000/uL', ' Absolute neutrophil count >= 1,500/uL', ' Platelets >= 100,000/uL', ' Total bilirubin =< 2 mg/dL', ' AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal', ' Creatinine less than or equal to 1.5 times the institutional upper limits of normal', ' Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix', ' Patients must have the ability to understand and the willingness to sign a written informed consent document', ' Patients who have had previous therapy with farnesyltransferase inhibitor', 'Exclusion Criteria:', ' Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had prior chemotherapy for metastatic disease are not eligible; prior adjuvant or neoadjuvant chemotherapy is allowed', ' Patients may not be receiving any other investigational agents', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777, Zarnestra™) or other agents used in the study (e.g., imidazoles, quinolones)', ' Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (> 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement', ' Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued', ' Grade 2 or more peripheral neuropathy', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with tipifarnib or other agents administered during the study.; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)', ' Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.', ' Time frame: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg + Tipifarnib 300 mg', ' Arm/Group Description: Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Number', ' Unit of Measure: participants Partial response: 11', ' Stable disease: 5', ' Complete response: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/33 (60.61%)', ' Neutropenia 4/33 (12.12%)', ' Anemia 2/33 (6.06%)', ' Cardiac Ischemia 1/33 (3.03%)', ' Nausea 3/33 (9.09%)', ' Vomiting 2/33 (6.06%)', ' Diarrhea 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', ' Infection 1/33 (3.03%)', ' Anorexia 1/33 (3.03%)', ' Hyperglycemia 1/33 (3.03%)', ' Hypocalcemia 2/33 (6.06%)', ' Hypokalemia 1/33 (3.03%)', ' Ataxia 1/33 (3.03%)', ' Insomnia 1/33 (3.03%)']}
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d22f01f0-b2be-45b9-8996-11727750b91e
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Single
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Adverse Events
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NCT00129935
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There were 80% more cases of embolisms in cohort 2 of the primary trial than cohort 1.
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Contradiction
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{'Clinical Trial ID': 'NCT00129935', 'Intervention': ['INTERVENTION 1: ', ' Arm A: EC-T', ' Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.', ' Docetaxel', ' Epirubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm B: ET-X', ' Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.', ' Docetaxel', ' Capecitabine', 'Epirubicin'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.', ' Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.', ' Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: TNM pathologic stage N1a, TNM pathologic stage N2a, TNM pathologic stage N3a.', ' Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.', ' Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.', ' Age >= 18 and <= 70 years old.', ' Performance status (Karnofsky index) >= 80.', ' Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).', ' Laboratory results (within 14 days prior to randomization):', ' Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;', ' Hepatic function: total bilirubin <= 1 upper normal limit (UNL); serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;', ' Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;', ' Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.', ' Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.', ' Patients able to comply with treatment and study follow-up.', ' Negative pregnancy test done in the 14 prior days to randomization.', 'Exclusion Criteria:', ' Prior systemic therapy for breast cancer.', ' Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.', ' Any T4 or M1 tumour.', ' Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.', ' HER2 positive breast cancer (IHC 3+ or positive FISH result).', ' Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCICTC v-2.0]).', ' Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled hypertension or high risk arrhythmias.', ' History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.', ' Active uncontrolled infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' Chronic treatment with corticosteroids.', ' Contraindications for corticosteroid administration.', ' Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.', ' Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.', ' Concomitant treatment with another therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease-free Survival (DFS) Event', ' A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Arm A: EC-T', ' Arm/Group Description: Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.', ' Docetaxel', ' Epirubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 669', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 127 19.0%', 'Results 2: ', ' Arm/Group Title: Arm B: ET-X', ' Arm/Group Description: Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.', ' Docetaxel', ' Capecitabine', ' Epirubicin', ' Overall Number of Participants Analyzed: 715', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 170 23.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 111/669 (16.59%)', ' Leukocytes * [1]1/669 (0.15%)', ' Hemoglobin * [1]1/669 (0.15%)', ' Hemoglobin * [2]0/669 (0.00%)', ' CNS cerebrovascular ischemia * [1]0/669 (0.00%)', ' CNS cerebrovascular ischemia * [3]0/669 (0.00%)', ' Heart Failure * [1]3/669 (0.45%)', ' Thrombosis/embolism * [1]1/669 (0.15%)', ' Thrombosis/embolism * [3]0/669 (0.00%)', 'Adverse Events 2:', ' Total: 138/715 (19.30%)', ' Leukocytes * [1]0/715 (0.00%)', ' Hemoglobin * [1]0/715 (0.00%)', ' Hemoglobin * [2]1/715 (0.14%)', ' CNS cerebrovascular ischemia * [1]1/715 (0.14%)', ' CNS cerebrovascular ischemia * [3]1/715 (0.14%)', ' Heart Failure * [1]1/715 (0.14%)', ' Thrombosis/embolism * [1]3/715 (0.42%)', ' Thrombosis/embolism * [3]2/715 (0.28%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
893d5684-03f8-4acd-86e4-6d38eea3ce16
|
|
Comparison
|
Adverse Events
|
NCT01596751
|
NCT00193050
|
There were 0 patients with Dysphagia or Fever in the primary trial and the secondary trial cohorts.
|
Entailment
|
[
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT01596751', 'Intervention': ['INTERVENTION 1: ', ' Phase Ib: Eribulin in Combination With PLX3397', ' Phase Ib:', ' 21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously, day 1 and 8', ' Cohort 1: 600 mg/day', ' Cohort 2: 800 mg/day', ' Cohort 3: 1000 mg/day'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed diagnosis of breast cancer with documented progressive disease.', ' Patients with stable brain metastases are eligible for this trial.', ' At least one prior chemotherapy regimen for metastatic breast cancer. Prior treatment must be discontinued at least 2 weeks before treatment start.', ' Concomitant therapy with bisphosphonates is allowed.', ' Stable dose coumadin anticoagulation is allowed, providing that anticoagulation can be safely held to an International Normalized Ratio (INR) within normal range for the purpose of tumor biopsy. Low molecular weight heparin (LMWH is the preferred method of anticoagulation.', ' Prothrombin time (PT)/International Normalized Ratio (INR) and partial thromboplastin time (PTT) within institutional normal limits within two weeks before initial biopsy.', ' Measurable disease, as defined by RECIST guidelines or evaluable disease. Bone metastases must be evaluable.', ' Disease amenable to core biopsy. Patients with pulmonary metastases as their only site of disease may enroll on this trial and will not undergo biopsy.', ' For Phase I: patients with human epidermal growth factor receptor 2 (HER2) overexpressing disease must have been previously treated with trastuzumab. Patients with HER2 overexpressing disease are not eligible for the Phase II trial.', ' Age eighteen years or older.', ' Eastern Cooperative Oncology Group (ECOG) performance status </= 2.', ' Life expectancy of >/= 12 weeks.', ' Patients with < grade 1 peripheral neuropathy are eligible for this trial.', ' Adequate bone marrow reserve: Absolute Neutrophil Count (ANC) >/= 1000, platelets >/= 100,000.', ' Adequate renal function: serum creatinine </= 1.5x upper limit of normal (ULN) OR calculated creatinine clearance 50 ml/min.', ' Sodium, potassium, and chloride levels within institutional normal limits.', ' Adequate hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 x ULN, and total bilirubin </= 1.5x upper limit of normal. In patients with liver dysfunction due to hepatic metastases, AST and ALT are permitted to be </= 5 times the ULN.', ' At baseline: Ejection fraction (EF) 50%, no evidence of QT prolongation, no history of congenital long QT syndrome, and no use of drugs known to increase the risk of Torsades de Point - patients may be eligible for study if the drug can be changed to another agent with less risk (such as changing from citalopram to an alternate antidepressant).', ' Able to take oral medications and maintain hydration.', ' Ability to give written informed consent and willingness to comply with the requirements of the protocol', ' Women of child-bearing potential must agree to use an effective method of birth control during treatment and for six months after receiving their last dose of study drug', ' Specific inclusion criteria for Phase II', ' Patients enrolling on the phase II portion of this trial must have ER, progesterone receptors (PR) and HER2 negative disease defined as less than 10% staining for ER and PR, and HER2 not amplified byFluorescent in situ hybridization (FISH), 0-1% by Immunohistochemistry (IHC), or 2+ by IHC and no evidence of amplification by FISH.', 'Exclusion Criteria:', ' Treatment with another chemotherapy or hormonal therapy within the past 2 weeks.', ' Treatment with trastuzumab, bevacizumab or other targeted therapies within the past 2 weeks.', ' Concurrent treatment with radiotherapy.', ' Ongoing treatment with any other investigational therapy.', ' Prior treatment with eribulin', ' Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol.', ' Inadequate bone marrow, renal, or hepatic function as defined above, or an active coagulopathy that precludes tissue biopsy.', ' Pregnant or lactating women and women of child-bearing potential who are not using an effective method of birth control. Women of childbearing potential must undergo a serum pregnancy test within seven days of starting the study drug.'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD) of PLX3397 Given in Combination With Standard Dose Eribulin in Participants With Metastatic Breast Cancer (Phase 1b)', ' The MTD was determined using a standard dose-escalation schema with 3 to 6 participants per cohort (3+3 design) for participants enrolled in Phase 1b. The starting dose level of PLX3397 was 600 mg/day and was raised in successive cohorts up to a dose of 1000 mg/day. Participants in each Phase Ib cohort were followed for dose limiting toxicities (DLTs) within the first 21 days of combination therapy and had to receive at least 14 days of PLX3397 and 2 doses of eribulin during the first cycle in order to be considered evaluable for DLT (unless the missed doses were due to a DLT). A toxicity was considered a DLT if it was treatment related and met specific requirements for type of toxicity and severity assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4. The MTD was defined as the lowest dose level at which 2 or more participants in a cohort experienced a DLT. The dose level just below the MTD was selected for Phase 2.', ' Time frame: Up to Day 21', 'Results 1: ', ' Arm/Group Title: Phase Ib: Eribulin in Combination With PLX3397', ' Arm/Group Description: Phase Ib:', ' 21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously, day 1 and 8', ' Cohort 1: 600 mg/day', ' Cohort 2: 800 mg/day', ' Cohort 3: 1000 mg/day', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: miligrams per day 1,000'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/5 (60.00%)', ' Febrile neutropenia 3/5 (60.00%)', ' Atrial fibrillation 0/5 (0.00%)', ' Myocardial Infarction 0/5 (0.00%)', ' Blurred Vision 0/5 (0.00%)', ' Dysphagia 0/5 (0.00%)', ' Fever 0/5 (0.00%)', ' General disorders and administration site conditions - Other 0/5 (0.00%)', ' Localized edema 0/5 (0.00%)', ' Non-cardiac chest pain 0/5 (0.00%)', ' Pain 0/5 (0.00%)', ' Sepsis 0/5 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00193050', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles', ' Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.', ' After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.', ' After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Adenocarcinoma of the breast confirmed by biopsy', ' Female Patients >18 years of age', ' Normal cardiac function', ' Ability to perform activities of daily living with minimal assistance', ' Chemotherapy naïve or have received prior chemotherapy > 5 years ago', ' Adequate bone marrow, liver and kidney function', ' Be informed of the investigational nature of this study', ' Sign an informed consent form', ' Sentinel lymph node and/or axillary dissection prior to enrollment', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Life expectancy of < than 6 months', ' History of significant heart disease', ' Prior chemotherapy or hormonal therapy', ' Concurrent Trastuzumab therapy', ' History of significant psychiatric disorders', ' History of active uncontrolled infection', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR)', ' For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles', ' Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.', ' After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.', ' After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Number', ' Unit of Measure: percentage of participants 18 (11 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/110 (15.45%)', ' Hemoglobin [1]1/110 (0.91%)', ' Esophagitis 1/110 (0.91%)', ' Dysphagia 1/110 (0.91%)', ' Nausea/Vomiting 1/110 (0.91%)', ' Nausea 1/110 (0.91%)', ' Fever 1/110 (0.91%)', ' Febrile Neutropenia 11/110 (10.00%)', ' Infection - Other [2]1/110 (0.91%)', ' Infection - Pneumonia 1/110 (0.91%)', ' Dyspnea 2/110 (1.82%)', ' Hypoxia 1/110 (0.91%)']}
|
4b46164d-a4c2-4738-be36-588ab231ceb1
|
Single
|
Adverse Events
|
NCT00320541
|
Cohort 2 of the primary trial recorded 10% more cases of Leukopenia than cohort 1.
|
Contradiction
|
[
0,
4,
13,
17
] |
[] |
{'Clinical Trial ID': 'NCT00320541', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel Plus Bevacizumab (PB)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', 'INTERVENTION 2: ', ' Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.', ' Must be able to measure the disease by specific medical parameters', ' May have received breast cancer treatment in the early stage of the disease', ' May be restricted in physically strenuous activity but able to carry out light work.', ' Must have adequate organ function as seen in blood test results.', 'Exclusion', ' Criteria:', ' Cancer that has spread to the brain.', ' Unstable heart problems', ' Unstable high blood pressure.', ' Breast cancer treatment after the disease has considered to spread to other areas or organs.', ' Unable to agree with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).', ' Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)', 'Results 1: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab (PB)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 94', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.489 (0.385 to 0.595)', 'Results 2: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 92', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.587 (0.479 to 0.689)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/94 (28.72%)', ' Anaemia 2/94 (2.13%)', ' Febrile neutropenia 2/94 (2.13%)', ' Leukopenia 1/94 (1.06%)', ' Neutropenia 0/94 (0.00%)', ' Thrombocytopenia 1/94 (1.06%)', ' Arrhythmia 0/94 (0.00%)', ' Atrial fibrillation 0/94 (0.00%)', ' Cardiac failure congestive 0/94 (0.00%)', ' Cardiomyopathy 0/94 (0.00%)', ' Pericardial effusion 0/94 (0.00%)', ' Tachycardia 0/94 (0.00%)', 'Adverse Events 2:', ' Total: 36/93 (38.71%)', ' Anaemia 2/93 (2.15%)', ' Febrile neutropenia 9/93 (9.68%)', ' Leukopenia 3/93 (3.23%)', ' Neutropenia 4/93 (4.30%)', ' Thrombocytopenia 1/93 (1.08%)', ' Arrhythmia 1/93 (1.08%)', ' Atrial fibrillation 1/93 (1.08%)', ' Cardiac failure congestive 3/93 (3.23%)', ' Cardiomyopathy 2/93 (2.15%)', ' Pericardial effusion 1/93 (1.08%)', ' Tachycardia 1/93 (1.08%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d9236874-7f3d-4402-9699-2889db9f5c61
|
|
Comparison
|
Results
|
NCT00057941
|
NCT01806259
|
DLT occurence, used as the outcome measurement in the secondary trial and Clinical Benefit Rate, used in the primary trial are not synonymous, and represent entirely different patient characteristics.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT00057941', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole and ZD1839', '[Not Specified]', 'INTERVENTION 2: ', ' Fulvestrant and ZD1839', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have estrogen and/or progesterone receptor positive histologically confirmed adenocarcinoma of the breast with measurable recurrent or metastatic carcinoma of the breast', ' Baseline measurements and evaluations of involved sites should be performed as close as possible to study entry, but must be within 4 weeks prior to randomization', ' Patients with available tissue blocks from either the primary or metastatic site must submit the tissue for EGFR analysis', ' All patients must be postmenopausal females defined by:', ' Prior bilateral oophorectomy or bilateral ovarian irradiation', ' No menstrual period for 12 months or longer. If age 55 years or less and on tamoxifen within the prior 6 months, must have an estradiol level in the postmenopausal range', ' Patients must not have had more than 2 prior chemotherapy regimens for metastatic disease and no chemotherapy within 3 weeks prior to randomization; no concurrent chemotherapy is allowed while on protocol therapy', ' Patients must not have prior hormonal therapy for metastatic disease; no prior therapy in the adjuvant setting with an estrogen receptor down-regulator (e.g. fulvestrant) or an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane, aminoglutethamide); non-protocol concurrent hormonal therapy is not allowed', ' Patients must not have had prior therapy with agents that target EGFR', ' Previous, but not concomitant, therapy with trastuzumab (Herceptin) is allowed; patients must not receive trastuzumab (Herceptin) within 3 weeks prior to randomization', ' Patients must have ECOG performance status of 0, 1, or 2', ' Neutrophils >= 1500/mm^3', ' Platelets >= 100,000/mm^3', ' Bilirubin =< 1.25 x upper limit of normal', ' SGPT (ALT) and SGOT (AST) =< 2.5 x upper limit of normal if no demonstrable liver metastases or =< 5 times upper limit of normal in the presence of liver metastases', ' Calculated creatinine clearance >= 30ml/min', ' INR, PT and PTT within normal range', ' Patients must not be receiving therapy with anticoagulants or have other contraindication to i.m. injections', ' Patients must not have a history of central nervous system metastasis', ' Patients may receive concurrent radiation therapy to painful sites of boney disease or areas of impending fracture as long as the radiation therapy is initiated prior to study entry and sites of measurable disease outside the radiation therapy port are available to follow; patient who have received prior radiation therapy must have recovered from toxicity of the prior radiation therapy', " Patients must not take the following medications that may alter ZD1839 pharmacokinetics while enrolled in this trial: phenytoin, carbamazapine, phenobarbitol, rifampicin, and St. John's Wort, oxcarbazepine, rifapentine, modafinil, and griseofulvin", ' Patients age =< 55 years must not be receiving LHRH agonists or antagonists within 3 months prior to randomization', ' Patients who have an ocular inflammation or infection should be fully treated before entry into the trial; patients with a neuropathic keratopathy or diabetes or those with anterior basement membrane disease must be advised of the need for frequent opthalmalogic exams', " Patients who continue to wear contact lenses must be advised that they have an increased risk of ocular events; the decision to wear contact lenses should be discussed with the patient's treating oncologist and ophthalmologist", ' Patients must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities', ' Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate', ' Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.', ' Time frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years', 'Results 1: ', ' Arm/Group Title: Anastrozole and ZD1839', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 72', ' Measure Type: Number', ' Unit of Measure: percentage of participants 44 (33 to 57)', 'Results 2: ', ' Arm/Group Title: Fulvestrant and ZD1839', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: percentage of participants 41 (29 to 53)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/74 (36.49%)', ' Anemia 1/74 (1.35%)', ' Sinus bradycardia 0/74 (0.00%)', ' Dyspepsia 0/74 (0.00%)', ' Dysphagia 1/74 (1.35%)', ' Gastritis 1/74 (1.35%)', ' Nausea 3/74 (4.05%)', ' Vomiting 2/74 (2.70%)', ' Diarrhea w/o prior colostomy 4/74 (5.41%)', ' Fatigue 2/74 (2.70%)', ' AST increased 5/74 (6.76%)', ' ALT increased 3/74 (4.05%)', ' Infection w/o neutropenia 1/74 (1.35%)', 'Adverse Events 2:', ' Total: 28/74 (37.84%)', ' Anemia 1/74 (1.35%)', ' Sinus bradycardia 1/74 (1.35%)', ' Dyspepsia 1/74 (1.35%)', ' Dysphagia 0/74 (0.00%)', ' Gastritis 0/74 (0.00%)', ' Nausea 3/74 (4.05%)', ' Vomiting 2/74 (2.70%)', ' Diarrhea w/o prior colostomy 10/74 (13.51%)', ' Fatigue 2/74 (2.70%)', ' AST increased 6/74 (8.11%)', ' ALT increased 3/74 (4.05%)', ' Infection w/o neutropenia 3/74 (4.05%)']}
|
{'Clinical Trial ID': 'NCT01806259', 'Intervention': ['INTERVENTION 1: ', ' Ketorolac 30 mg', ' Active drug to be compared with placebo', 'Ketorolac 30 mg IV', 'INTERVENTION 2: ', ' NaCl 0.9% 3mL', 'Ketorolac 30 mg IV'], 'Eligibility': ['Inclusion Criteria:', ' Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes', 'Exclusion Criteria:', ' Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )'], 'Results': ['Outcome Measurement: ', ' Recurrence-free Survival', ' 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Ketorolac 30 mg', ' Arm/Group Description: Active drug to be compared with placebo', ' Ketorolac 30 mg IV', ' Overall Number of Participants Analyzed: 96', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 80 83.3%', 'Results 2: ', ' Arm/Group Title: NaCl 0.9% 3mL', ' Arm/Group Description: Ketorolac 30 mg IV', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 96 89.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/96 (8.33%)', ' Hematoma requiring surgery 1/96 (1.04%)', ' Any type (not bleeding related) 7/96 (7.29%)', 'Adverse Events 2:', ' Total: 7/107 (6.54%)', ' Hematoma requiring surgery 0/107 (0.00%)', ' Any type (not bleeding related) 7/107 (6.54%)']}
|
e33825f1-45df-41f5-ba07-e9059636a146
|
Comparison
|
Results
|
NCT00295620
|
NCT03366428
|
the secondary trial and the primary trial use similar outcome measures, evaluating how long patients survive after treatment.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00295620', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Anastrozol', ' 1 mg per day for 2 years', 'INTERVENTION 2: ', ' Arm B: Anastrozol', ' 1 mg per day for 5 years'], 'Eligibility': ['Inclusion criteria:', ' Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.', ' No distant metastasis at randomization', ' No relapse at randomization', ' TNM- classification at time of diagnosis: T1-3, N0 and N+, M0', ' Estrogen- and or progesterone positive before the beginningof primary endocrine therapy', ' Endocrine therapy for 5 years (maximum deviation ±12 months)', ' Therapy break (from the preliminary therapie) maximum 12 months.', ' Informed Consent before the randomisation', 'Exclusion criteria:', ' Premenopausal patients or patients with non definable menopausal statusat time of randomisation', ' Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)', ' General contraindication respectively hypersensitivity to Anastrozol.', ' In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.', ' Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy', ' Known liver- and/or kidneyinsufficiency', ' Performance Index >2 according to WHO', ' Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma', ' Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.', ' Lacking compliance of the patient', ' Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial', ' Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival After Prolonged Endocrine Treatment', ' To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.', ' Time frame: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years', 'Results 1: ', ' Arm/Group Title: Arm A: Anastrozol', ' Arm/Group Description: 1 mg per day for 2 years', ' Overall Number of Participants Analyzed: 1281', ' Median (Inter-Quartile Range)', ' Unit of Measure: Years NA [1] (7.7 to NA)', 'Results 2: ', ' Arm/Group Title: Arm B: Anastrozol', ' Arm/Group Description: 1 mg per day for 5 years', ' Overall Number of Participants Analyzed: 1323', ' Median (Inter-Quartile Range)', ' Unit of Measure: Years NA [1] (8.1 to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 687/1710 (40.18%)', ' Anaemia 1/1710 (0.06%)', ' Anaemia macrocytic 0/1710 (0.00%)', ' Bone marrow oedema 3/1710 (0.18%)', ' Haemolytic anaemia 1/1710 (0.06%)', ' Immune thrombocytopenic purpura 1/1710 (0.06%)', ' Leukopenia 0/1710 (0.00%)', ' Lymph node calcification 1/1710 (0.06%)', ' Lymphadenitis 1/1710 (0.06%)', ' Lymphadenopathy 3/1710 (0.18%)', ' Mastocytosis 1/1710 (0.06%)', 'Adverse Events 2:', ' Total: 452/1705 (26.51%)', ' Anaemia 1/1705 (0.06%)', ' Anaemia macrocytic 1/1705 (0.06%)', ' Bone marrow oedema 0/1705 (0.00%)', ' Haemolytic anaemia 0/1705 (0.00%)', ' Immune thrombocytopenic purpura 0/1705 (0.00%)', ' Leukopenia 1/1705 (0.06%)', ' Lymph node calcification 0/1705 (0.00%)', ' Lymphadenitis 0/1705 (0.00%)', ' Lymphadenopathy 0/1705 (0.00%)', ' Mastocytosis 0/1705 (0.00%)']}
|
{'Clinical Trial ID': 'NCT03366428', 'Intervention': ['INTERVENTION 1: ', ' DS-8201a', ' Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH] +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available', ' Has a left ventricular ejection fraction (LVEF) 50%', ' Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1', 'Exclusion Criteria:', ' Has a medical history of myocardial infarction within 6 months before enrollment', ' Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions', ' Has uncontrolled or significant cardiovascular disease'], 'Results': ['Outcome Measurement: ', ' Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer', ' The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.', ' Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)', 'Results 1: ', ' Arm/Group Title: DS-8201a', ' Arm/Group Description: Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Maximum change from baseline in QTcF: >30 ms: 3 6.1%', ' Maximum change from baseline in QTcF: >60 ms: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/51 (17.65%)', ' Nausea 2/51 (3.92%)', ' Cellulitis 1/51 (1.96%)', ' Lung infection 1/51 (1.96%)', ' Femur fracture 1/51 (1.96%)', ' Post procedural complication 1/51 (1.96%)', ' Fracture 1/51 (1.96%)', ' Interstitial lung disease 1/51 (1.96%)', ' Pneumonitis 1/51 (1.96%)']}
|
5b0295e1-a322-40af-9acf-9cc1d55d3e64
|
Single
|
Eligibility
|
NCT00077857
|
Patients must be older than 18, female, have three or more target lesions and more than 1 regiment of chemotherapy to participate in the primary trial.
|
Contradiction
|
[
0,
1,
2,
5
] |
[] |
{'Clinical Trial ID': 'NCT00077857', 'Intervention': ['INTERVENTION 1: ', ' 1250 mg/m^2 Capecitabine + Docetaxel', ' 1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.', 'INTERVENTION 2: ', ' 825 mg/m^2 Capecitabine + Docetaxel', ' 825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' women >=18 years of age;', ' >=1 target lesion;', ' locally advanced or metastatic breast cancer;', ' demonstrated resistance to anthracycline;', ' >=2 regimens of chemotherapy for advanced/metastatic disease.', 'Exclusion Criteria:', ' previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;', ' previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Time to Progression of Disease or Death', ' Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.', ' Time frame: Event driven (after 350 events). Median observation time was approximately 16 months.', 'Results 1: ', ' Arm/Group Title: 1250 mg/m^2 Capecitabine + Docetaxel', ' Arm/Group Description: 1250 mg/m^2 capecitabine (Xeloda ) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere ) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.', ' Overall Number of Participants Analyzed: 230', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.9 (6.9 to 8.5)', 'Results 2: ', ' Arm/Group Title: 825 mg/m^2 Capecitabine + Docetaxel', ' Arm/Group Description: 825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.', ' Overall Number of Participants Analyzed: 229', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.8 (4.9 to 7.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/217 (18.89%)', ' Febrile neutropenia 13/217 (5.99%)', ' Neutropenia 6/217 (2.76%)', ' Leukopenia 2/217 (0.92%)', ' Anaemia 0/217 (0.00%)', ' Atrial flutter 0/217 (0.00%)', ' Cardiac failure 0/217 (0.00%)', ' Cardiogenic shock 1/217 (0.46%)', ' Cardiopulmonary failure 0/217 (0.00%)', ' Stomatitis all 5/217 (2.30%)', ' Diarrhoea 2/217 (0.92%)', ' Vomiting 2/217 (0.92%)', 'Adverse Events 2:', ' Total: 53/248 (21.37%)', ' Febrile neutropenia 14/248 (5.65%)', ' Neutropenia 4/248 (1.61%)', ' Leukopenia 0/248 (0.00%)', ' Anaemia 1/248 (0.40%)', ' Atrial flutter 1/248 (0.40%)', ' Cardiac failure 1/248 (0.40%)', ' Cardiogenic shock 0/248 (0.00%)', ' Cardiopulmonary failure 1/248 (0.40%)', ' Stomatitis all 0/248 (0.00%)', ' Diarrhoea 2/248 (0.81%)', ' Vomiting 2/248 (0.81%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3658f2f7-a497-4abb-badb-c877036456f2
|
|
Single
|
Results
|
NCT00303108
|
The Cohort of the primary trial which received D+C and Taxane Na‚àö√òve, produced marginally better results than the other cohort.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00303108', 'Intervention': ['INTERVENTION 1: ', ' D+C and Taxane Naive', ' Doxil, Carboplatin and Taxane naive', 'INTERVENTION 2: ', ' D+C and Taxane Pretreated', ' Doxil, Carboplatin and Taxane pretreated'], 'Eligibility': ['Inclusion Criteria:', ' Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease', ' Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.', ' Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study', ' Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy', ' For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC', ' For taxane-naïve patients, has had no prior chemotherapy for MBC', ' Has had cumulative doses of < 300 mg/m2 prior doxorubicin or < 450 mg/m2 prior epirubicin', ' Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.', ' Has an ECOG Performance Status (PS) 0-2 (see Appendix I)', ' Is a male or female greater than or equal to 18 years of age', ' Laboratory Values - Please refer to protocol section 4.2 for specific laboratory values.', ' Has a negative serum pregnancy test within 7 days prior to registration (woman of childbearing potential [WOCBP; not surgically sterilized and between menarche and 1 year postmenopause])', ' If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.', ' Has signed a Patient Informed Consent Form', ' Has signed a Patient Authorization Form (HIPAA Form)', ' Has a life expectancy of > 3 months', 'Exclusion Criteria:', ' Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities', ' Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil', ' Has evaluable only disease; eg, bone only, pleural, peritoneal only disease', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.', ' Is receiving concurrent investigational therapy or has received such therapy within 30 days', ' Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent', ' Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs', ' Is a pregnant or lactating woman', ' Is unable to comply with requirements of study'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.', ' Time frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.', 'Results 1: ', ' Arm/Group Title: D+C and Taxane Naive', ' Arm/Group Description: Doxil, Carboplatin and Taxane naive', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.8 (17.0 to 47.6)', 'Results 2: ', ' Arm/Group Title: D+C and Taxane Pretreated', ' Arm/Group Description: Doxil, Carboplatin and Taxane pretreated', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of participants 31.0 (17.6 to 47.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/83 (9.64%)', ' ANEMIA 1/83 (1.20%)', ' PANCYTOPENIA 1/83 (1.20%)', ' THROMBOCYTOPENIA 2/83 (2.41%)', ' ANOREXIA 1/83 (1.20%)', ' DEHYDRATION 2/83 (2.41%)', ' NAUSEA AND VOMITING 0/83 (0.00%)', ' VOMITING 1/83 (1.20%)', ' RENAL FAILURE ACUTE 1/83 (1.20%)', ' URINARY TRACT INFECTION 1/83 (1.20%)', ' PNEUMONIA 0/83 (0.00%)', 'Adverse Events 2:', ' Total: 3/46 (6.52%)', ' ANEMIA 0/46 (0.00%)', ' PANCYTOPENIA 0/46 (0.00%)', ' THROMBOCYTOPENIA 0/46 (0.00%)', ' ANOREXIA 0/46 (0.00%)', ' DEHYDRATION 0/46 (0.00%)', ' NAUSEA AND VOMITING 2/46 (4.35%)', ' VOMITING 1/46 (2.17%)', ' RENAL FAILURE ACUTE 0/46 (0.00%)', ' URINARY TRACT INFECTION 0/46 (0.00%)', ' PNEUMONIA 1/46 (2.17%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
37bc71d5-d9c0-4174-8da5-725d2d53a91b
|
|
Comparison
|
Intervention
|
NCT02781051
|
NCT01067976
|
The intervention for the primary trial requires participants to exercise for 12 weeks while wearing a fitbit, no physical activity is explicitly required for the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT02781051', 'Intervention': ['INTERVENTION 1: ', ' Physical Activity Intervention', ' Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', ' Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', ' Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.', ' Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', ' Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'], 'Eligibility': ['Inclusion Criteria:', ' Positive depression screen (PHQ-9) or current antidepressant treatment', ' Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ', ' Physically able to engage in physical activity', ' Written and verbal fluency in English', 'Exclusion Criteria:', ' Medical condition contraindicating physical activity participation', ' Recurrence of breast cancer', ' Ductal carcinoma in situ (DCIS) diagnosis', ' Cognitively unable to give informed consent', ' Non-English speaking'], 'Results': ['Outcome Measurement: ', ' Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer', ' Assess changes in physical activity at 6 months following physical activity intervention.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Physical Activity Intervention', ' Arm/Group Description: Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', ' Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', ' Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.', ' Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', ' Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: minutes per week 56.2 (23.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01067976', 'Intervention': ['INTERVENTION 1: ', ' CMRM vs UMRM', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.', ' If female, a digital XRM is required if any of the following criteria is met:', ' patient is younger than 50 years;', ' patient has heterogeneously or extremely dense breasts;', ' is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).', ' If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.', ' Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.', 'Exclusion Criteria:', ' Is a female patient who is pregnant or lactating', ' Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.', ' Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.', ' Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).', ' Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).', ' Has received chemotherapy or hormonal therapy for breast cancer within 6 months.', ' Has received hormone replacement therapy within 4 weeks prior to study drug administration.', ' Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application', ' Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM'], 'Results': ['Outcome Measurement: ', ' Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader', ' For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).', ' Time frame: Immediately before injection and after injection', 'Results 1: ', ' Arm/Group Title: CMRM vs UMRM', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 388', ' Mean (95% Confidence Interval)', ' Unit of Measure: difference in sensitivity (%) Reader 1: 46.6 (41.9 to 51.4)', ' Reader 2: 30.8 (25.7 to 35.9)', ' Reader 3: 23.3 (19.2 to 27.3)', ' Investigator: 17.8 (14.2 to 21.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/426 (0.00%)']}
|
51ac9fe0-2bfa-42f5-aaec-69e0c5cdff7c
|
Single
|
Results
|
NCT01302379
|
Both patient cohorts of the primary trial had a median Insulin change from baseline lower than -15%.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT01302379', 'Intervention': ['INTERVENTION 1: ', ' Metformin + Lifestyle Intervention', ' Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.', 'INTERVENTION 2: ', ' Placebo + Lifestyle Intervention', ' Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.'], 'Eligibility': ['Inclusion Criteria:', ' BMI at least 25.0 kg/m2', ' Diagnosed with Stage I, II, or III breast cancer within past 5 years', ' Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation', ' Not scheduled for or currently undergoing chemotherapy', ' Accessible geographically and by telephone', ' Able to communicate dietary and physical activity data via telephone', ' If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period', ' Post-menopausal at diagnosis', 'Exclusion Criteria:', ' Preliminary bloodwork outside of specified ranges', ' Evidence of renal insufficiency, liver disease, or congestive heart failure', ' Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)', ' Recent initiation (< 3 months ago) of thiazides or β-blockers', ' Taking insulin or other antidiabetic drug', ' Other primary or recurrent invasive cancer in past 10 years', ' Unable to commit to study requirements'], 'Results': ['Outcome Measurement: ', ' Insulin', ' Insulin measured as percent change from baseline', ' Time frame: change from baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Metformin + Lifestyle Intervention', ' Arm/Group Description: Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.', ' Overall Number of Participants Analyzed: 83', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -21.8 (-29.7 to -13.0)', 'Results 2: ', ' Arm/Group Title: Placebo + Lifestyle Intervention', ' Arm/Group Description: Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.', ' Overall Number of Participants Analyzed: 83', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -17.7 (-25.9 to -8.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/333 (1.50%)', ' transient ischemic attack1/333 (0.30%)', ' Injury due to fall1/333 (0.30%)', ' Abdominal pain1/333 (0.30%)', ' slurred speach1/333 (0.30%)', 'Adverse Events 2:', ' Total: 5/333 (1.50%)', ' transient ischemic attack1/333 (0.30%)', ' Injury due to fall1/333 (0.30%)', ' Abdominal pain1/333 (0.30%)', ' slurred speach1/333 (0.30%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8bcc9fa3-0317-471a-a5b5-b115b5b72dea
|
|
Single
|
Results
|
NCT00082433
|
the primary trial results suggest that 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle + Capecitabine, triples patient OS, compared to Capecitabine alone.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00082433', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone + Capecitabine', ' Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.', 'INTERVENTION 2: ', ' Capecitabine', 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'], 'Eligibility': ['Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).', ' Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.', ' Patients may not have any history of brain and/or leptomeningeal metastases.', ' Patients may not have Grade 2 or worse neuropathy at the time of study entry.', ' Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)'], 'Results': ['Outcome Measurement: ', ' Overall Survival (OS)', ' Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.', ' Time frame: from date of randomization until death', 'Results 1: ', ' Arm/Group Title: Ixabepilone + Capecitabine', ' Arm/Group Description: Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.', ' Overall Number of Participants Analyzed: 609', ' Median (95% Confidence Interval)', ' Unit of Measure: months 16.39 (14.95 to 17.91)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.', ' Overall Number of Participants Analyzed: 612', ' Median (95% Confidence Interval)', ' Unit of Measure: months 15.64 (13.86 to 17.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 192/603 (31.84%)', ' ANAEMIA 5/603 (0.83%)', ' LEUKOPENIA 1/603 (0.17%)', ' NEUTROPENIA 8/603 (1.33%)', ' LYMPH NODE PAIN 0/603 (0.00%)', ' THROMBOCYTOPENIA 3/603 (0.50%)', ' FEBRILE NEUTROPENIA 5/603 (0.83%)', ' PERICARDITIS 1/603 (0.17%)', ' ANGINA UNSTABLE 0/603 (0.00%)', ' CARDIAC FAILURE 0/603 (0.00%)', ' SINUS TACHYCARDIA 0/603 (0.00%)', ' ATRIAL FIBRILLATION 2/603 (0.33%)', 'Adverse Events 2:', ' Total: 205/595 (34.45%)', ' ANAEMIA 7/595 (1.18%)', ' LEUKOPENIA 8/595 (1.34%)', ' NEUTROPENIA 18/595 (3.03%)', ' LYMPH NODE PAIN 1/595 (0.17%)', ' THROMBOCYTOPENIA 4/595 (0.67%)', ' FEBRILE NEUTROPENIA 34/595 (5.71%)', ' PERICARDITIS 0/595 (0.00%)', ' ANGINA UNSTABLE 1/595 (0.17%)', ' CARDIAC FAILURE 1/595 (0.17%)', ' SINUS TACHYCARDIA 2/595 (0.34%)', ' ATRIAL FIBRILLATION 0/595 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
52610141-321d-4e3d-8660-ebc14b9f1696
|
|
Comparison
|
Adverse Events
|
NCT00570921
|
NCT00274456
|
There is one case of Cardiopulmonary failure in cohort 1 of the secondary trial, but none in cohort 1 of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT00570921', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Everolimus', ' Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal status, defined as any one of the following criteria: Documented history of bilateral oophorectomy, Age 60 years or more, OR Age 45 to 59 and satisfying one or more of the following criteria: Amenorrhea for at least 12 months and intact uterus OR Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration - within postmenopausal range including: Patients who have had a hysterectomy or Patients who have received hormone replacement', ' Patients must have histologically confirmed invasive breast cancer', ' Metastatic or locally advanced disease', ' Patients must have estrogen receptor and/or progesterone receptor positive disease', ' Measurable or evaluable disease', ' Failure of aromatase inhibitor therapy within the previous 6 months. Patients who received prior tamoxifen are eligible to enroll', ' Prior aromatase inhibitor therapy or other endocrine therapy must be discontinued at least 1 week prior to enrollment and any toxicity from such therapy must have reverted to grade I or less at the time of enrollment', ' Patients must not have received chemotherapy, radiation therapy, or had surgery within 4 weeks prior to enrollment and any toxicity from such therapy must have recovered to grade 1 or less prior to enrollment', ' Patients must not have received either of the study medications previously', ' WHO performance status of 0, 1, or 2', ' Adequate organ function defined as follows: Adequate renal function, defined by a serum creatinine within the upper limits of normal, Adequate liver function, defined by a bilirubin of < 1.5 the upper limit of normal (ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) of 2.5 times the ULN, Adequate bone marrow function, defined as an absolute neutrophil count (ANC) 1.5 x 109/L, platelet count (PLT) >100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) <1.3, and because fulvestrant is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia or in patients on anticoagulants', ' Patients will be asked to provide a tumor paraffin block if available', ' Ability to understand and sign a written informed consent for participation in the trial', 'Exclusion Criteria:', ' Known severe hypersensitivity to everolimus (or similar drugs) or any of the excipients of this product', ' Premenopausal status', ' Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ', ' Patients with brain metastasis or leptomeningeal involvement', ' Patients with malignant pleural effusion or ascites only disease', ' Rapidly progressive visceral disease', ' WHO performance status of 3 or 4', ' As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris or significant cardiac arrhythmia, Psychiatric illness/social situations that would limit compliance with study requirements, Severely impaired lung function such as severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease, a known forced expiratory volume at one second (FEV1) of < 1.5 liters, or dyspnea of grade III or greater, Uncontrolled diabetes as defined by a fasting blood sugar (FBS) of > 1.5 ULM, Known liver disease such as cirrhosis or chronic hepatitis, Known HIV positivity, OR known condition causing malabsorption', ' Chronic treatment with systemic steroids or other immunosuppressive agents', ' Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period', ' Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial', ' Prior treatment with an mTOR inhibitor', ' Treatment with a non-approved or investigational drug within 30 days or 5 half-lives of the drug, whichever is greater, before Day 1 of study treatment', ' In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections', ' History of hypersensitivity to castor oil'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' [Not Specified]', ' Time frame: Duration of time start of treatment to time of documented progression or death', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Everolimus', ' Arm/Group Description: Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.4 (1.9 to 12.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/33 (15.15%)', ' Left Ventricular Thrombus * 1/33 (3.03%)', ' Nausea * 1/33 (3.03%)', ' Acute Cholecystitis * 1/33 (3.03%)', ' Renal Failure * 1/33 (3.03%)', ' Pneumonia * 1/33 (3.03%)']}
|
{'Clinical Trial ID': 'NCT00274456', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 300 mg/m^2 q3w', ' ABI-007 300 mg/m^2 administered once every third week (q3w).', 'INTERVENTION 2: ', ' ABI-007 100 mg/m^2 Weekly', ' ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest'], 'Eligibility': ['Inclusion Criteria:', ' Patients had to meet the following criteria to be eligible for the study:', ' Pathologically confirmed adenocarcinoma of the breast.', ' No prior chemotherapy for metastatic breast cancer.', ' Stage IV disease.', ' Measurable disease (must have been 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were 1.0 cm).', ' At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.', ' At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.', ' At least 4 weeks since major surgery, with full recovery.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Age 18 years.', ' Patient had the following blood counts at Baseline:', ' Absolute neutrophil count (ANC) 1.5*10^9 cells/L', ' Platelets 100*10^9 cells/L', ' Hemoglobin (Hgb) 9 g/dL.', ' Patient had the following baseline blood chemistry levels:', ' Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) 2.5x upper limit of normal (ULN) range', ' Total bilirubin normal', ' Alkaline phosphatase 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL.', ' Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).', ' If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).', ' If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.', ' Informed consent had been obtained.', 'Exclusion Criteria:', ' Patients who met any of the following criteria were excluded from the study:', ' Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.', ' Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.', ' Concurrent immunotherapy or hormonal therapy for breast cancer.', ' Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.', ' Serious intercurrent medical or psychiatric illness, including serious active infection.', ' History of class II-IV congestive heart failure.', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.', ' Patients who had received an investigational drug within the previous 3 weeks.', ' Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.', ' Pregnant or nursing women', ' Patients with prior hypersensitivity to either Taxol or Taxotere.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator', ' Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.', ' Time frame: Day 1 up to 95 weeks', 'Results 1: ', ' Arm/Group Title: ABI-007 300 mg/m^2 q3w', ' Arm/Group Description: ABI-007 300 mg/m^2 administered once every third week (q3w).', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 37 (26.0 to 47.7)', ' Investigator assessed ORR: 46 (34.8 to 57.3)', 'Results 2: ', ' Arm/Group Title: ABI-007 100 mg/m^2 Weekly', ' Arm/Group Description: ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 45 (33.6 to 55.9)', ' Investigator assessed ORR: 63 (52.3 to 74.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/76 (18.42%)', ' Neutropenia 10/76 (13.16%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 0/76 (0.00%)', ' Optic ischaemic neuropathy 0/76 (0.00%)', ' Bowel peristalsis increased 1/76 (1.32%)', ' Colitis 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 12/76 (15.79%)', ' Neutropenia 2/76 (2.63%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 1/76 (1.32%)', ' Optic ischaemic neuropathy 1/76 (1.32%)', ' Bowel peristalsis increased 0/76 (0.00%)', ' Colitis 1/76 (1.32%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 1/76 (1.32%)']}
|
90203158-6477-4486-b8d9-09dcaca63617
|
Comparison
|
Adverse Events
|
NCT00574587
|
NCT00777049
|
There were no cases of Myocardial ischaemia in the primary trial or the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
] |
{'Clinical Trial ID': 'NCT00574587', 'Intervention': ['INTERVENTION 1: ', ' Stratum A: VR-Paclitaxel-Trastuzumab', ' Stratum A: Vorinostat 200 (Dose Level 1) or 300 mg (Dose level 2) by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery', 'INTERVENTION 2: ', ' Stratum B: VR-Paclitaxel-Trastuzumab', ' Stratum B: 300 mg by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: IIB, IIIA, IIIB or IIIC.', ' Tumor must be Her2/neu positive', ' No prior chemotherapy, radiation or definitive therapeutic surgery', 'Exclusion Criteria:', ' May not be receiving any other investigational agents', ' Uncontrolled intercurrent illness'], 'Results': ['Outcome Measurement: ', ' Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab', ' Dose limiting toxicity in cycle 1', ' Time frame: 3 weeks', 'Results 1: ', ' Arm/Group Title: Stratum A: VR-Paclitaxel-Trastuzumab', ' Arm/Group Description: Stratum A: Vorinostat 200 (Dose Level 1) or 300 mg (Dose level 2) by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg 300', 'Results 2: ', ' Arm/Group Title: Stratum B: VR-Paclitaxel-Trastuzumab', ' Arm/Group Description: Stratum B: 300 mg by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg 300'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' cardiac tamponade 0/3 (0.00%)', ' congestive heart failure 0/3 (0.00%)', ' pulmonary emobolism 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 2/23 (8.70%)', ' cardiac tamponade 0/23 (0.00%)', ' congestive heart failure 1/23 (4.35%)', ' pulmonary emobolism 1/23 (4.35%)']}
|
{'Clinical Trial ID': 'NCT00777049', 'Intervention': ['INTERVENTION 1: ', ' ER+ and/or PgR+ (Arm I)', ' Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', 'INTERVENTION 2: ', ' ER- and PgR- (Arm II)', ' Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent obtained prior to any study-related procedures', ' Women 18 years old', ' Patients with an ECOG performance status of 2 assessed within 2 weeks (14 days) prior to registration', ' Histologically or cytologically confirmed breast cancer with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' Measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines', ' HER2-negative patients by local laboratory testing (IHC 0 or 1+ staining, IHC 2+ staining but in situ hybridization negative, or in situ hybridization negative).', ' ER and PgR testing from a local laboratory is required prior to patient registration', ' For Arm I: at least two lines of prior endocrine therapy (in adjuvant and/or metastatic settings) are required. Up to two prior cytotoxic chemotherapies are allowed in the metastatic setting (prior adjuvant and neoadjuvant chemotherapy is allowed).', ' For Arm II: up to 2 prior cytotoxic chemotherapy regimens for treatment of metastatic or locally recurrent breast cancer are allowed.', ' Complete radiological tumor measurement within 4 weeks (28 days) prior to registration:', ' Chest: CT scan with intravenous contrast if the contrast is not medically contraindicated or MRI', ' Abdomen: CT scan with intravenous or oral contrast if the contrast is not medically contraindicated or MRI', ' Brain: CT scan or MRI', ' Bone: Whole body Bone Scintigraphy', ' Patients must meet the following laboratory criteria within 2 weeks (14 days) prior to registration:', ' Hematology', ' Neutrophil count of > 1200/mm3', ' Platelet count of > 100,000/mm3', ' Hemoglobin 90 g/L', ' Biochemistry', ' AST/SGOT and ALT/SGPT 2.5 x upper limit of normal (ULN) or 5.0 x ULN if the transaminase elevation is due to disease involvement', ' Serum bilirubin 1.5 x ULN', ' Serum creatinine 1.5 x ULN or 24-hour creatinine clearance 50 mL/min', ' Serum potassium, sodium, magnesium, phosphorus, and calcium within normal limits for the institution', ' Serum albumin LLN or 30g/L', ' Clinically euthyroid function (TSH and free T4). (Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism).', ' LVEF assessment (2-D echocardiogram or MUGA scan) performed within 6 weeks prior to registration, showing a LVEF value > 50%', ' Electrocardiogram performed within 1 week prior to registration (details about findings on the Electrocardiogram that are not acceptable for participating in the study are reported in the Exclusion criteria section)', ' Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to registration and agree to appropriate method of pregnancy prevention.', ' Patient should have an archival tumor sample available for confirmation of HER2, Estrogen and Progesterone status by the central lab.', 'Exclusion Criteria:', ' Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer', ' Patients who need valproic acid for any other medical condition during the study or within 5 days prior to first panobinostat treatment', ' Patients who have received prior systemic anti-cancer therapy (cytotoxic chemotherapy, endocrine therapy, targeted therapy, monoclonal antibody or biologic therapy) or investigational agent within the last 4 weeks prior to registration (6 weeks for nitrosoureas and mitomycin; 2 weeks for capecitabine)', ' Patients who have received prior radiotherapy to 25% of the bone marrow within the last 4 weeks prior to registration; local radiotherapy is allowed however all recently irradiated lesions should not be included in the measurable disease assessment.', ' Patients who have received prior investigational agents within the last 4 weeks prior to registration', ' Patients with unresolved diarrhea CTCAE grade 1', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat', ' History of cardiac dysfunction including any one of the following:', ' Complete left bundle branch block or obligate use of a cardiac pacemaker or congenital long QT syndrome or history or presence of ventricular tachyarrhythmias or clinically significant resting bradycardia (<50 beats per minute) or QTcF > 450 msec on screening ECG or right bundle branch block and left anterior hemiblock (bifascicular block)', ' Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria', ' Previous history angina pectoris or acute MI within 6 months of registration', ' Congestive Heart Failure (New York Heart Association functional classification III-IV)', ' History of unexplained syncope', ' Other clinically significant heart disease (e.g. cardiomyopathy, cardiac artery disease, uncontrolled hypertension, or history of poor compliance with an antihypertensive regimen)', ' Family history of long QT syndrome, unexplained syncope or unexplained sudden death', ' Acute or chronic liver or renal disease', ' Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes mellitus, active untreated or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol', ' Concomitant use of drugs with a risk of causing torsades de pointes where such treatments cannot be discontinued or switched to a different medication prior to starting study drug', ' Brain metastases, unless patient randomized on study at least 90 days from completion of brain radiotherapy and / or surgery without radiologic or functional evidence of progressive brain metastases, and off corticosteroids above the dose of 7.5 mg prednisone or equivalent; No concurrent radiotherapy for brain metastasis is allowed', ' Clinically significant third space fluid accumulation', ' Concurrent biphosphonates unless if initiated prior to study entry (at least 4 weeks before patient registration)', ' Pregnant (i.e., positive beta-human chorionic gonadotropin test) or breast feeding patient', ' Unable to swallow oral medications', ' Not willing to use a double barrier method of non-hormonal birth control. Contraception must be used during the study and for 30 days after last dose of study treatment.', ' Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.', ' The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).', ' Time frame: 6 years and 2 months', 'Results 1: ', ' Arm/Group Title: ER+ and/or PgR+ (Arm I)', ' Arm/Group Description: Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 1', ' Stable Disease / Incompete Response: 13', ' Progressive Disease: 14', 'Missing: 5', 'Results 2: ', ' Arm/Group Title: ER- and PgR- (Arm II)', ' Arm/Group Description: Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 0', ' Stable Disease / Incompete Response: 4', ' Progressive Disease: 14', 'Missing: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/32 (37.50%)', ' Anaemia 0/32 (0.00%)', ' Neutropenia 1/32 (3.13%)', ' Thrombocytopenia 4/32 (12.50%)', ' Atrial fibrillation 1/32 (3.13%)', ' Cardiac failure congestive 1/32 (3.13%)', ' Myocardial ischaemia 1/32 (3.13%)', ' Abdominal discomfort 0/32 (0.00%)', ' Ascites 1/32 (3.13%)', ' Constipation 0/32 (0.00%)', ' Rectal haemorrhage 1/32 (3.13%)', ' Vomiting 1/32 (3.13%)', ' Fatigue 1/32 (3.13%)', 'Adverse Events 2:', ' Total: 8/20 (40.00%)', ' Anaemia 1/20 (5.00%)', ' Neutropenia 0/20 (0.00%)', ' Thrombocytopenia 1/20 (5.00%)', ' Atrial fibrillation 0/20 (0.00%)', ' Cardiac failure congestive 0/20 (0.00%)', ' Myocardial ischaemia 0/20 (0.00%)', ' Abdominal discomfort 1/20 (5.00%)', ' Ascites 0/20 (0.00%)', ' Constipation 2/20 (10.00%)', ' Rectal haemorrhage 0/20 (0.00%)', ' Vomiting 0/20 (0.00%)', ' Fatigue 0/20 (0.00%)']}
|
03334f23-49ab-47e5-b420-a6753ce6e832
|
Single
|
Adverse Events
|
NCT02370238
|
There were 2 cases of Angina in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT02370238', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel+Reparixin (Group 1) - ITT Population', ' paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.', 'INTERVENTION 2: ', ' Paclitaxel+Placebo (Group 2)', ' paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Female aged 18 years.', ' Patients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released.', ' TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.', ' Patients must be newly diagnosed metastatic or must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > 12 months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > 6 months from the end of previous (neo)adjuvant treatment', ' Patients with at least one baseline measurable lesion according to RECIST criteria version 1.1.', ' Zubrod (Eastern Co-operative Oncology Group [ECOG]) Performance Status (PS) of 0-1.', ' Life expectancy of at least three months.', ' Patients must be able to swallow and retain oral medication (intact tablet).', ' Able to undergo all screening assessments outlined in the protocol.', ' Adequate organ function (defined by the following parameters):', ' Serum creatinine < 140 μmol/L (< 1.6 mg/dL) or creatinine clearance > 60 mL/min.', ' Serum hemoglobin 9 g/dL; absolute neutrophil count 1.5 x 109/L; platelets 100 x 109/L.', " Serum bilirubin 1.5 x upper normal limit (UNL) except patients with Gilbert's syndrome", ' Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) 2.5 x UNL but 5.0 x UNL in case of liver metastases; alkaline phosphatase (ALP) UNL but i) 2.5 x UNL in case of liver metastases and ii) 5 UNL in case of bone metastases; albumin 2.5 g/dl.', ' No history or evidence by CT scan or MRI, of brain metastases or leptomeningeal disease.', ' No known hepatitis B virus (not due to immunization), hepatitis C virus, human immunodeficiency virus-I and -II positive status.', ' Dated and signed IEC/IRB-approved informed consent.', 'Exclusion Criteria:', ' Prior therapy for metastatic TNBC (chemotherapy, hormone therapy or biological therapy), Patients may receive bisphosphonates and other therapies to treat bone metastases, however if used, bone lesions will not be considered as measurable disease.', ' Less than four weeks since last radiotherapy (excluding palliative radiotherapy).', ' Pregnancy or lactation or unwillingness to use adequate method of birth control.', ' Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.', ' Active or uncontrolled infection.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function.', ' G>1 pre-existing peripheral neuropathy', ' Any other invasive malignancy from which the patient has been disease-free for less than 5 years with the exception of curatively treated basal or squamous cell skin cancer', ' Hypersensitivity to:', ' paclitaxel', ' ibuprofen or to more than one non-steroidal anti-inflammatory drug.', ' medications belonging to the class of sulfonamides, with the exception of sulfanilamides (e.g., sulfamethoxazole).'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was defined as the number of days between the date of randomization and the date of clinical disease progression, according to RECIST criteria version 1.1, as assessed by Independent Radiology Review, or to death due to any cause, whichever occurred first.', ' Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.', ' Time frame: Baseline up to every 8 weeks until disease progression or death, whichever occurs first, up to 721 days', 'Results 1: ', ' Arm/Group Title: Paclitaxel+Reparixin (Group 1) - ITT Population', ' Arm/Group Description: paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.', ' Overall Number of Participants Analyzed: 62', ' Median (Inter-Quartile Range)', ' Unit of Measure: Days 166 (62 to 292)', 'Results 2: ', ' Arm/Group Title: Paclitaxel+Placebo (Group 2)', ' Arm/Group Description: paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.', ' Overall Number of Participants Analyzed: 61', ' Median (Inter-Quartile Range)', ' Unit of Measure: Days 171 (105 to 393)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/61 (21.31%)', ' Anaemia 1/61 (1.64%)', ' Febrile neutropenia 1/61 (1.64%)', ' Cardiac failure congestive 0/61 (0.00%)', ' Pericardial effusion 0/61 (0.00%)', ' Constipation 1/61 (1.64%)', ' Intestinal perforation 1/61 (1.64%)', ' Stomatitis 0/61 (0.00%)', ' Non-cardiac chest pain 2/61 (3.28%)', ' Condition aggravated 1/61 (1.64%)', ' General physical health deterioration 1/61 (1.64%)', 'Adverse Events 2:', ' Total: 12/60 (20.00%)', ' Anaemia 1/60 (1.67%)', ' Febrile neutropenia 0/60 (0.00%)', ' Cardiac failure congestive 1/60 (1.67%)', ' Pericardial effusion 1/60 (1.67%)', ' Constipation 0/60 (0.00%)', ' Intestinal perforation 0/60 (0.00%)', ' Stomatitis 1/60 (1.67%)', ' Non-cardiac chest pain 0/60 (0.00%)', ' Condition aggravated 0/60 (0.00%)', ' General physical health deterioration 1/60 (1.67%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a847cfc1-9556-4a55-9698-69c22696148f
|
|
Single
|
Adverse Events
|
NCT01075100
|
No mental health issues were observed in the primary trial.
|
Entailment
|
[
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{'Clinical Trial ID': 'NCT01075100', 'Intervention': ['INTERVENTION 1: ', ' Triple Negative', ' ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', 'INTERVENTION 2: ', ' HR Positive', ' ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:', ' Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease', ' Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as 20 mm with conventional techniques (CT, MRI, X-ray) or as 10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.', ' Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:', 'Has had no prior treatment with ixabepilone or platinum agents', ' Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy', ' 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to <Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to <Grade 1 (if applicable).', ' Has an ECOG Performance Status (PS) 0-2', ' Is 18 years of age', ' Has a life expectancy of at least 12 weeks', ' Has laboratory values of:', ' White blood cell (WBC) count 3000 x 106/L Absolute neutrophil count (ANC) 1500 x 106/L Hemoglobin 9 g/dL Total bilirubin 1x upper limit of normal (ULN) AST and ALT 2.5 x ULN Alkaline phosphatase 2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine 1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count 100,000 x 106/L', ' If patient has had radiation therapy, it has been completed >3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.', ' Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause', ' If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter', ' Has signed the most recent Patient Informed Consent Form', ' Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.', 'Exclusion Criteria:', ' A patient will be excluded from this study if he or she meets any of the following criteria:', ' Had prior treatment with ixabepilone or other epothilones', ' Had prior radiation to 30% of major bone marrow containing areas (pelvis, lumbar spine)', ' Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the patient has life-threatening or rapidly progressing visceral disease', ' Has HER2+ disease (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells]), a FISH result of more than 6 HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals of >2.2)', ' Has only lytic bone disease or nonmeasurable disease only', ' Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor®EL (polyoxyethylated castor oil) or has history of severe allergic reactions to cisplatin or other platinum-containing compounds', ' Has been treated previously with a platinum-containing agent', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Washout periods for these prior therapies are specified in Section 5.', ' Is receiving concurrent investigational therapy or has received such therapy within the 30 days prior to dosing Day 1', ' Has neuropathy (motor or sensory) >Grade 1', ' Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible.', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection', ' Has clinically relevant coagulopathy either secondary to hepatic dysfunction or an underlying condition requiring therapeutic anticoagulation (specifically, A-fib, history of DVT). A daily aspirin or Plavix for CAD are permitted.', ' Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs', ' Is a pregnant or breast feeding woman', ' Is unable to comply with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 24 months', 'Results 1: ', ' Arm/Group Title: Triple Negative', ' Arm/Group Description: ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.4 (17.7 to 45.8)', 'Results 2: ', ' Arm/Group Title: HR Positive', ' Arm/Group Description: ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34 (21.5 to 48.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/48 (20.83%)', ' NEUTROPENIA 1/48 (2.08%)', ' THROMBOCYTOPENIA 0/48 (0.00%)', ' VOLUME BLOOD DECREASED 1/48 (2.08%)', ' FIBRILLATION ATRIAL 1/48 (2.08%)', ' HYPOTENSION 1/48 (2.08%)', ' ABDOMINAL PAIN 1/48 (2.08%)', ' APPETITE DECREASED 0/48 (0.00%)', ' DEHYDRATION 4/48 (8.33%)', ' DIARRHEA 4/48 (8.33%)', ' NAUSEA 3/48 (6.25%)', ' VOMITING 2/48 (4.17%)', ' FEVER 1/48 (2.08%)', ' RIGORS 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 5/53 (9.43%)', ' NEUTROPENIA 1/53 (1.89%)', ' THROMBOCYTOPENIA 1/53 (1.89%)', ' VOLUME BLOOD DECREASED 0/53 (0.00%)', ' FIBRILLATION ATRIAL 0/53 (0.00%)', ' HYPOTENSION 0/53 (0.00%)', ' ABDOMINAL PAIN 0/53 (0.00%)', ' APPETITE DECREASED 1/53 (1.89%)', ' DEHYDRATION 0/53 (0.00%)', ' DIARRHEA 0/53 (0.00%)', ' NAUSEA 1/53 (1.89%)', ' VOMITING 1/53 (1.89%)', ' FEVER 1/53 (1.89%)', ' RIGORS 1/53 (1.89%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fcbb7e0f-d106-44bd-a252-9b57adc6f071
|
|
Single
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Results
|
NCT03584009
|
Participants in the primary trial administered with Fulvestrant 500mg via intramuscular injection had a higher % of clinical benefit than participants who were administered an additional 160 mg of Neratinib.
|
Contradiction
|
[
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[] |
{'Clinical Trial ID': 'NCT03584009', 'Intervention': ['INTERVENTION 1: ', ' Venetoclax + Fulvestrant', ' Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).', 'INTERVENTION 2: ', ' Fulvestrant', ' Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).'], 'Eligibility': ['Inclusion Criteria:', ' Histological or cytological confirmation of estrogen receptor-positive (ER+) invasive carcinoma of the breast. ER+, HER2- negative invasive carcinoma of the breast with evaluable sample for BCL-2 IHC value at the time of screening. Participants who were originally diagnosed with HER2-positive breast cancer that converted to HER2-negative MBC are not eligible.', ' Evidence of metastatic or locally advanced disease not amenable to surgical or local therapy with curative intent.', ' Be postmenopausal or pre- or perimenopausal women amenable to being treated with the luteinizing hormone-releasing hormone (LHRH) agonist goserelin.', ' Participants must not have received more than two prior lines of hormonal therapy in the locally advanced or metastatic setting. In addition, at least one line of treatment must be a CDK4/6i AND participants must have experienced disease recurrence or progression during or after CDK4/6i therapy, which must have been administered for a minimum of 8 weeks prior to progression.', ' Participants for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at the time of entry into the study, as per national or local treatment guidelines.', ' Women of childbearing potential (i.e., not postmenopausal for at least 12 months or surgically sterile) must have had a negative serum pregnancy test result at screening, within 14 days prior to the first study drug administration.', ' For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 2 years after the last dose of study drug (or based on the local prescribing information for fulvestrant). Women must refrain from donating eggs during this same period.', ' Willing to provide tumor biopsy sample.', ' Had at least one measurable lesion via RECIST v1.1.', ' Had an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.', ' Had adequate organ and marrow function.', ' Had a life expectancy > 3 months.', ' To full fill the coagulation requirements for patient with or without therapeutic anticoagulation.', 'Exclusion criteria:', ' Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), venetoclax, or any agent whose mechanism of action is to inhibit BCL-2.', ' Pregnant, lactating, or intending to become pregnant during the study.', ' Known untreated or active Central Nervous System (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control.', ' Prior chemotherapy in the locally advanced or metastatic setting regardless of the duration of the treatment.', ' Any anti-cancer therapy received within 21 days of the first dose of study drug, including chemotherapy, radiotherapy, hormonal therapy, immunotherapy, antineoplastic vaccines, or other investigational therapy. (Radiotherapy with palliative intent to non-target sites is allowed).', ' Concurrent radiotherapy to any site or prior radiotherapy within 21 days of Cycle 1 Day 1 or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) or prior radiotherapy to > 25% of bone marrow.', ' Current severe, uncontrolled, systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic or infectious disease.', ' Any major surgery within 28 days of the first dose of study drug or anticipation of the need for major surgery during the course of study treatment.', ' Consumption of one or more of the following within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges including marmalade containing Seville oranges; Star fruit (carambola).', ' Administration within 7 days prior first dose of study treatment of Steroid therapy for anti-neoplastic intent, Strong or moderate CYP3A inhibitors or Strong or moderate CYP3A inducers.', ' Need for current chronic corticosteroid therapy (> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids).', ' Known infection with (human immunodeficiency virus) HIV or human T-cell leukemia virus 1.', ' Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day).', ' Positive test results for hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at screening. Participants who were positive for HCV antibody should have been negative for HCV by PCR to be eligible for study participation. Participants with a past or resolved hepatitis B virus (HBV) infection (defined as having a positive total HBcAb and negative hepatitis B surface antigen [HbsAg]) may be included if HBV DNA is undetectable. These participants should have been willing to undergo monthly DNA testing.', ' Participants who had a positive HCV antibody test are eligible for the study if a PCR assay is negative for HCV RNA.', ' History of other malignancies within the past 5 years except for treated skin basal cell carcinoma, squamous cell carcinoma, non-malignant melanoma <= 1.0 mm without ulceration, localized thyroid cancer, or cervical carcinoma in-situ.', ' Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study.', ' Cardiopulmonary dysfunction.', " Other medical or psychiatric conditions that, in the opinion of the investigatory, may interfere with the participant's participation in the study.", ' Inability or unwillingness to swallow pills or receive intramuscular (IM) injections.', ' History of malabsorption syndrome or other condition that would interfere with enteral absorption.', " History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).", ' Concurrent hormone replacement therapy.', ' Inability to comply with study and follow-up procedures.', ' History or active cardiopulmonary dysfunction.', ' Known hypersensitivity to any of the study medications (fulvestrant, venetoclax) or to any of the excipients.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1', ' Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir). In addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm.', ' Time frame: Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)', 'Results 1: ', ' Arm/Group Title: Venetoclax + Fulvestrant', ' Arm/Group Description: Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 11.8 (4.44 to 23.87)', 'Results 2: ', ' Arm/Group Title: Fulvestrant', ' Arm/Group Description: Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 13.7 (5.70 to 26.26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/50 (8.00%)', ' Pyrexia 1/50 (2.00%)', ' Lower respiratory tract infection 1/50 (2.00%)', ' Urosepsis 1/50 (2.00%)', ' Ejection fraction decreased 1/50 (2.00%)', ' Flank pain 0/50 (0.00%)', ' Bone pain 0/50 (0.00%)', ' Pleural effusion 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 2/51 (3.92%)', ' Pyrexia 0/51 (0.00%)', ' Lower respiratory tract infection 0/51 (0.00%)', ' Urosepsis 0/51 (0.00%)', ' Ejection fraction decreased 0/51 (0.00%)', ' Flank pain 1/51 (1.96%)', ' Bone pain 1/51 (1.96%)', ' Pleural effusion 1/51 (1.96%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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f82d94fe-c633-4bae-b28d-074196a08577
|
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Comparison
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Intervention
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NCT00659373
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NCT02202252
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the primary trial has a 5 year long intervention, the duration of the secondary trial is not specified in the intervention section.
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Entailment
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[
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2,
3,
4,
5,
6
] |
[
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3,
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8,
5,
10,
5
] |
{'Clinical Trial ID': 'NCT00659373', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen', ' Tamoxifen 20mg orally daily for 5 years', 'INTERVENTION 2: ', ' Ovarian Function Suppression', ' Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)', ' Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Completely resected disease', ' Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy', ' Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:', ' Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist', ' Ovarian irradiation', ' Bilateral oophorectomy', ' Hormone receptor status:', ' Estrogen and/or progesterone receptor positive', ' Each tumor must be hormone receptor positive', ' PATIENT CHARACTERISTICS:', ' Premenopausal', ' Can speak and read the local language(s) fluently', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)', ' Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.', ' Time frame: 1 year after patient randomization to parent IBCSG 24-02 study', 'Results 1: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20mg orally daily for 5 years', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: standardized units -.04 (0.49)', 'Results 2: ', ' Arm/Group Title: Ovarian Function Suppression', ' Arm/Group Description: Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)', ' Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.', ' Overall Number of Participants Analyzed: 54', ' Mean (Standard Deviation)', ' Unit of Measure: standardized units -0.21 (0.92)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: 0/54 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02202252', 'Intervention': ['INTERVENTION 1: ', ' Single Drain', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', 'INTERVENTION 2: ', ' Double Drain', ' Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer', ' Modified radical mastectomy', 'Exclusion Criteria:', ' Distant metastasis', ' Male breast cancer', 'Bleeding diathesis'], 'Results': ['Outcome Measurement: ', ' Patient Comfort Scale', ' Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).', ' Time frame: Postoperative 5 days', 'Results 1: ', ' Arm/Group Title: Single Drain', ' Arm/Group Description: Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 8)', 'Results 2: ', ' Arm/Group Title: Double Drain', ' Arm/Group Description: Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' Total: 0/30 (0.00%)']}
|
e5379a89-f880-44c1-bee0-a0d8ad2abfce
|
Single
|
Eligibility
|
NCT00717886
|
Prior axillary surgery, axillary radiation, breast cancer and breast radiation are not permitted for entry to the primary trial, patients with prior High-dose chemotherapy can still enter if they satisfy all other inclusion criteria.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00717886', 'Intervention': ['INTERVENTION 1: ', ' Upper Extremity Lymphatic Mapping for Breast Cancer Patients', ' Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.'], 'Eligibility': ['Inclusion Criteria:', ' Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.', ' Females > 21 years of age', 'Exclusion Criteria:', ' Prior ipsilateral axillary surgery', ' Prior ipsilateral axillary radiation', ' Prior ipsilateral breast cancer', ' Prior ipsilateral breast radiation', ' Allergy to isosulfan blue dye', ' History of ipsilateral upper extremity lymphedema', ' Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast', ' Prior history of neoadjuvant chemotherapy for current breast cancer', ' Bulky axillary disease at presentation (N2)'], 'Results': ['Outcome Measurement: ', ' Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).', ' [Not Specified]', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Upper Extremity Lymphatic Mapping for Breast Cancer Patients', ' Arm/Group Description: Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d811aaec-b3bd-4376-a9d6-d14eacae875a
|
|
Single
|
Eligibility
|
NCT00050167
|
Only Patients with metastasis in less than 9 infraclavicular lymph nodes are eligible for the primary trial.
|
Contradiction
|
[
0,
6
] |
[] |
{'Clinical Trial ID': 'NCT00050167', 'Intervention': ['INTERVENTION 1: ', ' Weekly Paclitaxel (WP)', ' Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles', 'INTERVENTION 2: ', ' Docetaxel and Capecitabine (DX)', ' Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.', ' Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.', " High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.", " Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).", ' Patients with bilateral breast cancers are eligible.', ' Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.', ' Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound', ' Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.', ' Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.', ' Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.', ' Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.', ' In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockcroft and Gault Equation: Cockcroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body weight [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value', ' Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.', ' Patients who have overexpression of the her-2/neu oncogene are eligible for the study.', 'Exclusion Criteria:', ' Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.', ' Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.', ' Severe hypersensitivity reactions to agents formulated in either cremophor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.', ' Those patients with history of other malignancies will be excluded, except non-melanoma skin cancer and non-invasive cervical cancer.', ' Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.', ' Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.', ' Patients who have had an organ allograft are ineligible.', ' Patients with serious concurrent infections are ineligible.', ' Sexually active male patients unwilling to practice contraception during the study are ineligible.', ' Patients with pre-existing peripheral neuropathy > grade 1.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Reoccurrence', ' Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).', ' Time frame: Median of 50 months', 'Results 1: ', ' Arm/Group Title: Weekly Paclitaxel (WP)', ' Arm/Group Description: Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 301', ' Log Mean (95% Confidence Interval)', ' Unit of Measure: participants 90.7 (86.4 to 93.7)', 'Results 2: ', ' Arm/Group Title: Docetaxel and Capecitabine (DX)', ' Arm/Group Description: Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.', ' Overall Number of Participants Analyzed: 300', ' Log Mean (95% Confidence Interval)', ' Unit of Measure: participants 87.5 (82.7 to 91.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 81/301 (26.91%)', ' Neutropenia 2/297 (0.67%)', ' Fluid retention 1/297 (0.34%)', ' Nausea 5/297 (1.68%)', ' Vomiting 0/297 (0.00%)', ' Diarrhea 12/297 (4.04%)', ' Constipation 2/297 (0.67%)', ' Fatigue 25/297 (8.42%)', ' Alopecia 0/297 (0.00%)', ' Allergic reaction 2/297 (0.67%)', ' Stomatitis 0/297 (0.00%)', ' Neutropenic Infection 2/297 (0.67%)', ' Neutropenic Fever 0/297 (0.00%)', 'Adverse Events 2:', ' Total: 293/300 (97.67%)', ' Neutropenia 45/293 (15.36%)', ' Fluid retention 0/293 (0.00%)', ' Nausea 12/293 (4.10%)', ' Vomiting 5/293 (1.71%)', ' Diarrhea 17/293 (5.80%)', ' Constipation 6/293 (2.05%)', ' Fatigue 66/293 (22.53%)', ' Alopecia 0/293 (0.00%)', ' Allergic reaction 4/293 (1.37%)', ' Stomatitis 5/293 (1.71%)', ' Neutropenic Infection 20/293 (6.83%)', ' Neutropenic Fever 13/293 (4.44%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
99312d82-614c-4422-b6e6-104fe5a7fa54
|
|
Comparison
|
Adverse Events
|
NCT02049957
|
NCT01506609
|
There is are the same total number of patients in the primary trial as in the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
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[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
] |
{'Clinical Trial ID': 'NCT02049957', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane', ' Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).', 'INTERVENTION 2: ', ' Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant', ' Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).'], 'Eligibility': ['Inclusion Criteria', ' Each patient must meet all of the following inclusion criteria to be enrolled in the study:', ' Phase 1b and Phase 2', ' Advanced or metastatic breast cancer.', ' Histological or cytological confirmation of ER+ status (defined as > 1% positive tumor cells), and histological or cytological confirmation of HER2-negative (HER2-) status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.', ' Female patients 18 years of age or older who are postmenopausal for at least 1 year before the Screening visit, where menopause is defined by: Age 55 years and 1 year or more of amenorrhea. Surgical menopause with bilateral oophorectomy', ' Age < 55 years and 1 year or more of amenorrhea, with an estradiol assay < 20 pg/mL', ' Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.', ' Have a history of brain metastasis are eligible for the study provided that all the following criteria are met:', ' Brain metastases which have been treated', ' No evidence of disease progression for 3 months or hemorrhage after treatment', ' Off-treatment with dexamethasone for 4 weeks before administration of the first dose of MLN0128', ' No ongoing requirement for dexamethasone or anti-epileptic drugs', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.', ' Clinical laboratory values as specified below within 4 weeks before the first dose of MLN0128:', ' Bone marrow reserve consistent with absolute neutrophil count (ANC) 1.5 x 10^9/L; platelet count 100 x 10^9/L; hemoglobin 9 g/dL', ' Total bilirubin 1.5 x the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN ( 5 x ULN if liver metastases are present)', ' Creatinine clearance 50 mL/min based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection', ' Fasting serum glucose 130 mg/dL and fasting triglycerides 300 mg/dL', ' Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of institutional standard of normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks before the first dose of MLN0128 (ie, if the institutional standard of normal is 50%, LVEF may be as low as 45% to be eligible for the study).', ' Able to provide paraffin blocks or a minimum of 10 unstained slides of available archival tumor tissues (paraffin blocks are preferred). If archival tumor tissue is not available, a tumor biopsy may be performed before the patient begins treatment with MLN0128. If fewer than 10 slides are available or the tumor content/area requirements are not met, study eligibility will be determined upon discussion with the sponsor.', ' Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.', ' Voluntary written consent must be given before the performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.', ' Phase 1b Only: In addition to the previously mentioned inclusion criteria, each patient must meet the following inclusion criterion to be enrolled in the phase 1b portion of the study:', ' Patients may have SD or disease progression during their most recent treatment with exemestane or fulvestrant, or everolimus in combination with either exemestane (any country) or fulvestrant (US only). Exemestane or fulvestrant in combination with MLN0128 can also be initiated as a new line of therapy.', ' Phase 2 Only: In addition to the previously mentioned inclusion criteria, each patient must meet all of the following inclusion criteria to be enrolled in the phase 2 portion of the study:', ' Measurable disease defined as follows:', ' At least 1 extra-osseous lesion that can be accurately measured in at least 1 dimension. The lesion must measure 20 mm with conventional imaging techniques or 10 mm with spiral computed tomography (CT) or magnetic resonance imaging (MRI), or', ' Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable disease as defined above', " Patients must have had disease progression during treatment with everolimus in combination with either exemestane (any country) or fulvestrant (US only) (duration of treatment 4 weeks) and must have tolerated everolimus treatment in combination with exemestane (any country) or fulvestrant (US only) adequately according to the treating physician's judgment. Everolimus in combination with exemestane or fulvestrant is not required to be the most recent treatment before enrollment, but progression on the most recent anticancer therapy is required for enrollment.", ' Exclusion Criteria', ' Patients meeting any of the following exclusion criteria are not to be enrolled in the study:', ' Phase 1b and Phase 2', ' Prior anticancer therapy or other investigational therapy within 2 weeks before administration of the first dose of MLN0128 (except for exemestane or fulvestrant, which should be continued). Treatment with everolimus must be discontinued 2 weeks before administration of the first dose of MLN0128.', ' Chronic concomitant therapy with bisphosphonates or denosumab for the prevention of bone metastases. Concomitant treatment with bisphosphonates or denosumab is permitted for treatment of osteoporosis or management of existing bone metastases if initiated at least 4 weeks before administration of the first dose of MLN0128.', ' Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of MLN0128 (patients already receiving erythropoietin on a chronic basis for 4 weeks are eligible).', ' Previous treatment with dual PI3K/mTOR inhibitors or TORC1/2 inhibitors.', ' Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128.', ' Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met.', ' Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study.', ' Known human immunodeficiency virus infection.', ' History of any of the following within the last 6 months before administration of the first dose of MLN0128:', ' Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures', ' Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures', ' Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia)', ' Placement of a pacemaker for control of rhythm', ' New York Heart Association Class III or IV heart failure', ' Pulmonary embolism', ' Significant active cardiovascular or pulmonary disease before administration of the first dose of MLN0128, including:', ' Uncontrolled hypertension (ie, systolic blood pressure > 180 mm Hg; diastolic blood pressure > 95 mm Hg)', ' Pulmonary hypertension', ' Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air', ' Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement', ' Medically significant (symptomatic) bradycardia', ' History of arrhythmia requiring an implantable cardiac defibrillator', ' Baseline prolongation of the rate-corrected QT interval (QTc; eg, repeated demonstration of QTc interval > 480 ms, or history of congenital long QT syndrome, or torsades de pointes)', ' Diagnosed or treated for another malignancy within 2 years before administration of the first dose of MLN0128 or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.', ' Phase 1b Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 1b portion of the study:', ' More than 3 prior chemotherapy regimens for locally advanced or metastatic disease.', ' Phase 2 Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 2 portion of the study:', ' More than 1 prior chemotherapy regimen for locally advanced or metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', ' An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.', ' A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator.', ' Time frame: First dose of study drug through 30 days after the last dose (Up to 52 months)', 'Results 1: ', ' Arm/Group Title: Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane', ' Arm/Group Description: Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any AE: 6 100.0%', 'SAEs: 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant', ' Arm/Group Description: Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any AE: 6 100.0%', 'SAEs: 2 33.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Angina pectoris 0/6 (0.00%)', ' Pericardial effusion 0/6 (0.00%)', ' Diplopia 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Colitis 0/6 (0.00%)', ' Gastritis 0/6 (0.00%)', ' Nausea 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)', ' General physical health deterioration 0/6 (0.00%)', ' Generalised oedema 0/6 (0.00%)', ' Hepatic failure [1]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Angina pectoris 0/6 (0.00%)', ' Pericardial effusion 0/6 (0.00%)', ' Diplopia 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Colitis 0/6 (0.00%)', ' Gastritis 0/6 (0.00%)', ' Nausea 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)', ' General physical health deterioration 0/6 (0.00%)', ' Generalised oedema 0/6 (0.00%)', ' Hepatic failure [1]0/6 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01506609', 'Intervention': ['INTERVENTION 1: ', ' Group 2 Placebo + Carboplatin/Paclitaxel', ' Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', 'INTERVENTION 2: ', ' Group 2 Veliparib + Carboplatin/Paclitaxel', ' Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.', ' Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.', ' Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.', ' If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.', ' Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.', ' Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.', ' Subject must have adequate bone marrow, renal and hepatic function.', ' Subject must not be pregnant or plan to conceive a child.', 'Exclusion Criteria:', ' Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.', ' More than 2 prior lines of cytotoxic chemotherapy.', ' Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.', ' Prior taxane therapy for metastatic breast cancer.', ' A history of or evidence of brain metastases or leptomeningeal disease.', ' A history of uncontrolled seizure disorder.', ' Pre-existing neuropathy from any cause in excess of Grade 1.', ' Known history of allergic reaction to cremophor/paclitaxel.', ' Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.', ' Pregnant or breastfeeding.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.', ' Time frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.', 'Results 1: ', ' Arm/Group Title: Group 2 Placebo + Carboplatin/Paclitaxel', ' Arm/Group Description: Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.3 (9.3 to 14.5)', 'Results 2: ', ' Arm/Group Title: Group 2 Veliparib + Carboplatin/Paclitaxel', ' Arm/Group Description: Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 95', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.1 (11.5 to 16.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)', ' ANAEMIA 0/2 (0.00%)', ' FEBRILE NEUTROPENIA 0/2 (0.00%)', ' LYMPHADENOPATHY 0/2 (0.00%)', ' NEUTROPENIA 0/2 (0.00%)', ' PANCYTOPENIA 0/2 (0.00%)', ' THROMBOCYTOPENIA 0/2 (0.00%)', ' ATRIAL FIBRILLATION 0/2 (0.00%)', ' CARDIAC TAMPONADE 0/2 (0.00%)', ' PERICARDIAL EFFUSION 0/2 (0.00%)', ' TACHYCARDIA 0/2 (0.00%)', ' ABDOMINAL PAIN 0/2 (0.00%)', ' ABDOMINAL PAIN UPPER 0/2 (0.00%)', 'Adverse Events 2:', ' Total: 0/1 (0.00%)', ' ANAEMIA 0/1 (0.00%)', ' FEBRILE NEUTROPENIA 0/1 (0.00%)', ' LYMPHADENOPATHY 0/1 (0.00%)', ' NEUTROPENIA 0/1 (0.00%)', ' PANCYTOPENIA 0/1 (0.00%)', ' THROMBOCYTOPENIA 0/1 (0.00%)', ' ATRIAL FIBRILLATION 0/1 (0.00%)', ' CARDIAC TAMPONADE 0/1 (0.00%)', ' PERICARDIAL EFFUSION 0/1 (0.00%)', ' TACHYCARDIA 0/1 (0.00%)', ' ABDOMINAL PAIN 0/1 (0.00%)', ' ABDOMINAL PAIN UPPER 0/1 (0.00%)']}
|
b02c99f3-70bd-4404-8d80-c57c6dfef7b7
|
Single
|
Adverse Events
|
NCT00454532
|
Less than half of patients in cohorts 1 in the primary trial experienced adverse events, but more than 45% of patients cohort 2 did experience adverse events.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00454532', 'Intervention': ['INTERVENTION 1: ', ' Level 1', '10g/day', 'INTERVENTION 2: ', ' Level 2', '20g/day'], 'Eligibility': ['Key Inclusion Criteria:', ' Women 18 years or older', ' Histologically confirmed breast cancer', ' Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)', ' Availability of estrogen and progesterone receptor status', ' At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy', ' For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer', ' Life expectancy 12 weeks', ' Eastern Cooperative Oncology Group performance status 2', ' Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.', ' Key Exclusion Criteria:', ' Inability to understand/unwillingness to sign a written informed consent', ' Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator', ' Currently using an investigational agent', ' Clinically significant gastrointestinal abnormalities', ' Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication', ' Concurrent palliative radiation or anti-cancer treatment', ' Women who report pregnancy, are breast-feeding or have a positive pregnancy test'], 'Results': ['Outcome Measurement: ', ' Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)', ' Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0', ' Time frame: Monthly', 'Results 1: ', ' Arm/Group Title: Level 1', ' Arm/Group Description: 10g/day', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Number', ' Unit of Measure: participants Elevated AST: 1', ' Diarrhea: 0', ' Fatigue: 0', 'Pain-rib cage: 0', 'Results 2: ', ' Arm/Group Title: Level 2', ' Arm/Group Description: 20g/day', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants Elevated AST: 0', ' Diarrhea: 1', ' Fatigue: 1', 'Pain-rib cage: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/11 (45.45%)', ' Hemorrhage, GI-abdomen NOS 21/11 (9.09%)', ' Pain-liver 21/11 (9.09%)', ' Infection-ulcer 20/11 (0.00%)', ' Hemoglobin 20/11 (0.00%)', ' Hypoglycemia 20/11 (0.00%)', ' Pain-rib cage due to vomiting 20/11 (0.00%)', ' Obstruction-gu ureter 1/11 (9.09%)', ' Hemorrhage gu-bladder 21/11 (9.09%)', ' Pain-breast 21/11 (9.09%)', ' Pleural effusion 22/11 (18.18%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Hemorrhage, GI-abdomen NOS 20/6 (0.00%)', ' Pain-liver 20/6 (0.00%)', ' Infection-ulcer 20/6 (0.00%)', ' Hemoglobin 20/6 (0.00%)', ' Hypoglycemia 20/6 (0.00%)', ' Pain-rib cage due to vomiting 20/6 (0.00%)', ' Obstruction-gu ureter 0/6 (0.00%)', ' Hemorrhage gu-bladder 20/6 (0.00%)', ' Pain-breast 20/6 (0.00%)', ' Pleural effusion 20/6 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3cbf2726-ddb0-460c-9dd2-082b8dda495d
|
|
Comparison
|
Intervention
|
NCT01912612
|
NCT02392611
|
In the primary trial only 1 cohort is administered the intervention, whereas in the secondary trial both cohorts receive the intervention, but cohort 2 recieves more than double the dose of cohort 1.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01912612', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Patients With Pain)', ' Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.', ' Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.', 'INTERVENTION 2: ', ' Arm 2 (Patients Without Pain -- Control)', ' Patient reported pain and symptoms assessment for comparison at baseline.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients at least 25 years of age', ' Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment. All indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment. Concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted.', ' Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture', ' Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)', ' Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception', ' Willing to withdraw from selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressants (TCA) prior to treatment initiation', ' Patients who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, meloxicam, gabapentin, pregabalin) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study', ' Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.', 'Exclusion Criteria:', ' Prior use of duloxetine or milnacipran.', ' Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)', ' Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase inhibitor within 14 days prior to registration.', ' Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing', ' Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living', " Significant risk of suicide based on the Investigator's judgment", " History or behavior that would, in the Investigator's judgment, prohibit compliance for the duration of the study.", ' History of alcohol or other substance abuse or dependence within the year prior to registration', ' Known chronic liver disease, end stage renal disease, or creatinine clearance <30 mL/min as defined by Cockcroft-Gault equation', ' Uncontrolled narrow-angle glaucoma.', ' Clinically significant coagulation disorder', ' History of seizure disorder', ' Pregnant or breast-feeding. Urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain.', ' Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules.', " Currently taking SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or TCA regimen (including Wellbutrin) for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient's treating psychiatrist to taper cases off these medications prior to study treatment).", ' Controls are patients without chronic pain who otherwise meet the following eligibility criteria (inclusion #1, 2, 8, exclusion #1, 2, 4, 5, worst pain score 0-1, and not currently on medication for pain)'], 'Results': ['Outcome Measurement: ', ' Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine', ' Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.', ' Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)', ' 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)', ' Range of pain score 0-10 (0=no pain; 10=worst pain)', ' Time frame: 5 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1 (Patients With Pain)', ' Arm/Group Description: Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.', ' Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.', ' Overall Number of Participants Analyzed: 35', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 35 participants', ' 6.54 (1.868)', ' 5 weeks: 31 participants', ' 4.06 (2.744)', 'Results 2: ', ' Arm/Group Title: Arm 2 (Patients Without Pain -- Control)', ' Arm/Group Description: Patient reported pain and symptoms assessment for comparison at baseline.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Baseline: 40 participants', ' 0.25 (0.494)', ' 5 weeks: 0 participants'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/35 (2.86%)', ' congestive heart failure *1/35 (2.86%)', 'Adverse Events 2:', ' Total: 0/40 (0.00%)', ' congestive heart failure *0/40 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02392611', 'Intervention': ['INTERVENTION 1: ', ' Monotherapy: Alobresib 0.6 mg', ' Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', 'INTERVENTION 2: ', ' Monotherapy: Alobresib 1.4 mg', ' Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.'], 'Eligibility': ['Key Inclusion Criteria:', ' Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is available', ' Group 2: Post-menopausal women with advanced stage estrogen receptor positive breast cancer who are candidates for exemestane or fulvestrant', ' Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or for which no standard therapy is available', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 1', ' Adequate organ function defined as follows:', ' Hematologic: Platelets 100 x 10^9/L; Hemoglobin 9.0 g/ dL; Absolute neutrophil count (ANC) 1.5 x 10^9/L (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit). Participants in the Group 3 lymphoma expansion may be enrolled with an ANC of 1.0 x 10^9 /L; Platelets 75 x 10^9 /L.', ' Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) (if liver metastases are present, 5 x ULN); Total or conjugated bilirubin 1.5 x ULN', ' Renal: Serum creatinine 1.5 x ULN or creatinine clearance (CrCl) 60 ml/min as calculated by the cockcroft-gault method', ' Coagulation: International Normalized Ratio (INR) 1.2', ' Key Exclusion Criteria:', ' Known brain metastasis or leptomeningeal disease', ' Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1', ' Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug', ' History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). Individuals who screen-fail due to this criterion are not eligible to be re-screened', ' Clinically significant bleeding within 28 days of study Day 1', ' Known human immunodeficiency virus (HIV) infection', ' Hepatitis B surface antigen positive', ' Hepatitis C virus (HCV) antibody positive', ' No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.', ' Note: Other protocol defined Inclusion/Exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing Dose Limiting Toxicities (DLTs)', ' A DLT was a toxicity, considered possibly related to alobresib, and which occurred during DLT assessment window (Day 1 through Cycle 1 Day 28) in each cohort: Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm^3); Grade 3 neutropenia (ANC< 1000/mm^3) with fever (a single temperature of > 38.3°C or a sustained temperature of 38°C for more than 1 hour [hr]); Grade 3 thrombocytopenia; Grade 2 bleeding; Grade 3 non hematologic toxicity, except Grade 3 nausea or emesis with maximum duration of 48 hrs on adequate medical therapy and Grade 3 diarrhea which persists for < 72 hrs in absence of maximal medical therapy; Grade 2 non hematologic treatment-emergent adverse event (TEAE) of potential clinical significance; treatment interruption 7 days due to unresolved toxicity; and any Grade 3 or 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to alobresib.', ' Time frame: Baseline (Day 1) up to 28 days', 'Results 1: ', ' Arm/Group Title: Monotherapy: Alobresib 0.6 mg', ' Arm/Group Description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: Monotherapy: Alobresib 1.4 mg', ' Arm/Group Description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/2 (50.00%)', ' Thrombocytopenia 0/2 (0.00%)', ' Atrioventricular block complete 0/2 (0.00%)', ' Adrenal haemorrhage 0/2 (0.00%)', ' Constipation 0/2 (0.00%)', ' Pain 0/2 (0.00%)', ' Pyrexia 0/2 (0.00%)', ' Cholangitis 1/2 (50.00%)', ' Pyelonephritis acute 0/2 (0.00%)', ' Sepsis 1/2 (50.00%)', ' Deep vein thrombosis 0/2 (0.00%)', 'Adverse Events 2:', ' Total: 1/1 (100.00%)', ' Thrombocytopenia 1/1 (100.00%)', ' Atrioventricular block complete 0/1 (0.00%)', ' Adrenal haemorrhage 0/1 (0.00%)', ' Constipation 0/1 (0.00%)', ' Pain 0/1 (0.00%)', ' Pyrexia 1/1 (100.00%)', ' Cholangitis 0/1 (0.00%)', ' Pyelonephritis acute 0/1 (0.00%)', ' Sepsis 0/1 (0.00%)', ' Deep vein thrombosis 0/1 (0.00%)']}
|
e7741151-2b2c-4e78-a4df-fe998c580714
|
Single
|
Results
|
NCT00376688
|
Less than 1/10 the primary trial subjects experienced a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00376688', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Temsirolimus)', ' Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Temsirolimus: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic or recurrent breast cancer not amenable to local therapy (surgery and radiation) (histologic/cytologic confirmation of recurrence preferred, but not required)', ' Either the primary or metastatic tumor must be positive for estrogen receptor (>= 1% by immunohistochemical staining) and/or progesterone receptor (>= 1% by immunohistochemical staining) and/or human epidermal growth factor receptor (HER2neu) (3+ immunohistochemical staining or fluorescence in situ hybridization [FISH] positive)', ' Patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' There are no limitations on the number of prior therapy regimens; however, patients who have had prior exposure to rapamycin or any other mechanistic target of rapamycin (mTOR) inhibitor are excluded from the trial', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Absolute neutrophil count >= 1,500/uL', ' Platelets >= 100,000/uL', ' Total bilirubin =< institutional upper limit of normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional upper limit of normal', ' Creatinine =< 2.0 x normal institutional upper limit of normal', ' Cholesterol =< 350 mg/dL (fasting)', ' Triglycerides =< 400 mg/dL (fasting)', ' Albumin >= 3.3 mg/dL', ' Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of child-bearing potential must have a negative pregnancy test prior to treatment on study; breastfeeding should be discontinued if the mother is treated with temsirolimus', ' Ability to understand and the willingness to sign a written informed consent document', ' Tissue for correlative studies must be available and the subject must agree to use of tissue for these studies', 'Exclusion Criteria:', ' Patients must be off of hormonal agents used for the treatment of breast cancer for one week with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist', ' Patients should have recovered from the adverse effects of prior chemotherapy; in general, this will mean that the patient would have been due or overdue for the next dose of the prior regimen: three weeks should have elapsed for a regimen administered once every three weeks, etc', ' Radiotherapy should have been completed', ' Three weeks should have elapsed since prior therapy with monoclonal antibodies', ' Patients may not be receiving any other investigational agents or herbal preparations; patients may not be taking corticosteroids except in low doses as replacement for adrenal insufficiency or for short -term (less than 5 days) use for other reasons', ' Patients with known brain metastases are not permitted on study unless the metastases have been controlled by prior surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for at least 4 weeks', " Patients cannot be receiving enzyme-inducing antiepileptic drugs (enzyme-inducing antiepileptic drugs [EIAEDs]; e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels; use of agents that potently inhibit CYP3A (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited; CCI-779 can inhibit CYP2D6, and may decrease metabolism (and increase drug levels) of drugs that are substrates for CYP2D6, such as codeine; the appropriateness of use of such agents is left to physician discretion; if there is any doubt about eligibility based on concomitant medication, the study chair, Dr Fleming, should be contacted; all concomitant medications must be recorded", ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study', ' Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin) are not eligible for this trial'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)', ' Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.', ' Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;', ' Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits', ' Time frame: Up to 24 months', 'Results 1: ', ' Arm/Group Title: Treatment (Temsirolimus)', ' Arm/Group Description: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Temsirolimus: Given IV', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Number', ' Unit of Measure: percentage of participants 9.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/31 (29.03%)', ' Abdominal pain * [1]2/31 (6.45%)', ' Nausea * [2]2/31 (6.45%)', ' Vomiting * [3]2/31 (6.45%)', ' Death NOS * [4]3/31 (9.68%)', ' Platelet count decreased * [5]2/31 (6.45%)', ' Dyspnea * [6]5/31 (16.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8cff36b0-a022-4469-8d14-7120be891cb1
|
|
Comparison
|
Eligibility
|
NCT00304096
|
NCT00876395
|
A minimum bodyweight of 50kg is required to participate in either the primary trial or the secondary trial.
|
Contradiction
|
[
14
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20
] |
{'Clinical Trial ID': 'NCT00304096', 'Intervention': ['INTERVENTION 1: ', ' Stratum 1: Received Hormonal Therapy', ' Participants received hormonal therapy', 'INTERVENTION 2: ', ' Stratum 2: Had Not Received Hormonal Therapy', ' Participants had not received hormonal therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed adenocarcinoma of the breast', ' Stage III or IV disease', ' Primary or recurrent disease', ' Invasive lobular carcinoma allowed', ' HLA-A1, -A2, -A3, or -A31 positive', ' Underwent and recovered from prior primary therapy', ' Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months', ' Must have at least one undissected axillary and/or inguinal lymph node basin', ' No history of brain metastases', ' Hormone receptor status', ' Estrogen receptor-positive or -negative tumor', ' PATIENT CHARACTERISTICS:', ' ECOG performance status of 0 or 1', ' Body weight > 110 lbs (without clothes)', ' Male or female', ' Menopausal status not specified', ' Absolute neutrophil count > 1000/mm^3', ' Platelet count > 100,000/mm^3', ' Hemoglobin > 9 g/dL', ' Hemoglobin A1c < 7%', ' AST and ALT 2.5 x upper limit of normal (ULN)', ' Bilirubin 2.5 x ULN', ' Alkaline phosphatase 2.5 x ULN', ' Creatinine 1.5 x ULN', ' HIV negative', ' Hepatitis C negative', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No known or suspected allergies to any component of the vaccine', ' No active infection requiring antibiotics', ' No New York Heart Association class III or IV heart disease', ' No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:', ' Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms', ' Clinical evidence of vitiligo', ' Other forms of depigmenting illness', ' Mild arthritis requiring nonsteroidal antiinflammatory drugs', ' No medical contraindication or potential problem that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' More than 4 weeks since prior surgery', ' More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy', ' More than 4 weeks since prior and no concurrent allergy desensitization injections', ' More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids', ' No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)', ' Prior or concurrent topical corticosteroids allowed', ' More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)', ' More than 4 weeks since prior and no concurrent other investigational medication', ' More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents', ' Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed', ' No prior vaccination with any synthetic peptides in this protocol', ' Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered 2 weeks prior to or 2 weeks after study vaccine', ' Short term therapy for acute conditions not related to breast cancer allowed', ' No concurrent illegal drugs'], 'Results': ['Outcome Measurement: ', ' The Number of Participants Who Experienced Dose-limiting Adverse Events', ' Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity', ' Time frame: 30 days post administration of last vaccine', 'Results 1: ', ' Arm/Group Title: Stratum 1: Received Hormonal Therapy', ' Arm/Group Description: Participants received hormonal therapy', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: Stratum 2: Had Not Received Hormonal Therapy', ' Arm/Group Description: Participants had not received hormonal therapy', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Fever [1]1/6 (16.67%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)', ' Fever [1]0/5 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00876395', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Paclitaxel + Trastuzumab', ' Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', 'INTERVENTION 2: ', ' Placebo + Paclitaxel + Trastuzumab', ' Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'], 'Eligibility': ['Inclusion Criteria:', ' Adult Women ( 18 years old).', ' Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.', ' Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.', ' HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).', ' Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.', ' Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.', ' Documentation of negative pregnancy test.', ' Organ functions at time of inclusion.', 'Exclusion Criteria:', ' Prior mTOR inhibitors for the treatment of cancer.', ' Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).', ' Radiotherapy to 25% of the bone marrow within 4 weeks prior to randomization', ' History of central nervous system metastasis.', ' Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.', ' Serious peripheral neuropathy.', ' Cardiac disease or dysfunction.', ' Uncontrolled hypertension.', 'HIV.', 'Pregnant,'], 'Results': ['Outcome Measurement: ', " Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population", ' PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.', ' Time frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Paclitaxel + Trastuzumab', ' Arm/Group Description: Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', ' Overall Number of Participants Analyzed: 480', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.95 (14.55 to 17.91)', 'Results 2: ', ' Arm/Group Title: Placebo + Paclitaxel + Trastuzumab', ' Arm/Group Description: Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.49 (12.29 to 17.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 173/472 (36.65%)', ' Anaemia 6/472 (1.27%)', ' Febrile neutropenia 4/472 (0.85%)', ' Iron deficiency anaemia 1/472 (0.21%)', ' Leukopenia 2/472 (0.42%)', ' Neutropenia 2/472 (0.42%)', ' Thrombocytopenia 4/472 (0.85%)', ' Acute myocardial infarction 1/472 (0.21%)', ' Aortic valve incompetence 0/472 (0.00%)', ' Atrial fibrillation 2/472 (0.42%)', ' Cardiac arrest 1/472 (0.21%)', 'Adverse Events 2:', ' Total: 40/238 (16.81%)', ' Anaemia 0/238 (0.00%)', ' Febrile neutropenia 1/238 (0.42%)', ' Iron deficiency anaemia 0/238 (0.00%)', ' Leukopenia 0/238 (0.00%)', ' Neutropenia 2/238 (0.84%)', ' Thrombocytopenia 0/238 (0.00%)', ' Acute myocardial infarction 0/238 (0.00%)', ' Aortic valve incompetence 1/238 (0.42%)', ' Atrial fibrillation 0/238 (0.00%)', ' Cardiac arrest 0/238 (0.00%)']}
|
4ce24508-3d12-499f-ab7f-4b437ea51366
|
Single
|
Results
|
NCT00633464
|
The Ixabepilone 40 mg/m^2 group in the primary trial reported worse results than the Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2 group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00633464', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 40 mg/m^2', ' ixabepilone 40 mg/m^2 every 3 weeks', 'INTERVENTION 2: ', ' Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2', ' cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer', ' Prior adjuvant or neoadjuvant anthracycline-based chemotherapy', 'Exclusion Criteria:', ' Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+', ' Neuropathy > Grade 1', ' Prior systemic therapy for metastatic disease'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])', ' The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.', ' Time frame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)', 'Results 1: ', ' Arm/Group Title: Ixabepilone 40 mg/m^2', ' Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)', 'Results 2: ', ' Arm/Group Title: Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2', ' Arm/Group Description: cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 35.9 (21.2 to 52.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/40 (22.50%)', ' FEBRILE NEUTROPENIA 0/40 (0.00%)', ' NEUTROPENIA 0/40 (0.00%)', ' TACHYCARDIA 0/40 (0.00%)', ' SINUS ARRHYTHMIA 1/40 (2.50%)', ' STOMATITIS 0/40 (0.00%)', ' VOMITING 1/40 (2.50%)', ' ABDOMINAL PAIN 0/40 (0.00%)', ' RECTAL HAEMORRHAGE 0/40 (0.00%)', ' GASTROINTESTINAL HAEMORRHAGE 1/40 (2.50%)', ' DIARRHOEA 0/40 (0.00%)', ' PYREXIA 2/40 (5.00%)', ' CHEST PAIN 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 12/37 (32.43%)', ' FEBRILE NEUTROPENIA 2/37 (5.41%)', ' NEUTROPENIA 2/37 (5.41%)', ' TACHYCARDIA 2/37 (5.41%)', ' SINUS ARRHYTHMIA 0/37 (0.00%)', ' STOMATITIS 1/37 (2.70%)', ' VOMITING 1/37 (2.70%)', ' ABDOMINAL PAIN 1/37 (2.70%)', ' RECTAL HAEMORRHAGE 1/37 (2.70%)', ' GASTROINTESTINAL HAEMORRHAGE 0/37 (0.00%)', ' DIARRHOEA 1/37 (2.70%)', ' PYREXIA 0/37 (0.00%)', ' CHEST PAIN 1/37 (2.70%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2514da19-b30a-44bb-8853-4545e97295da
|
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