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Single
|
Eligibility
|
NCT00411788
|
If Hannah has been taking ketoconazole to treat athlete's foot for 6 weeks, until today, she will be eligible for the primary trial next Tuesday.
|
Contradiction
|
[
18,
33
] |
[] |
{'Clinical Trial ID': 'NCT00411788', 'Intervention': ['INTERVENTION 1: ', ' Sirolimus and Trastuzumab', ' Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed HER2 overexpressing (IHC 3+ and/or FISH +) metastatic breast cancer with measurable disease. Patients with either HER2 3+ positive tumors by immunohistochemistry (Dako Herceptest®) or gene amplification (> 2 copies) by fluorescence in-situ hybridation (FISH) are eligible.', ' Progression following at least 8 weeks of standard doses of Herceptin or a Herceptin containing regimen.', ' Off Herceptin for a minimum of 2 weeks.', ' Patients must have measurable disease as defined by RECIST guidelines (the lesion that will be biopsied on study cannot be the only measurable lesion).', ' Life expectancy > 3 months', ' Age 18 years', ' ECOG performance status 2', ' Adequate bone marrow function as indicated by the following:', ' ANC 1500/µL', ' Platelets 100,000/µL', ' Hemoglobin 9 g/dL', ' Adequate liver function, as indicated by bilirubin 1.5 x ULN, AST or ALT <2x ULN.', ' Adequate renal function, as indicated by creatinine <1.5 x upper limit of normal (ULN)', ' Ability to understand and the willingness to sign a written informed consent.', ' Adequate birth control: 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 and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and nursing patients are excluded because the effects of the combination of Rapamycin on a fetus or nursing child are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Fasting serum cholesterol <350 mg/d L and triglycerides < 400 mg/ d L.', ' Biopsy is required but patients or physicians may opt out of this part of the trial if sufficient justification is provided. Justification must be provided to the PI in writing indicating excessive physical risk or psychological trauma if biopsy is undertaken.', 'Exclusion Criteria:', ' Active infection or treatment for systemic infections within 14 days of enrollment', ' Patients with active brain metastases requiring treatment, inclusive but not limited to surgery, radiation, and corticosteroids (patients with asymptomatic non- progressing brain metastasis who have completed treatment 30 days before enrollment and without evidence of progression on a post treatment MRI may be considered for the study).', ' Pregnant or lactating women', ' Prior chemotherapy within the last 4 weeks (last 6 weeks for nitrosureas/mitomycin)', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).', ' Prior therapy with rapamycin, rapamycin analogs, or experimental agents targeting mTOR.', ' Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.', ' Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to trial medications', ' Patients may not be receiving any other investigational agents within 30 days before enrollment.', ' 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 because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.', ' HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.', " Use of all herbal and alternative medications within 4 weeks. All herbal and alternative medications should be discontinued while on study, these include but not limited to: Hydrastis canadensis (goldenseal) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - trifolium pratense (wild cherry) - matricaria chamomila (chamomile) - Glycyrrhiza glabra (licorice) - dillapiol - naringenim.", ' Use of any of these medications within 4 weeks; cyclosporine, diltiazen, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, erythromycin, clarithromycin, itraconazole, erythromycin, metoclopramide, nevirapine, phenobarbital, phenytoin, indinavir, fosamprenavir, nefazadone, St Johns Wort.', ' Consumption of grapefruit juice is prohibited during the study.', ' Use of warfarin (Coumadin), immunosuppressive agents or chronic oral, intravenous or topical steroid'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients Who Are Progression-free (CR, PR and Stable Disease)', ' To determine the clinical activity of oral daily rapamycin administered in combination with weekly intravenous trastuzumab in patients with HER2 overexpressing advanced breast cancer, the primary outcome is to determine the proportion of patients who are progression-free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD).who are progression free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD). Response objectives assessed using response evaluation criteria (RECIST) 1.0', ' This primary outcome was reworded from its original format when results were entered.', ' Time frame: 16 weeks', 'Results 1: ', ' Arm/Group Title: Sirolimus and Trastuzumab', ' Arm/Group Description: Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/9 (11.11%)', ' Cardiac Dysfunction *1/9 (11.11%)', ' Hyperglycemia *1/9 (11.11%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0e8d1b4f-d6f6-455a-a7e3-07f67a8fbcc8
|
|
Comparison
|
Intervention
|
NCT00382785
|
NCT00784849
|
Neither the primary trial or the secondary trial use Low Dose Magnesium Oxide, Biopsies or Mometasone in their intervention.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2
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{'Clinical Trial ID': 'NCT00382785', 'Intervention': ['INTERVENTION 1: ', ' Moderated Group', ' one 12-week online support group led by a professional healthcare provider', 'INTERVENTION 2: ', ' Non-facilitated (Peer-led)', ' 12-week online support in a peer-led format'], 'Eligibility': ['Inclusion Criteria: Clinical diagnosis of breast cancer', ' Female', ' At least 21 years of age', ' Internet access; Able to read and write English', ' Have completed treatment for breast cancer in the past 36 months or are receiving treatment', ' Do not currently belong to an online or face-to-face cancer support group', ' Internet access', 'Exclusion Criteria:', ' Male', ' not diagnosed with breast cancer', ' under 21 years of age', ' received treatment more than 36 months ago for breast cancer', ' no Internet access', ' unable to read and write English'], 'Results': ['Outcome Measurement: ', ' Scores on the Personal Resource Questionnaire 85.', ' The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90', ' Time frame: 16 weeks', 'Results 1: ', ' Arm/Group Title: Moderated Group', ' Arm/Group Description: one 12-week online support group led by a professional healthcare provider', ' Overall Number of Participants Analyzed: 25', ' Mean (Standard Error)', ' Unit of Measure: Scores on a scale 50.22 (3.23)', 'Results 2: ', ' Arm/Group Title: Non-facilitated (Peer-led)', ' Arm/Group Description: 12-week online support in a peer-led format', ' Overall Number of Participants Analyzed: 26', ' Mean (Standard Error)', ' Unit of Measure: Scores on a scale 53.44 (3.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/25 (0.00%)', 'Adverse Events 2:', ' Total: 0/26 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00784849', 'Intervention': ['INTERVENTION 1: ', ' Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue', ' One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes'], 'Eligibility': ['Inclusion Criteria:', ' Stage 0,I, II breast cancer', ' Clinical node status N0, N1', ' No know allergy to iodine, lymphazurin or methylene blue dyes', 'Exclusion Criteria:', ' Patient cannot be pregnant or nursing', ' Prisoners will not be eligible', ' Women under the age of 18 will not be eligible', ' Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes'], 'Results': ['Outcome Measurement: ', ' The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)', ' [Not Specified]', ' Time frame: intraoperatively; up to 6 hours', 'Results 1: ', ' Arm/Group Title: Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue', ' Arm/Group Description: One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Number', ' Unit of Measure: participants Radioactive: 58', ' Blue: 55', ' Radioactive and Blue: 55', ' Efferent blue lymphatics leading up to the SLN: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/62 (0.00%)']}
|
9a346aac-46c2-4a50-8f3a-309b3b7bc295
|
Comparison
|
Adverse Events
|
NCT02132949
|
NCT01111825
|
Between both of the patient cohorts of the primary trial and the secondary trial there was only a single patient with a deficiency of granulocytes in the blood.
|
Entailment
|
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8,
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13,
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16,
17,
18,
19,
20,
21,
22,
23,
24,
25
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[
0,
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3,
4,
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16,
17,
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24,
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26,
27,
28,
29
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{'Clinical Trial ID': 'NCT02132949', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab', ' Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.', 'INTERVENTION 2: ', ' Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab', ' Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.'], 'Eligibility': ['Inclusion Criteria:', ' Male and female participants with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Participants with inflammatory breast cancer must be able to have a core needle biopsy', ' Primary tumor greater than (>) 2 centimeters (cm) in diameter, or > 5 millimeters (mm) in diameter and node-positive', ' HER2-positive breast cancer confirmed by a central laboratory', ' Availability of tumor tissue specimen', ' Baseline LVEF greater than or equal to (>/=) 55%', ' Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1', ' At least 4 weeks since major unrelated surgery, with full recovery', ' Women of childbearing potential and male participants with partners of childbearing potential must agree to use a "highly effective" non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner. Contraception must continue for the duration of study treatment and for at least 7 months after the last dose of study treatment', 'Exclusion Criteria:', ' Metastatic disease (Stage IV) or bilateral breast cancer', ' Participants who have had an incisional biopsy of the primary tumor or the primary tumor excised', ' Prior breast or non-breast malignancy within 5 years prior to study entry, except for carcinoma in situ and basal cell and squamous cell carcinoma of the skin. Participants with malignancies occurring more than 5 years prior to study entry are permitted if curatively treated', ' Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer', ' Participants with a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are not allowed to enter the study if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast (they are allowed to enter the study if treated with surgery alone)', ' High-risk participants who have received chemopreventive drugs in the past are not allowed to enter the study', ' Inadequate bone marrow, renal, or liver function', ' History or evidence of cardiovascular condition', ' Dyspnea at rest or other diseases that require continuous oxygen therapy', ' Severe, uncontrolled systemic disease', ' Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications', ' Pregnancy or breast-feeding women', ' Participants who received any investigational treatment within 4 weeks of study start', ' Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids])', ' Known hypersensitivity to any of the study drugs or excipients'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period', " Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later.", ' Time frame: From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)', 'Results 1: ', ' Arm/Group Title: Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab', ' Arm/Group Description: Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.', ' Overall Number of Participants Analyzed: 199', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.5 (0.31 to 4.34)', 'Results 2: ', ' Arm/Group Title: Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab', ' Arm/Group Description: Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.', ' Overall Number of Participants Analyzed: 198', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0 (0.00 to 1.85)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 56/199 (28.14%)', ' AGRANULOCYTOSIS 1/199 (0.50%)', ' ANAEMIA 1/199 (0.50%)', ' BONE MARROW FAILURE 1/199 (0.50%)', ' FEBRILE NEUTROPENIA 11/199 (5.53%)', ' LEUKOPENIA 1/199 (0.50%)', ' NEUTROPENIA 1/199 (0.50%)', ' PANCYTOPENIA 1/199 (0.50%)', ' ACUTE MYOCARDIAL INFARCTION 1/199 (0.50%)', ' ATRIAL FLUTTER 1/199 (0.50%)', ' ATRIAL THROMBOSIS 0/199 (0.00%)', ' CARDIAC FAILURE 3/199 (1.51%)', 'Adverse Events 2:', ' Total: 66/198 (33.33%)', ' AGRANULOCYTOSIS 0/198 (0.00%)', ' ANAEMIA 0/198 (0.00%)', ' BONE MARROW FAILURE 0/198 (0.00%)', ' FEBRILE NEUTROPENIA 27/198 (13.64%)', ' LEUKOPENIA 0/198 (0.00%)', ' NEUTROPENIA 2/198 (1.01%)', ' PANCYTOPENIA 1/198 (0.51%)', ' ACUTE MYOCARDIAL INFARCTION 0/198 (0.00%)', ' ATRIAL FLUTTER 0/198 (0.00%)', ' ATRIAL THROMBOSIS 1/198 (0.51%)', ' CARDIAC FAILURE 4/198 (2.02%)']}
|
{'Clinical Trial ID': 'NCT01111825', 'Intervention': ['INTERVENTION 1: ', ' Phase 2 Triple -ve', ' Phase 2, Triple - Negative cohort', 'INTERVENTION 2: ', ' Phase 2 HER2+', ' Phase 2, HER2 - Amplified (HER2-Positive) cohort'], 'Eligibility': ['Inclusion Criteria:', ' Phase I HER2-amplified Cohort', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridisation (FISH) ( 2.0)', ' Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days.', ' May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days.', ' Radiographic progression of disease while on treatment with trastuzumab or lapatinib as defined by RECIST 1.1 criteria.', ' No restriction on prior chemotherapy regimens for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Phase II HER2-amplified Cohort', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).', ' Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days.', ' May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days.', ' Radiographic progression of disease while on treatment with trastuzumab as defined by RECIST 1.1 criteria.', ' Prior therapy inclusion: no more than four prior chemotherapy regimens allowed for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Phase II Triple-negative Cohort - As of 2/10/12, this cohort is closed to accrual', ' Invasive adenocarcinoma negative for estrogen receptor (<5%) and progesterone receptor (<5%) expression and a lack of HER2 overexpression and/or amplification as determined by immunohistochemistry (<3+) or FISH (<2.0).', ' Prior therapy inclusion: no more than four prior chemotherapy regimens allowed for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Phase II HER2-Positive Cohort with dose escalation', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (IHC) (3+) or FISH ( 2.0).', ' Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days.', ' May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days.', ' Radiographic progression of disease while on treatment with trastuzumab as defined by RECIST v 1.1.', ' Prior therapy inclusion: no restriction on prior chemotherapy regimens for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' Inclusion Criteria for all subjects (HER2-Amplified and Triple-negative)', ' Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.', ' Metastatic disease that is or has been pathologically documented.', ' At least one measurable metastatic lesion according to RECIST 1.1 criteria. Ascites, pleural effusions, and bone metastases are not considered measurable. Minimum indicator lesion size 10 mm by helical CT or 20 mm by conventional techniques.', ' Pathological nodes must be 15 mm by the short axis to be considered measurable.', ' Age 18, as no dosing or adverse event data are currently available on the use of neratinib or temsirolimus in patients <18 years of age, children are excluded from this study.', ' Patients must be willing to discontinue sex hormonal therapy, e.g., birth control pills, hormonal replacement therapy, prior to enrollment. Women of childbearing potential must consent to effective contraception while on treatment and for a period thereafter.', ' Negative serum human chorionic gonadotropin pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after menopause.', ' Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of steroids and anticonvulsants for 3 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status score of 2.', ' Patients must have normal organ and marrow function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) 2.5x institutional upper limit of normal except for patients with liver metastases. For patients with liver metastases, AST/ALT/Alkaline phosphatase 5.0x institutional upper limit of normal. Total bilirubin within institutional limits except for patients with liver metastases. For patients with liver metastases, total bilirubin 1.5x institutional upper limit of normal. Creatinine clearance within normal limits or 60 mL/min, prothrombin time and partial thromboplastin time 1.5x institutional upper limit of normal except for patients on Coumadin or low molecular weight heparin, leukocytes 3,000/μl, absolute neutrophil count 1,000/μl, and platelets 75,000/μl', ' Able to swallow and retain oral medication.', ' The following criteria were removed for all patients in Protocol Amendment 10, and are only applicable to first 34 HER2+ patients in Phase 2 who are not subject to dose-escalation of temsirolimus:', ' Able and willing to consent for biopsy of metastatic breast cancer prior to treatment. Consent to preservation of frozen and fixed samples of tumor cores for evaluation. (HER2-amplified patients who have previously provided samples of metastatic breast cancer as part of institutional review board #06-163 will be exempt)', ' Consent to evaluation of primary tumor biopsy specimen.', 'Exclusion Criteria:', ' Potential subjects will be excluded from enrollment into this study if they meet any of the following criteria:', ' Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to neratinib or temsirolimus.', ' Unable to consent to biopsy of metastatic disease or for whom a biopsy would be medically unsafe.', ' Women who are pregnant or breast feeding.', ' Life expectancy <3 months.', ' Completion of previous chemotherapy regimen <3 weeks prior to the start of study treatment. Prior hormonal therapy must be discontinued prior to treatment start. Biologic therapy with bevacizumab for the treatment of metastatic disease must be discontinued 3 weeks from the start of protocol treatment.', ' Concurrent radiotherapy is not permitted for disease progression on treatment on protocol, but might be allowed for pre-existing non-target lesions with approval from the principal investigator of the trial.', ' Concurrent medical conditions which may increase the risk of toxicity, including ongoing or active infection, history of significant bleeding disorder unrelated to cancer (congenital bleeding disorders, acquired bleeding disorders within one year), HIV-positive or active hepatitis.', ' History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, and left ventricular ejection fraction less than 50% measured by a multigated blood pool imaging of the heart (MUGA scan) or an echocardiogram (ECHO).', ' QT corrected interval > 0.47 seconds.', ' Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease.', ' History of an invasive second primary malignancy diagnosed within the previous 3 years, except for stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.', ' History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.', ' Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary to participation in this clinical trial.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) (Phase II)', ' ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: 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.', ' A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.', ' Time frame: From enrollment date to first documented response, or last tumor assessment, assessed up to two years', 'Results 1: ', ' Arm/Group Title: Phase 2 Triple -ve', ' Arm/Group Description: Phase 2, Triple - Negative cohort', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Phase 2 HER2+', ' Arm/Group Description: Phase 2, HER2 - Amplified (HER2-Positive) cohort', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 5 13.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/8 (37.50%)', ' Anaemia 0/8 (0.00%)', ' Febrile neutropenia 0/8 (0.00%)', ' Polycythaemia 0/8 (0.00%)', ' Acute coronary syndrome 0/8 (0.00%)', ' Vertigo 0/8 (0.00%)', ' Eyelid oedema 1/8 (12.50%)', ' Constipation 0/8 (0.00%)', ' Diarrhoea 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', ' Stomatitis 0/8 (0.00%)', ' Upper gastrointestinal haemorrhage 0/8 (0.00%)', ' Vomiting 0/8 (0.00%)', ' Chest pain 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Polycythaemia 0/6 (0.00%)', ' Acute coronary syndrome 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Eyelid oedema 0/6 (0.00%)', ' Constipation 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Nausea 0/6 (0.00%)', ' Stomatitis 0/6 (0.00%)', ' Upper gastrointestinal haemorrhage 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Chest pain 1/6 (16.67%)']}
|
949d79e0-95db-47a2-802a-6280c0255923
|
Comparison
|
Adverse Events
|
NCT01325207
|
NCT02429427
|
Patients participating in the primary trial and the secondary trial experienced serious eye disorders.
|
Contradiction
|
[
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19,
20,
21,
22,
23,
24,
25
] |
[
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{'Clinical Trial ID': 'NCT01325207', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1 - Trastuzumab 10mg IT 2/Week', ' Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', '1 cycle = 28 days.', 'INTERVENTION 2: ', ' Cohort 2 - Trastuzumab 20mg IT 2/Week', ' Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', '1 cycle = 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' ELIGIBILITY CRITERIA', ' HER2 positive (IHC 3+ and/or FISH positive) breast cancer patients with leptomeningeal metastases by MRI or CSF (if MRI is negative).', ' o Review will be performed for cases not reviewed at Northwestern for confirmation, but will not preclude patients from entering the trial (pathology report is sufficient for registration).', ' Patients can have concomitant brain metastases as long as they do not require active treatment or have been treated.', ' Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma will be eligible for phase I', ' Life expectancy > 8 weeks', ' Normal renal (creatinine < 1.5 ULN), liver (bilirubin < 1.5 x ULN, transaminases < 3.0 x ULN, except in known hepatic metastasis, wherein may be < 5 x ULN) and blood counts (WBC > 3.0, Neutrophils > 1500, platelets >100 000, Hemoglobin > 10).', ' LVEF > 50%', ' KPS > 50', ' Age > 18 years', ' Cannot be on systemic agents (chemotherapy) that have CNS penetration unless they develop leptomeningeal metastases while on these agent(s) and have controlled systemic disease. May continue on IV trastuzumab, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy. Patients requiring systemic chemotherapy are eligible but will not be able to start treatment until after the first assessment by imaging and cytology.', ' Patients may need a CSF flow study at the discretion of the treating principal investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed.', ' Patients should be > 2 weeks from RT treatment and all effects of treatment should have resolved', ' No limit on prior systemic or IT therapies.', ' CSF sampling to document LM if not documented on MRI.', ' Must be willing to have an Ommaya reservoir placed.', ' NO history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 3 years.', ' Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.', ' Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.', ' Women may not be pregnant or breast-feeding.', ' Ability to sign an informed consent; can be signed by family member or health care proxy. Informed consent must be done prior to registration on study.', ' All patients must have given signed, informed consent prior to registration on study.', ' No known hypersensitivity to trial medications Note: The eligibility criteria listed above are interpreted literally and cannot be waived.', 'Exclusion Criteria:', ' - Any deviations from the inclusion criteria'], 'Results': ['Outcome Measurement: ', ' Number of Dose Limiting Toxicities (DLT) of IT Trastuzumab in Sequential Cohorts of Escalating Doses for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.', ' Patients will be treated using a standard 3+3 dose-escalation design for cohorts 1 and 2. This will be followed by an accelerated phase I for cohorts 3 and 4, and then a standard 3 + 3 for the 5th cohort. In the accelerated phase (cohorts 3 and 4), 1 patient will be enrolled per cohort; if a toxicity is seen in that patient then the cohort would be expanded to 6 patients to allow for 1/6 patients per cohort to have a dose limiting toxicity (DLT) before dose escalation. Cohort 5 will enroll a total of 6 patients regardless of the toxicity experienced in patient one. However, if 2 or more DLTs are observed in cohort 5, cohort 4 will be reopened to enroll of a total of 6 patients. Whatever dose is ultimately declared the MTD should have 6 patients total. If 1/6 DLTs are seen in cohort 5 that will be considered the MTD.', ' Dosing is as follows:', ' Cohort 1-10 mg IT Cohort 2-20 mg IT Cohort 3-40 mg IT Cohort 4-60 mg IT Cohort 5-80 mg IT', ' Time frame: From treatment initiation through the first 4 weeks of treatment.', 'Results 1: ', ' Arm/Group Title: Cohort 1 - Trastuzumab 10mg IT 2/Week', ' Arm/Group Description: Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', ' 1 cycle = 28 days.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: DLTs 0', 'Results 2: ', ' Arm/Group Title: Cohort 2 - Trastuzumab 20mg IT 2/Week', ' Arm/Group Description: Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', ' 1 cycle = 28 days.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: DLTs 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Pericardial effusion [1]0/3 (0.00%)', ' Abdominal muscle wall hemorrhage [2]0/3 (0.00%)', ' Dehydration [3]0/3 (0.00%)', ' Gastroenteritis 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Vomiting [4]0/3 (0.00%)', ' Colonic perforation [5]0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Chemical meningitis 0/3 (0.00%)', ' Lung infection 0/3 (0.00%)', ' Wound infection 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 2/3 (66.67%)', ' Pericardial effusion [1]0/3 (0.00%)', ' Abdominal muscle wall hemorrhage [2]0/3 (0.00%)', ' Dehydration [3]0/3 (0.00%)', ' Gastroenteritis 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Vomiting [4]0/3 (0.00%)', ' Colonic perforation [5]0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Chemical meningitis 0/3 (0.00%)', ' Lung infection 0/3 (0.00%)', ' Wound infection 1/3 (33.33%)']}
|
{'Clinical Trial ID': 'NCT02429427', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.', 'INTERVENTION 2: ', ' Placebo', ' Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Placebo: Two capsules once daily with food'], 'Eligibility': ['Inclusion Criteria:', ' Completely resected (greater or equal 1mm), histologically or cytologically proven unilateral breast cancer', ' Female greater or equal 18 years of age', ' If (neo) adjuvant chemotherapy received, patient must have received at least 4 cycles. Chemotherapy must be completed prior to study entry', ' Hormone Receptor negatives must have received prior chemotherapy', ' Study entry must be within any of the following timelines: 3 months of the end of definitive breast surgery OR between 3 weeks and 4 months after day 1 of the last cycle of adjuvant chemotherapy OR 6 weeks of the end of radiotherapy.', ' WHO performance status 0 or 1', ' Pre-treatment haematology and biochemistry values within acceptable local limits: Haemoglobin, white blood cell greater or equal to 3.0 x 109/l or absolute neutrophil count greater or equal to 1.51 x 109/l, Platelets greater or equal to 100 x 109/l, Serum bilirubin less than 1.5 x upper normal limit , Alkaline phosphatase less or equal to 1.5 x upper normal limit , Serum creatinine less than 1.5 x upper normal limit', ' Negative pregnancy test for patients with child-bearing potential', ' Normal baseline ECG and clinical cardiovascular assessment after completion of all (neo) adjuvant chemotherapy', ' No previous or current evidence for metastatic disease', ' Be accessible for and consent to long term follow-up', ' Written informed consent prior to commencement of specific protocol procedures must be obtained and documented according to the local regulatory requirements', ' Exclusion Criteria', ' Patients with node negative, T1, Grade 1 breast cancer', ' Unresectable, metastatic or bilateral breast cancer', ' Active or previous peptic ulceration or gastrointestinal bleeding in the last year', ' Active or previous history of inflammatory bowel disease', ' A past history of adverse reaction/hypersensitivity to NSAIDs, including celecoxib and salicylates, or sulphonamides', ' On current or planned chronic NSAIDs therapy (except low dose aspirin 100 mg four times per day or 325mg once daily).', ' Current or long-term use of oral corticosteroids', ' Known or suspected congestive heart failure (greater than New York Heart Association I) and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension (ie BP greater than 160/90mmHg) under treatment with two anti-hypertensive drugs, rhythm abnormalities requiring permanent treatment.', ' Patients with diabetes controlled by diet and oral medication are eligible for the study however patients with insulin dependent diabetes are excluded', ' Past history of stroke/Transient ischaemic attack, symptomatic peripheral vascular disease or carotid disease', ' Previously entered into an adjuvant chemotherapy trial for which approval for entry into REACT has not been granted', ' ER receptor status unknown, Human epidermal growth factor receptor 2 or FISH positive, or Human epidermal growth factor receptor 2 status unknown', ' 14. Hormone Receptor negative and not received (neo)adjuvant chemotherapy 15. Use of hormone replacement therapy within the last 6 weeks 16. Pregnant or lactating women or women of childbearing potential unwilling/unable to use non-hormonal contraception 17. No previous or concomitant malignancies except adequately treated squamous cell / basal cell carcinoma of the skin, in situ carcinoma of the cervix or ductal carcinoma in situ/lobular carcinoma in situ of the breast, unless there has been a disease-free interval of 10 years or more 18. Psychiatric or addictive disorders which could preclude obtaining informed consent 19. Clinical evidence of severe osteoporosis and/or history of osteoporotic fracture'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients.', ' From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death)', ' Time frame: Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.', ' Overall Number of Participants Analyzed: 1763', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 2 Year DFS rate: 91 (90 to 93)', ' 5 Year DFS rate: 84 (82 to 86)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Placebo: Two capsules once daily with food', ' Overall Number of Participants Analyzed: 876', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 2 Year DFS rate: 90 (87 to 92)', ' 5 Year DFS rate: 83 (81 to 86)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 148/1755 (8.43%)', ' Anaemia * 1/1755 (0.06%)', ' Neutropenia * 0/1755 (0.00%)', ' Thrombocytopenia * 0/1755 (0.00%)', ' Thrombocytopenic purpura * 1/1755 (0.06%)', ' Acute cardiac event * 1/1755 (0.06%)', ' Aortic valve incompetence * 1/1755 (0.06%)', ' Arrhythmia * 1/1755 (0.06%)', ' Atrial fibrillation * 1/1755 (0.06%)', ' Cardiac failure * 0/1755 (0.00%)', ' Cardiac tamponade * 0/1755 (0.00%)', 'Adverse Events 2:', ' Total: 64/868 (7.37%)', ' Anaemia * 2/868 (0.23%)', ' Neutropenia * 2/868 (0.23%)', ' Thrombocytopenia * 1/868 (0.12%)', ' Thrombocytopenic purpura * 0/868 (0.00%)', ' Acute cardiac event * 0/868 (0.00%)', ' Aortic valve incompetence * 0/868 (0.00%)', ' Arrhythmia * 1/868 (0.12%)', ' Atrial fibrillation * 0/868 (0.00%)', ' Cardiac failure * 1/868 (0.12%)', ' Cardiac tamponade * 1/868 (0.12%)']}
|
6e080a1e-a03e-4547-a7c4-c9d5a80de977
|
Single
|
Eligibility
|
NCT01730729
|
Patients with severe malabsorption disorders are ineligible for the primary trial, unless they are able to receive intravenous (IV) alimentation.
|
Contradiction
|
[
24,
31,
30
] |
[] |
{'Clinical Trial ID': 'NCT01730729', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cabergoline)', ' Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.', ' cabergoline: Given orally'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically confirmed metastatic breast cancer; tissue (a minimum of 3 slides) from the most recent biopsy is required for review and confirmation of eligibility; NOTE: material should ideally be from the metastatic disease, however material from the primary tumor is acceptable if that is all that is available', ' Patients must have stage IV breast cancer', ' Patients must have tumors (primary or metastatic) that stain positively for the prolactin receptor', ' Patients may have measurable or evaluable 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 CT scan', ' Evaluable disease is disease that does not meet the criteria for measurable disease; examples would include patients with effusions or bone-only disease', ' Women of childbearing potential must commit to the use of effective barrier (non-hormonal) contraception while on study', ' Patients must have a life expectancy of greater than 12 weeks', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2', ' Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment', ' Leukocytes >= 3,000/uL (microliter)', ' Absolute neutrophil count >= 1,500/uL', ' Platelets >= 100,000/uL', ' Child Pugh score =< 10', ' Patients must be able to swallow and retain oral medication', ' All patients must have given signed, informed consent prior to registration on study', 'Exclusion Criteria:', ' Women who are pregnant or lactating are not eligible for study treatment', ' Patients who are undergoing concomitant radiotherapy are NOT eligible for participation', ' Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment is allowed with a 2 week washout period prior to registration', ' Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration', ' Patients who are receiving concomitant D2-antagonists (such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide) are NOT eligible for participation; patients must be off any such medications by the time of registration', ' Patients with known brain metastases are NOT eligible for participation', ' Patients with any of the following conditions or complications are NOT eligible for participation:', ' Uncontrolled hypertension', ' Known hypersensitivity to ergot derivatives', ' History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve (to be determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis)', ' History of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders', ' Gastrointestinal (GI) tract disease resulting in an inability to take oral medication', ' Malabsorption syndrome', ' Require intravenous (IV) alimentation', ' History of prior surgical procedures affecting absorption', " Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)"], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR) at 2 Months', ' Overall Response Rate (ORR) is defined as the number of patients that achieved Complete Response (CR) or Partial Response (PR) and will be assessed after 8 weeks (2 cycles) of therapy using CT scan images and RECIST guidelines.', ' 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 of LD.', ' Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded 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 of LD since the treatment started', ' Time frame: After 8 weeks (2 cycles) of treament', 'Results 1: ', ' Arm/Group Title: Treatment (Cabergoline)', ' Arm/Group Description: Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.', ' cabergoline: Given orally', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/20 (20.00%)', ' Death NOS 1/20 (5.00%)', ' Pain 1/20 (5.00%)', ' Dyspnea 2/20 (10.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
63218fb2-3f5b-4738-bea8-11fbbc560949
|
|
Single
|
Intervention
|
NCT01953003
|
Patients receiving intervention 1 of the primary trial, will be administered medication orally and intraveinously.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT01953003', 'Intervention': ['INTERVENTION 1: ', ' Arm A : iv Vinflunine Plus Capecitabine', ' Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.', ' vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²', ' Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²', 'INTERVENTION 2: ', ' Arm B : Capecitabine', ' 1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest', ' Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'], 'Eligibility': ['INCLUSION CRITERIA:', ' Written informed consent', ' Histologically or cytologically confirmed Her-2 negative carcinoma of the breast', ' Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy', ' One, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting. At least one of the regimens must have been given for the treatment of advanced disease.', ' Prior treatment must have included both an anthracycline and a taxane. minimum cumulative dose of 180 mg/m² of doxorubicin or of 300 mg/m² of epirubicin', ' Documented progression on or within 12 months of the most recent chemotherapy.', ' Prior hormone therapy is allowed', ' Prior radiation therapy is allowed to less than 30% of the bone marrow', ' LMeasurable or non measurable disease defined according to RECIST V1.1', ' Adequate recovery from recent surgery', ' Estimated life expectancy superior or equal of 12 weeks', ' KPS equal or superior to 70%', ' Age equal or superior to 21 years and < 80 years', ' ANC) equal or superior to 1.5 x 109/L, platelet count equal or superior to 100 x109/L and haemoglobin > 10 g/dL.', ' Bilirubin inferior or equal to 1.5 x upper limit of normal (ULN), AST and ALT inferior or equal to 2.5 x ULN or inferior or equal to 5 x ULN in the case of liver metastases, alkaline phosphatase inferior or equal to 5 x ULN.', ' Calculated creatinine clearance superior or equal to 50 mL/min', ' Normal ECG', ' Patients on coumadin or warfarin must be on stable doses and INR inferior or equal to 3', ' Women of childbearing potential must be using a medically accepted method of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration.', ' Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.', ' EXCLUSION CRITERIA', ' Known or with clinical evidence of brain metastasis or leptomeningeal involvement.', ' Pulmonary lymphangitis or symptomatic pleural effusion (grade > 2) that results in pulmonary dysfunction requiring active treatment.', ' Patients having received any other experimental drug or chemotherapy within 30 days', ' History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence', ' Pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade >1', ' Patients having received > 3 regimens of chemotherapy', ' Prior therapy with capecitabine and/or vinca-alkaloids', ' History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of the study drugs', ' Known or suspected DPD', ' Pregnant or lactating; With positive pregnancy test at inclusion', ' Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment', ' Known history of HIV infection', ' Inability to take and/or absorb oral medication', ' Any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation.', ' Prior BMT or autologous stem cell infusion following high-dose chemotherapy.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.', ' Time frame: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years', 'Results 1: ', ' Arm/Group Title: Arm A : iv Vinflunine Plus Capecitabine', ' Arm/Group Description: Vinflunine dose 280 mg/m on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.', ' vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m ', ' Capecitabine: Arm A : 1650 mg/m Arm B : 2500 mg/m ', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Number of events (Participants): 42 75.0%', ' Number of censored observations (Participants): 14 25.0%', 'Results 2: ', ' Arm/Group Title: Arm B : Capecitabine', ' Arm/Group Description: 1250 mg/m twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest', ' Capecitabine: Arm A : 1650 mg/m Arm B : 2500 mg/m ', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Number of events (Participants): 46 82.1%', ' Number of censored observations (Participants): 10 17.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/56 (26.79%)', ' Febrile neutropenia 2/56 (3.57%)', ' Leukopenia 1/56 (1.79%)', ' Neutropenia 1/56 (1.79%)', ' Thrombocytopenia 1/56 (1.79%)', ' Anaemia 0/56 (0.00%)', ' Abdominal Pain 2/56 (3.57%)', ' Ileus 2/56 (3.57%)', ' Intestinal obstruction 1/56 (1.79%)', ' Mouth ulceration 1/56 (1.79%)', ' Fatigue 1/56 (1.79%)', ' Pain 1/56 (1.79%)', ' Chest discomfort 0/56 (0.00%)', ' Death 1/56 (1.79%)', 'Adverse Events 2:', ' Total: 7/55 (12.73%)', ' Febrile neutropenia 0/55 (0.00%)', ' Leukopenia 0/55 (0.00%)', ' Neutropenia 0/55 (0.00%)', ' Thrombocytopenia 0/55 (0.00%)', ' Anaemia 1/55 (1.82%)', ' Abdominal Pain 0/55 (0.00%)', ' Ileus 0/55 (0.00%)', ' Intestinal obstruction 0/55 (0.00%)', ' Mouth ulceration 0/55 (0.00%)', ' Fatigue 0/55 (0.00%)', ' Pain 0/55 (0.00%)', ' Chest discomfort 1/55 (1.82%)', ' Death 0/55 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d7fa4f81-e108-491f-9b08-c147a33863e8
|
|
Single
|
Results
|
NCT00849472
|
Two dozen the primary trial participants are classified as having Pathologic Complete Response (pCR) in the Breast and Nodes.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f24afb09-ea65-457f-9f9b-0db3cc3101ac
|
|
Single
|
Adverse Events
|
NCT00403130
|
There were no cases of Leukopenia, Epitasis or Arrhythmia observed in patients participating in the primary trial.
|
Contradiction
|
[
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': ''}
|
3cd79df2-e6dd-41dd-b819-4d993b5f7aed
|
|
Single
|
Eligibility
|
NCT00090857
|
Candidates for the primary trial must have a bone density scan 1 month prior to study entry, if the results from this are more than 2 standard deviations below normal, the study physician can still decide to let them participate.
|
Entailment
|
[
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT00090857', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.', 'INTERVENTION 2: ', ' Placebo', ' Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' At increased risk for the development or recurrence of breast cancer, defined as an estradiol level 9 pg/mL', ' No evidence of suspicious or malignant disease, based on the following examinations:', ' Clinical bilateral breast examination within the past 6 months', ' Bilateral* mammogram within 3 months before randomization OR within 30 days after randomization', ' Pelvic exam normal within the past 5 years', ' General physical exam within the past 6 months NOTE: *Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS)', ' Bone density scan within 2 standard deviations from normal within the past 30 days', ' Bone density scan 2 standard deviations below normal allowed if approved by the study physician', ' At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS)', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 35 and over', ' Sex', ' Female', ' Menopausal status', ' Postmenopausal, defined by any of the following criteria:', ' At least 12 months without spontaneous menstrual bleeding', ' Prior hysterectomy and bilateral salpingo-oophorectomy', ' 55 years of age with a prior hysterectomy with or without oophorectomy', ' < 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range', ' Performance status', ' Normal activity must not be restricted for a significant portion of the day', ' Life expectancy', ' At least 10 years', ' Hematopoietic', ' Complete blood count with differential normal', ' Prior benign neutropenia allowed provided the granulocyte count is 1,500/mm^3', ' Hepatic', ' Bilirubin normal', ' Alkaline phosphatase normal', ' SGOT and SGPT normal', ' Renal', ' Creatinine normal', ' Cardiovascular', ' No uncontrolled cardiovascular disease', ' Other', ' Not pregnant', ' No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No osteoporosis', ' No hyperlipidemia', ' No mental health status resulting in cognitive or emotional impairment that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' Not specified', ' Endocrine therapy', ' More than 30 days since prior AND no concurrent use of any of the following hormonal agents:', ' Estrogen or progesterone replacement therapy', ' Oral contraceptives', ' Raloxifene or other plasma estrogen receptor modulators (SERMs)', ' Androgens (e.g., danazol)', ' Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide)', ' Prolactin inhibitors (e.g., bromocriptine)', ' Antiandrogens (e.g., cyproterone)', ' More than 60 days since prior AND no concurrent tamoxifen', ' No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)', ' No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)', ' Dietary soy allowed', ' Radiotherapy', ' See Disease Characteristics', ' Surgery', ' See Disease Characteristics', ' No prior bilateral mastectomy', ' Other', ' More than 60 days since prior treatment for invasive breast cancer or DCIS', ' More than 30 days since prior bisphosphonates or calcitonin', ' No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS', ' No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents', ' No concurrent calcitonin', ' No concurrent bisphosphonate therapy', ' Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed'], 'Results': ['Outcome Measurement: ', ' Change in Lumbar Density From Baseline to 12 Months', ' The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.', ' Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.', ' Overall Number of Participants Analyzed: 29', ' Median (Full Range)', ' Unit of Measure: g/cm^2 -0.036 (-0.092 to 0.272)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.', ' Overall Number of Participants Analyzed: 13', ' Median (Full Range)', ' Unit of Measure: g/cm^2 -0.021 (-0.180 to 0.064)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/33 (3.03%)', ' Pain - Head/Headache 1/33 (3.03%)', ' Urticaria (hives, welts, wheals) 1/33 (3.03%)', ' Pruritus / Itching 1/33 (3.03%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)', ' Pain - Head/Headache 0/16 (0.00%)', ' Urticaria (hives, welts, wheals) 0/16 (0.00%)', ' Pruritus / Itching 0/16 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d2d6f646-5881-42a2-b965-0c6f79e89463
|
|
Single
|
Results
|
NCT00022672
|
There were no patients in either cohort of the primary trial with a PFS exceeding one year.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00022672', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Anastrozole', ' Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.', 'INTERVENTION 2: ', ' Anastrozole', ' 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' postmenopausal women;', ' metastatic breast cancer suitable for endocrine therapy;', ' positive hormone receptor status;', ' Human epidermal growth factor receptor 2 (HER2) overexpression.', 'Exclusion Criteria:', ' patients on hormone replacement therapy;', ' previous chemotherapy for metastatic disease;', ' uncontrolled cardiac disease and history of cardiac failure.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.', ' Time frame: 24 Months, End of Study (Up to 5 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Anastrozole', ' Arm/Group Description: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.', ' Overall Number of Participants Analyzed: 103', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 24 Months: 4.8 (3.7 to 7)', ' End of Study: 5.8 (4.6 to 8.3)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.', ' Overall Number of Participants Analyzed: 104', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 24 Months: 2.4 (2 to 4.6)', ' End of Study: 2.9 (2.1 to 4.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 25/103 (24.27%)', ' Febrile neutropenia 1/103 (0.97%)', ' Myocardial infarction 1/103 (0.97%)', ' Myocardial ischaemia 1/103 (0.97%)', ' Middle ear inflammation 1/103 (0.97%)', ' Vomiting 3/103 (2.91%)', ' Nausea 2/103 (1.94%)', ' Abdominal pain 1/103 (0.97%)', ' Constipation 1/103 (0.97%)', ' Diarrhoea 1/103 (0.97%)', ' Gastritis 1/103 (0.97%)', ' Intestinal obstruction 1/103 (0.97%)', 'Adverse Events 2:', ' Total: 6/104 (5.77%)', ' Febrile neutropenia 1/104 (0.96%)', ' Myocardial infarction 1/104 (0.96%)', ' Myocardial ischaemia 0/104 (0.00%)', ' Middle ear inflammation 0/104 (0.00%)', ' Vomiting 0/104 (0.00%)', ' Nausea 0/104 (0.00%)', ' Abdominal pain 0/104 (0.00%)', ' Constipation 0/104 (0.00%)', ' Diarrhoea 0/104 (0.00%)', ' Gastritis 0/104 (0.00%)', ' Intestinal obstruction 0/104 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
428d5165-560b-4783-8c4b-5fd3a3289cab
|
|
Comparison
|
Intervention
|
NCT02536794
|
NCT00712985
|
the primary trial and the secondary trial both administer Zometa to their patients through IV, although in different doses.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT02536794', 'Intervention': ['INTERVENTION 1: ', ' Treatment (MEDI4736, Tremelimumab)', ' Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.', ' Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV', ' Laboratory Biomarker Analysis: Correlative studies', ' Pharmacological Study: Correlative studies', ' Tremelimumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have a histologically documented (either primary or metastatic site) diagnosis of breast cancer that is HER2 non-overexpressing by immunohistochemistry, namely 0 or 1; if they have an equivocal immunohistochemistry, 2, the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio < 2 and HER2 copy number < 4); estrogen receptor (ER) positivity is defined as 1% or greater', ' Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Patients who are ER negative must have progressed through at least one prior chemotherapy regimen in the metastatic setting or within 12 months of their last adjuvant systemic treatment; patients who are ER positive must have progressed through standard hormone therapy options and have received at least one line of chemotherapy in the metastatic setting', ' Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry', ' Radiation therapy must be completed at least 2 weeks prior to study entry; radiated lesions may not serve as measurable disease unless they have been radiated over 12 months prior to enrollment', ' Patients may have parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery); leptomeningeal disease is excluded; must have completed any prescribed steroid taper', ' Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment', ' Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2', ' Absolute neutrophil count >= 1,000/mcL', ' Platelets >= 50,000/mcl', ' Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (or =< 3 times ULN in case of liver metastasis)', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 2.5 X institutional ULN (or =< 5 times ULN in case of liver metastasis)', ' Creatinine =< 2 ng/ml', ' Females of child-bearing potential (FOCBP) and males must agree to use 2 methods of adequate contraception prior to study entry, for the duration of study participation, and for number (#) days following completion of therapy; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:', ' Has not undergone a hysterectomy or bilateral oophorectomy', ' Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)', ' FOCBP must have a negative pregnancy test within 7 days prior to registration on study', ' Willingness to provide a fresh biopsy prior to study enrollment and after 2 cycles of treatment', ' Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are not eligible.', ' Current or prior use of immunosuppressive therapy within 2 weeks of starting investigational therapy', ' Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration for at least 2 weeks; NOTE: Vitamin supplements are acceptable', ' Patients may not have received any other investigational agents within 4 weeks prior to registration', ' Prior treatment with immune therapy (including but not limited to cluster of differentiation [CD]137, OX40, programmed death [PD]-1, PD-L1 or cytotoxic T-lymphocyte antigen 4 [CTLA4] inhibitors)', ' Prior severe infusion reaction to a monoclonal antibody', ' Patients with a history of or active autoimmune disease within the past 3 years with the following exceptions:', ' Vitiligo or alopecia', ' Hypothyroidism on stable doses of thyroid replacement therapy', ' Psoriasis not requiring systemic therapy within the past 3 years', ' History of primary immunodeficiency disease or tuberculosis', ' Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) are not eligible; other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study', ' Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:', ' Uncontrolled pulmonary, renal, or hepatic dysfunction', ' Ongoing or active infection requiring systemic treatment', ' Known active or chronic viral hepatitis or human immunodeficiency virus (HIV)', ' Psychiatric illness/social situations that would limit compliance with study requirements', " Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints", ' Female patients who are pregnant or nursing are not eligible'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR) in Patients With Metastatic HER2 Negative Breast Cancer Treated With Durvalumab in Combination With Tremelimumab', ' Overall response rate is defined as the number of patients with partial response (PR), plus those with complete response (CR) using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 with the following definitions:', ' Complete Response - Disappearance of all lesions Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.', ' Time frame: Up to a maximum of 49 cycles where 1 cycle = 4 weeks for the first 4 cycles and than 1 cycle =2 weeks for 45 cycles', 'Results 1: ', ' Arm/Group Title: Treatment (MEDI4736, Tremelimumab)', ' Arm/Group Description: Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.', ' Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV', ' Laboratory Biomarker Analysis: Correlative studies', ' Pharmacological Study: Correlative studies', ' Tremelimumab: Given IV', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/30 (60.00%)', ' Myocarditis and Ventricular Tachycardia 1/30 (3.33%)', ' Vomiting 1/30 (3.33%)', ' Vomiting [1]1/30 (3.33%)', ' Enteritis [2]1/30 (3.33%)', ' Fever and chills [3]2/30 (6.67%)', ' Fever [4]1/30 (3.33%)', ' Hepatitis 2/30 (6.67%)', ' Hepatitis [5]1/30 (3.33%)', ' Spontaneous bacterial peritonitis 1/30 (3.33%)', ' Urosepsis [6]1/30 (3.33%)', ' Disease progression 2/30 (6.67%)']}
|
{'Clinical Trial ID': 'NCT00712985', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid 5 mg IV', ' Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases).', ' Calculated creatinine clearance > 40 ml/min', ' Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening.', ' Urine NTx > 50 nano moles(nM)based on second morning void.', ' Signed informed consent.', ' Ambulatory patients at least 18 years of age.', ' Eastern Cooperative Oncology Group (ECOG)0-2.', ' Ability to comply with trial requirements.', 'Exclusion Criteria:', ' Bone Metastases.', ' Any woman of child bearing potential.', ' Patients with fractures occurring within three months prior to randomization. - Greater than a 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).', ' Calculated creatinine clearance less than 30 mL/min at screening.', ' Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL).', ' Liver Function tests (LFT)> 2.0 x upper limit of normal (ULN).', ' Serum alkaline phosphatase > 1.5 x ULN. History of hypersensitivity to bisphosphonates.', ' Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml).', ' History of uveitis or iritis, except when secondary to trauma, and must have resolved > 2 years prior to entry.', ' A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.', ' Previous major solid organ transplant recipient or on a transplant waiting list.', ' Treatment with any investigational drug within 30 days prior to randomization.', " History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis.", ' Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months.', ' Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.', ' Prior treatment with IV bisphosphonates within the last 2 years.', ' Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*). *NOTE: If used less than 8 weeks, the washout period is 6 months.', ' Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.', ' Any treatment with strontium ranelate, samarium, sodium fluoride or parathyroid hormone.', ' Use of systemic high dose corticosteroids at an average dose of > 7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.', ' Known hypersensitivity to zoledronic acid or other bisphosphonates.', ' Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months', ' 17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.', ' Time frame: One year', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid 5 mg IV', ' Arm/Group Description: Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}
|
6e7df2e4-11b3-4183-aefc-760f85809515
|
Single
|
Results
|
NCT01439711
|
One patient in the primary trial had a 2.87 cm3 decrease in Total MRI Functional Tumor Volume (FTV) over 3 months.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01439711', 'Intervention': ['INTERVENTION 1: ', ' Letrozole + MRI', ' Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.'], 'Eligibility': ['Eligibility Criteria:', ' Histologic documentation: Pathologic confirmation of ductal carcinoma in situ (DCIS) of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration. Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study.', ' Patients with microinvasion on diagnostic core biopsy, defined as tumor 1 mm in greatest dimension, will be allowed to participate.', ' All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment.', ' Tissue samples: Patient has diagnostic tissue available for correlative studies.', ' Clinical stage: Tis or T1mi N0, M0', " Hormone receptor status: DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol. Greater than or equal to 1% cells will be considered to be positive.", ' Menopausal status: Patients must be postmenopausal defined as:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more amenorrhea, with an estradiol assay < 20pg/ml', ' Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)', ' The use of GnRH analogs to achieve post menopausal status is not allowed.', ' Prior treatment:', ' No prior surgical excision in the index breast for current DCIS diagnosis of DCIS', ' Any exogenous hormone therapy must be completed 4 weeks prior to registration', ' Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible', ' No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis', ' Contraindication to MRI: No contraindications to breast MRI', 'Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion 1 cm and 7 cm', ' DCIS must be visible on MRI based on central review.', ' Patients with palpable DCIS or adenopathy are not eligible to participate.', ' Patients with multifocal or bilateral disease are eligible.', ' History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy.', ' Age: Patients 18 years of age', 'Performance Status: ECOG performance status 0 or 1', ' Pregnancy/nursing status: Not pregnant or nursing', ' Required Initial Laboratory Values:', ' ANC 1,000/μL', ' Platelet count 100,000/μL', ' Serum creatinine 1.7 mg/dL', ' Bilirubin 2.0 mg/dL', ' AST/ALT 2.5 times upper limit of normal', ' Serum estradiol level assay < 20 pg/mL *Required for patients < 55 years of age and one year or more of amenorrhea'], 'Results': ['Outcome Measurement: ', ' Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)', ' Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.', ' Time frame: up to 3 months from start of treatment', 'Results 1: ', ' Arm/Group Title: Letrozole + MRI', ' Arm/Group Description: Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.', ' Overall Number of Participants Analyzed: 68', ' Mean (95% Confidence Interval)', ' Unit of Measure: cubic centimeters -1.93 (-2.87 to -0.98)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/90 (2.22%)', ' Heart failure 1/90 (1.11%)', ' Restrictive cardiomyopathy 1/90 (1.11%)', ' Fever 1/90 (1.11%)', ' Hypokalemia 1/90 (1.11%)', ' Arthralgia 1/90 (1.11%)', ' Myalgia 1/90 (1.11%)', ' Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify 1/90 (1.11%)', ' Hypertension 2/90 (2.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45e6b4b6-ca31-4318-936e-5b27cbca47a2
|
|
Single
|
Eligibility
|
NCT00458237
|
Patient who have recently undergone External beam radiation therapy are eligible for the primary trial.
|
Entailment
|
[
0,
6
] |
[] |
{'Clinical Trial ID': 'NCT00458237', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Everolimus (Dose Level 1) and Trastuzumab', ' Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Phase I: Everolimus (Dose Level 2) and Trastuzumab', ' Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, with stage IV disease', ' Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.', ' Primary tumor or metastasis must overexpress HER2', ' Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.', ' Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.', ' Patients may have received prior radiation therapy', ' Patients may have received hormonal therapy in the adjuvant or metastatic setting', ' 18 years of age or older', ' Life expectancy of greater than 6 months', ' Normal organ and marrow function as defined in the protocol', ' Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal', 'Exclusion Criteria:', ' Treatment with any investigational drug within 4 weeks', ' Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent', ' Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001', ' An active, bleeding diathesis or an oral anti-vitamin K medication', ' Prior treatment with an mTOR inhibitor', ' History of non-compliance with medical regimens', ' Unwillingness or inability to comply with the protocol', ' Major surgery within 2 weeks before study entry', ' Patients with active brain metastases or leptomeningeal carcinomatosis', ' Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration', ' Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.', ' Pregnant or breast-feeding women', ' HIV positive patients', ' Known hypersensitivity to RAD001 (everolimus) or other rapamycins'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD)', ' The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):', ' Any grade 4 hematologic toxicity, excluding anemia.', ' Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.', ' Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity.', ' Time frame: Cycle One (first 21 days of treatment)', 'Results 1: ', ' Arm/Group Title: Phase I: Everolimus (Dose Level 1) and Trastuzumab', ' Arm/Group Description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants with DLT 0', 'Results 2: ', ' Arm/Group Title: Phase I: Everolimus (Dose Level 2) and Trastuzumab', ' Arm/Group Description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants with DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Muco/stomatitis (symptom) oral cavity 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Vascular access-Thrombosis/embolism [1]0/3 (0.00%)', ' Leukocytes 0/3 (0.00%)', ' Lymphopenia 0/3 (0.00%)', ' Neutrophils 0/3 (0.00%)', ' Platelets 0/3 (0.00%)', ' Hypokalemia 0/3 (0.00%)', ' Thrombosis/thrombus/embolism [2]0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' Muco/stomatitis (symptom) oral cavity 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Vascular access-Thrombosis/embolism [1]0/3 (0.00%)', ' Leukocytes 0/3 (0.00%)', ' Lymphopenia 1/3 (33.33%)', ' Neutrophils 0/3 (0.00%)', ' Platelets 0/3 (0.00%)', ' Hypokalemia 0/3 (0.00%)', ' Thrombosis/thrombus/embolism [2]0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
22a6d10e-55c5-4a8c-8010-3e8252bcb279
|
|
Comparison
|
Intervention
|
NCT00593346
|
NCT00902330
|
the primary trial treament last for a shorter period of time than the secondary trial treatment, but is administered much more often.
|
Contradiction
|
[
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%)']}
|
7fd1ae1e-bfdb-4c37-aaea-ed97663758e3
|
Single
|
Adverse Events
|
NCT03078751
|
Cohort 1 of the primary trial reported one case of AML.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT03078751', 'Intervention': ['INTERVENTION 1: ', ' Ribociclib + Adjuvant Endocrine Therapy (ET)', ' Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)', 'INTERVENTION 2: ', ' Placebo + Adjuvant Endocrine Therapy (ET)', ' Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen'], 'Eligibility': ['Key Inclusion Criteria:', ' Histologically confirmed unilateral primary invasive adenocarcinoma of the breast', ' Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer', ' Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen', ' Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue', ' Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of 4 cycles or 12 weeks which included taxanes prior to screening', ' Patient has completed adjuvant radiotherapy (if indicated) prior to screening', ' Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET', ' ECOG Performance Status 0 or 1', ' Adequate bone marrow and organ function', ' Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits', ' QTcF interval < 450 msec and mean resting heart rate 50-90 bpm', ' Key Exclusion Criteria:', ' Prior treatment with CDK4/6 inhibitor', ' Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years', ' Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin', ' Distant metastases of breast cancer beyond regional lymph nodes', ' Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery', ' Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias', ' Uncontrolled hypertension with systolic blood pressure >160 mmHg', ' Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.', ' Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the study', ' Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events and Serious Adverse Events', ' These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not', ' Time frame: Up to 26 months', 'Results 1: ', ' Arm/Group Title: Ribociclib + Adjuvant Endocrine Therapy (ET)', ' Arm/Group Description: Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Participants Adverse Events: 25', ' Serious Adverse Events: 4', 'Results 2: ', ' Arm/Group Title: Placebo + Adjuvant Endocrine Therapy (ET)', ' Arm/Group Description: Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: Participants Adverse Events: 21', ' Serious Adverse Events: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/26 (15.38%)', ' Disseminated intravascular coagulation 1/26 (3.85%)', ' Cardiac failure congestive 1/26 (3.85%)', ' Breast cellulitis 1/26 (3.85%)', ' Cellulitis 1/26 (3.85%)', ' Acute myeloid leukaemia 1/26 (3.85%)', ' Seizure 0/26 (0.00%)', ' Pulmonary embolism 1/26 (3.85%)', 'Adverse Events 2:', ' Total: 2/24 (8.33%)', ' Disseminated intravascular coagulation 0/24 (0.00%)', ' Cardiac failure congestive 0/24 (0.00%)', ' Breast cellulitis 0/24 (0.00%)', ' Cellulitis 1/24 (4.17%)', ' Acute myeloid leukaemia 0/24 (0.00%)', ' Seizure 1/24 (4.17%)', ' Pulmonary embolism 0/24 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
50d119f6-a657-4619-918e-7617ac57f052
|
|
Single
|
Eligibility
|
NCT01009918
|
There are no racial criteria for entry into the primary trial, however there are gender criteria.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20
] |
[] |
{'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': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e436827b-10db-4179-bf8f-07786ee6145b
|
|
Single
|
Eligibility
|
NCT00631852
|
Patients with hemophilia are excluded from the primary trial.
|
Entailment
|
[
12,
19
] |
[] |
{'Clinical Trial ID': 'NCT00631852', 'Intervention': ['INTERVENTION 1: ', ' American Ginseng Root', ' four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery'], 'Eligibility': ['Inclusion Criteria:', ' Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging', ' Surgical patients undergoing lumpectomy, subtotal or total mastectomy', ' 18 years of age or greater', ' female', ' available tissue blocks from diagnostic biopsy', ' negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal', ' must be willing to forego surgery for minimum of 5 days', ' ability and willingness to sign written consent', ' if hypertensive, on stable dose of medication at least 30 days', ' if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days', ' ECOG status < 2 or Karnofsky of 60% or greater', 'Exclusion Criteria:', ' previous or current malignancy, excluding non-melanomic skin cancer', ' evidence of distant metastatic disease', ' history of chemotherapy, biologic or radiotherapy with 6 months of biopsy', ' usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug', ' history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG', ' history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications', ' active bleeding or a pathological condition that carries a high risk of bleeding', ' any swallowing dysfunction', ' uncontrolled intercurrent illness', ' poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)', ' known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.', ' uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)', ' pregnant or breast feeding women Women must be willing to use birth control throughout study duration.', ' current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy', ' current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy', ' current monoamine oxidase inhibitors treatment'], 'Results': ['Outcome Measurement: ', ' Adiponectin', ' Change from baseline to completion of treatment with LEAG.', ' Time frame: mean of 11.8 days', 'Results 1: ', ' Arm/Group Title: American Ginseng Root', ' Arm/Group Description: four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 1308 (11,985)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/16 (6.25%)', ' hemorrhage/ bleeding * [1]1/16 (6.25%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fcc6708a-b0fc-4215-a45f-02b1e0e2d30a
|
|
Comparison
|
Eligibility
|
NCT00944047
|
NCT00228943
|
Patients with tumors underexpressing HER2 are excluded from the primary trial, but may be included in the secondary trial.
|
Entailment
|
[
0,
4
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00944047', 'Intervention': ['INTERVENTION 1: ', ' Intervention Arm', ' Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery', ' nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks', ' trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks', ' Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles', ' cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)', ' Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.', ' - Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.', ' Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.', ' -All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.'], 'Eligibility': ['Inclusion Criteria:', ' Female patient 18 years of age', ' Histologically proven stage II or III adenocarcinoma of the breast', ' Must be candidate for neoadjuvant treatment (Tumor size 2 cm, T2, T3, T4 and/or clinical N1 or N2).', ' HER-2/neu 1+ or 2+ by immunohistochemistry', ' Must have operable tumor.', ' Performance status of 2 or better per SWOG criteria', ' LVEF 55% by echocardiogram performed within 4 weeks prior to treatment initiation', ' If patient of childbearing potential, pregnancy test is negative', ' Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.', ' Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL', ' Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min', ' Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL', ' Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.', ' Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.', 'EXCLUSION CRITERIA:', ' Patient with metastatic breast cancer.', ' Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry', ' Women with HER 2 FISH amplified tumors (FISH ratio >2.2)', ' Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.', ' Locally advanced, inoperable tumors will be excluded.', ' The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction < 55%', ' Pregnancy or lactation', ' Patients with inadequate laboratory values (as defined above) are excluded from study.', ' Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.', ' Patients with active infection are excluded from study.', ' Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).', ' Patients with emotional limitations are excluded from study.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response', ' [Not Specified]', ' Time frame: 22 weeks', 'Results 1: ', ' Arm/Group Title: Intervention Arm', ' Arm/Group Description: Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery', ' nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks', ' trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks', ' Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles', ' cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)', ' Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.', ' - Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.', ' Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.', ' -All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: percentage of participants 26'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/32 (15.63%)', ' Pain * 1/32 (3.13%)', ' Febrile neutropenia * 2/32 (6.25%)', ' Pneumonia * 1/32 (3.13%)', ' Syncope * 1/32 (3.13%)']}
|
{'Clinical Trial ID': 'NCT00228943', 'Intervention': ['INTERVENTION 1: ', ' Full Strength Acute Tryptophan Depletion', '[Not Specified]', 'INTERVENTION 2: ', ' Half-Strength Tryptophan Depletion - Control', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' At least 18 years of age', ' Willing and able to provide informed consent', ' Reporting daily hot flashes', ' Able to read, write, and speak English', ' Postmenopausal to limit sample variability (> 12 months amenorrhea)', ' Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.', ' These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.', 'Exclusion Criteria:', ' Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.'], 'Results': ['Outcome Measurement: ', ' Serum Tryptophan Levels', ' Mean serum tryptophan levels (blood draw) at the end of the nadir period.', ' Time frame: baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours', 'Results 1: ', ' Arm/Group Title: Full Strength Acute Tryptophan Depletion', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 24', ' Mean (Standard Deviation)', ' Unit of Measure: nmol/ml 0.0034 (.0027)', 'Results 2: ', ' Arm/Group Title: Half-Strength Tryptophan Depletion - Control', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: nmol/ml 0.02 (0.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
d63706f1-4fb8-488d-8f86-c1a19df341d4
|
Single
|
Eligibility
|
NCT02694029
|
Candidates for the primary trial are expected to be capable of holding their breath for half a minute.
|
Entailment
|
[
0,
6
] |
[] |
{'Clinical Trial ID': 'NCT02694029', 'Intervention': ['INTERVENTION 1: ', ' Radiation With ABC', ' Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH', ' Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH', 'INTERVENTION 2: ', ' Radiation VRT', ' VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH', ' VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH'], 'Eligibility': ['Inclusion Criteria:', ' Women with diagnosis of breast malignancy', ' Women whom requires left chest wall post-mastectomy radiation with or without bolus', ' Age 18 years.', ' Performance status ECOG </=3', ' Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.', ' Patient must be able to maintain a 30 second breath hold.', ' Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)', 'Exclusion Criteria:', ' 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.', ' Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.'], 'Results': ['Outcome Measurement: ', ' Residual Motion During Deep Inspiratory Breath-Hold (DIBH)', ' Residual motion is measured as range of breast/chest wall motion during the ABC or VisionRT assisted DIBH beam delivery. The range of motion will be measured in a unit of millimeter.', ' Time frame: All patients received treatment for 2 hours for a minimum of 6 weeks', 'Results 1: ', ' Arm/Group Title: Radiation With ABC', ' Arm/Group Description: Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH', ' Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH', ' Overall Number of Participants Analyzed: 10', ' Mean (Full Range)', ' Unit of Measure: mm 0.27 (-3.0 to 3.1)', 'Results 2: ', ' Arm/Group Title: Radiation VRT', ' Arm/Group Description: VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH', ' VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH', ' Overall Number of Participants Analyzed: 10', ' Mean (Full Range)', ' Unit of Measure: mm 0.27 (-1.8 to 1.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ab357056-67a7-4227-966d-8c96eb1640fd
|
|
Single
|
Eligibility
|
NCT00635050
|
Patients with Breast cancers that have estrogen receptors are excluded from the primary trial.
|
Entailment
|
[
0,
2
] |
[] |
{'Clinical Trial ID': 'NCT00635050', 'Intervention': ['INTERVENTION 1: ', ' Doxil, Paclitaxel, Cyclophosphamide + Avastin', ' Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.', ' Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.', ' Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed, measurable, invasive breast carcinoma T >2cm, Nany, M0.', ' Patients with node-negative, ER or PR-positive tumors 4 cm in size whose tumors are low risk (defined as a score of 0-17) on an Oncotype DX profile are not eligible.', ' 19 years of age or greater', ' Known ER, PR and HER-2 status (FISH assay to be done on specimens with 2+ or 3+ immunohistochemical staining for HER-2): patients with gene amplification on FISH study will be considered to be HER-2 positive. Patients for this study must be FISH negative if immunohistochemical stain is 2+ or 3+ positive; patients with negative, 0 or 1+ immunohistochemical stain for HER-2 are eligible.', ' Known axillary nodal status: aspiration cytology or biopsy', ' Documented menopausal status premenopausal (having menstrual periods or FSH <35) or postmenopausal ( 12 months since last menstrual period with intact uterus and at least one ovary or FSH 35 or previous bilateral oophorectomy', ' Non-pregnant if premenopausal (negative serum or urine pregnancy test within 7 days of starting chemotherapy) and not breast feeding', ' Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.', ' Life expectancy of less than 12 weeks', ' 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 Avastin cancer study', ' Pregnant or lactating women.', ' History of cardiac disease, with New York Heart Association Grade II or greater or clinical evidence of congestive heart failure.', ' Serious comorbid medical conditions which would impair the ability to receive chemotherapy on time', ' Previous invasive cancer within the last 5 years', ' Altered mental status or dementia which would interfere with understanding of informed consent and ability to comply with study and follow-up procedures.', ' Hypersensitivity to Doxil, doxorubicin, cyclophosphamide, cremophore (contained in teniposide, cyclosporine, and vitamin K), or to any component of Avastin', ' Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medication)', ' Unstable angina pectoris', ' History of myocardial infarction or unstable angina within 12 months prior to beginning therapy', ' History of stroke or TIA at any time', ' Clinically significant vascular (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, aortic dissection) or peripheral vascular disease with 6 months prior to beginning therapy', ' History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to beginning therapy', ' Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy or anticipation of need for major surgical procedure during the course of the study', ' Patients must have a 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.', ' No distant metastases on bone scan and on CT scans of chest and abdomen (no metastasis on optional PET scan is an acceptable alternative; if PET scan is done for any reason it must show no evidence of distant metastasis). Baseline PET scan is recommended but not required for all patients.', ' No CNS metastasis', ' Hbg 9 gm, platelets 100,000, granulocytes 1000, total or direct bilirubin 1.2, creatinine 2.0 and urine protein:creatinine ratio <1.0', ' No prior chemotherapy or radiotherapy and 4 weeks of prior antiestrogen or aromatase inhibitor therapy', ' No concomitant hormone replacement (i.e. estrogen or progestin) therapy', ' PS less than or equal to one', 'Exclusion Criteria:', ' Minor surgical procedure (excluding placement of a vascular access device) such as fine needle aspiration or core needle biopsy within 7 days of beginning therapy', ' Urine protein:creatinine ratio 1.0 at initial screening', ' Known hypersensitivity to any component of Avastin', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of beginning therapy', ' Serious, non-healing wound, active ulcer, or untreated bone fracture', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' Known CNS metastasis, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.'], 'Results': ['Outcome Measurement: ', ' Rate of Achievement of Pathological Complete Response (pCR)', ' Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes.', ' Time frame: After completion of at least 8 of the 9 chemotherapy doses and operation.', 'Results 1: ', ' Arm/Group Title: Doxil, Paclitaxel, Cyclophosphamide + Avastin', ' Arm/Group Description: Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.', ' Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.', ' Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: pathology specimens from participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/32 (3.13%)', ' hospitalization [1]1/32 (3.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0359eef3-6339-485e-95bc-0cb6fa7bcd12
|
|
Comparison
|
Intervention
|
NCT00791037
|
NCT00606931
|
the primary trial and the secondary trial do not use the same route of administration for their interventions.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT00791037', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)', ' Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.', ' Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.', ' HER-2/neu peptide vaccine: Given ID', ' leukapheresis: Undergo leukapheresis', ' ex vivo-expanded HER2-specific T cells: Given IV', ' cyclophosphamide: Given IV', ' sargramostim: Given ID', ' laboratory biomarker analysis: Correlative study'], 'Eligibility': ['Inclusion Criteria:', ' Patients with HER2+ Stage IV breast cancer that have been maximally treated and not achieved a complete remission', ' Patients must have stable or slowly progressive disease state, measurable disease as:', ' Extraskeletal disease that can be accurately measured >= 10 mm by standard imaging techniques that can include but not limited to computed tomography (CT), positron emission tomography (PET), PET/CT, magnetic resonance imaging (MRI);', ' Skeletal or bone-only disease which is measurable by fludeoxyglucose (FDG) PET or PET/CT imaging will also be allowed', ' Patients can be currently receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy', ' HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 2+ or 3+, or documented gene amplification by fluorescence in situ hybridization (FISH) analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH', ' Subjects must have a Performance Status Score (Southwest Oncology Group [SWOG]/Zubrod Scale) = 0, 1 or 2', ' Patients must be off all immunosuppressive treatments such as chemotherapy or systemic steroid therapy a minimum of 14 days prior to initiation of study (i.e. first vaccination)', ' Patients on trastuzumab and/or lapatinib must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) equal to or greater than the lower limit of normal for the facility within 90 days of eligibility determination', ' Men and women of reproductive ability must agree to contraceptive use during the entire study period', ' Patients must have an expected survival of 6 months', ' White blood cell (WBC) >= 3000/mm^3', ' Absolute neutrophil count (ANC) >= 1000/mm^3', ' Hemoglobin (Hgb) >= 10 mg/dl', ' Platelets >= 75,000/mm^3', ' Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min', ' Total bilirubin =< 2.5 mg/dl', ' Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN)', ' Patients must be >= 18 years old', 'Exclusion Criteria:', ' Patients with any of the following cardiac conditions:', ' Symptomatic restrictive cardiomyopathy;', ' Unstable angina within 4 months prior to enrollment;', ' New York Heart Association functional class III-IV heart failure on active treatment', ' Patients with any contraindication to receiving rhuGM-CSF based products', ' Patients with any clinically significant autoimmune disease uncontrolled with treatment', ' Patients with a history of brain metastases must have a stable head imaging study within 30 days of eligibility determination; specifically, patients with active brain metastases will not be eligible for study', ' Patients who are simultaneously enrolled in any other treatment study', ' Pregnant or breast-feeding women'], 'Results': ['Outcome Measurement: ', ' Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0', ' Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.', ' Time frame: Up to 4 months after first booster vaccine', 'Results 1: ', ' Arm/Group Title: Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)', ' Arm/Group Description: Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.', ' Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.', ' HER-2/neu peptide vaccine: Given ID', ' leukapheresis: Undergo leukapheresis', ' ex vivo-expanded HER2-specific T cells: Given IV', ' cyclophosphamide: Given IV', ' sargramostim: Given ID', ' laboratory biomarker analysis: Correlative study', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/23 (4.35%)', ' Unrelated Pulmonary Embolus 1/23 (4.35%)']}
|
{'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']}
|
57ef3c6c-b4e1-4302-b423-aa9faca21200
|
Single
|
Adverse Events
|
NCT00091442
|
There were more cases of Febrile neutropenia than eukopenia observed in the primary trial, but less cases of Febrile neutropenia than Neutropenia.
|
Entailment
|
[
0,
2,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT00091442', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel', ' Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.', 'INTERVENTION 2: ', ' DOXIL+Docetaxel', ' DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study', ' Participants who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease', ' Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction', 'Exclusion Criteria:', ' More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer', ' Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)', ' Less than 2 months since the last dose of trastuzumab', ' Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy', ' Radiation to areas of disease within 30 days before study enrollment', ' History of New York Heart Association Class II or greater cardiac disease or other clinical evidence of congestive heart failure'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.', ' Time frame: From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled', 'Results 1: ', ' Arm/Group Title: Docetaxel', ' Arm/Group Description: Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.', ' Overall Number of Participants Analyzed: 373', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.0 (5.9 to 7.7)', 'Results 2: ', ' Arm/Group Title: DOXIL+Docetaxel', ' Arm/Group Description: DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.', ' Overall Number of Participants Analyzed: 378', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.8 (8.1 to 10.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 59/373 (15.82%)', ' Neutropenia 14/373 (3.75%)', ' Febrile neutropenia 10/373 (2.68%)', ' Leukopenia 1/373 (0.27%)', ' Anaemia 2/373 (0.54%)', ' Lymphadenopathy 0/373 (0.00%)', ' cardiac failure 2/373 (0.54%)', ' Atrial fibrillation 1/373 (0.27%)', ' Pericardial effusion 2/373 (0.54%)', ' Cardiac failure congestive 1/373 (0.27%)', ' Cardiomyopathy 0/373 (0.00%)', 'Adverse Events 2:', ' Total: 69/377 (18.30%)', ' Neutropenia 17/377 (4.51%)', ' Febrile neutropenia 10/377 (2.65%)', ' Leukopenia 4/377 (1.06%)', ' Anaemia 2/377 (0.53%)', ' Lymphadenopathy 1/377 (0.27%)', ' cardiac failure 1/377 (0.27%)', ' Atrial fibrillation 1/377 (0.27%)', ' Pericardial effusion 0/377 (0.00%)', ' Cardiac failure congestive 0/377 (0.00%)', ' Cardiomyopathy 1/377 (0.27%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
29d5779b-c228-4b82-9ca8-075beadae879
|
|
Single
|
Intervention
|
NCT00591864
|
the primary trial patients receive Trametinib, Akt Inhibitor GSK2141795 PO QD on days 1-28, up to a maximum of 8 cycles.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00591864', 'Intervention': ['INTERVENTION 1: ', ' Study Participants', ' There are no arms or subgroups in this study.'], 'Eligibility': ['Inclusion Criteria:', ' This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.', ' Patients must not be lactating or pregnant.', ' All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.', ' women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).', 'Exclusion Criteria:', ' They are unable to understand and sign the consent form', ' They are pregnant or lactating', ' They are physically unable to sit upright and still for 40 minutes.', ' The breast MRI is for screening purposes or to determine the status of breast augmentation.', ' They have undergone breast surgery within the previous year'], 'Results': ['Outcome Measurement: ', ' Sensitivity on the Per Patient Level', ' Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.', ' Time frame: within 1 week of surgery or biopsy', 'Results 1: ', ' Arm/Group Title: Study Participants', ' Arm/Group Description: There are no arms or subgroups in this study.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants Sensitivity by MBI: 25', 'Sensitivity by MRI: 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/89 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4e124d90-68d7-40bd-a8b1-27cb49d64c64
|
|
Single
|
Intervention
|
NCT00291694
|
the route of administration for both interventions in the primary trial is a topical skin cream.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00291694', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Randomized to receive celecoxib daily for 12 months', 'INTERVENTION 2: ', ' Placebo', ' Randomized to receive placebo daily for 12 months'], 'Eligibility': ['Inclusion Criteria:', ' women who have a high risk of breast cancer', ' older than 18 years', 'Exclusion Criteria:', ' anticoagulants', ' marked breast tenderness', ' pregnant or within twelve months of breast feeding/childbirth'], 'Results': ['Outcome Measurement: ', ' Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67', ' Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.', ' Time frame: Baseline and 12 months', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Randomized to receive celecoxib daily for 12 months', ' Overall Number of Participants Analyzed: 43', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -1.2 (-18 to 14.8)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Randomized to receive placebo daily for 12 months', ' Overall Number of Participants Analyzed: 21', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -2.0 (-8.8 to 12.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/43 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0a9a7f5b-eb32-4a11-86e3-5a9a6377eea3
|
|
Single
|
Adverse Events
|
NCT01674062
|
One patient in the primary trial was observed suffering from Enteritis.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT01674062', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab (Cohorts 1 and 2)', ' Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.'], 'Eligibility': ['Inclusion Criteria:', ' Females greater than or equal to ( ) 18 years of age, with histologically-confirmed HER2-positive breast cancer', ' Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease', ' Less than or equal to ( ) 3 chemotherapy regimens prior to study entry', ' Last trastuzumab dose 9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and 4 weeks for participants receiving pertuzumab monotherapy', ' Left ventricular ejection fraction 55% at study entry', 'Exclusion Criteria:', ' Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab', ' Brain metastases', ' History of any cardiac adverse event related to trastuzumab therapy', ' Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix'], 'Results': ['Outcome Measurement: ', ' Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment', ' Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.', ' Time frame: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab (Cohorts 1 and 2)', ' Arm/Group Description: Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.2 (17.4 to 32.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/66 (18.18%)', ' Palpitations * 1/66 (1.52%)', ' Haematemesis * 1/66 (1.52%)', ' Performance status decreased * 1/66 (1.52%)', ' Hepatic failure * 1/66 (1.52%)', ' Cellulitis * 1/66 (1.52%)', ' Device related infection * 1/66 (1.52%)', ' Pneumonia * 1/66 (1.52%)', ' Pneumonia pneumococcal * 1/66 (1.52%)', ' Femur fracture * 0/66 (0.00%)', ' Hypokalaemia * 1/66 (1.52%)', ' Back pain * 2/66 (3.03%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f4c7dae5-012f-4f05-b5ba-da072fe1359c
|
|
Comparison
|
Intervention
|
NCT01067976
|
NCT00941330
|
Unlike the secondary trial, the primary trial does not provide a duration of cycles or any dosages in the intervention section.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'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%)']}
|
{'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%)']}
|
927bbb75-37da-4b75-9483-252d31a0fd98
|
Single
|
Adverse Events
|
NCT01610284
|
1 patient in the primary trial had a cardiac related adverse event.
|
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': 'NCT01610284', 'Intervention': ['INTERVENTION 1: ', ' BKM120 100mg + Fulvestrant', ' BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', 'INTERVENTION 2: ', ' Placebo + Fulvestrant', ' BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'], 'Eligibility': ['Key Inclusion Criteria:', ' Locally advanced or metastatic breast cancer', ' HER2-negative and hormone receptor-positive status (common breast cancer classification tests)', ' Postmenopausal woman', ' A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)', ' Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment', ' Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1', ' Adequate bone marrow and organ function defined by laboratory values', ' Key Exclusion Criteria:', ' Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant', ' More than one prior chemotherapy line for metastatic disease', ' Symptomatic brain metastases', ' Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent', ' Active heart (cardiac) disease as defined in the protocol', ' Certain scores on an anxiety and depression mood questionnaires'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort', ' Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.', ' 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 approximately 4 years', 'Results 1: ', ' Arm/Group Title: BKM120 100mg + Fulvestrant', ' Arm/Group Description: BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 576', ' Median (95% Confidence Interval)', ' Unit of Measure: Months FAS-Full population: 576 participants', ' 6.9 (6.8 to 7.8)', ' FAS-Main cohort: 427 participants', ' 6.8 (5.0 to 7.0)', ' FAS-PI3K pathway activated: 188 participants', ' 6.8 (4.9 to 7.1)', ' FAS-PI3K pathway non-activated: 239 participants', ' 6.9 (4.6 to 7.2)', ' FAS-PI3K pathway unknown: 149 participants', ' 8.7 (7.0 to 12.4)', 'Results 2: ', ' Arm/Group Title: Placebo + Fulvestrant', ' Arm/Group Description: BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 571', ' Median (95% Confidence Interval)', ' Unit of Measure: Months FAS-Full population: 571 participants', ' 5.0 (4.0 to 5.2)', ' FAS-Main cohort: 424 participants', ' 4.5 (3.3 to 5.0)', ' FAS-PI3K pathway activated: 184 participants', ' 4.0 (3.1 to 5.2)', ' FAS-PI3K pathway non-activated: 240 participants', ' 4.6 (3.3 to 5.1)', ' FAS-PI3K pathway unknown: 147 participants', ' 6.8 (5.0 to 8.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 146/573 (25.48%)', ' Anaemia 4/573 (0.70%)', ' Disseminated intravascular coagulation 0/573 (0.00%)', ' Neutropenia 1/573 (0.17%)', ' Thrombocytopenia 0/573 (0.00%)', ' Acute coronary syndrome 1/573 (0.17%)', ' Angina pectoris 1/573 (0.17%)', ' Atrial fibrillation 2/573 (0.35%)', ' Atrial flutter 0/573 (0.00%)', ' Cardiac arrest 1/573 (0.17%)', ' Cardiac failure 0/573 (0.00%)', 'Adverse Events 2:', ' Total: 101/570 (17.72%)', ' Anaemia 3/570 (0.53%)', ' Disseminated intravascular coagulation 1/570 (0.18%)', ' Neutropenia 1/570 (0.18%)', ' Thrombocytopenia 1/570 (0.18%)', ' Acute coronary syndrome 0/570 (0.00%)', ' Angina pectoris 1/570 (0.18%)', ' Atrial fibrillation 0/570 (0.00%)', ' Atrial flutter 1/570 (0.18%)', ' Cardiac arrest 0/570 (0.00%)', ' Cardiac failure 1/570 (0.18%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
80a5cdbc-0721-41b6-af1a-28e3f46557ce
|
|
Comparison
|
Adverse Events
|
NCT00217672
|
NCT00110084
|
the primary trial had three times the occurence rate of fistula enterovesical as the secondary trial.
|
Contradiction
|
[
0,
4
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT00110084', 'Intervention': ['INTERVENTION 1: ', ' Nab-paclitaxel/Gemcitabine', ' Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive breast cancer', ' - Clinical evidence of metastatic disease', ' + No bone metastases or other non-measurable disease as the only evidence of metastasis', ' Measurable disease, defined as at least 1 measurable lesion', ' - The following are considered non-measurable disease:', ' Small lesions (< 2 cm)', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural or pericardial effusions', ' Inflammatory breast disease', ' Lymphangitis cutis or pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' HER2(human epidermal growth factor receptor 2)-positive disease allowed provided patient has received prior treatment with trastuzumab', ' No evidence of active brain metastasis, including leptomeningeal involvement', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over Sex', ' Female Menopausal status', ' Not specified Performance status', ' ECOG 0-1 Life expectancy', ' At least 12 weeks Hematopoietic', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hemoglobin 9 g/dL Hepatic', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Bilirubin 1.5 times ULN Renal', ' Creatinine 1.5 mg/dL Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after completion of study treatment', ' No pre-existing peripheral neuropathy > grade 1', ' No other clinically significant illness or significant medical condition that would preclude study participation', ' No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs', ' No serious medical risk factors involving any of the major organ systems that would preclude study participation', ' No active stage III or IV invasive non-breast malignancy within the past 5 years', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' See Disease Characteristics Chemotherapy', ' No more than 1 prior adjuvant chemotherapy regimen', ' No prior chemotherapy for metastatic disease', ' At least 6 months since prior adjuvant or neoadjuvant taxane', ' More than 2 weeks since prior cytotoxic chemotherapy', ' Prior neoadjuvant chemotherapy allowed', ' No other concurrent chemotherapy Endocrine therapy', ' Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy', ' Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment', ' More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy', ' No concurrent radiotherapy Surgery', ' Not specified Other', ' More than 2 weeks since prior investigational drugs', ' No concurrent participation in another clinical trial that is studying investigational procedures or therapies', ' Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients With Confirmed Responses', ' Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.', ' Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.', ' Time frame: Two consecutive evaluations at least 6 weeks apart', 'Results 1: ', ' Arm/Group Title: Nab-paclitaxel/Gemcitabine', ' Arm/Group Description: Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants Confirmed response: 25', 'Assessable: 50'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/50 (22.00%)', ' Anemia 3/50 (6.00%)', ' Febrile neutropenia 1/50 (2.00%)', ' Arrythmia 1/50 (2.00%)', ' Ileus 1/50 (2.00%)', ' Nausea 1/50 (2.00%)', ' Pain-Abdominal 1/50 (2.00%)', ' Vomiting 1/50 (2.00%)', ' Bronchial infection 1/50 (2.00%)', ' Sepsis 1/50 (2.00%)', ' Neutropenia 2/50 (4.00%)', ' Platelet count decreased 1/50 (2.00%)', ' Dehydration 1/50 (2.00%)', ' Arthralgia 1/50 (2.00%)']}
|
af710d36-8062-4412-8d11-1c57a14b5e5a
|
Single
|
Adverse Events
|
NCT00717405
|
There were several patients who contracted Pneumonia in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00717405', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab + Trastuzumab', ' Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.'], 'Eligibility': ['Inclusion Criteria:', ' adult females, >=18 years of age;', ' inflammatory breast cancer;', ' HER2-positive tumors;', ' performance status 0-2.', 'Exclusion Criteria:', ' metastases;', ' previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;', ' clinically significant cardiovascular disease, or history of thrombotic disorders.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification', ' PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.', ' Time frame: From baseline through Week 25 (Up to 6 months)', 'Results 1: ', ' Arm/Group Title: Bevacizumab + Trastuzumab', ' Arm/Group Description: Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.46 (49.41 to 77.51)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/52 (38.46%)', ' Febrile bone marrow aplasia * 5/52 (9.62%)', ' Febrile neutropenia * 6/52 (11.54%)', ' Leukopenia * 6/52 (11.54%)', ' Atrial tachycardia * 1/52 (1.92%)', ' Vomiting * 1/52 (1.92%)', ' Tooth loss * 1/52 (1.92%)', ' Hyperthermia * 1/52 (1.92%)', ' Malaise * 1/52 (1.92%)', ' Pyrexia * 1/52 (1.92%)', ' Impaired healing * 3/52 (5.77%)', ' Inflammation * 1/52 (1.92%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c91c7dc1-17b7-4475-9aec-38999a18a306
|
|
Comparison
|
Adverse Events
|
NCT00243503
|
NCT00448279
|
the primary trial and the secondary trial observed a different number of adverse events in their patients.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5,
6
] |
{'Clinical Trial ID': 'NCT00243503', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Sunitinib', ' Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.', ' HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)', ' Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.', 'Exclusion Criteria:', ' Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted', ' Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.', ' Prior treatment on a SU11248 clinical trial.', ' Uncontrolled brain metastases.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Confirmed Objective Disease Response', ' Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.', ' Time frame: From start of treatment through 18 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Sunitinib', ' Arm/Group Description: Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.', ' Overall Number of Participants Analyzed: 57', ' Measure Type: Number', ' Unit of Measure: percentage of participants 36.8 (24.4 to 50.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 25/60 (41.67%)', ' Anaemia * 1/60 (1.67%)', ' Febrile neutropenia * 2/60 (3.33%)', ' Idiopathic thrombocytopenic purpura * 1/60 (1.67%)', ' Thrombocytopenia * 3/60 (5.00%)', ' Cardiac failure * 1/60 (1.67%)', ' Cardiac failure acute * 1/60 (1.67%)', ' Cardiogenic shock * 1/60 (1.67%)', ' Left ventricular dysfunction * 1/60 (1.67%)', ' Anal fistula * 1/60 (1.67%)']}
|
{'Clinical Trial ID': 'NCT00448279', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy Alone', " Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.", 'INTERVENTION 2: ', ' Chemotherapy + Trastuzumab', " Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death."], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' metastatic breast cancer;', ' HER2 overexpression (IHC 3+ and/or FISH positive);', ' disease progression during or after previous 1st line chemotherapy plus Herceptin;', ' scheduled to receive 2nd line chemotherapy.', 'Exclusion Criteria:', ' incompatibility with previous Herceptin therapy;', 'pregnancy.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) - Percentage of Participants With an Event', ' PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.', ' Time frame: Baseline (BL) and every 8 weeks thereafter', 'Results 1: ', ' Arm/Group Title: Chemotherapy Alone', " Arm/Group Description: Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.", ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.6', 'Results 2: ', ' Arm/Group Title: Chemotherapy + Trastuzumab', " Arm/Group Description: Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.", ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/26 (15.38%)', ' Febrile neutropenia * 1/26 (3.85%)', ' Gastric volvulus * 20/26 (0.00%)', ' General Malaise * 21/26 (3.85%)', ' Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)', ' Acute renal failure * 21/26 (3.85%)', 'Adverse Events 2:', ' Total: 1/28 (3.57%)', ' Febrile neutropenia * 0/28 (0.00%)', ' Gastric volvulus * 21/28 (3.57%)', ' General Malaise * 20/28 (0.00%)', ' Hospitalisation for intrapleuric chemotherapy and thoracentesis * 20/28 (0.00%)', ' Acute renal failure * 20/28 (0.00%)']}
|
5357ce66-7f7b-4ffd-926c-f6116f5a2e20
|
Single
|
Eligibility
|
NCT00399529
|
Women with chronic obstructive pulmonary disease that do not require systemic corticosteroids, are eligible for the primary trial.
|
Entailment
|
[
8
] |
[] |
{'Clinical Trial ID': 'NCT00399529', 'Intervention': ['INTERVENTION 1: ', ' Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide', ' Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.', ' Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study', ' Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically confirmed HER-2/neu-overexpressing adenocarcinoma of the breast; this is defined as HER-2+ by immunohistochemistry (IHC) 3+ staining or Fluorescence In-Situ Hybridization (FISH). Prior adjuvant Trastuzumab therapy is permitted. Patients must not be eligible for therapy of known curative potential for metastatic breast cancer if it is identified during the course of the study.', ' Patients may have measurable or evaluable disease.', ' Stable central nervous system (CNS) disease that has been adequately treated and is not under active treatment allowed.', ' Age 18 years or older.', ' Able to give informed consent.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.', ' No systemic oral steroids administered within 28 days prior to initiating treatment on protocol. Topical, ocular, and nasal steroids are allowed, as are those applied to mucus membranes.', " No prior or currently active autoimmune disease requiring management with systemic immunosuppression. This includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.", ' Not pregnant, and on appropriate birth control if of child-bearing potential.', ' No history of other malignancies within the prior five years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, and superficial bladder cancer).', ' Adequate bone marrow reserve with absolute neutrophil count (ANC) > 1000 and platelets > 100,000.', ' Adequate renal function with serum creatinine < 2.0.', " Adequate hepatic reserve with serum bilirubin < 2.0, aspartate transaminase (AST) and alanine aminotransferase (ALT) < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome.", ' Adequate cardiac reserve with a cardiac ejection fraction within the lower limit of facility normal by MUGA, or 45% by echocardiogram.', ' No active major medical or psychosocial problems that could be complicated by study participation.', ' HIV negative.', 'Exclusion Criteria:', ' No histologic documentation of breast adenocarcinoma.', ' Breast adenocarcinoma that is not amplified for HER-2/neu gene expression by at least 2-fold by FISH analysis, or that is less than IHC 3+ when FISH negative.', ' Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram.', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest.', ' History of autoimmune disease as detailed above.', ' Systemic oral corticosteroid treatment within 28 days prior to initiating treatment on study.', ' Uncontrolled medical problems.', ' Evidence of active acute or chronic infection.', ' Chemotherapy, radiation therapy, or biologic therapy (except Trastuzumab) within 28 days prior to initiating treatment on study. Hormonal therapy and supportive therapy with bisphosphonates will be allowed.', ' Participation in an investigational new drug trial within 28 days prior to initiating treatment on study.', ' Pregnant or breast feeding.', ' Hepatic, renal, or bone marrow dysfunction as detailed above.', ' Concurrent malignancy or history of other malignancy within the last five years except as noted above.', ' Corn allergy.', ' Known severe hypersensitivity to Trastuzumab (excluding mild to moderate infusion reactions that are easily managed and do not recur).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Safety is measured as the number of patients that experienced adverse events related to study drug.', ' Time frame: From first dose through 30 days after last dose of study drug, up to 9 months', 'Results 1: ', ' Arm/Group Title: Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide', ' Arm/Group Description: Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.', ' Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study', ' Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Fatigue: 8 40.0%', ' Urticaria: 7 35.0%', ' Pruritus: 6 30.0%', ' Fever: 5 25.0%', ' Flu-like symptoms: 4 20.0%', ' Lymphadenopathy: 4 20.0%', ' Abdominal pain: 3 15.0%', ' Rash: 3 15.0%', ' Malaise: 3 15.0%', ' Chills: 3 15.0%', ' Dizziness: 2 10.0%', ' Anorexia: 1 5.0%', ' Erythema: 1 5.0%', ' Headache: 1 5.0%', ' Nausea: 1 5.0%', ' Arm pain: 1 5.0%', ' Cancer site pain: 1 5.0%', ' Leg pain: 1 5.0%', ' Groin tightness: 1 5.0%', ' Erythema at vaccine sites: 20 100.0%', ' Pruritus at vaccine sites: 20 100.0%', ' Induration at vaccine sites: 20 100.0%', ' Pain at vaccine sties: 17 85.0%', ' Rash at vaccine sites: 7 35.0%', ' Blister at vaccine sites: 5 25.0%', ' Hyperpigmentation at vaccine sites: 4 20.0%', ' Bruising at vaccine sites: 3 15.0%', ' Edema at vaccine sites: 2 10.0%', 'Vaccine site flare: 2 10.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/20 (5.00%)', ' Urticaria *1/20 (5.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3c7ecca8-5397-41f5-b72b-84217bf3acd2
|
|
Comparison
|
Adverse Events
|
NCT00615901
|
NCT00829166
|
the primary trial recorded more seizures than the secondary trial, despite having less than one tenth the number of patients in its total cohort.
|
Entailment
|
[
0,
5
] |
[
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': 'NCT00615901', 'Intervention': ['INTERVENTION 1: ', ' Cohort A (CMF at 14 Day Intervals)', ' This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.', ' cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSKCC within 3 months of enrollment. Patients with inflammatory breast cancer are not eligible for the study. Pathology will be assessed in the standard fashion. Results of HER-2/neu, estrogen receptor, and progesterone receptor are required for study entry.', ' The patient cannot be Her-2/neu over-expressing either by immunohistochemistry or FISH as per hospital laboratory standard whether institutional or outside laboratory.', ' Patients must be > than or equal to 18 years of age', ' Patients must have a Karnofsky score of > than or equal to 80', ' Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue at least 24 hours prior to enrollment and while participating in this trial.', ' Patients will have completed their definitive breast surgery (mastectomy or breast conserving surgery)', ' Patients must be ready to begin therapy within 84 days from the final surgical procedure required to treat their primary tumor', ' Patients must be stage I-II', ' Absolute neutrophil count (ANC) > than or equal to 1500/µL and platelet count > than or equal to 100,000/µL', ' Total bilirubin must be < than or equal to 1.1 mg/dL or within normal institutional limits if outside MSKCC. Transaminases (SGOT/AST and/or SGPT/ALT) may be up to < than or equal to 92.5 U/L or < than or equal to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.', ' Serum creatinine must be within 0.6-1.3 mg/dL or within normal institutional limits if outside MSKCC.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Patients must give written, informed consent indicating their understanding and willingness to participate in the study.', ' Brachytherapy after lumpectomy is permitted.', 'Exclusion Criteria:', ' Stage III-IV breast cancer', ' Prior chemotherapy or radiation therapy is excluded except for brachytherapy.Radiation for patients on this protocol will be given, if indicated, after the completion of chemotherapy.', ' Pregnant or lactating patients', ' Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least five years.', ' Patients with unstable angina, congestive heart failure, current use of digitalis, betablockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or with a history of a myocardial infarction within 12 months.', ' Patients with a psychiatric illness that would prevent them from understanding the nature of the investigational therapy and complying with protocol requirements.', ' Patients with concurrent medical conditions, which, in the judgment of the investigator, would make them inappropriate candidates for study enrollment', ' Patients with active, unresolved infections', ' Patients that have known sensitivity to E. coli derived proteins, PEG-filgrastim, filgrastim, or any component products.', ' Patients must be Her 2/neu non-over-expressing.'], 'Results': ['Outcome Measurement: ', ' The Number of Patients Who Completed 8 Cycles.', ' the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A (CMF at 14 Day Intervals)', ' Arm/Group Description: This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.', ' cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: participants 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/38 (5.26%)', ' Febrile neutropenia 0/38 (0.00%)', ' Abdominal pain 1/38 (2.63%)', ' Skin infection 0/38 (0.00%)', ' Seizure 1/38 (2.63%)']}
|
{'Clinical Trial ID': 'NCT00829166', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.', 'INTERVENTION 2: ', ' Lapatinib + Capecitabine', ' Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'], 'Eligibility': ['Inclusion Criteria:', ' HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results', ' Histologically or cytologically confirmed invasive breast cancer', ' Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent', ' Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator', ' Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded', ' Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment', 'Exclusion Criteria:', ' History of treatment with trastuzumab emtansine', ' Prior treatment with lapatinib or capecitabine', ' Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of radiation therapy within 14 days of randomization', ' Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization', ' History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction or unstable angina within 6 months of randomization', ' Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnancy or lactation', ' Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis', ' History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab', ' Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency', ' Current treatment with sorivudine or its chemically related analogs, such as brivudine'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)', ' PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.', ' Time frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 495', ' Measure Type: Number', ' Unit of Measure: percentage of participants 53.5', 'Results 2: ', ' Arm/Group Title: Lapatinib + Capecitabine', ' Arm/Group Description: Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.', ' Overall Number of Participants Analyzed: 496', ' Measure Type: Number', ' Unit of Measure: percentage of participants 61.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 92/490 (18.78%)', ' Anaemia * 1/490 (0.20%)', ' Anaemia of malignant disease * 0/490 (0.00%)', ' Febrile neutropenia * 0/490 (0.00%)', ' Neutropenia * 0/490 (0.00%)', ' Thrombocytopenia * 4/490 (0.82%)', ' Angina pectoris * 0/490 (0.00%)', ' Atrial fibrillation * 1/490 (0.20%)', ' Cardiomyopathy * 1/490 (0.20%)', ' Coronary artery disease * 0/490 (0.00%)', ' Pericardial effusion * 0/490 (0.00%)', 'Adverse Events 2:', ' Total: 99/488 (20.29%)', ' Anaemia * 1/488 (0.20%)', ' Anaemia of malignant disease * 1/488 (0.20%)', ' Febrile neutropenia * 2/488 (0.41%)', ' Neutropenia * 1/488 (0.20%)', ' Thrombocytopenia * 1/488 (0.20%)', ' Angina pectoris * 1/488 (0.20%)', ' Atrial fibrillation * 0/488 (0.00%)', ' Cardiomyopathy * 0/488 (0.00%)', ' Coronary artery disease * 1/488 (0.20%)', ' Pericardial effusion * 2/488 (0.41%)']}
|
2c53e14a-719c-4994-9090-73f9bddb60ba
|
Single
|
Results
|
NCT00089999
|
In total more participants in the primary trial had no tumor Response, than partial response, and only 3 patients had a complete response.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00089999', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib 1500 mg QD', ' Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.', 'INTERVENTION 2: ', ' Lapatinib 500 mg BID', ' Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.', ' Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)', ' Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)', ' Adequate renal, hepatic and cardiac function', 'Exclusion criteria:', ' Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.', ' Patients with active brain metastases', ' Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)', ' OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.', ' Time frame: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)', 'Results 1: ', ' Arm/Group Title: Lapatinib 1500 mg QD', ' Arm/Group Description: Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: Participants CR: 0', 'PR: 15', 'Results 2: ', ' Arm/Group Title: Lapatinib 500 mg BID', ' Arm/Group Description: Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: Participants CR: 0', 'PR: 18'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/69 (21.74%)', ' Anaemia 0/69 (0.00%)', ' Febrile neutropenia 1/69 (1.45%)', ' Thrombocytopenia 0/69 (0.00%)', ' Left ventricular dysfunction 0/69 (0.00%)', ' Pericardial effusion 1/69 (1.45%)', ' Diarrhoea 1/69 (1.45%)', ' Constipation 0/69 (0.00%)', ' Gastritis 1/69 (1.45%)', ' Oesophagitis 1/69 (1.45%)', ' Vomiting 1/69 (1.45%)', ' Asthenia 0/69 (0.00%)', ' Pyrexia 0/69 (0.00%)', 'Adverse Events 2:', ' Total: 18/69 (26.09%)', ' Anaemia 1/69 (1.45%)', ' Febrile neutropenia 0/69 (0.00%)', ' Thrombocytopenia 1/69 (1.45%)', ' Left ventricular dysfunction 1/69 (1.45%)', ' Pericardial effusion 0/69 (0.00%)', ' Diarrhoea 1/69 (1.45%)', ' Constipation 1/69 (1.45%)', ' Gastritis 0/69 (0.00%)', ' Oesophagitis 0/69 (0.00%)', ' Vomiting 0/69 (0.00%)', ' Asthenia 2/69 (2.90%)', ' Pyrexia 1/69 (1.45%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7c1b03bc-d299-4ee8-b9ee-3d253f3fc33a
|
|
Comparison
|
Intervention
|
NCT00820222
|
NCT01819233
|
the secondary trial and the primary trial interventions both require subjects to follow caloric restricted diets or gluten free diets, while completing food diaries.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT00820222', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib Plus Capecitabine', ' Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.', 'INTERVENTION 2: ', ' Trastuzumab Plus Capecitabine', ' Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Females at least 18 years old;', ' ECOG Performance Status 0-2;', ' Histologically or cytologically confirmed HER2-positive invasive breast cancer, with Stage IV disease;', ' Prior treatment with taxanes or anthracyclines is required;', ' Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and radiation therapy is permitted;', ' Baseline LVEF 50% and not lower than the institutional lower limit of normal;', ' Concurrent treatment with bisphosphonates is permitted, however treatment must be initiated prior to the first dose of study therapy;', ' Able to swallow and retain oral medications;', ' Women with potential to have children must be willing to practice acceptable methods of birth control during the study;', ' Normal organ and marrow function.', 'Exclusion Criteria:', ' History and/or current evidence of CNS metastases. Baseline MRI scan by Independent Reviewer to confirm no brain mets;', ' Concurrent treatment with an investigational agent or participation in another treatment clinical trial;', ' Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab (including but not limited to trastuzumab-DM1 and neratinib) and capecitabine;', ' Known DPD deficiency;', ' Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for treatment of cancer;', ' History of allergic reactions attributed to compounds chemically related to lapatinib (quinazolines), capecitabine, fluorouracil or any excipients;', ' Concomitant use of CYP3A4 inhibitors or inducers;', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel;', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast and other known contraindication to MRI;', " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the patient's safety or compliance to study procedures;", " have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease);", ' Any on-going toxicity from prior anti cancer therapy except alopecia;', ' Active cardiac disease;', ' Uncontrolled infection;', ' History of other malignancy, unless curatively treated with no evidence of disease for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are eligible;', ' Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of protocol treatment;', ' Pregnant or lactating females.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse', ' CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.', ' Time frame: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012', 'Results 1: ', ' Arm/Group Title: Lapatinib Plus Capecitabine', ' Arm/Group Description: Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 251', ' Measure Type: Number', ' Unit of Measure: participants 8', 'Results 2: ', ' Arm/Group Title: Trastuzumab Plus Capecitabine', ' Arm/Group Description: Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 250', ' Measure Type: Number', ' Unit of Measure: participants 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/270 (15.19%)', ' Anaemia 1/270 (0.37%)', ' Leukopenia 0/270 (0.00%)', ' Neutropenia 2/270 (0.74%)', ' Pancytopenia 0/270 (0.00%)', ' Thrombocytopenia 1/270 (0.37%)', ' Left ventricular dysfunction 0/270 (0.00%)', ' Abdominal pain 1/270 (0.37%)', ' Abdominal pain upper 1/270 (0.37%)', ' Colitis 0/270 (0.00%)', ' Constipation 2/270 (0.74%)', ' Diarrhoea 4/270 (1.48%)', ' Dyspepsia 1/270 (0.37%)', 'Adverse Events 2:', ' Total: 51/267 (19.10%)', ' Anaemia 1/267 (0.37%)', ' Leukopenia 1/267 (0.37%)', ' Neutropenia 6/267 (2.25%)', ' Pancytopenia 1/267 (0.37%)', ' Thrombocytopenia 0/267 (0.00%)', ' Left ventricular dysfunction 2/267 (0.75%)', ' Abdominal pain 1/267 (0.37%)', ' Abdominal pain upper 0/267 (0.00%)', ' Colitis 1/267 (0.37%)', ' Constipation 0/267 (0.00%)', ' Diarrhoea 10/267 (3.75%)', ' Dyspepsia 0/267 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01819233', 'Intervention': ['INTERVENTION 1: ', ' Behavioral Dietary Intervention', ' Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', ' Behavioral dietary intervention: Receive caloric restricted dietary intervention', ' Therapeutic conventional surgery: Undergo definitive lumpectomy', ' Radiation therapy: Undergo radiation therapy', ' Counseling intervention: Receive dietary counseling', ' Quality-of-life assessment: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer', ' Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes', ' The patient must be female', ' Age >= 18', ' If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision', ' Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:', ' History/physical examination, including breast exam and documentation of weight and Karnofsky performance status of 80-100% for at least 60 days prior to study entry', ' Ipsilateral mammogram within 6 months prior to study entry', ' Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry', ' Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy', ' Patient must capable of and provide study specific informed consent prior to study entry', ' Body mass index (BMI) >= 21', ' Weight >= 100 lbs', ' No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix', ' Patient must not have any of the following severe, active co-morbidity, defined as follows:', ' Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months', ' Transmural myocardial infarction within the last 6 months', ' Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration', ' Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration', ' Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol', ' Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism', ' Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash', ' No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields', ' Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator', ' Inflammatory bowel disease', ' Celiac disease', ' Chronic pancreatitis', ' Chronic diarrhea or vomiting', ' Active eating disorder', ' Creatinine < 1.7', ' Not currently taking steroids', ' No currently active pituitary secreting tumors up to physician discretion', ' No history of or current active drug/alcohol dependence', ' No patients being decisionally impaired', 'Exclusion Criteria:', ' Patient is not a candidate for breast conservation', ' Patient is male', ' Age < 18 years', ' Patient requires regional lymph node irradiation therapy', ' Patient has evidence of distant metastases', ' Karnofsky performance status less than 80% within 60 days prior to study', ' Ipsilateral mammogram done greater than 6 months prior to study', ' Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)', ' Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines', ' BMI < 21', ' Weight < 100 lbs', ' Weight loss >= 10% in the last 3 months (mos)', ' Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration', ' Two or more breast cancers not resectable through a single lumpectomy incision', ' Non-epithelial breast malignancies such as sarcoma or lymphoma', ' Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields', ' Severe, active co-morbidity, defined as follows:', ' Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months', ' Transmural myocardial infarction within the last 6 months', ' Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration', ' Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration', ' Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol', ' Acquired immune deficiency syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism', ' Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash', ' Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator', ' Inflammatory bowel disease', ' Celiac disease', ' Chronic pancreatitis', ' Chronic diarrhea or vomiting', ' Active eating disorder', ' Creatinine >= 1.7', ' Current use of steroids', ' Pituitary secreting tumors up to physician discretion', ' Active drug/alcohol dependence or abuse history', ' Decisionally impaired patients'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Are Adherent to the Diet Restriction', ' Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.', ' Time frame: Up to week 12', 'Results 1: ', ' Arm/Group Title: Behavioral Dietary Intervention', ' Arm/Group Description: Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', ' Behavioral dietary intervention: Receive caloric restricted dietary intervention', ' Therapeutic conventional surgery: Undergo definitive lumpectomy', ' Radiation therapy: Undergo radiation therapy', ' Counseling intervention: Receive dietary counseling', ' Quality-of-life assessment: Ancillary studies', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants 28 [1] (NA to 74.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/38 (0.00%)']}
|
bfb617c8-51ae-4ab2-be05-6346daad5437
|
Single
|
Eligibility
|
NCT00404066
|
Abnormal LVEF, Pregnancy or lactating automatically eliminates patients from participating in the primary trial, unless treated with herbal medicines.
|
Contradiction
|
[
17,
22,
28,
29
] |
[] |
{'Clinical Trial ID': 'NCT00404066', 'Intervention': ['INTERVENTION 1: ', ' Neoadjuvant Chemotherapy', ' Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.'], 'Eligibility': ['INCLUSION CRITERIA', ' Female', ' Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+', ' Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes).', ' At least one bi-dimensional, measurable indicator lesion.', ' Between 18 and 70 years of age', ' Eastern Cooperative Oncology Group (ECOG) performance status 2 / Karnofsky 60% at screening and on the first day of treatment.', ' Informed consent must be obtained prior to registration.', ' Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan.', ' Absolute neutrophil count > 1,500/mm³', ' Hemoglobin > 8.0 g/dL', ' Platelet count > 100,000/mm³', ' Creatinine within normal institutional limits', ' Total Bilirubin equal to or less than institutional upper limit of normal (ULN)', ' Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.', ' Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator', ' Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.', ' All herbal (alternative) medicines are prohibited.', ' Medications prohibited during the administration of lapatinib .', ' Women of child-bearing potential must have negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.', ' Peripheral neuropathy: must be < grade 1', ' Able to swallow and retain oral medication', ' EXCLUSION CRITERIA', ' Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.', ' Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.', ' More than 3 months between histologic diagnosis and registration on this study.', ' History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.', ' Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up.', ' Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year.', ' Pregnant or lactating', ' Of childbearing potential and not employing adequate contraception', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.', ' HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.', " GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).", ' History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80.', ' Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment ).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathologic Complete Response (pCR)', ' Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Neoadjuvant Chemotherapy', ' Arm/Group Description: Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 38.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/21 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
dcc5c3b0-848b-4ef4-afe6-e9c9933e33af
|
|
Comparison
|
Adverse Events
|
NCT00455533
|
NCT00767520
|
Throughout both the secondary trial and the primary trial there was only one case of pregnancy, in 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,
20,
21,
22,
23
] |
[
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': 'NCT00455533', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', 'INTERVENTION 2: ', ' Paclitaxel', ' paclitaxel 80 mg/m^2 administered IV every week for 12 weeks'], 'Eligibility': ['Inclusion criteria', ' Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of 2 cm', ' All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status', ' No prior treatment for breast cancer excluding therapy for DCIS', ' Karnofsky performance status of 80 - 100', ' left ventricular ejection fraction (LVEF) 50% by echocardiogram or multiple gated acquisition (MUGA)', ' Adequate hematologic, hepatic and renal function', ' Exclusion Criteria', ' women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug', ' Women who are pregnant or breastfeeding', ' Inflammatory or metastatic breast cancer', ' Unfit for breast and/or axillary surgery', ' Evidence of baseline sensory or motor neuropathy', ' Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection', ' History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Pathologic Complete Response (pCR)', ' The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.', ' Time frame: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', ' Overall Number of Participants Analyzed: 148', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 24.3 (18.6 to 30.8)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: paclitaxel 80 mg/m^2 administered IV every week for 12 weeks', ' Overall Number of Participants Analyzed: 147', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 25.2 (19.4 to 31.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/145 (11.72%)', ' ANAEMIA 0/145 (0.00%)', ' LEUKOPENIA 2/145 (1.38%)', ' NEUTROPENIA 1/145 (0.69%)', ' LEUKOCYTOSIS 1/145 (0.69%)', ' THROMBOCYTOPENIA 1/145 (0.69%)', ' FEBRILE NEUTROPENIA 1/145 (0.69%)', ' THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)', ' CARDIAC FAILURE 1/145 (0.69%)', ' ATRIAL FIBRILLATION 1/145 (0.69%)', 'Adverse Events 2:', ' Total: 11/144 (7.64%)', ' ANAEMIA 1/144 (0.69%)', ' LEUKOPENIA 0/144 (0.00%)', ' NEUTROPENIA 0/144 (0.00%)', ' LEUKOCYTOSIS 0/144 (0.00%)', ' THROMBOCYTOPENIA 0/144 (0.00%)', ' FEBRILE NEUTROPENIA 1/144 (0.69%)', ' THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)', ' CARDIAC FAILURE 0/144 (0.00%)', ' ATRIAL FIBRILLATION 0/144 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00767520', 'Intervention': ['INTERVENTION 1: ', ' Exemestane + Dasatinib', ' Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Exemestane + Placebo', ' Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis', ' Prior therapy with a non-steroidal aromatase inhibitor', ' Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)', ' Documented breast cancer with tumor 28 days prior to study entry', ' Women who are NOT of childbearing potential', ' Must be able to take oral medication', ' Performance Status 0 or 1', 'Exclusion Criteria:', ' Pleural or pericardial effusion or ascites (of any etiology; Grade 1) within 6 months prior to study entry', ' Any chemotherapy, immunotherapy < 6 months before study entry. Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI', ' Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry', ' Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer', ' Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years', ' Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding', ' Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval > 450 msec at baseline (Fridericia correction)', ' Hematologic abnormality Grade 2', ' Hypocalcemia of Grade 1', " Any Chemistry abnormality of Grade 2 [except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease]", ' Pregnant Women and Women of Childbearing Potential (WOCBP)', ' Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)', ' Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)', ' Potent inhibitors of CYP3A4 isoenzyme', ' Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo', ' PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase ( 20%) in sum of longest diameters from smallest value during study (including baseline).', ' Time frame: Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)', 'Results 1: ', ' Arm/Group Title: Exemestane + Dasatinib', ' Arm/Group Description: Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 79', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 18.1 (15.1 to 24.3)', 'Results 2: ', ' Arm/Group Title: Exemestane + Placebo', ' Arm/Group Description: Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 78', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 16.1 (12.1 to 18.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/79 (27.85%)', ' Anaemia 0/79 (0.00%)', ' Right ventricular dysfunction 1/79 (1.27%)', ' Diarrhoea 1/79 (1.27%)', ' Vomiting 2/79 (2.53%)', ' Abdominal pain 0/79 (0.00%)', ' Colonic obstruction 0/79 (0.00%)', ' Dysphagia 1/79 (1.27%)', ' Nausea 1/79 (1.27%)', ' Mucosal inflammation 1/79 (1.27%)', ' Performance status decreased 1/79 (1.27%)', ' Sudden death 1/79 (1.27%)', 'Adverse Events 2:', ' Total: 13/76 (17.11%)', ' Anaemia 1/76 (1.32%)', ' Right ventricular dysfunction 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Vomiting 2/76 (2.63%)', ' Abdominal pain 1/76 (1.32%)', ' Colonic obstruction 1/76 (1.32%)', ' Dysphagia 0/76 (0.00%)', ' Nausea 1/76 (1.32%)', ' Mucosal inflammation 0/76 (0.00%)', ' Performance status decreased 0/76 (0.00%)', ' Sudden death 0/76 (0.00%)']}
|
18fcd396-cb03-4e80-bb2d-ee03c12ba32a
|
Single
|
Results
|
NCT00038103
|
There is no significant difference in the proportions of Subjects With Clinical Benefit in the Exemestane + Celecoxib cohort and in the Exemestane alone cohort of the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
694c5820-ebb6-4271-8685-a0b51c637f7f
|
|
Single
|
Results
|
NCT00662025
|
on assessment 0 the primary trial Participants had a confirmed disappearance of all target and non-target lesions.
|
Contradiction
|
[
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': ''}
|
b87abb47-13b6-4dbe-9cfd-e63075b676aa
|
|
Single
|
Eligibility
|
NCT00754845
|
Patients who received over 5 years of anastrozole therapy, completed under a year ago, are eligible for the primary trial.
|
Contradiction
|
[
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00754845', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' letrozole: Given orally', 'INTERVENTION 2: ', ' Placebo', ' Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' placebo: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Previously diagnosed with primary breast cancer', ' Must have received 4½ - 6 years of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane), either as initial therapy or after prior tamoxifen citrate, including treatment received as part of clinical trial CAN-NCIC-MA17', ' Completed aromatase inhibitor therapy 2 years ago', ' No metastatic or recurrent disease, contralateral breast cancer, or ductal carcinoma in situ in either breast, as determined by the following:', ' Clinical examination of the breast area, axillae, and neck within the past 60 days', ' Mammogram within the past 12 months*', ' Chest x-ray within the past 60 days', ' Bone scan, if alkaline phosphatase > 2 times normal and/or there are symptoms of metastatic disease AND confirmatory x-ray, if bone scan results are questionable, within the past 60 days', ' Abdominal ultrasound, liver scan, or CT scan of the abdomen within the past 60 days, if ALT, AST, or alkaline phosphatase > 2 times normal NOTE: *A baseline mammogram is not required for patients who have undergone bilateral complete mastectomy', ' Hormone-receptor status:', ' Estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) primary tumor at the time of diagnosis, defined as a tumor receptor content of > 10 fmol/mg protein or receptor positive by immunocytochemical assay (for patients not previously enrolled on clinical trial CAN-NCIC-MA17)', ' ER+ and/or PR+ primary tumor OR hormone receptor status of primary tumor unknown (for patients previously enrolled on clinical trial CAN-NCIC-MA17)', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Life expectancy 5 years', ' WBC > 3.0 x 10^9/L OR granulocyte count (polymorphs + bands) 1.5 times 10^9/L', ' Platelet count > 100 x 10^9/L', ' AST and/or ALT < 2 times upper limit of normal (ULN)*', ' Alkaline phosphatase < 2 times ULN*', ' Able (i.e. sufficiently fluent) and willing to complete quality-of-life questionnaires in either English or French (NCIC CTG participating centers)', ' Inability to complete questionnaires due to illiteracy in English or French, loss of sight, or other equivalent reason allowed', ' Accessible for treatment and follow-up', ' No other prior or concurrent malignancy except adequately treated, superficial squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or other cancer treated > 5 years ago that is presumed cured NOTE: *Elevated levels allowed provided imaging examinations have ruled out metastatic disease', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No concurrent selective estrogen receptor modulator (e.g., raloxifene, idoxifene)', ' No other concurrent anticancer therapy'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS)', ' It is defined as the months from the day of randomization to the earliest date when a recurrence of the primary disease (recurrence in the breast, chest wall and nodal sites or the development of metastatic disease) or a contralateral breast cancer was observed. Subjects who died without recurrence of the primary disease or the development of the contralateral breast cancer were censored at their death date. If a patient has not recurred, developed a contralateral breast cancer, or died, disease-free survival was censored on the date of the last day the patient was known to be alive. Probability of disease free survival at 5 years is estimated and reported.', ' Time frame: Unitil the end of study with a median follow up of 75 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' letrozole: Given orally', ' Overall Number of Participants Analyzed: 959', ' Measure Type: Number', ' Unit of Measure: probability of DFS at 5 years 0.95 (0.93 to 0.96)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' placebo: Given orally', ' Overall Number of Participants Analyzed: 959', ' Measure Type: Number', ' Unit of Measure: probability of DFS at 5 years 0.91 (0.89 to 0.93)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/959 (1.56%)', ' CNS hemorrhage/bleeding 20/959 (0.00%)', ' Melena/GI bleeding 21/959 (0.10%)', ' Rectal bleeding/ hematochezia 21/959 (0.10%)', ' Cardiac troponin I (cTnI) 0/959 (0.00%)', ' Thrombosis/embolism 20/959 (0.00%)', ' Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia) 21/959 (0.10%)', ' Edema 21/959 (0.10%)', ' Cardiac left ventricular function 21/959 (0.10%)', 'Adverse Events 2:', ' Total: 19/954 (1.99%)', ' CNS hemorrhage/bleeding 21/954 (0.10%)', ' Melena/GI bleeding 20/954 (0.00%)', ' Rectal bleeding/ hematochezia 20/954 (0.00%)', ' Cardiac troponin I (cTnI) 1/954 (0.10%)', ' Thrombosis/embolism 21/954 (0.10%)', ' Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia) 21/954 (0.10%)', ' Edema 20/954 (0.00%)', ' Cardiac left ventricular function 21/954 (0.10%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
eb025223-1b4a-4df7-a85e-2eeeb62a6bf5
|
|
Single
|
Adverse Events
|
NCT02149524
|
None of the adverse events which occurred in the primary trial were not GI related.
|
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': 'NCT02149524', 'Intervention': ['INTERVENTION 1: ', ' Herceptin (Trastuzumab)', ' Intravenous administration', ' Herceptin (trastuzuamb): Intravenous administration', 'INTERVENTION 2: ', ' SB3 (Proposed Trastuzumab Biosimilar)', ' Intravenous administration', ' SB3 (proposed trastuzumab biosimilar): Intravenous administration'], 'Eligibility': ['Inclusion Criteria:', ' Female aged 18-65 years', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer with:', ' tumour size 2 cm', ' histologically confirmed primary invasive carcinoma of the breast', ' HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+', ' Known hormone receptor (oestrogen receptor and progesterone receptor) status', ' Baseline left ventricular ejection fraction (LVEF) 55% measured by echocardiography or multiple gated acquisition (MUGA) scan', ' Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures', 'Exclusion Criteria:', ' Metastatic (stage IV) or bilateral or multifocal/multicentric breast cancer', ' History of any prior invasive breast carcinoma, except for subjects with a past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) treated with surgery only', ' Past or current history of malignant neoplasms within 5 years prior to Randomisation, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin (malignant neoplasms occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)', ' Previous history of radiation therapy, immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy) Major surgery within 4 weeks prior to Randomisation and minor surgery within 2 weeks prior to Randomisation (major surgery is defined as surgery which requires general anaesthesia)', ' Serious cardiac illness that would preclude the use of trastuzumab such as:', ' history of documented congestive heart failure (CHF) (New York Heart Association, NYHA, class II or greater heart disease)', ' LVEF < 55% by echocardiography or MUGA scan', ' angina pectoris requiring anti-anginal medication', ' evidence of transmural infarction on electrocardiogram (ECG)', ' uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg)', ' clinically significant valvular heart disease', ' high risk uncontrolled arrhythmias', ' Serious pulmonary illness enough to cause dyspnoea at rest or requiring supplementary oxygen therapy', ' Known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection', ' Other concurrent serious illnesses that may interfere with planned therapy including severe cardiovascular, pulmonary, metabolic or infectious conditions', ' Known hypersensitivity to the investigational product (IPs), non-IPs or any of the ingredients or excipients of the IPs or non-IPs', ' Known hypersensitivity to murine proteins', ' Known history of dihydropyrimidine dehydrogenase (DPD) deficiency', ' Pre-existing peripheral sensory or motor neuropathy grade 2, defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0', ' Pregnant or lactating women. A pregnancy test result is required for all women of childbearing potential including women who had menopause onset within 2 years prior to Randomisation. Women of childbearing potential must agree to use contraceptive methods (see section 7.4.2) during the study and 6 months after the last dose of IP', ' Concurrent hormonal therapy including birth control pills, ovarian hormone replacement for menopause, selective oestrogen receptor modulator (SERM) either for osteoporosis or breast cancer prevention', ' Subjects unwilling to follow the study requirements'], 'Results': ['Outcome Measurement: ', ' The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour', ' [Not Specified]', ' Time frame: Week 24', 'Results 1: ', ' Arm/Group Title: Herceptin (Trastuzumab)', ' Arm/Group Description: Intravenous administration', ' Herceptin (trastuzuamb): Intravenous administration', ' Overall Number of Participants Analyzed: 398', ' Measure Type: Number', ' Unit of Measure: percentage of responders 42.0', 'Results 2: ', ' Arm/Group Title: SB3 (Proposed Trastuzumab Biosimilar)', ' Arm/Group Description: Intravenous administration', ' SB3 (proposed trastuzumab biosimilar): Intravenous administration', ' Overall Number of Participants Analyzed: 402', ' Measure Type: Number', ' Unit of Measure: percentage of responders 51.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 58/438 (13.24%)', ' Febrile neutropenia 13/438 (2.97%)', ' Neutropenia 5/438 (1.14%)', ' Anaemia 0/438 (0.00%)', ' Thrombocytopenia 0/438 (0.00%)', ' Haemolytic anaemia 1/438 (0.23%)', ' Leukopenia 1/438 (0.23%)', ' Cardiac failure congestive 0/438 (0.00%)', ' Supraventricular tachycardia 0/438 (0.00%)', ' Myocardial infarction 1/438 (0.23%)', ' Vertigo 0/438 (0.00%)', 'Adverse Events 2:', ' Total: 56/437 (12.81%)', ' Febrile neutropenia 10/437 (2.29%)', ' Neutropenia 7/437 (1.60%)', ' Anaemia 2/437 (0.46%)', ' Thrombocytopenia 1/437 (0.23%)', ' Haemolytic anaemia 0/437 (0.00%)', ' Leukopenia 0/437 (0.00%)', ' Cardiac failure congestive 3/437 (0.69%)', ' Supraventricular tachycardia 1/437 (0.23%)', ' Myocardial infarction 0/437 (0.00%)', ' Vertigo 1/437 (0.23%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
23df2cc2-6aae-4251-a8a7-e2f5a65f176a
|
|
Comparison
|
Eligibility
|
NCT00418028
|
NCT00293540
|
Samantha has recently received a liver transplant, and is taking the combined oral contraceptive pill, she is not eligible for the primary trial, but is eligible for the secondary trial.
|
Contradiction
|
[
7,
10
] |
[
3,
4
] |
{'Clinical Trial ID': 'NCT00418028', 'Intervention': ['INTERVENTION 1: ', ' Arm A (Cint)', ' Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.', 'INTERVENTION 2: ', ' Arm B (Ccont)', ' Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.'], 'Eligibility': ['Inclusion Criteria', ' Patients diagnosed with metastatic breast cancer', ' Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).', ' The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).', ' Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)', ' Patients with a life expectancy of at least 3 months.', ' Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.', 'Exclusion criteria:', ' Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.', ' Patients previously treated with capecitabine.', ' Patients with organ transplants.', ' Other diseases or severe affections:', ' Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.', ' Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.', ' Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.', ' Severe renal impairment (baseline creatinine clearance < 30 ml/min)', ' Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.', ' Patients with an active infection.', ' Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.', ' Patients showing the following laboratory values:', ' Neutrophil count < 555 x 109/l', ' Platelet count< 100 x 109/l', ' Serum creatinine > 1,5 x upper normality limit', ' seric bilirubin > 2,0 x upper normality limit', ' ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases', ' Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases.', ' Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.', ' Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.', ' Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.', ' Patients who have received more than two cycles of chemotherapy for the metastatic disease.', ' Patients Her2 + per FISH ó +++ Immunohistochemistry'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).', ' Time frame: After 1 year from the treatment start day.', 'Results 1: ', ' Arm/Group Title: Arm A (Cint)', ' Arm/Group Description: Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.', ' Overall Number of Participants Analyzed: 72', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.68 (6.55 to 11.05)', 'Results 2: ', ' Arm/Group Title: Arm B (Ccont)', ' Arm/Group Description: Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.', ' Overall Number of Participants Analyzed: 84', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.84 (6.02 to 8.06)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/95 (13.68%)', ' Neutrophils/granulocytes (ANC/AGC)1/95 (1.05%)', ' Ventricular arrhythmia1/95 (1.05%)', ' Diarrhea6/95 (6.32%)', ' Obstruction1/95 (1.05%)', ' Mucositis/stomatitis1/95 (1.05%)', ' Febrile neutropenia2/95 (2.11%)', ' Infection with unknown ANC0/95 (0.00%)', ' Dizziness1/95 (1.05%)', ' Renal failure0/95 (0.00%)', 'Adverse Events 2:', ' Total: 4/97 (4.12%)', ' Neutrophils/granulocytes (ANC/AGC)1/97 (1.03%)', ' Ventricular arrhythmia0/97 (0.00%)', ' Diarrhea0/97 (0.00%)', ' Obstruction0/97 (0.00%)', ' Mucositis/stomatitis0/97 (0.00%)', ' Febrile neutropenia0/97 (0.00%)', ' Infection with unknown ANC1/97 (1.03%)', ' Dizziness0/97 (0.00%)', ' Renal failure1/97 (1.03%)']}
|
{'Clinical Trial ID': 'NCT00293540', 'Intervention': ['INTERVENTION 1: ', ' A Mid-luteal Surgery', '[Not Specified]', 'INTERVENTION 2: ', ' B Mid-follicular Surgery', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Estrogen receptor or progesterone receptor positive breast cancer', ' Premenopausal with regular menstrual cycles', 'Exclusion Criteria:', ' Current oral contraceptives'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.', ' Time frame: Up to 9 years', 'Results 1: ', ' Arm/Group Title: A Mid-luteal Surgery', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 115', ' Median (95% Confidence Interval)', ' Unit of Measure: years 2.14 (1.53 to 2.67)', 'Results 2: ', ' Arm/Group Title: B Mid-follicular Surgery', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 119', ' Median (95% Confidence Interval)', ' Unit of Measure: years 2.00 (1.61 to 2.31)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/115 (0.00%)', ' Deep vein thrombosis * [1]0/115 (0.00%)', 'Adverse Events 2:', ' Total: 1/119 (0.84%)', ' Deep vein thrombosis * [1]1/119 (0.84%)']}
|
1bd51c93-d7a8-4da4-825d-ada625033c34
|
Single
|
Results
|
NCT01827787
|
The Triple-Negative Breast Cancer cohort of the primary trial had a much lower ORR than the HR+/HER2- cohort.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT01827787', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: HR+/HER2-', ' Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.', 'INTERVENTION 2: ', ' Cohort 2: TNBC', ' Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven invasive breast cancer, locally recurrent or metastatic, with at least one measureable lesion according to RECIST v1.1', ' Hormone receptor positive or hormone receptor negative HER2-negative disease', ' Up to one prior line of chemotherapy for advanced disease is allowed (discontinued at least 14 days prior to initiation of protocol therapy)', ' Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable', ' No limit on prior lines of endocrine therapy, but must be discontinued at least 7 days prior to initiation of protocol therapy', ' Must have completed any prior radiotherapy at least 2 weeks prior to initiation of protocol therapy', ' Must have recovered from reversible effects of prior therapies to no more than grade 1 toxicity, with the exception of alopecia', ' Agree to use adequate contraception for the duration of study participation', 'Exclusion Criteria:', ' Pregnant or breastfeeding', ' Prior treatment with eribulin', ' Prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer unless diagnosed and definitively treated at least 3 years before enrollment in this study', ' Clinically significant cardiovascular impairment', ' Active brain metastases or unevaluated neurologic symptoms suggestive of brain metastases', ' Pulmonary dysfunction requiring the use of oxygen', ' Prior organ allograft requiring immunosuppression', ' HIV positive on combination antiretroviral therapy', ' Pre-existing grade 3 or 4 neuropathy', ' Hypersensitivity to halichondrin B or halichondrin B chemical derivative', ' Uncontrolled intercurrent illness', ' Inability to read in English'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.', ' Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)', 'Results 1: ', ' Arm/Group Title: Cohort 1: HR+/HER2-', ' Arm/Group Description: Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: percentage of participants 35.6 (24 to 49)', 'Results 2: ', ' Arm/Group Title: Cohort 2: TNBC', ' Arm/Group Description: Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle', ' Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.2 (5 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/45 (48.89%)', ' Anemia 0/45 (0.00%)', ' Febrile neutropenia 2/45 (4.44%)', ' Diarrhea 1/45 (2.22%)', ' Mucositis oral 1/45 (2.22%)', ' Nausea 0/45 (0.00%)', ' Vomiting 1/45 (2.22%)', ' Fatigue 1/45 (2.22%)', ' Lip infection 0/45 (0.00%)', ' Alkaline phosphatase increased 1/45 (2.22%)', ' Aspartate aminotransferase increased 1/45 (2.22%)', ' Lymphocyte count decreased 1/45 (2.22%)', 'Adverse Events 2:', ' Total: 13/38 (34.21%)', ' Anemia 2/38 (5.26%)', ' Febrile neutropenia 2/38 (5.26%)', ' Diarrhea 1/38 (2.63%)', ' Mucositis oral 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Vomiting 2/38 (5.26%)', ' Fatigue 0/38 (0.00%)', ' Lip infection 1/38 (2.63%)', ' Alkaline phosphatase increased 0/38 (0.00%)', ' Aspartate aminotransferase increased 0/38 (0.00%)', ' Lymphocyte count decreased 0/38 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
58c58b68-fc9a-438c-8a85-9233dde714c9
|
|
Single
|
Adverse Events
|
NCT00965523
|
The most common adverse events in the primary trial where Infection and Stomatitis.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00965523', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion criteria:', ' Female patients with histologically or cytologically confirmed breast cancer.', ' Patients who have received prior chemotherapy including anthracycline and taxane.', ' Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.', ' Patients with a measurable lesion.', ' Patients with an expected survival of 3 months from the start of study drug therapy.', ' Female patients in whom continued administration of E7389 following Study 221 will be useful.', ' Patients who have met the criteria for starting the next cycle in Study 221.', ' Namely, patients who meet all of the following criteria:', ' Neutrophil count >= 1,500 /µL', ' Platelet count >= 100,000 /µL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)', ' Total bilirubin <= 1.5 times ULN', ' Serum creatinine <= 1.5 times ULN', ' Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)', 'Exclusion criteria:', ' Patients with systemic infection with a fever ( 38.0°C).', ' Patients with pleural effusion, ascites or pericardial fluid requiring drainage.', ' Patients with brain metastasis presenting clinical symptoms.', ' Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.', ' Patients with serious complications:', ' Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)', ' Patients with myocardial infarction within 6 months prior to study entry', ' Patients with a complication of hepatic cirrhosis', ' Patients with interstitial pneumonia and pulmonary fibrosis', ' Patients with a bleeding tendency', ' Patients with an active double cancer.', ' Pregnant women or nursing mothers.', ' Patients who have received extensive radiotherapy ( 30% of bone marrow).', ' Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.', ' Patients who are participating in other clinical studies.', ' Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Adverse Events.', ' [Not Specified]', ' Time frame: Every week during treatment and up to 30 days after last dose of study treatment', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Number', ' Unit of Measure: Participants 81'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/81 (17.28%)', ' Neutropenia1/81 (1.23%)', ' Cataract1/81 (1.23%)', ' Ascites1/81 (1.23%)', ' Gastritis Hemorrhagic1/81 (1.23%)', ' Nausea1/81 (1.23%)', ' Stomatitis2/81 (2.47%)', ' Malaise1/81 (1.23%)', ' Oedema1/81 (1.23%)', ' Pain1/81 (1.23%)', ' Pyrexia1/81 (1.23%)', ' Infection2/81 (2.47%)', ' Upper Limb Fracture1/81 (1.23%)', ' Dehydration1/81 (1.23%)', ' Hypercalcemia1/81 (1.23%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
843778c6-a320-49a1-93a0-5dc6239b822a
|
|
Single
|
Adverse Events
|
NCT00080301
|
There were 2 more cases of Gastrointestinal Haemorrhage in cohort 2 of the primary trial, than in cohort 1.
|
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
] |
[] |
{'Clinical Trial ID': 'NCT00080301', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone + Capecitabine', ' Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine 1250 mg/m2 BID x 14 days'], 'Eligibility': ['Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.', ' Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).', ' Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.', ' Patients must be resistant to taxane therapy.', ' Patients may not have any history of brain and/or leptomeningeal metastases.', ' Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).', ' Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)', " PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.", ' Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity', 'Results 1: ', ' Arm/Group Title: Ixabepilone + Capecitabine', ' Arm/Group Description: Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days', ' Overall Number of Participants Analyzed: 375', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.85 (5.45 to 6.97)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine 1250 mg/m2 BID x 14 days', ' Overall Number of Participants Analyzed: 377', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 4.17 (3.81 to 4.50)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 127/368 (34.51%)', ' ANAEMIA 3/368 (0.82%)', ' LEUKOPENIA 0/368 (0.00%)', ' NEUTROPENIA 0/368 (0.00%)', ' COAGULOPATHY 3/368 (0.82%)', ' LYMPHADENOPATHY 0/368 (0.00%)', ' THROMBOCYTOPENIA 2/368 (0.54%)', ' BONE MARROW FAILURE 0/368 (0.00%)', ' FEBRILE NEUTROPENIA 4/368 (1.09%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/368 (0.00%)', ' ATRIAL FLUTTER 0/368 (0.00%)', ' CARDIAC ARREST 0/368 (0.00%)', 'Adverse Events 2:', ' Total: 151/369 (40.92%)', ' ANAEMIA 11/369 (2.98%)', ' LEUKOPENIA 6/369 (1.63%)', ' NEUTROPENIA 18/369 (4.88%)', ' COAGULOPATHY 0/369 (0.00%)', ' LYMPHADENOPATHY 1/369 (0.27%)', ' THROMBOCYTOPENIA 7/369 (1.90%)', ' BONE MARROW FAILURE 1/369 (0.27%)', ' FEBRILE NEUTROPENIA 15/369 (4.07%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/369 (0.27%)', ' ATRIAL FLUTTER 1/369 (0.27%)', ' CARDIAC ARREST 1/369 (0.27%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a5486f80-69e5-4a5a-8435-f82f39cddf85
|
|
Single
|
Adverse Events
|
NCT00171314
|
There are four types of adverse events in the primary trial, for which no occurences are recorded.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00171314', 'Intervention': ['INTERVENTION 1: ', ' Upfront Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', 'INTERVENTION 2: ', ' Delayed Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.'], 'Eligibility': ['Inclusion Criteria:', ' Stage I-IIIa breast cancer', ' Postmenopausal', ' Recent surgery for breast cancer', 'Exclusion Criteria:', ' Metastatic disease', ' Invasive bilateral disease', ' Clinical or radiological evidence of existing fracture in spine or hip', ' Other protocol-defined inclusion / exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy', ' Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.', ' Time frame: From Baseline - 12 months', 'Results 1: ', ' Arm/Group Title: Upfront Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 254', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change 2.680 (2.8451)', 'Results 2: ', ' Arm/Group Title: Delayed Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 269', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change -3.314 (3.9632)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/254 (18.50%)', ' Anaemia 1/254 (0.39%)', ' Febrile neutropenia 1/254 (0.39%)', ' Lymphadenopathy 1/254 (0.39%)', ' Acute myocardial infarction 1/254 (0.39%)', ' Angina pectoris 0/254 (0.00%)', ' Angina unstable 0/254 (0.00%)', ' Bundle branch block left 0/254 (0.00%)', ' Cardiac failure 4/254 (1.57%)', ' Coronary artery disease 0/254 (0.00%)', ' Coronary artery stenosis 1/254 (0.39%)', 'Adverse Events 2:', ' Total: 56/269 (20.82%)', ' Anaemia 1/269 (0.37%)', ' Febrile neutropenia 0/269 (0.00%)', ' Lymphadenopathy 0/269 (0.00%)', ' Acute myocardial infarction 0/269 (0.00%)', ' Angina pectoris 3/269 (1.12%)', ' Angina unstable 1/269 (0.37%)', ' Bundle branch block left 1/269 (0.37%)', ' Cardiac failure 1/269 (0.37%)', ' Coronary artery disease 1/269 (0.37%)', ' Coronary artery stenosis 0/269 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c2c60b25-f255-48ba-bcb7-2bcd2de4315d
|
|
Comparison
|
Intervention
|
NCT00068601
|
NCT01684215
|
the primary trial and the secondary trial do not employ the same route of administration for their interventions.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00068601', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy', ' Patients receive cyclophosphamide-containing chemotherapy alone.', ' cyclophosphamide: Part of planned chemotherapy regimen', 'INTERVENTION 2: ', ' Chemotherapy Plus Goserelin', ' Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' goserelin acetate: Given subcutaneously'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer', ' Stage I-IIIA', ' Operable disease', ' Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative', ' Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:', ' 3-month/4-course anthracycline-based regimen', ' 6- to 8-month/course anthracycline-based regimen', ' 6- to 8-month/course non-anthracycline-based regimen', ' Hormone receptor status:', ' Estrogen receptor negative', ' Progesterone receptor negative', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 to 49', ' Sex', ' Female', ' Menopausal status', ' Premenopausal', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Not specified', ' Other', ' Not pregnant or nursing', ' Fertile patients must use effective barrier contraception', ' No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' See Disease Characteristics', ' No prior cytotoxic chemotherapy', ' Endocrine therapy', ' No other concurrent hormonal therapy', ' Radiotherapy', ' Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed', ' Surgery', ' See Disease Characteristics', ' Other', ' Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed'], 'Results': ['Outcome Measurement: ', ' Rate of Premature Ovarian Failure at 2 Years', ' Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy', ' Arm/Group Description: Patients receive cyclophosphamide-containing chemotherapy alone.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 21.7%', 'Results 2: ', ' Arm/Group Title: Chemotherapy Plus Goserelin', ' Arm/Group Description: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' goserelin acetate: Given subcutaneously', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 5 7.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/111 (0.00%)', ' Thrombosis/thrombus/embolism 0/111 (0.00%)', 'Adverse Events 2:', ' Total: 1/103 (0.97%)', ' Thrombosis/thrombus/embolism 1/103 (0.97%)']}
|
{'Clinical Trial ID': 'NCT01684215', 'Intervention': ['INTERVENTION 1: ', ' PD-0332991 100 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', 'INTERVENTION 2: ', ' PD-0332991 125 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.'], 'Eligibility': ['Inclusion Criteria:', ' Phase 1', ' In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.', ' In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 or 1.', ' Resolved acute effects of any prior therapy to baseline severity or Grade 1', ' Phase 2', ' Adult women ( 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 to 2.', 'Exclusion Criteria:', ' Phase 1', ' Active uncontrolled or symptomatic CNS metastases.', ' Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse', ' Active or unstable cardiac disease or history of heart attack within 6 months', ' Phase 2', ' HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.', ' Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.', ' Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1', ' DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.', ' Time frame: Lead-in period (Day -7) up to Day 28 (Cycle 1)', 'Results 1: ', ' Arm/Group Title: PD-0332991 100 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: PD-0332991 125 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)']}
|
a8167a90-8ccf-4024-a4cc-8c1b047fd548
|
Single
|
Intervention
|
NCT00106002
|
the primary trial participants are treated with 600 mg of Pemetrexed orally twice a month until complete response or disease progression.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00106002', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed', ' 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression'], 'Eligibility': ['Inclusion Criteria:', ' Must have been diagnosed with either advanced or metastatic breast cancer.', ' Chemotherapy has not been given for advanced or metastatic breast cancer.', ' The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.', ' Able to carry out work of a light nature (for example, light housework, office work).', ' Must be at least 18 years old.', 'Exclusion Criteria:', ' Have received prior bone marrow or peripheral stem cell transplantation.', ' Have received prior chemotherapy for metastatic breast cancer.', ' Are currently pregnant or breast-feeding.', ' Have an active infection that your doctor decides will affect your safety.', ' Are unable to take folic acid or vitamin B12.'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression', 'Results 1: ', ' Arm/Group Title: Pemetrexed', ' Arm/Group Description: 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 8', ' Stable Disease: 14', ' Progressive Disease: 9', ' Best Response Not Evaluable: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14', ' Anaemia 2/36 (5.56%)', ' Febrile neutropenia 1/36 (2.78%)', ' Angina pectoris 1/36 (2.78%)', ' Abdominal pain upper 1/36 (2.78%)', ' Diarrhoea 1/36 (2.78%)', ' Nausea 3/36 (8.33%)', ' Vomiting 2/36 (5.56%)', ' Asthenia 1/36 (2.78%)', ' Fatigue 1/36 (2.78%)', ' Cellulitis 2/36 (5.56%)', ' Peritonitis bacterial 1/36 (2.78%)', ' Upper respiratory tract infection 1/36 (2.78%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
bdca0fa1-a3fa-4dcf-8f58-15d130dbfa75
|
|
Comparison
|
Intervention
|
NCT01067976
|
NCT00941330
|
Unlike the secondary trial, the primary trial only provides the duration of cycles and drug doses in the intervention section.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'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%)']}
|
{'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%)']}
|
277f5d17-36cc-44c5-9b94-7e052f2bdb2c
|
Single
|
Adverse Events
|
NCT01492101
|
There less than 1% of either cohort of the primary trial was effect by Pancytopenia, but just over 5% of cohort 1 patients suffered from Coagulopathy.
|
Contradiction
|
[
0,
4,
5,
11,
15
] |
[] |
{'Clinical Trial ID': 'NCT01492101', 'Intervention': ['INTERVENTION 1: ', ' NKTR-102', ' NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.', 'INTERVENTION 2: ', " Physician's Treatment of Choice", " Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:", ' eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel'], 'Eligibility': ['Inclusion Criteria (major highlights):', ' Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated', ' Patient can have either measurable or non-measurable disease by RECIST.', ' Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine', ' Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.', ' Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate hematopoietic, liver and kidney functions.', ' Exclusion Criteria (major highlights):', ' Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.', ' Patient with any major surgery within 28 days prior to randomization.', ' Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).', ' Patient with prior treatment for cancer with a camptothecin derivative.', ' Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.', ' Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.', ' Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.', ' Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.', ' Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.', ' Patients with significant cardiovascular impairment.'], 'Results': ['Outcome Measurement: ', ' Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population', ' Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.', ' Time frame: 36 Months', 'Results 1: ', ' Arm/Group Title: NKTR-102', ' Arm/Group Description: NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.', ' Overall Number of Participants Analyzed: 429', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 12.4 (11.0 to 13.6)', 'Results 2: ', " Arm/Group Title: Physician's Treatment of Choice", " Arm/Group Description: Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:", ' eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel', ' Overall Number of Participants Analyzed: 423', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 10.3 (9.0 to 11.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 128/425 (30.12%)', ' Febrile neutropenia *2/425 (0.47%)', ' Anaemia *2/425 (0.47%)', ' Pancytopenia *2/425 (0.47%)', ' Coagulopathy *1/425 (0.24%)', ' Idiopathic thrombocytopenic purpura *0/425 (0.00%)', ' Microangiopathic haemolytic anaemia *1/425 (0.24%)', ' Neutropenia *0/425 (0.00%)', ' Pericardial effusion *1/425 (0.24%)', ' Acute coronary syndrome *1/425 (0.24%)', 'Adverse Events 2:', ' Total: 129/406 (31.77%)', ' Febrile neutropenia *6/406 (1.48%)', ' Anaemia *0/406 (0.00%)', ' Pancytopenia *0/406 (0.00%)', ' Coagulopathy *0/406 (0.00%)', ' Idiopathic thrombocytopenic purpura *1/406 (0.25%)', ' Microangiopathic haemolytic anaemia *0/406 (0.00%)', ' Neutropenia *1/406 (0.25%)', ' Pericardial effusion *1/406 (0.25%)', ' Acute coronary syndrome *0/406 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fcb195de-2143-44d8-8c46-136104554e2d
|
|
Single
|
Eligibility
|
NCT00317720
|
Patients must have at least 3 prior treatments with trastuzumab to be eligible for the primary trial.
|
Contradiction
|
[
0,
2
] |
[] |
{'Clinical Trial ID': 'NCT00317720', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + RAD001', ' Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.'], 'Eligibility': ['Inclusion Criteria:', ' History of biopsy-proven HER-2-overexpressing breast cancer and radiographic evidence of metastatic disease. The HER-2 status can be determined either by immunohistochemistry (score, 3+) or by fluorescence in situ hybridization.', ' History of trastuzumab resistance, defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patient may not have received more than 2 prior trastuzumab-based regimens and one lapatinib-based regimen (either as single agent or in combination with chemotherapy)for metastatic breast cancer. Patients who develop metastatic disease during or after adjuvant or neoadjuvant trastuzumab are eligible.', ' Performance status 0-2 (by Eastern Cooperative Oncology Group (ECOG) scale).', ' Absolute neutrophil count (ANC) 1500/µl or higher; Platelets 100,000/µl or higher; Hemoglobin 9.0 gm/dL or higher; Serum creatinine 2.0 mg/dL or lower; Total bilirubin 1.5 mg/dL or lower; Serum glutamic pyruvic transaminase (SGPT) up to 3* upper limit of normal; Alkaline phosphatase up to 3* upper limit of normal; Calcium 11.0 mg/dL or lower.', ' Age 18 years or older.', ' Patients must not be pregnant. A pregnancy test will be obtained if the patient is a woman of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).', ' Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.', ' Patients must have measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral computed tomography (CT) scan.', ' Patients may not be receiving any other investigational agents, and must not have received investigational agents within 15 days of enrollment.', ' Left ventricular ejection fraction determined by echocardiogram or multigated acquisition (MUGA) (cardiac scan) must be 50% or higher.', 'Exclusion Criteria:', ' 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', ' Prior treatment with any investigational drug within the preceding 15 days', ' Chronic treatment with systemic steroids or another immunosuppressive agent', ' Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases, and patients diagnosed with brain mets or leptomeningeal disease (LMD) within 3 months.', ' Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)', ' Patients who have received prior treatment with an mTor inhibitor.', ' History of noncompliance to medical regimens.', ' Patients unwilling to or unable to comply with the protocol.', ' Patients who are receiving any other investigational agents', ' Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent.'], 'Results': ['Outcome Measurement: ', ' Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)', ' In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized.', ' Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common Terminology Criteria (CTC) version 3.0 except fatigue. Participants underwent clinical evaluation every 3 weeks (one cycle) and radiologic evaluations every 6 weeks. After the second cycle, participants underwent a radiologic evaluation using the same imaging technique used at initial evaluation (ie, computed tomography or magnetic resonance imaging).', ' Time frame: Following two 3 week cycles of therapy', 'Results 1: ', ' Arm/Group Title: Trastuzumab + RAD001', ' Arm/Group Description: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: mg 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/47 (100.00%)', ' Anemia 4/47 (8.51%)', ' Lymphopenia 13/47 (27.66%)', ' Neutropenia 9/47 (19.15%)', ' Thrombocytopenia 4/47 (8.51%)', ' Diarrhea 9/47 (19.15%)', ' Fatigue 9/47 (19.15%)', ' Hyperglycemia 13/47 (27.66%)', ' Hypokalemia 6/47 (12.77%)', ' Hyperlipidemia 4/47 (8.51%)', ' Infection 4/47 (8.51%)', ' Mucositis 9/47 (19.15%)', ' Transaminitis 2/47 (4.26%)', ' Thrombosis/embolism 2/47 (4.26%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
70337af9-3d4a-44bc-bbfa-0d97ea88553c
|
|
Single
|
Eligibility
|
NCT00334542
|
A Female patients with a mastectomy would be excluded from the primary trial.
|
Contradiction
|
[
6
] |
[] |
{'Clinical Trial ID': 'NCT00334542', 'Intervention': ['INTERVENTION 1: ', ' Simvastatin', ' Simvastatin 40 mg for 24-28 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' History of histologically confirmed breast cancer, meeting 1 of the following staging criteria:', ' Ductal carcinoma in situ', ' Stage I-III invasive breast cancer', ' At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy', ' May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed 3 months ago', ' At least 1 healthy intact breast', ' No prior radiotherapy or mastectomy', ' Prior biopsies allowed', ' Any hormone-receptor status', ' PATIENT CHARACTERISTICS:', ' Female', ' Pre- or post-menopausal', ' ECOG performance status 0-2', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective nonhormonal contraception', ' No active liver disease', ' AST and ALT 3 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components', ' No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator)', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No daily alcohol use > 3 standard drinks per day', ' Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor', ' No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months', ' No hormone replacement therapy (HRT) within the past 3 months', ' No prior estrogen and/or progesterone HRT 5 years in duration', ' Vaginal estrogen preparations allowed', ' No concurrent HRT', ' No other cholesterol-lowering drug, including a statin, within the past 3 months', ' No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil', ' No concurrent daily grapefruit juice consumption > 8 ounces per day', ' No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer'], 'Results': ['Outcome Measurement: ', ' Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline', ' [Not Specified]', ' Time frame: Baseline and week 24', 'Results 1: ', ' Arm/Group Title: Simvastatin', ' Arm/Group Description: Simvastatin 40 mg for 24-28 weeks', ' Overall Number of Participants Analyzed: 47', ' Median (95% Confidence Interval)', ' Unit of Measure: mg/dl hsCRP: -0.15 (-1 to 0)', ' Total cholesterol: -54 (-58.5 to -39)', ' High-density lipoprotein cholesterol (HDL): -1 (-2 to 3)', ' Estrogen (estrone sulfate): -81.5 (-225.5 to -40.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/50 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9cf89221-5801-4709-a098-de763b6e702e
|
|
Single
|
Eligibility
|
NCT01031446
|
Sarah has been experiencing epileptic seizures from a brain tumor. This will not prevent her from participating in the primary trial.
|
Contradiction
|
[
5
] |
[] |
{'Clinical Trial ID': 'NCT01031446', 'Intervention': ['INTERVENTION 1: ', ' RAD001 and Cisplatin and Paclitazel', ' Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive mammary carcinoma', ' Stage IV disease', ' Basal-like disease (triple-negative, hormone-refractory, HER2-negative)', ' No locally recurrent breast cancer', ' No symptomatic brain metastases', ' Patients with a history of brain metastases are eligible provided they are clinically stable for > 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers', ' Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers', ' PATIENT CHARACTERISTICS:', ' Pre- or post-menopausal', ' European Cooperative Oncology Group (ECOG) performance status 0-1', ' Life expectancy 6 months', ' Absolute neutrophil count (ANC) 1,000/mm^3', ' Platelet count 100,000/mm^3', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)', ' Direct bilirubin will be measured in patients with Gilbert syndrome', ' serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)', ' Alkaline phosphatase 3 times ULN (in the presence of liver metastasis)', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment', ' Able to swallow and retain oral medication', ' No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel', ' No concurrent uncontrolled illness including, but not limited to, any of the following:', ' Ongoing or active infection requiring parenteral antibiotics', ' Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)', ' New York Heart Association class III-IV congestive heart failure', ' Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months', ' Uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support)', ' Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0])', ' Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)', ' Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary', ' No symptomatic neuropathy grade 2', ' No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ', ' No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies', ' No history of hepatitis B or C', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from prior therapy', ' Prior total cumulative life-time dose of doxorubicin 360 mg/m^2 or epirubicin 640 mg/m^2', ' No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy)', ' At least 2 weeks since prior investigational drugs', ' At least 14 days since prior and no concurrent herbal or dietary supplements', ' At least 14 days since prior and no concurrent CYP3A4 inducers', ' At least 7 days since prior and no concurrent CYP3A4 inhibitors', ' Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry', ' No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)'], 'Results': ['Outcome Measurement: ', ' Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer', ' The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.', ' Time frame: at 8 weeks', 'Results 1: ', ' Arm/Group Title: RAD001 and Cisplatin and Paclitazel', ' Arm/Group Description: Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: mg/m2 Cisplatin: 25', 'Paclitaxel: 80'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/55 (16.36%)', ' neutrophils2/55 (3.64%)', ' leukocytes1/55 (1.82%)', ' platelets1/55 (1.82%)', ' febrile neutropenia, ANC < 1.0 x 10e9L, fever 38.5 degrees Celsius1/55 (1.82%)', ' anemia2/55 (3.64%)', ' thrombocytopenia2/55 (3.64%)', ' ventricular tachycardia1/55 (1.82%)', ' pain-abdomen3/55 (5.45%)', ' diarrhea1/55 (1.82%)', ' nausea3/55 (5.45%)', ' vomiting3/55 (5.45%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f89883ea-dd60-4d5f-9354-13fbca2aeec8
|
|
Comparison
|
Adverse Events
|
NCT01301729
|
NCT02129556
|
Only 1 respiratory adverse event was recorded across the duration of both the secondary trial and the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
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': 'NCT01301729', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants , >/= 18 years of age', ' Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)', ' HER2-positive primary disease', ' Participants must have received Herceptin in the adjuvant and/or neoadjuvant setting', ' Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive breast cancer', ' Measurable disease according to RECIST 1.0', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines', ' At least 3 weeks after prior surgery or radiotherapy', 'Exclusion Criteria:', ' Pregnant or breastfeeding women', ' Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)', ' Pleural effusions, ascites or bone lesions as only manifestation of disease', ' Brain metastases', ' Invasive malignancy other than metastatic breast cancer', ' Inadequate bone marrow, hepatic or renal function', ' Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.', ' Time frame: From the date of informed consent to the date of death or progressive disease (up to 28 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.', ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.9 (6.28 to 13.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/32 (15.63%)', ' Leukopenia 1/32 (3.13%)', ' Neutropenia 1/32 (3.13%)', ' Cataract 1/32 (3.13%)', ' Infection 1/32 (3.13%)', ' Upper respiratory tract infection 1/32 (3.13%)', ' Completed suicide 1/32 (3.13%)']}
|
{'Clinical Trial ID': 'NCT02129556', 'Intervention': ['INTERVENTION 1: ', ' Phase Ib 2 mg/kg', ' HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy', 'INTERVENTION 2: ', ' Phase Ib 10 mg/kg', ' HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy'], 'Eligibility': ['Inclusion criteria for screening:', ' Female gender', ' Age 18 years', ' Histologically confirmed breast adenocarcinoma that is unresectable loco-regional, or metastatic.', ' Locally confirmed HER2-positivity (immunohistochemistry score 3+) or ERBB2-amplification (Ratio ERBB2/centromeres 2.0 or mean gene copy number 6) of primary tumor or of biopsy from metastatic or unresectable loco-regional lesion.', ' Trastuzumab resistant disease, defined by:', ' progression of disease while on-treatment with trastuzumab', ' recurrence while on adjuvant trastuzumab or within 12 months of completing adjuvant trastuzumab', ' Any number of prior lines of anti-HER2 therapy acceptable. Patients for whom the treatment with the current first-line combination of trastuzumab, pertuzumab and taxanes is not an option can be considered for enrollment', ' If a patient has received a subsequent anti-HER2 therapy, she must also have progressed on the subsequent therapy.', ' Presence of at least one measurable lesion (RECIST 1.1)', ' LVEF 50%', ' Patient agrees to submit an FFPE tumor biopsy for central confirmation of HER2 positivity and central assessment of PD-L1 status.', ' Written Informed Consent (IC) for screening procedures and trial participation must be signed and dated by the patient and the Investigator prior to screening.', ' Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial, including consent to translational research on FFPE and fresh frozen tumor biopsies in case the patient is enrolled into the trial.', ' The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1', ' Life expectancy >3 months.', ' Hematopoietic status:', ' Absolute neutrophil count 1.5 × 109/L,', ' Platelet count 100 × 109/L,', ' Hemoglobin 9 g/dL', ' Hepatic status:', " Serum total bilirubin 1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.", ' AST and ALT 2.5 × ULN; if the patient has liver metastases, ALT and AST must be 5 × ULN.', ' Renal status:', ' Creatinine 1.5 ×ULN or creatinine clearance > 60 ml/min', ' Proteinuria <1 g/day', ' International Normalized Ratio (INR) or Prothrombin Time (PT) 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT (partial thromboplastin time) is within therapeutic range of intended use of anticoagulant.', ' Inclusion criteria for enrollment:', ' All inclusion criteria for screening, plus:', ' Central lab confirmation on a metastatic biopsy (or biopsy from unresectable loco-regional disease) of:', ' HER2-positivity (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres 2.0 or mean gene copy number 6),', ' Presence of PD-L1 expression assessed by IHC (during the phase II portion of the trial a parallel, secondary cohort of 15 patients with PD-L1 negative disease will be enrolled)', ' Patient agrees to submit tumor tissue for translational research:', ' tissue biopsy from unresectable loco-regional or metastatic disease obtained 1 year prior to enrollment or new tissue material from a recently obtained surgical or diagnostic biopsy. For patients who have presented with stage 4 disease de novo, a biopsy taken from the presumed primary breast lesion is acceptable (provided this was taken 1 year prior to enrollment).', ' if available: FFPE tumor block from primary surgery or diagnostic biopsy.', ' if available: pre-treatment fresh frozen tumor biopsy.', ' if feasible: FFPE tumor block from post-treatment biopsy will be taken at time of disease progression or end of all treatment if ended prior to progression. This re-biopsy is strongly advised.', ' if feasible: fresh frozen tumor biopsy from post-treatment biopsy will be taken at time of disease progression or end of all treatment if ended prior to progression.', ' Patient agrees to submit baseline (pre-treatment) blood and serial plasma for translational research', ' For patient of childbearing potential, negative serum pregnancy test. Pregnancy test has to be repeated within 72h before treatment start.', ' All anti-cancer treatment including endocrine therapy, with the exception of trastuzumab, must stop 3 weeks prior to first dose of trial treatment.', ' Exclusion criteria for screening:', ' Prior therapy with other anti-PD-1, anti- PD-L1, L2 or anti-CTLA4 therapy.', ' No FFPE material to centrally assess HER2-positivity and PD-L1 expression.', ' Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), or positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative]).', ' Interstitial lung disease', ' History of or active pneumonitis requiring treatment with steroids', ' Active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of investigational product and have not required high-dose steroid treatment in the last 4 weeks).', ' Leptomeningeal disease', ' History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification 3), angina, myocardial infarction or ventricular arrhythmia.', ' Previous severe hypersensitivity reaction to treatment with another monoclonal antibody.', ' Active infection requiring systemic therapy.', ' Chronic systemic therapy with immunosuppressive agents including cortico¬steroids.', " Concurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient's safety.", ' Known history of uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen.', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent.', ' Treatment with an investigational agent in the 4 weeks before enrollment.', " Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the trial.", ' Chemotherapy, radioactive therapy, and/or biological cancer therapy within 3 weeks prior to the first trial dose and has not recovered to CTCAE v.4 grade 1 or better from adverse events.', ' Pregnant or lactating women; lactation has to stop before enrollment.', ' The patient of childbearing potential who is unwilling to use highly effective contraception during treatment and up to 7 months after stop of trial treatment. Acceptable methods are intrauterine devices (without hormones), bilateral tubal occlusion, vasectomized partner or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.', ' Unresolved or unstable, serious adverse events from prior administration of another investigational drug.', ' Active or uncontrolled infection CTCAE v.4 grade 2 or higher.', ' Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment.', ' Exclusion criteria for enrollment:', ' All exclusion criteria for screening apply for enrollment as well. Excluded are especially patients who have received any of the treatments below:', ' Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment.', ' History of CNS metastases or spinal cord compression if they have not been clinically stable for at least 4 weeks before first dose of investigational product and require high-dose steroid treatment.', ' Treatment with an investigational agent in the 4 weeks before enrollment.', ' Patient has not recovered to CTCAE v.4 grade 1 or better from adverse events of prior therapy, except alopecia grade 2.', ' Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), or positive for Hepatitis B or Hepatitis C.'], 'Results': ['Outcome Measurement: ', ' Dose-Limiting Toxicity (DLT) of MK-3475 in Combination With Trastuzumab', ' Determination of dose-limiting toxicity (DLT) which is defined as an adverse event or abnormal laboratory value assessed as suspected to be trial treatment related (possible, probable or definite) and unrelated to disease or disease progression. Toxicities and lab values will be graded according to the NCI CTCAE (v4.0).', ' Any grade-3 or greater non-hematological adverse event lasting at least one week;', ' Any grade-4 hematological toxicity; or,', ' Any adverse event resulting in a delay starting cycle 2 of more than 14 days.', ' Time frame: Within the first 21 days', 'Results 1: ', ' Arm/Group Title: Phase Ib 2 mg/kg', ' Arm/Group Description: HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Phase Ib 10 mg/kg', ' Arm/Group Description: HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/6 (66.67%)', ' Anemia 0/6 (0.00%)', ' Takotsubo cardiomyopathy 1/6 (16.67%)', ' Pericardial effusion 0/6 (0.00%)', ' Vertigo 1/6 (16.67%)', ' Retinal vein occlusion 0/6 (0.00%)', ' Gastroenteritis 1/6 (16.67%)', ' Vomiting 1/6 (16.67%)', ' Diarrhea 0/6 (0.00%)', ' Death 2/6 (33.33%)', ' Bile duct dilatation 0/6 (0.00%)', ' Hepatic hemorrhage 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 25/52 (48.08%)', ' Anemia 1/52 (1.92%)', ' Takotsubo cardiomyopathy 0/52 (0.00%)', ' Pericardial effusion 2/52 (3.85%)', ' Vertigo 0/52 (0.00%)', ' Retinal vein occlusion 1/52 (1.92%)', ' Gastroenteritis 0/52 (0.00%)', ' Vomiting 0/52 (0.00%)', ' Diarrhea 1/52 (1.92%)', ' Death 9/52 (17.31%)', ' Bile duct dilatation 1/52 (1.92%)', ' Hepatic hemorrhage 1/52 (1.92%)']}
|
a289f67c-ff56-44a9-b3da-152fb0d20271
|
Single
|
Eligibility
|
NCT02635737
|
Patients with ICDs may be eligible for the primary trial.
|
Contradiction
|
[
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT02635737', 'Intervention': ['INTERVENTION 1: ', ' Sentimark Device Placement', ' Sentimark device placed in women having mastectomy surgery', ' Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation'], 'Eligibility': ['Inclusion Criteria:', ' Participant is willing and able to give informed consent for participation in the study;', ' Female, aged 18 years or above;', ' Diagnosed with breast cancer (invasive or dcis);', ' Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study;', ' Undergoing mastectomy breast surgery.', 'Exclusion Criteria:', ' Patients with a Pacemaker or implanted device;', ' Patients requiring an MRI scan prior to surgery;', ' Patients with known coagulopathy or receiving anticoagulant medication including warfarin, heparin, clopidogrel or rivaroxaban;', ' Patients receiving Neoadjuvant chemotherapy;', ' Patients who are pregnant or lactating;', ' Patients scheduled for immediate breast reconstruction;', ' Patients who have received Sienna (iron oxide) injection in the previous six months;', ' Patients with an existing breast haematoma close to the target lesion.'], 'Results': ['Outcome Measurement: ', ' Migration of Sentimark Device', ' Migration of the device>10mm between mammograms, clip position >40mm from target lesion', ' Time frame: 1-4 weeks from placement', 'Results 1: ', ' Arm/Group Title: Sentimark Device Placement', ' Arm/Group Description: Sentimark device placed in women having mastectomy surgery', ' Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of Magseed migrating >10mm 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
10ed1242-c6ab-4ad0-b93c-4738857f543a
|
|
Single
|
Eligibility
|
NCT02692755
|
Asian, white british and white irish women are eligible for the primary trial, as long as they do not have uncontrolled or symptomatic brain metastases.
|
Contradiction
|
[
0,
1,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT02692755', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib + Letrozole or Fulvestrant', ' Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months'], 'Eligibility': ['Inclusion Criteria:', ' Self-identified Black, African or African American women of 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)', ' ER-positive and/or PgR-positive tumor based on local laboratory results', ' HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)', ' Patients must be appropriate candidates for letrozole or fulvestrant therapy', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Adequate bone marrow function:', ' Absolute Neutrophil Count (ANC) 1,000/mm3 (1.0 x 109/L);', ' Platelets 100,000/mm3 (100 x 109/L);', ' Hemoglobin 9 g/dL (90 g/L).', 'Exclusion Criteria:', ' Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4', " Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.", ' Previous CDK4/6 inhibitor', '-'], 'Results': ['Outcome Measurement: ', ' Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event', ' For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of >38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour."', ' Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Palbociclib + Letrozole or Fulvestrant', ' Arm/Group Description: Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/35 (22.86%)', ' Heart failure 1/35 (2.86%)', ' Colitis 1/35 (2.86%)', ' Diarrhea 1/35 (2.86%)', ' Fever 1/35 (2.86%)', ' Upper respiratory infection 1/35 (2.86%)', ' Urinary tract infection 1/35 (2.86%)', ' Neutrophil count decreased 1/35 (2.86%)', ' Anorexia 1/35 (2.86%)', ' Suicidal ideation 1/35 (2.86%)', ' Acute kidney injury 1/35 (2.86%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
683b9885-4027-4108-b37e-61255611538a
|
|
Single
|
Intervention
|
NCT00600340
|
Cohorts 1 of the primary trial recieves Bevacizumab at a higher frequency and dose than cohort 2.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00600340', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab Plus Paclitaxel', ' Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', 'INTERVENTION 2: ', ' Bevacizumab Plus Capecitabine', ' Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks'], 'Eligibility': ['Inclusion Criteria', ' Written informed consent obtained prior to any study-specific procedure.', ' Age 18 years.', ' Able to comply with the protocol.', ' Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.', ' Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.', ' Life expectancy more than 12 weeks.', ' Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:', ' Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.', ' Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin.', ' Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that:', ' no more than 30% of marrow-bearing bone was irradiated', ' the last fraction of radiotherapy was administered 3 weeks prior to randomization.', ' Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF 50% by either echocardiogram or multigated acquisition scan (MUGA).', ' Adequate hematological function', ' Absolute neutrophil count (ANC) 1.5 x 109/L', ' Platelet count 100 x 109/L', ' Hemoglobin 9 g/dL (may be transfused to maintain or exceed this level).', ' Adequate liver function', ' Total bilirubin 1.25 x upper normal limit (ULN)', ' Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5.0 x ULN in patients with liver metastases.', ' Adequate renal function', ' Serum creatinine 1.25 x ULN or calculated creatinine clearance 50 mL/min.', ' Urine dipstick for proteinuria < +2. Patients discovered to have +2 proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate 1g of protein in 24 hours', ' The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization', ' Patients on heparin treatment should have a baseline activated partial thromboplastin time (aPTT) between 1.5 - 2.5 times ULN or patients value before starting heparin treatment', ' Patients on low molecular weight heparins (LMWH) should receive daily dose of 1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent anticoagulant, according to package insert', ' Patients on coumarin derivatives should have an international normalized ratio (INR) between 2.0 and 3.0 assessed at baseline in two consecutive measurements 1-4 days apart', ' Patients not receiving anticoagulant medication must have an INR 1.5 and aPTT 1.5 times ULN within 7 days prior to randomization', ' Exclusion Criteria', ' Previous chemotherapy for metastatic or locally recurrent breast cancer.', ' Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization.', ' Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above).', ' Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.', ' Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization.', ' Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases.', ' History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).', ' Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.', ' Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization.', ' Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).', ' Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).', ' History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.', ' Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg).', ' Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.', ' Non-healing wound, active peptic ulcer or bone fracture.', ' History of abdominal fistula, or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization.', ' Active infection requiring i.v. antibiotics at randomization.', ' Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.', ' Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug.', ' Men who do not agree to use effective contraception during the study and for a period of 6 months following the last administration of study drug.', ' Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study', ' Clinically significant malabsorption syndrome or inability to take oral medication.', ' Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake.', ' Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.', ' Evidence of any other disease, metabolic or psychological 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 patient compliance with study routines, or places the patient at high risk from treatment related complications.', ' Known Dihydropyrimidine Dehydrogenase (DPD) deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency)', ' Known hypersensitivity to any of the study drugs (including 5-FU) or excipients. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. History of hypersensitivity reactions with drugs formulated in Cremophor® EL (polyoxyethylated castor oil), or previous therapy with bevacizumab.'], 'Results': ['Outcome Measurement: ', ' Overall Survival (PP Population)', " Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.", ' Time frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab Plus Paclitaxel', ' Arm/Group Description: Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', ' Overall Number of Participants Analyzed: 266', ' Median (95% Confidence Interval)', ' Unit of Measure: months 30.2 (25.6 to 32.6)', 'Results 2: ', ' Arm/Group Title: Bevacizumab Plus Capecitabine', ' Arm/Group Description: Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m twice-daily, days 1-14, every 3 weeks', ' Overall Number of Participants Analyzed: 265', ' Median (95% Confidence Interval)', ' Unit of Measure: months 26.1 (22.3 to 29.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 65/284 (22.89%)', ' Anaemia 0/284 (0.00%)', ' Febrile neutropenia 2/284 (0.70%)', ' Leukopenia 1/284 (0.35%)', ' Neutropenia 1/284 (0.35%)', ' Acute coronary syndrome 0/284 (0.00%)', ' Acute myocardial infarction 1/284 (0.35%)', ' Atrial fibrillation 1/284 (0.35%)', ' Atrioventricular block 1/284 (0.35%)', ' Atrioventricular block complete 0/284 (0.00%)', ' Cardio-respiratory arrest 0/284 (0.00%)', 'Adverse Events 2:', ' Total: 68/277 (24.55%)', ' Anaemia 4/277 (1.44%)', ' Febrile neutropenia 1/277 (0.36%)', ' Leukopenia 1/277 (0.36%)', ' Neutropenia 1/277 (0.36%)', ' Acute coronary syndrome 1/277 (0.36%)', ' Acute myocardial infarction 0/277 (0.00%)', ' Atrial fibrillation 0/277 (0.00%)', ' Atrioventricular block 0/277 (0.00%)', ' Atrioventricular block complete 1/277 (0.36%)', ' Cardio-respiratory arrest 1/277 (0.36%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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a47e048a-56aa-49e0-9903-563f53797b6e
|
|
Comparison
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Eligibility
|
NCT00356148
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NCT01856543
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Women of any age can participate in the primary trial and the secondary trial.
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Contradiction
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[
0,
1
] |
[
0,
1
] |
{'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%)']}
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{'Clinical Trial ID': 'NCT01856543', 'Intervention': ['INTERVENTION 1: ', ' Eucerin', ' Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.', 'Eucerin', 'INTERVENTION 2: ', ' Mometasone Furoate 0.1%', ' Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.', 'Mometasone F'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 years', ' Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC', ' Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT', ' ECOG Performance Status of 0 or 1', 'Exclusion Criteria:', ' Male', ' Patients with clinical evidence of gross disease', ' Patients who are pregnant or breastfeeding', ' Prior radiation therapy to the ipsilateral chest wall or thorax', ' Patients requiring a chest wall boost', ' Concurrent chemotherapy (biologic agents are allowed)', ' Psychiatric illness that would prevent the patient from giving informed consent', ' Inability or unwillingness to comply with skin care instructions and follow-up', ' Allergy to either Eucerin or MF', ' Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT', ' Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)', ' Treatment with palliative or pre-operative radiation'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Moist Desquamation', ' Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Eucerin', ' Arm/Group Description: Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.', ' Eucerin', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: % of participants w/moist desquamation 66.7', 'Results 2: ', ' Arm/Group Title: Mometasone Furoate 0.1%', ' Arm/Group Description: Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.', ' Mometasone F', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: % of participants w/moist desquamation 43.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/73 (4.11%)', ' Chest Pain - cardiac 1/73 (1.37%)', ' Myocarditis 1/73 (1.37%)', ' Pericarditis 1/73 (1.37%)', ' Ventricular tachycardia 1/73 (1.37%)', ' Skin infection 0/73 (0.00%)', ' Dermatitis radiation 0/73 (0.00%)', ' Dyspnea 1/73 (1.37%)', 'Adverse Events 2:', ' Total: 3/70 (4.29%)', ' Chest Pain - cardiac 0/70 (0.00%)', ' Myocarditis 0/70 (0.00%)', ' Pericarditis 0/70 (0.00%)', ' Ventricular tachycardia 0/70 (0.00%)', ' Skin infection 2/70 (2.86%)', ' Dermatitis radiation 1/70 (1.43%)', ' Dyspnea 0/70 (0.00%)']}
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690de5e2-3d7f-407e-8eb9-783adf58841b
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Comparison
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Adverse Events
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NCT01234337
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NCT00217672
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More than 2 cases of Anaphylaxis occurred in either the primary trial or the secondary trial.
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Contradiction
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0,
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2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
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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%)']}
|
f5477a02-dde7-44c8-80b5-2cdb9fa66f23
|
Single
|
Eligibility
|
NCT03511378
|
Patients must have a life expectancy over a year to participate in the primary trial.
|
Contradiction
|
[
0,
8
] |
[] |
{'Clinical Trial ID': 'NCT03511378', 'Intervention': ['INTERVENTION 1: ', " Lupin's Pegfilgrastim", ' 6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.', " Lupin's Pegfilgrastim: Administration of Pegfilgrastim", 'INTERVENTION 2: ', ' Neulasta®', ' 6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.', ' Neulasta®: Administration of Neulasta®'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be able and willing to give written informed consent prior to any study related procedures', ' Ambulatory, female patients with an age 18 years', ' Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.', ' Patients who are planned and eligible to receive/ receiving myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin', ' Patients who have not received any hematopoietic growth factors (e.g. G-CSF, PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the past', ' Patients with baseline WBC LLN/ 3.5 x 109/L, ANC of 1.5 x 109/L, platelet count 100 x 109/L and hemoglobin 8.5 g/dL', ' Patients with ECOG Performance status of 2', ' Patient who have estimated life expectancy of more than six months', ' No evidences of hemorrhage', 'Exclusion Criteria:', ' 1 Male patients', ' 2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product', ' 3. Patients weighing <45 Kg', ' 4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain', ' 5. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study', ' 6. Patients with prior bone marrow or stem cell transplantation', ' 7. Patients with chronic use of oral corticosteroids (Except 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.', ' 8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy', ' 9. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 1.5 X ULN of the reference range at the screening assessment]', ' 10. Patients with seropositivity for HIV or HBV or HCV', ' 11. Known cases of Sickle Cell Anemia', ' 12. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening', ' 13. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography', " 14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient's involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease]", ' 15. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study', ' 16. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.', ' 17. Women of child-bearing potential who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last dose of study drug.', ' 18. Pregnant and Breast feeding women.'], 'Results': ['Outcome Measurement: ', ' Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).', ' The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim.', ' Time frame: End of cycle 4, Day 84', 'Results 1: ', " Arm/Group Title: Lupin's Pegfilgrastim", ' Arm/Group Description: 6 mg, subcutaneous injection on day 2/3 of each 21 3 day cycle. Number of cycles: 4.', " Lupin's Pegfilgrastim: Administration of Pegfilgrastim", ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: Proportion of patients with antibodies 0.0145', 'Results 2: ', ' Arm/Group Title: Neulasta ', ' Arm/Group Description: 6 mg, subcutaneous injection on day 2/3 of each 21 3 day cycle. Number of cycles: 4.', ' Neulasta : Administration of Neulasta ', ' Overall Number of Participants Analyzed: 68', ' Measure Type: Number', ' Unit of Measure: Proportion of patients with antibodies 0.0441'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/70 (0.00%)', ' Neutropenia 0/70 (0.00%)', ' Anaemia 0/70 (0.00%)', 'Adverse Events 2:', ' Total: 2/68 (2.94%)', ' Neutropenia 2/68 (2.94%)', ' Anaemia 1/68 (1.47%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
dc184dcb-a22d-4cac-bee1-6c182692e522
|
|
Comparison
|
Intervention
|
NCT03076190
|
NCT03196635
|
Molecular Breast Imaging is not applied in either the primary trial or the secondary trial interventions.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT03076190', 'Intervention': ['INTERVENTION 1: ', ' Active Control Group', ' Health Education Active Control Group', 'INTERVENTION 2: ', ' My Surgical Success Treatment Group', ' My Surgical Success Intervention Group'], 'Eligibility': ['Inclusion Criteria:', ' Age 18+', ' Scheduled for breast cancer surgery', ' English speaking', ' Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video', 'Exclusion Criteria:', ' Any conditions causing inability to complete study procedures (e.g. education, cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the investigator.', ' Known pregnancy', ' Ongoing legal action related to pain or disability claim'], 'Results': ['Outcome Measurement: ', ' Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning', ' Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.', ' Time frame: Immediately post-treatment', 'Results 1: ', ' Arm/Group Title: Active Control Group', ' Arm/Group Description: Health Education Active Control Group', ' Overall Number of Participants Analyzed: 32', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.3)', ' Relevant: 4.7 (1.51)', ' Useful: 4.67 (1.52)', ' Satisfaction: 4.67 (1.56)', ' Likely to Use: 5.03 (1.3)', 'Results 2: ', ' Arm/Group Title: My Surgical Success Treatment Group', ' Arm/Group Description: My Surgical Success Intervention Group', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.2)', ' Relevant: 5.0 (1.6)', ' Useful: 5.1 (1.3)', ' Satisfaction: 5.2 (1.2)', ' Likely to Use: 5.3 (1.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT03196635', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants, PA Compression Image Sets', ' All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', 'INTERVENTION 2: ', ' All Study Participants, TC Compression Image Sets', ' All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for FFDM screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.', 'Exclusion Criteria:', ' Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;', ' Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years ( 5 years) of the study exam date;', ' Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;', ' Are currently lactating; or', ' Have breast implants.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets', ' One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.', ' Time frame: Through study completion, on average 1 month', 'Results 1: ', ' Arm/Group Title: All Study Participants, PA Compression Image Sets', ' Arm/Group Description: All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%', 'Results 2: ', ' Arm/Group Title: All Study Participants, TC Compression Image Sets', ' Arm/Group Description: All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' ']}
|
4dfbdeba-cae0-48b2-a38d-07338512904e
|
Comparison
|
Results
|
NCT01097460
|
NCT01009918
|
Every patient in the primary trial and the secondary trial suffered at least 1 Treatment-emergent adverse event over a span of 2 years.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'Clinical Trial ID': 'NCT01097460', 'Intervention': ['INTERVENTION 1: ', ' MM-111 + Herceptin', ' MM-111 will be combined with Herceptin', ' MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)', ' Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy', " The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes", ' 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 (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1)', ' Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).', ' Patients should have a life expectancy of at least 12 weeks', ' Patients must have adequate bone marrow reserves', ' Patients must have adequate hepatic function', ' Patients must have adequate renal function', ' Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy.', ' Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-111.', 'Exclusion Criteria:', ' Patients who are pregnant or lactating', ' Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing.', ' Patients with untreated and/or symptomatic metastatic CNS malignancies.', ' Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin.', ' Patients who have received other recent antitumor therapy including:', ' Treatment with Herceptin within the 28 days prior to the first scheduled day of dosing with MM-111', " Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed.)", ' Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111', ' Patients who have previously received MM-111', ' Patients with NYHA Class III or IV congestive heart failure or LVEF < 50%', ' Patients with a history of allogeneic transplant', ' Patients with known HIV, hepatitis B or C (if patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial)', " Patients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results"], 'Results': ['Outcome Measurement: ', " Incidence of Treatment-emergent AE's", ' [Not Specified]', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: MM-111 + Herceptin', ' Arm/Group Description: MM-111 will be combined with Herceptin', ' MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/16 (12.50%)', ' PERICARDIAL EFFUSION * 1/16 (6.25%)', ' TRACHEAL OBSTRUCTION * 1/16 (6.25%)', ' PLEURAL EFFUSION * 1/16 (6.25%)', ' DEEP VEIN THROMBOSIS * 1/16 (6.25%)']}
|
{'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%)']}
|
62489179-bb30-4b96-a904-ea907dd05e23
|
Single
|
Eligibility
|
NCT01011946
|
All patients in the primary trial must have a bilateral breast mammography prior to study entry.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT01011946', 'Intervention': ['INTERVENTION 1: ', ' Positron Emission Mammography', ' Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).'], 'Eligibility': ['Inclusion Criteria:', ' Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).', 'Exclusion Criteria:', ' Children (<18 years old)', ' Pregnant or Lactating women', ' Diabetic patients (Type I or II)', ' Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM', ' Patients who have NOT undergone a standard of care bilateral breast MRI at UC.'], 'Results': ['Outcome Measurement: ', ' Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer', ' Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as "normal" or "abnormal". Lymph Node (LN) sampling and histopathology determined true positives and true negatives.', ' Time frame: PEM was performed prior to surgery and LN sampling immediately following surgery', 'Results 1: ', ' Arm/Group Title: Positron Emission Mammography', ' Arm/Group Description: Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: percentage of subjects Sensitivity: 83.3 (51.6 to 97.9)', ' Specificity: 52.0 (31.3 to 72.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45891239-bb78-4f83-8306-8edceb8247fe
|
|
Comparison
|
Intervention
|
NCT00258349
|
NCT01328249
|
Cohort 1 of the primary trial does not receive any Eribulin Mesylate or Vorinostat, whereas both cohorts in the secondary trial receive some of both.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT00258349', 'Intervention': ['INTERVENTION 1: ', ' Vorinostat +Trastuzumab', ' Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;', ' Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle'], 'Eligibility': ['Inclusion Criteria:', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No active or ongoing infection', ' No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat or other agents used in study', ' No psychiatric illness or social situation that would preclude study compliance', ' No other uncontrolled illness', ' More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1 week for capecitabine) and recovered', ' More than 3 weeks since prior radiotherapy and recovered', ' Recovered from prior therapy', ' At least 2 weeks since prior valproic acid', ' More than 4 weeks since prior investigational agents', ' More than 4 weeks since prior lapatinib ditosylate', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' Measurable disease, defined as >= 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan', ' No other concurrent investigational agents', ' Concurrent bisphosphonates allowed provided therapy was initiated prior to study treatment', ' No other concurrent anticancer therapy', ' Recurrent or progressive disease while receiving prior trastuzumab (Herceptin) (with or without chemotherapy) OR relapsed within 3 months of last dose of prior adjuvant trastuzumab for metastatic disease', ' Histologically confirmed breast cancer', ' Must overexpress HER-2 gene', ' Metastatic or chest wall recurrent disease', ' Site of measurable disease must not have been irradiated (except chest wall recurrence treated with adjuvant radiation therapy)', ' No untreated brain metastases', ' Previously treated brain metastasis responsive to radiotherapy and/or surgery allowed provided the brain is not the sole site of measurable disease', ' ECOG 0-2', ' Absolute neutrophil count >= 1,500/mm^3', ' Platelet count >= 100,000/mm^3', ' Hemoglobin >= 9 g/dL', ' AST and ALT =< 2 times upper limit of normal', " Bilirubin =< 1.5 mg/dL (3 mg/dL in the presence of Gilbert's disease provided direct bilirubin is normal)", ' Creatinine =< 1.5 mg/dL', ' LVEF normal by nuclear scan or echocardiogram', ' No evidence of PR prolongation or AV block by EKG', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia'], 'Results': ['Outcome Measurement: ', ' Response Rate', ' Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.', ' Time frame: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy', 'Results 1: ', ' Arm/Group Title: Vorinostat +Trastuzumab', ' Arm/Group Description: Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;', ' Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0 (0 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/9 (22.22%)', ' Thrombocytopenia 2/9 (22.22%)', ' Dyspnea 0/9 (0.00%)']}
|
{'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%)']}
|
9ec1e3f0-64a2-4629-aee8-cdb516fd27f3
|
Single
|
Eligibility
|
NCT00371254
|
Patients must have eceptorsestrogen receptor (ER) -, progesterone receptor (PR) - and human epidermal growth factor receptor 2 (HER2) - non metastatic breast cancer, aswell as not having Dysphagia.
|
Contradiction
|
[
0,
2,
8,
12
] |
[] |
{'Clinical Trial ID': 'NCT00371254', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib 100 mg BID', ' Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.', 'INTERVENTION 2: ', ' Dasatinib 70 mg BID', ' Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.'], 'Eligibility': ['Inclusion Criteria:', ' females, 18 or older', " recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer", ' paraffin-embedded tissue block must be available', ' measurable disease', ' prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)', ' 0, 1 or 2 chemotherapies in the metastatic setting', ' adequate organ function', 'Exclusion Criteria:', ' Metastatic disease confined to bone only', ' Symptomatic CNS metastasis', ' Concurrent medical condition which may increase the risk of toxicity', ' Unable to take oral medication'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Response (CR) or Partial Response (PR)', ' Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.', ' Time frame: Baseline to end of study drug therapy (up to 65 weeks).', 'Results 1: ', ' Arm/Group Title: Dasatinib 100 mg BID', ' Arm/Group Description: Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: participants 2', 'Results 2: ', ' Arm/Group Title: Dasatinib 70 mg BID', ' Arm/Group Description: Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/44 (31.82%)', ' MYOPERICARDITIS 1/44 (2.27%)', ' PERICARDIAL EFFUSION 2/44 (4.55%)', ' NAUSEA 1/44 (2.27%)', ' ASCITES 1/44 (2.27%)', ' VOMITING 2/44 (4.55%)', ' DYSPHAGIA 1/44 (2.27%)', ' CONSTIPATION 1/44 (2.27%)', ' ABDOMINAL PAIN 1/44 (2.27%)', ' PYREXIA 2/44 (4.55%)', ' GENERALISED OEDEMA 1/44 (2.27%)', ' GENERAL PHYSICAL HEALTH DETERIORATION 1/44 (2.27%)', ' INFECTION 1/44 (2.27%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
91f23b55-38b6-41c4-af30-baa15e989aa7
|
|
Single
|
Results
|
NCT00374322
|
the primary trial results show that Participants receiving lapatinib 1500 milligrams (mg) orally were twice as likely to achieve DFS at 5 years than placebo patients.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] |
[] |
{'Clinical Trial ID': 'NCT00374322', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib 1500 mg', ' Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.', 'INTERVENTION 2: ', ' Placebo', ' Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (TX or T1-4) of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor;', ' Had tumors that overexpress ErbB2 defined as 3+ by IHC or c-erbB2 gene amplification by FISH (ErbB2 expression/amplification must be documented prior to study entry; however, a tumor tissue sample must be sent to a central laboratory for subsequent re-analysis of ErbB2 status);', ' Have Stage I through Stage IIIc disease according to the American Joint Committee on Cancer (6th edition) staging criteria for breast cancer and meet one of the following criteria:', ' node-positive disease defined as: one positive lymph node by sentinel node biopsy OR at least 1 positive lymph node found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN1 or cN2 (if sentinel node biopsy is positive, subject may either undergo an axillary node dissection or radiotherapy to the axilla).', ' node-positive disease evaluated as: ipsilateral axillary lymph nodes cN0-2 by clinical evaluation and axillary lymph nodes pNX, pN0(i+), or pN1-3 by pathological evaluation [patients with pN3 (Stage IIIc disease) must be disease free following completion of neoadjuvant or adjuvant chemotherapy for at least 12 months and must not have been lost to follow up].', ' OR node-negative disease defined as: negative sentinel node biopsy OR no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN0.', ' node-negative disease categorized as: high-risk disease (tumor >2.0 cm if ER and/or progesterone receptor (PgR) positive disease is present or tumor >1.0 cm if ER and PgR negative disease) OR intermediate-risk disease (tumor 1.0-2.0 cm and ER and/or PgR positive disease).', ' Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible;', ' Have undergone either mastectomy OR lumpectomy;', ' Have received and completed treatment with a neoadjuvant or adjuvant chemotherapy regimen containing either an anthracycline or a taxane; or any cyclophosphamide, methotrexate and 5-fluorouracil (CMF) regimen;', ' May continue to receive endocrine therapy while taking study medication, if endocrine therapy was initiated as either adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer or for ovarian function suppression; however, endocrine therapy may not be initiated while taking study medication. Endocrine therapy agents may be switched while participating in this study (e.g., stop tamoxifen and start letrozole);', ' May have received prior radiotherapy as treatment for primary tumor; however, is not required for study entry;', ' May continue to receive radiotherapy while taking study medication, if radiotherapy was initiated as adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer;', ' May continue to receive bisphosphonates only for treatment of documented osteoporosis, but not as treatment or prophylaxis of bone metastases;', ' All women eligible for adjuvant treatment with trastuzumab, including those diagnosed and treated within the last six months, must be considered for such treatment prior to being offered participation in this study. Participation in this study will be allowed only if the physician and patient have considered and discussed at length the advantages of trastuzumab, but have mutually decided against initiating trastuzumab therapy.', ' Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry;', ' if signs or symptoms suggestive of either recurrence of disease or metastatic disease are present, the appropriate radiological imaging must be performed', ' if the following laboratory results are present, the appropriate radiological imaging must be performed:', ' for AST/ALT 2×ULN or ALP 2×ULN (not in the bone fraction), an abdominal CT or MRI must be done', ' for ALP 2×ULN in the bone fraction, a bone scan must be done; a confirmatory x-ray, CT scan or MRI scan or biopsy is required if the results of the bone scan are inconclusive', ' Have a unilateral/bilateral mammogram within 12 months prior to study entry;', ' Have an analysis of both ER and PgR on the primary tumor prior to study entry;', ' Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans;', ' Have an Eastern Cooperative Oncology Group Performance Status of 0 to 1;', ' Women with a history of non-breast malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Women with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin;', ' Are able to swallow and retain oral medication;', ' Have a paraffin-embedded tissue block from an archived tumor tissue from the primary tumor or twenty (20) slides of paraffin-embedded tissue available for biomarker analysis;', ' Have adequate organ function defined as: absolute neutrophil count 1.5× 10^9/L; hemoglobin 9 g/dL; platelets 75 × 10^9/L; albumin 2.5 g/dL; serum bilirubin 1.25 ×ULN; aspartate aminotransferase and alanine aminotransferase 3 × ULN and serum creatinine 2.0 mg/dL or calculated creatinine clearance 40 mL/min', ' Have signed the informed consent form (ICF);', ' Women of child-bearing potential must have a negative serum pregnancy test at screening and agree to complete abstinence from intercourse or consistent and correct use of an acceptable methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication:', 'Exclusion Criteria:', ' Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry;', ' Had metachronous invasive breast cancer (breast cancers diagnosed at different times);', ' Have a prior history of other breast cancer malignancies, including DCIS;', ' Are unable to provide archived tumor tissue samples for assay;', ' Had prior therapy with an ErbB1 and/or ErbB2 inhibitor; women who experienced a hypersensitivity or allergic reaction to trastuzumab during the first infusion and were unable to complete this infusion are eligible;', ' Receive concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication;', ' Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;', ' Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded;', " Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety;", ' Have an active or uncontrolled infection;', ' Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;', ' Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;', ' Are pregnant or breastfeeding;', ' Receive concurrent treatment with an investigational agent; women, who are in follow-up in another clinical trial where the primary endpoint has been met and the interval between assessments is 12 months and radiological imaging is not required at these assessments, are eligible;', ' Receive concurrent treatment with a selected list of strong inducers and inhibitors of CYP3A4;', ' Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;', ' Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients;'], 'Results': ['Outcome Measurement: ', ' Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])', ' DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.', ' Time frame: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])', 'Results 1: ', ' Arm/Group Title: Lapatinib 1500 mg', ' Arm/Group Description: Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 1571', ' Measure Type: Number', ' Unit of Measure: Participants Any recurrence or death: 252', ' Censored, New Anti-cancer Agent/Radiotherapy: 1', ' Censored, Follow-up Ended: 1318', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 1576', ' Measure Type: Number', ' Unit of Measure: Participants Any recurrence or death: 290', ' Censored, New Anti-cancer Agent/Radiotherapy: 1', ' Censored, Follow-up Ended: 1285'], 'Adverse Events': ['Adverse Events 1:', ' Total: 99/1573 (6.29%)', ' Neutropenia 2/1573 (0.13%)', ' Left ventricular dysfunction 3/1573 (0.19%)', ' Cardiac failure 0/1573 (0.00%)', ' Myocardial infarction 2/1573 (0.13%)', ' Acute myocardial infarction 0/1573 (0.00%)', ' Atrial fibrillation 0/1573 (0.00%)', ' Atrioventricular block first degree 1/1573 (0.06%)', ' Myocardial ischaemia 0/1573 (0.00%)', ' Pericardial effusion 1/1573 (0.06%)', 'Adverse Events 2:', ' Total: 78/1574 (4.96%)', ' Neutropenia 0/1574 (0.00%)', ' Left ventricular dysfunction 1/1574 (0.06%)', ' Cardiac failure 3/1574 (0.19%)', ' Myocardial infarction 0/1574 (0.00%)', ' Acute myocardial infarction 1/1574 (0.06%)', ' Atrial fibrillation 1/1574 (0.06%)', ' Atrioventricular block first degree 0/1574 (0.00%)', ' Myocardial ischaemia 1/1574 (0.06%)', ' Pericardial effusion 0/1574 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7eea6ac2-ef9a-4c3e-b14d-eb9671dab89d
|
|
Comparison
|
Eligibility
|
NCT02650193
|
NCT00656669
|
Patients with Class III obesity cannot be included in the primary trial, but can be entered into the secondary trial, as long as they do not have uncontrolled Hypertension.
|
Entailment
|
[
0,
15
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18
] |
{'Clinical Trial ID': 'NCT02650193', 'Intervention': ['INTERVENTION 1: ', ' Cycle 0: HSP-130 3mg', ' Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', 'INTERVENTION 2: ', ' Cycles 0: HSP-130 6mg', ' Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'], 'Eligibility': ['Inclusion Criteria:', ' A subject will be eligible for study participation if all of the following criteria are met at Screening:', ' Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities', ' Females 18 years', ' Histologically confirmed and documented invasive breast cancer', ' Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up', ' Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy', ' Zubrod/WHO/ECOG performance status 2', ' Adequate bone marrow, hepatic, and renal function reserve as evidenced by:', ' Hemoglobin 10 mg/dl', ' ANC 1.5 x 10^9/L', ' Platelet count of 100 x 10^9/L', ' Total bilirubin 2 mg/dl', ' Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3 x the upper limit of normal (ULN) of the reference lab', ' Serum creatinine of 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of 60 mg/min', ' Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive', ' Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study', ' Medically acceptable forms of birth control can include, with approval of the treating physician:', ' Barrier methods (condom or diaphragm with spermicide)', ' Intrauterine device (IUD)', ' Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)', ' Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit', ' Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study', 'Exclusion Criteria:', ' A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:', ' Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF', ' Prior autologous stem cell harvest of any type', ' Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents', ' Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin', ' For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction', ' Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years', ' Known HER2 + ( overexpressing breast cancer)', ' Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer', ' Grade 2 underlying neuropathy', ' Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections', ' Treatment with systemically active antibiotics within 72 hours before chemotherapy', ' Known infection with HIV', ' Known sickle cell disease', ' Known severe persistent drug-induced myelosuppression', ' New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130', ' Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130', ' Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product', ' Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study', ' Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130', ' Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication'], 'Results': ['Outcome Measurement: ', ' Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0', " Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", ' Time frame: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'Results 1: ', ' Arm/Group Title: Cycle 0: HSP-130 3mg', ' Arm/Group Description: Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: hour*10^9 Neutrophils per Liter 3900.482 (683.6870)', 'Results 2: ', ' Arm/Group Title: Cycles 0: HSP-130 6mg', ' Arm/Group Description: Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: hour*10^9 Neutrophils per Liter 5880.985 (1287.2887)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * 0/6 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00656669', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib Monotherapy', ' Patients who completed the Sunitinib monotherapy segment'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.', ' Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).', ' Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.', ' Male or female, 18 years of age or older.', ' ECOG performance status 0 or 1.', ' Adequate organ function as defined in the protocol.', 'Exclusion Criteria:', ' Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.', ' Metastatic (Stage IV) breast cancer', ' Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.', ' Current therapeutic treatment on another clinical trial with an investigational agent.', ' Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus', ' Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.', ' Hypertension that cannot be controlled by medications.', ' Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.', ' Known human immunodeficiency virus (HIV) infection.', ' Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.'], 'Results': ['Outcome Measurement: ', ' Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy', ' Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.', ' Time frame: baseline through end of segment 1 (2 weeks)', 'Results 1: ', ' Arm/Group Title: Sunitinib Monotherapy', ' Arm/Group Description: Patients who completed the Sunitinib monotherapy segment', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: mm Hg 14.0 (12.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)', ' LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)', ' NAUSEA *0/23 (0.00%)', ' VOMITING *0/23 (0.00%)', ' BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)', ' INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)', ' NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)']}
|
a2d489d5-3677-43ef-b03a-33d571c0c3b2
|
Comparison
|
Adverse Events
|
NCT00423917
|
NCT00082641
|
the primary trial and the secondary trial both report cases of confusion in their patient cohorts.
|
Entailment
|
[
0,
5
] |
[
0,
7,
8,
15
] |
{'Clinical Trial ID': 'NCT00423917', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Bevacizumab', ' Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed breast cancer', ' Metastatic disease', ' Must have received an aromatase inhibitor (e.g., letrozole, anastrozole, or exemestane) in an adjuvant or metastatic setting', ' If tumor is HER2 positive (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) the patient must have received 1 prior trastuzumab (Herceptin®)-containing regimen unless there is a contraindication to trastuzumab', ' Measurable or nonmeasurable disease, including any of the following :', ' Bone metastasis', ' Pleural/pericardial effusion', ' Ascites', ' Inflammatory skin changes', ' No microscopic residual disease only', ' Enrolled on or refused enrollment on clinical trial NCCTG-N0392', ' No evidence of active brain metastasis including leptomeningeal involvement', ' CNS metastasis controlled (i.e., at least 2 months of no symptoms or evidence of progression) by prior surgery and/or raditherapy are allowed', ' Hormone receptor status:', ' Estrogen and/or progesterone receptor-positive tumor', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Female patients must be post-menopausal based on any 1 of the following criteria:', ' Age 60 years', ' Age 45 years with last menstrual period 12 months prior to study entry', ' Estradiol and follicle-stimulating hormone levels in postmenopausal range', ' History of bilateral oophorectomy', ' ECOG performance status 0-2', ' Life expectancy > 3 months', ' Fertile patients must use effective contraception during and for 30 days after completion of study treatment', ' WBC 3,000 mg/dL', ' Hemoglobin > 8 g/dL', ' Absolute neutrophil count > 1,000/mm³', ' Platelet count 100,000/mm³', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN', ' AST and ALT 2.5 times ULN', ' Creatinine 1.5 times ULN', ' Urine protein < 1+ OR < 1 g of protein by 24-hour urine collection', ' No nephrotic syndrome', ' No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart)', ' Patients who have recently started or adjusted antihypertensive medications are eligible provided BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days', ' No clinically significant cardiac disease, including any of the following:', ' Congestive heart failure', ' Symptomatic coronary artery disease', ' Unstable angina', ' Cardiac arrhythmias not well controlled with medication', ' Myocardial infarction within the past 12 months', ' No arterial or venous thrombosis within the past 12 months', ' No hemoptysis or gastrointestinal hemorrhage within the past 6 months', ' No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks', ' No significant traumatic injury within the past 4 weeks', ' No active, unresolved infection', ' No history of hypertensive crisis or hypertensive encephalopathy', ' No history of bleeding diathesis or uncontrolled coagulopathy', ' No history of cerebrovascular accident, hemorrhage, or stroke', ' No allergy or hypersensitivity to drug product excipients, murine antibodies, or agents chemically similar to study drugs', ' No other malignancy within the past 3 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No other serious medical condition that would preclude study therapy or compliance', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Prior radiotherapy to a target lesion allowed provided there has been clear progression since radiotherapy was completed', ' At least 4 weeks since prior radiotherapy', ' Single-dose radiation for palliation or to a nontarget lesion only allowed within the past 4 weeks', ' No more than 1 prior chemotherapy regimen for metastatic disease', ' No more than 2 prior endocrine (hormonal) therapy regimens in the neoadjuvant, adjuvant, or metastatic setting', ' At least 4 weeks since prior major surgery or open biopsy', ' At least 4 weeks since prior chemotherapy or immunologic therapy', ' At least 2 weeks since prior and no concurrent use of any of the following agents:', ' Aspirin (daily low-dose [81 mg] aspirin allowed])', ' Thrombolytic agents', ' Anticoagulants (low-dose anticoagulation therapy to maintain patency of a vascular access device is allowed)', ' No concurrent treatment in another clinical study with investigational procedures or investigational therapies', ' No other concurrent anticancer therapy, including chemotherapy, biologic agents, or radiotherapy', ' No routine use of granulocyte colony-stimulating factors during course 1', ' No concurrent oprelvekin'], 'Results': ['Outcome Measurement: ', ' Six-month Progression-free Survival (PFS) Rate at 6 Months', ' The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 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. Additionally, if some patients are lost to follow-up not having been observed for at least 6 months, an estimate and 95% confidence interval for the 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. 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: at 6 months', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Bevacizumab', ' Arm/Group Description: Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: percentage of patients 39 (23 to 58)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/33 (12.12%)', ' Diarrhea 1/33 (3.03%)', ' Intracranial hemorrhage 1/33 (3.03%)', ' Ischemia cerebrovascular 1/33 (3.03%)', ' Confusion 1/33 (3.03%)', ' Skin disorder 1/33 (3.03%)']}
|
{'Clinical Trial ID': 'NCT00082641', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).', ' autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules', 'INTERVENTION 2: ', ' Arm II', ' Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.', ' autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer meeting the following criteria:', ' Clinically locally advanced disease (stage III) with a primary tumor at least 4 cm by mammogram, ultrasound, or palpation AND/OR palpable axillary nodes larger than 1 cm', ' Planned neoadjuvant chemotherapy', ' p53-overexpressing tumor by immunohistochemistry', ' Delayed-type hypersensitivity to at least 1 of 3 standard antigens', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 19 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' ECOG 0-1', ' Life expectancy', ' Not specified', ' Hematopoietic', ' WBC > 4,000/mm^3', ' Platelet count > 100,000/mm^3', ' Hepatic', ' Bilirubin < 2 times upper limit of normal (ULN)', ' Hepatitis B surface antigen negative', ' Hepatitis C antibody negative', ' Renal', ' Creatinine < 2 times ULN', ' Immunologic', ' HIV negative', ' No prior or concurrent autoimmune disorder', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for at least 6 months after study participation', ' No other concurrent illness that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' See Disease Characteristics', ' No prior chemotherapy', ' Endocrine therapy', ' Not specified', ' Radiotherapy', ' Not specified', ' Surgery', ' See Disease Characteristics', ' Other', ' No concurrent participation in another therapeutic clinical trial'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Experienced Toxicity to the Vaccine', ' This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.', ' Time frame: 1 week after each vaccine dose.', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).', ' autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Arm II', ' Arm/Group Description: Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.', ' autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/11 (45.45%)', ' Nausea 1/11 (9.09%)', ' Vomiting 1/11 (9.09%)', ' Fever 1/11 (9.09%)', ' skin infection [1]1/11 (9.09%)', ' Hip fracture 0/11 (0.00%)', ' Confusion 1/11 (9.09%)', 'Adverse Events 2:', ' Total: 1/12 (8.33%)', ' Nausea 0/12 (0.00%)', ' Vomiting 0/12 (0.00%)', ' Fever 0/12 (0.00%)', ' skin infection [1]0/12 (0.00%)', ' Hip fracture 1/12 (8.33%)', ' Confusion 0/12 (0.00%)']}
|
943ff737-4edd-4dbd-a3c9-213e3e0234d8
|
Single
|
Eligibility
|
NCT01042938
|
Only patients capable of understanding english are eligible for the primary trial.
|
Entailment
|
[
0,
11
] |
[] |
{'Clinical Trial ID': 'NCT01042938', 'Intervention': ['INTERVENTION 1: ', ' Curcumin C3 Complex', ' Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).', 'INTERVENTION 2: ', ' Placebo', ' Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.', ' Participants must be at least 21 years of age.', ' Participants must not be pregnant.', ' Participants can be from any racial or ethnic origin.', ' Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.', ' Participants with in situ breast cancer are eligible.', ' Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible.', ' Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation.', ' A time period of three weeks must elapse after chemotherapy and surgery before beginning the study.', ' The total dose prescribed to the whole breast should be 50 Gy or greater.', ' Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English).', ' Participants must be able to swallow medication.', ' Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically.', ' Participant must give informed consent.', 'Exclusion Criteria:', ' Patients with bilateral breast cancer are not eligible.', ' Patients who have had previous radiation therapy to the breast or chest are not eligible.', ' Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible.', ' Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible.', ' Patients cannot have had breast reconstructions, implants, and/or expanders.', ' Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible.', ' Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible.', ' Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN).'], 'Results': ['Outcome Measurement: ', ' Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients', ' The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.', ' Time frame: 4-7 weeks (prescribed course of radiation)', 'Results 1: ', ' Arm/Group Title: Curcumin C3 Complex', ' Arm/Group Description: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).', ' Overall Number of Participants Analyzed: 14', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.6 (0.994)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).', ' Overall Number of Participants Analyzed: 16', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 3.4 (0.554)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
be50c45f-ec51-40c8-904f-ffc200d39d9d
|
|
Comparison
|
Intervention
|
NCT04030104
|
NCT02525718
|
Intervention 1 for the secondary trial and the primary trial either include no treatment at all, or a placebo.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT04030104', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)', ' Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol', ' Patient age, indication for study entry and available medical history', ' Evaluable mammograms and OA and IUS video loops and stills for each mass', 'Exclusion Criteria:', ' Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers', ' Reader-02 Proficiency Test and training cases'], 'Results': ['Outcome Measurement: ', ' Gain in Specificity at Fixed 98% Sensitivity (fSp)', ' Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 38.22 (24.85 to 51.59)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 47.20 (35.91 to 58.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/480 (0.42%)', ' Device breakage [1]1/480 (0.21%)', ' Lung cancer [2]1/480 (0.21%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT02525718', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)', 'INTERVENTION 2: ', ' 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone', ' Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.', ' Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.', '(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.'], 'Eligibility': ['Inclusion Criteria:', ' Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.', 'Exclusion Criteria:', ' Patients under the age of 18, or over the age of 79', ' Allergy to local anesthetics or corticosteroids', ' Patients with history of chronic pain or with chronic use of opioid analgesics', ' Patients with history of lung disease or prior anterior thoracotomy or median sternotomy'], 'Results': ['Outcome Measurement: ', ' Quality of Recovery Score', ' The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:', ' Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.', ' PMID: 10740540', ' Time frame: 24 hours post-operatively', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)', ' Overall Number of Participants Analyzed: 22', ' Median (Inter-Quartile Range)', ' Unit of Measure: score on a scale 165 (143 to 179)', 'Results 2: ', ' Arm/Group Title: 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone', ' Arm/Group Description: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.', ' Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.', '(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.', ' Overall Number of Participants Analyzed: 23', ' Median (Inter-Quartile Range)', ' Unit of Measure: score on a scale 169 (155 to 182)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/22 (0.00%)', 'Adverse Events 2:', ' Total: 0/23 (0.00%)']}
|
f53c8212-6da8-470f-a392-1bb037ed90e8
|
Single
|
Results
|
NCT02622074
|
There were twice as many patients with DLT in cohort 2 of the primary trial than in cohort 1.
|
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,
24,
25,
26,
27
] |
[] |
{'Clinical Trial ID': 'NCT02622074', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: KNp / KAC', ' Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.', 'INTERVENTION 2: ', ' Cohort B: KNpCb (Regimen 1) / KAC', ' Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Has previously untreated, locally advanced TNBC.', ' Is able to provide 2 core needle biopsies from the primary tumor at screening to the central laboratory and agrees to have a core needle biopsy after single dose pembrolizumab treatment if tumor biopsy is feasible as judged by the investigator.', ' Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Has adequate organ function.', ' Females of childbearing potential must be willing to use adequate contraception for the course of the study through 12 months after the last dose of study drug for participants receiving cyclophosphamide and through 6 months after the last dose of study drug for participants who do not receive cyclophosphamide.', 'Exclusion Criteria:', ' Has evidence of metastatic breast cancer, concurrent bilateral invasive breast cancer, or inflammatory breast cancer.', ' Has another malignancy within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative surgery, or in situ cervical cancer.', ' Has received prior chemotherapy, targeted therapy, radiation therapy, immunotherapy that targets immune checkpoints, co-stimulatory or co-inhibitory pathways for T cell receptors within the past 12 months.', ' Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.', ' Has received a live vaccine within 30 days of the first dose of study drug.', ' Has an active autoimmune disease that has required systemic treatment in past 2 years.', ' Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.', ' Has a known history of Human Immunodeficiency Virus (HIV).', ' Has known active Hepatitis B or Hepatitis C.', ' Has evidence of current pneumonitis.', ' Has a history of non-infectious pneumonitis requiring treatment with steroids or a history of interstitial lung disease.', ' Has an active infection requiring systemic therapy.', ' Has significant cardiovascular disease, such as: History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months; Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV', ' Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.', ' Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of trial treatment for participants who have received cyclophosphamide, and for six months after the last dose of study medication for participants who have not.', ' Has a known hypersensitivity to the components of the study drug or its analogs.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)', ' The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:', ' Hematologic:', ' Grade 4 neutropenia lasting 8 days;', ' Febrile neutropenia Grade 3 or Grade 4; or', ' Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding', ' Non-hematologic:', ' Grade 4 toxicity;', ' Grade 3 symptomatic hepatic toxicities lasting >48 hours, or Grade 3 asymptomatic hepatic toxicities lasting 7 days; or', ' Grade 3 non-hematologic, non-hepatic organ toxicity, with exceptions', ' Other:', ' Any treatment delays for 14 days due to unresolved toxicity;', ' Grade 5 treatment-related adverse event (AE);', ' A dose reduction of study treatment during the DLT evaluation period.', ' Time frame: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.', 'Results 1: ', ' Arm/Group Title: Cohort A: KNp / KAC', ' Arm/Group Description: Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 20.0%', 'Results 2: ', ' Arm/Group Title: Cohort B: KNpCb (Regimen 1) / KAC', ' Arm/Group Description: Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 40.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/10 (50.00%)', ' Anaemia 0/10 (0.00%)', ' Febrile neutropenia 1/10 (10.00%)', ' Lymphadenitis 0/10 (0.00%)', ' Neutropenia 0/10 (0.00%)', ' Abdominal pain upper 0/10 (0.00%)', ' Colitis 0/10 (0.00%)', ' Diarrhoea 0/10 (0.00%)', ' Nausea 1/10 (10.00%)', ' Oesophagitis 0/10 (0.00%)', ' Pyrexia 0/10 (0.00%)', ' Autoimmune hepatitis 0/10 (0.00%)', ' Influenza 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 4/10 (40.00%)', ' Anaemia 0/10 (0.00%)', ' Febrile neutropenia 2/10 (20.00%)', ' Lymphadenitis 0/10 (0.00%)', ' Neutropenia 1/10 (10.00%)', ' Abdominal pain upper 0/10 (0.00%)', ' Colitis 0/10 (0.00%)', ' Diarrhoea 0/10 (0.00%)', ' Nausea 0/10 (0.00%)', ' Oesophagitis 0/10 (0.00%)', ' Pyrexia 1/10 (10.00%)', ' Autoimmune hepatitis 0/10 (0.00%)', ' Influenza 0/10 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7b7e6e8b-aa62-4fcd-af1e-c243995243d1
|
|
Single
|
Results
|
NCT02162719
|
the primary trial does not investigate the effects of its intervention on patient tpCR.
|
Entailment
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT02162719', 'Intervention': ['INTERVENTION 1: ', ' Ipatasertib and Paclitaxel', ' Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', 'INTERVENTION 2: ', ' Placebo and Paclitaxel', ' Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization', ' Measurable disease, according to the RECIST v1.1', ' Adequate hematologic and organ function within 14 days before the first study treatment', ' For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment', 'Exclusion Criteria:', ' Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent', ' Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1', ' Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer', ' Previous therapy with Akt, PI3K, and/or mTOR inhibitors', ' Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study', ' Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.', ' Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)', 'Results 1: ', ' Arm/Group Title: Ipatasertib and Paclitaxel', ' Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 6.18 (4.57 to 7.33)', 'Results 2: ', ' Arm/Group Title: Placebo and Paclitaxel', ' Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 4.93 (3.58 to 5.36)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/61 (29.51%)', ' Pancytopenia 0/61 (0.00%)', ' Febrile Neutropenia 2/61 (3.28%)', ' Constipation 0/61 (0.00%)', ' Diarrhoea 3/61 (4.92%)', ' Nausea 1/61 (1.64%)', ' Pancreatitis 1/61 (1.64%)', ' Death 0/61 (0.00%)', ' Pyrexia 2/61 (3.28%)', ' Cholestasis 0/61 (0.00%)', ' Atypical Pneumonia 1/61 (1.64%)', ' Cystitis 0/61 (0.00%)', ' Gastroenteritis 0/61 (0.00%)', ' Influenza 0/61 (0.00%)', 'Adverse Events 2:', ' Total: 12/62 (19.35%)', ' Pancytopenia 1/62 (1.61%)', ' Febrile Neutropenia 0/62 (0.00%)', ' Constipation 1/62 (1.61%)', ' Diarrhoea 0/62 (0.00%)', ' Nausea 0/62 (0.00%)', ' Pancreatitis 0/62 (0.00%)', ' Death 1/62 (1.61%)', ' Pyrexia 1/62 (1.61%)', ' Cholestasis 1/62 (1.61%)', ' Atypical Pneumonia 0/62 (0.00%)', ' Cystitis 1/62 (1.61%)', ' Gastroenteritis 1/62 (1.61%)', ' Influenza 1/62 (1.61%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
74a53536-bb9d-4c64-9280-679d7b660cdd
|
|
Single
|
Adverse Events
|
NCT00728949
|
There were 6 adverse event categories for cohort 1 of the primary trial which recorded at least three cases.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT00728949', 'Intervention': ['INTERVENTION 1: ', ' IMC-A12 (Cixutumumab) + Antiestrogen Therapy', ' Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.', 'INTERVENTION 2: ', ' IMC-A12 (Cixutumumab)', ' Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' The patient has histologically or cytologically-confirmed invasive breast cancer, which at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is not required if clinical evidence of stage IV disease recurrence is available', ' Tumors are positive for estrogen receptors (ER), progesterone receptors (PgR), or both (ie, 10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR; positive biochemical test results are also acceptable)', ' The patient has received prior antiestrogen therapy:', ' With at least one antiestrogen agent (with or without ovarian suppression) administered for 3 months in the adjuvant or metastatic setting; and', ' Experienced disease progression while on or within 12 months after receiving the last dose of endocrine therapy', ' The patient is postmenopausal and/or meets at least one of the following criteria:', ' Age 18 years with an intact uterus and amenorrhea for 12 months, with estradiol and/or follicle-stimulating hormone (FSH) values in the postmenopausal range', ' History of bilateral oophorectomy', ' History of bilateral salpingo-oophorectomy', ' History of radiation castration and amenorrheic for 3 months', ' The patient has fasting serum glucose < 120 mg/dL or below the ULN', 'Exclusion Criteria:', ' The patient has received more than two regimens of prior chemotherapy in the metastatic (or locally advanced and inoperable breast cancer) and adjuvant setting', ' The patient has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting glucose at study entry < 120 mg/dL or below ULN) and that they are on a stable dietary and/or therapeutic regimen for this condition', ' The patient is known to be positive for infection with the human immunodeficiency virus'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. 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 unequivocal progression of non-target lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS will be estimated following the Kaplan-Meier method.', ' Time frame: From randomization up to 35.1 Months', 'Results 1: ', ' Arm/Group Title: IMC-A12 (Cixutumumab) + Antiestrogen Therapy', ' Arm/Group Description: Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: months 2.0 (1.9 to 3.4)', 'Results 2: ', ' Arm/Group Title: IMC-A12 (Cixutumumab)', ' Arm/Group Description: Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).', ' Overall Number of Participants Analyzed: 31', ' Median (90% Confidence Interval)', ' Unit of Measure: months 3.1 (1.9 to 4.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/56 (28.57%)', ' Pancytopenia 0/56 (0.00%)', ' Pericarditis 0/56 (0.00%)', ' Abdominal pain 1/56 (1.79%)', ' Anal fissure 1/56 (1.79%)', ' Ascites 1/56 (1.79%)', ' Constipation 0/56 (0.00%)', ' Diarrhoea 1/56 (1.79%)', ' Nausea 0/56 (0.00%)', ' Oesophageal pain 0/56 (0.00%)', ' Vomiting 0/56 (0.00%)', ' Disease progression 2/56 (3.57%)', ' Infusion related reaction 1/56 (1.79%)', ' Pain 0/56 (0.00%)', 'Adverse Events 2:', ' Total: 11/37 (29.73%)', ' Pancytopenia 1/37 (2.70%)', ' Pericarditis 1/37 (2.70%)', ' Abdominal pain 2/37 (5.41%)', ' Anal fissure 0/37 (0.00%)', ' Ascites 0/37 (0.00%)', ' Constipation 1/37 (2.70%)', ' Diarrhoea 1/37 (2.70%)', ' Nausea 2/37 (5.41%)', ' Oesophageal pain 1/37 (2.70%)', ' Vomiting 2/37 (5.41%)', ' Disease progression 2/37 (5.41%)', ' Infusion related reaction 0/37 (0.00%)', ' Pain 1/37 (2.70%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6b35c306-a699-44f2-8606-a58d58fc18f3
|
|
Comparison
|
Intervention
|
NCT00784849
|
NCT02104895
|
Breast breast irradiation is used in some form for both cohorts of the secondary trial, but not at all in the primary trial.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT00784849', 'Intervention': ['INTERVENTION 1: ', ' Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue', ' One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes'], 'Eligibility': ['Inclusion Criteria:', ' Stage 0,I, II breast cancer', ' Clinical node status N0, N1', ' No know allergy to iodine, lymphazurin or methylene blue dyes', 'Exclusion Criteria:', ' Patient cannot be pregnant or nursing', ' Prisoners will not be eligible', ' Women under the age of 18 will not be eligible', ' Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes'], 'Results': ['Outcome Measurement: ', ' The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)', ' [Not Specified]', ' Time frame: intraoperatively; up to 6 hours', 'Results 1: ', ' Arm/Group Title: Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue', ' Arm/Group Description: One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Number', ' Unit of Measure: participants Radioactive: 58', ' Blue: 55', ' Radioactive and Blue: 55', ' Efferent blue lymphatics leading up to the SLN: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/62 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02104895', 'Intervention': ['INTERVENTION 1: ', ' Whole Breast Irradiation (WBI)', ' Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', 'INTERVENTION 2: ', ' Partial Breast Irradiation (APBI)', ' Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Age at presentation >40 y', ' Tumor size <25 mm', ' Wide excision or quadrantectomy with clear margins (>5 mm)', ' Clips placed in tumor bed', ' Full informed consent from patient', 'Exclusion Criteria:', ' Cardiac dysfunction', ' Forced expiratory volume in 1 second (FEV1) <1 L/m', ' Extensive intraductal carcinoma', ' Multifocal cancer', ' Psychiatric problems', ' Recurrent breast cancer'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Breast Tumor Recurrence', ' We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"', 'Time frame: 5-year', 'Results 1: ', ' Arm/Group Title: Whole Breast Irradiation (WBI)', ' Arm/Group Description: Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.4', 'Results 2: ', ' Arm/Group Title: Partial Breast Irradiation (APBI)', ' Arm/Group Description: Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/260 (0.00%)', 'Adverse Events 2:', ' Total: 0/246 (0.00%)']}
|
62f50fe5-a83d-4f07-9dc7-8f495254d398
|
Single
|
Eligibility
|
NCT00121134
|
the primary trial requires participants to have a primary tumor > 5cm in longest dimension.
|
Contradiction
|
[
0,
3
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
edcae553-8a0a-45d2-a0fa-4db68608ef03
|
|
Single
|
Intervention
|
NCT00748553
|
Patients in the primary trial receive 5 doses of Azacitidine (Vidaza) every month and 3 doses of Nab-paclitaxel (Abraxane) per month.
|
Entailment
|
[
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': ''}
|
a1b3667f-bfa5-426a-975a-20ed350c12c0
|
|
Single
|
Results
|
NCT02915744
|
The difference in median, maximum and minimum Overall Survival (OS) of Patients between the two cohort of the primary trial was less than one month.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT02915744', 'Intervention': ['INTERVENTION 1: ', ' NKTR-102', ' In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.', 'INTERVENTION 2: ', " Treatment of Physician's Choice (TPC)", ' In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.'], 'Eligibility': ['Inclusion Criteria:', ' Female or male, age 18 years.', ' Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1.1.', ' Patients must have a history of brain metastases that are non-progressing.', ' For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted agents may be required.', ' Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).', ' Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.', ' All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).', ' Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.', ' Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.', ' Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.', 'Exclusion Criteria:', ' Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.', ' High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic).', ' Major surgery within 28 days prior to randomization.', ' Concomitant use of any anticancer therapy or use of any investigational agent(s).', ' Received prior treatment for cancer with a camptothecin-derived agent.', ' Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis.', ' Chronic or acute GI disorders resulting in diarrhea of any severity grade.', ' Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.', ' Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.', ' Hepatitis B or C, tuberculosis, or HIV.', ' Cirrhosis.', ' Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.', ' Daily use of oxygen supplementation.', ' Significant known cardiovascular impairment.', ' Prior treatment with NKTR-102.', ' Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.', ' Known intolerance or hypersensitivity to any of the products used in this study or their excipients.', ' For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Overall Survival (OS) of Patients', " To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.", ' Time frame: Within 3 years from study start', 'Results 1: ', ' Arm/Group Title: NKTR-102', ' Arm/Group Description: In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.', ' Overall Number of Participants Analyzed: 92', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.8 (6.1 to 10.2)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice (TPC)", ' Arm/Group Description: In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.', ' Overall Number of Participants Analyzed: 86', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.5 (5.8 to 10.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 33/90 (36.67%)', ' Febrile Neutropenia Grade 3 0/90 (0.00%)', ' Atrial Fibrillation Grade 3 1/90 (1.11%)', ' Cardiac Tamponade Grade 4 0/90 (0.00%)', ' Blindness Grade 3 0/90 (0.00%)', ' Colitis Grade 2 1/90 (1.11%)', ' Esophagitis Grade 3 1/90 (1.11%)', ' Vomiting Grade 2 3/90 (3.33%)', ' Diarrhea Grade 3 5/90 (5.56%)', ' Intestinal Obstruction Grade 3 1/90 (1.11%)', 'Adverse Events 2:', ' Total: 24/77 (31.17%)', ' Febrile Neutropenia Grade 3 1/77 (1.30%)', ' Atrial Fibrillation Grade 3 0/77 (0.00%)', ' Cardiac Tamponade Grade 4 1/77 (1.30%)', ' Blindness Grade 3 1/77 (1.30%)', ' Colitis Grade 2 0/77 (0.00%)', ' Esophagitis Grade 3 0/77 (0.00%)', ' Vomiting Grade 2 1/77 (1.30%)', ' Diarrhea Grade 3 0/77 (0.00%)', ' Intestinal Obstruction Grade 3 0/77 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
903617fa-7c40-45ac-a03c-498f51879408
|
|
Single
|
Adverse Events
|
NCT00171314
|
There are four types of adverse events in the primary trial, for which one occurence is recorded.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00171314', 'Intervention': ['INTERVENTION 1: ', ' Upfront Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', 'INTERVENTION 2: ', ' Delayed Zoledronic Acid', ' Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.'], 'Eligibility': ['Inclusion Criteria:', ' Stage I-IIIa breast cancer', ' Postmenopausal', ' Recent surgery for breast cancer', 'Exclusion Criteria:', ' Metastatic disease', ' Invasive bilateral disease', ' Clinical or radiological evidence of existing fracture in spine or hip', ' Other protocol-defined inclusion / exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy', ' Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.', ' Time frame: From Baseline - 12 months', 'Results 1: ', ' Arm/Group Title: Upfront Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 254', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change 2.680 (2.8451)', 'Results 2: ', ' Arm/Group Title: Delayed Zoledronic Acid', ' Arm/Group Description: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 269', ' Mean (Standard Deviation)', ' Unit of Measure: Percent Change -3.314 (3.9632)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/254 (18.50%)', ' Anaemia 1/254 (0.39%)', ' Febrile neutropenia 1/254 (0.39%)', ' Lymphadenopathy 1/254 (0.39%)', ' Acute myocardial infarction 1/254 (0.39%)', ' Angina pectoris 0/254 (0.00%)', ' Angina unstable 0/254 (0.00%)', ' Bundle branch block left 0/254 (0.00%)', ' Cardiac failure 4/254 (1.57%)', ' Coronary artery disease 0/254 (0.00%)', ' Coronary artery stenosis 1/254 (0.39%)', 'Adverse Events 2:', ' Total: 56/269 (20.82%)', ' Anaemia 1/269 (0.37%)', ' Febrile neutropenia 0/269 (0.00%)', ' Lymphadenopathy 0/269 (0.00%)', ' Acute myocardial infarction 0/269 (0.00%)', ' Angina pectoris 3/269 (1.12%)', ' Angina unstable 1/269 (0.37%)', ' Bundle branch block left 1/269 (0.37%)', ' Cardiac failure 1/269 (0.37%)', ' Coronary artery disease 1/269 (0.37%)', ' Coronary artery stenosis 0/269 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9436e18a-a055-41c3-980f-bf451b4da7ee
|
|
Comparison
|
Adverse Events
|
NCT01201265
|
NCT00932373
|
1 patient in the primary trial was affected by Sepsis, and several were affected in the secondary trial.
|
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,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29
] |
{'Clinical Trial ID': 'NCT01201265', 'Intervention': ['INTERVENTION 1: ', ' All Participants', ' Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants, >/= 18 years of age', ' Metastatic breast cancer', ' Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease', ' Treatment-naïve for metastatic breast cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Adequate hematological, renal and liver function', ' Patients should have received Anthracyclines and Taxanes in the adjuvant setting', ' Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products', 'Exclusion Criteria:', ' Prior first line treatment for metastatic breast cancer', ' Central nervous system (CNS) metastasis', ' Uncontrolled hypertension (> 170/95 mmHg)', ' Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline', ' Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.', ' Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)', ' Requirement of chronic use of immunosuppressive agents', ' HIV, hepatitis B or hepatitis C infection'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.', ' Time frame: From the date of registration until the disease progression or death (up to 1541 days).', 'Results 1: ', ' Arm/Group Title: All Participants', ' Arm/Group Description: Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: days 255 (157 to 465)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/40 (42.50%)', ' Anaemia 2/40 (5.00%)', ' Febrile Neutropenia 3/40 (7.50%)', ' Neutropenia 2/40 (5.00%)', ' Thrombocytopenia 5/40 (12.50%)', ' Pericardial Effusion 1/40 (2.50%)', ' Abdominal Pain Lower 1/40 (2.50%)', ' Disease Progression 6/40 (15.00%)', ' Fatigue 1/40 (2.50%)', ' Pyrexia 3/40 (7.50%)', ' Septic Shock 1/40 (2.50%)', ' Streptococcal Infection 1/40 (2.50%)']}
|
{'Clinical Trial ID': 'NCT00932373', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks', ' Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks', 'INTERVENTION 2: ', ' Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks', ' Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented, incurable, locally advanced or metastatic breast cancer', ' Evaluable or measurable HER2-positive disease', ' History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer', ' Previous treatment with chemotherapy for MBC', ' Granulocyte count 1,500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL', ' Serum bilirubin 1.5 mg/dL; AST, ALT, and alkaline phosphatase 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN', ' Serum creatinine 1.5 mg/dL or creatinine clearance of 60 mL/min based on a 24-hour urine collection', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2', ' Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment', 'Exclusion Criteria:', ' History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication', ' History of Grade 3 hypersensitivity reaction to trastuzumab', ' History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued', ' Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment', ' Require supplemental oxygen for daily activities', ' Grade 2 peripheral neuropathy', ' Bisphosphonate therapy for symptomatic hypercalcemia', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment', ' Any experimental therapy within 4 weeks of first study treatment', ' Any major surgical procedure within 4 weeks of first study treatment', ' History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis', ' Pregnancy or lactation', ' Cardiac troponin I 0.2 ng/mL', ' Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan', ' Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment', ' The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.', ' The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.', ' Time frame: Study treatment initiation until 30 or 90 days after last administration of study treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks', ' Arm/Group Description: Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: percentage of participants At least 1 AE: 100', 'AEs with Grade >=3: 33.3', ' At least 1 SAE: 33.3', ' AEs related to treatment: 66.7', 'Results 2: ', ' Arm/Group Title: Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks', ' Arm/Group Description: Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: percentage of participants At least 1 AE: 100', 'AEs with Grade >=3: 100', ' At least 1 SAE: 100', ' AEs related to treatment: 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Pain 0/3 (0.00%)', ' Cellulitis 0/3 (0.00%)', ' Influenza 0/3 (0.00%)', ' Osteomyelitis 0/3 (0.00%)', ' Pneumonia 0/3 (0.00%)', ' Humerus Fracture 0/3 (0.00%)', ' Brain Oedema 0/3 (0.00%)', ' Cerebral Haemorrhage 0/3 (0.00%)', ' Convulsion 0/3 (0.00%)', ' Dysarthria 0/3 (0.00%)', ' Hepatic Encephalopathy 0/3 (0.00%)', ' Confusional State 0/3 (0.00%)', ' Dyspnoea 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 1/1 (100.00%)', ' Pain 0/1 (0.00%)', ' Cellulitis 0/1 (0.00%)', ' Influenza 0/1 (0.00%)', ' Osteomyelitis 0/1 (0.00%)', ' Pneumonia 0/1 (0.00%)', ' Humerus Fracture 0/1 (0.00%)', ' Brain Oedema 0/1 (0.00%)', ' Cerebral Haemorrhage 0/1 (0.00%)', ' Convulsion 0/1 (0.00%)', ' Dysarthria 0/1 (0.00%)', ' Hepatic Encephalopathy 0/1 (0.00%)', ' Confusional State 0/1 (0.00%)', ' Dyspnoea 0/1 (0.00%)']}
|
f57403d9-7278-481e-bcb9-066bf31b6158
|
Comparison
|
Adverse Events
|
NCT00688909
|
NCT00129376
|
Patients in the primary trial and the secondary trial did not suffer from any of the same adverse events.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00688909', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:', ' Age 50 y and amenorrheic for 12 or more months.', ' Age 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.', ' Age < 50 y and amenorrheic for 12 or more months.', ' Prior bilateral oophorectomy.', ' Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards.', ' Age > 55 y and prior hysterectomy.', ' Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.', ' Hormone receptor-positive tumors as defined by institutional standards.', ' ECOG performance status of 0, 1, or 2', ' Consent to participate in the trial. -', 'Exclusion Criteria:', ' Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.', ' Recent history of pain associated with non-traumatic bone fracture.', ' Pain requiring chronic use of analgesics (due to any reason).', ' History of rheumatological disease except osteoarthritis.', ' Prior hormonal therapy with AIs other than anastrozole.', ' Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.', ' Concomitant disease which significantly affects quality of life.', ' Patient unable to complete self administered questionnaire.', ' Patients unable to sign consent form.', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.', ' The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.', ' Time frame: End of Study (24 weeks)', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.', ' Overall Number of Participants Analyzed: 261', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 25 9.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/261 (1.92%)', ' Cholecystitis chronic 1/261 (0.38%)', ' Post procedural bile leak 1/261 (0.38%)', ' Spinal column stenosis 1/261 (0.38%)', ' Depression 1/261 (0.38%)', ' Mania 1/261 (0.38%)', ' Pulmonary embolism 1/261 (0.38%)']}
|
{'Clinical Trial ID': 'NCT00129376', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide Followed Docetaxel', ' Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy.', ' Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.', ' Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM).', ' Age >= 18 and <= 70 years old.', ' Performance status as per Karnofsky index >= 80.', ' Minimum life expectancy of 6 months.', ' Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF).', ' Haematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >=10 g/dl.', ' Hepatic function: total bilirubin <= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 5 x UNL.', ' Renal function: creatinine <= 1.5 x UNL; creatinine clearance >= 60 ml/min.', ' Patients able to comply with study requirements.', ' Negative pregnancy test.', ' Adequate contraceptive method during the study and up to 3 months after definitive surgery.', 'Exclusion Criteria:', ' Previous systemic therapy for breast cancer treatment.', ' Previous treatments with anthracyclines or taxanes for any malignancy.', ' Previous radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women.', ' Previous motor or sensorial neurotoxicity grade >=2.', ' Other serious pathologies: congestive heart failure or angina pectoris; history of myocardial infarction in the previous year; uncontrolled hypertension (HT) or high risk arrhythmias.', ' History of neurological or psychiatric impairment, precluding patients from providing free informed consent.', ' Active infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' History of previous or current malignancies other than breast cancer, except for basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).', ' Chronic treatment with corticoids unless the treatment started > 6 months before registration to the study, and low doses are administered.', ' Substitutive hormonal therapy. This treatment must be interrupted before inclusion in the study.', ' Concomitant treatment with other investigational products or administration in the 30 previous days.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate', ' Pathological complete response was defined by the Miller & Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.', ' Time frame: Up to 29 weeks', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide Followed Docetaxel', ' Arm/Group Description: Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 11 18.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/63 (19.05%)', ' Febrile neutropenia * [1]4/63 (6.35%)', ' Congestive heart failure * [2]1/63 (1.59%)', ' Cardiac-ischemia/infarction * 1/63 (1.59%)', ' Vomiting * [1]1/63 (1.59%)', ' Acute Pharyngitis * 1/63 (1.59%)', ' Infection * 3/63 (4.76%)', ' Neutrophil count decreased * [1]1/63 (1.59%)', ' Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%)']}
|
ec601f6b-6ce3-4df7-b7b3-fbde1a241e93
|
Comparison
|
Intervention
|
NCT00291135
|
NCT00291694
|
The duration of treatment in the primary trial is half as long as in the secondary trial, but twice as frequent.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00291135', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Letrozole, 2.5 mg daily for six months'], 'Eligibility': ['Inclusion Criteria:', ' evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast', ' on hormone replacement therapy', ' postmenopausal', ' increased risk of developing breast cancer based on personal or family history', ' never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months', ' women who have a high risk of breast cancer', ' older than 18 years', 'Exclusion Criteria:', ' anticoagulants', ' marked breast tenderness', ' pregnant or within twelve months of breast feeding/childbirth'], 'Results': ['Outcome Measurement: ', ' Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.', ' Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.', ' Time frame: Baseline, 6 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole, 2.5 mg daily for six months', ' Overall Number of Participants Analyzed: 42', ' Median (Full Range)', ' Unit of Measure: Change in % of cells positive for Ki-67 -2.3 (-21.0 to 7.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/42 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00291694', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Randomized to receive celecoxib daily for 12 months', 'INTERVENTION 2: ', ' Placebo', ' Randomized to receive placebo daily for 12 months'], 'Eligibility': ['Inclusion Criteria:', ' women who have a high risk of breast cancer', ' older than 18 years', 'Exclusion Criteria:', ' anticoagulants', ' marked breast tenderness', ' pregnant or within twelve months of breast feeding/childbirth'], 'Results': ['Outcome Measurement: ', ' Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67', ' Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.', ' Time frame: Baseline and 12 months', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Randomized to receive celecoxib daily for 12 months', ' Overall Number of Participants Analyzed: 43', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -1.2 (-18 to 14.8)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Randomized to receive placebo daily for 12 months', ' Overall Number of Participants Analyzed: 21', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -2.0 (-8.8 to 12.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/43 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
0f0e5a8e-3972-46c2-84dd-7436e82a9787
|
Single
|
Results
|
NCT00191152
|
The longest Time to Disease Progression the primary trial was over 21 days in the Docetaxel Plus Capecitabine group.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT00191152', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine Plus Docetaxel', ' gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.', ' Treatment continues until progression of disease at which time crossover treatment begins.', 'INTERVENTION 2: ', ' Docetaxel Plus Capecitabine', ' docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease', ' Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen', ' Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease', ' Patients must have either measurable or non-measurable (evaluable) disease', ' Prior radiation therapy allowed of less than 25% of the bone marrow', 'Exclusion Criteria:', ' Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)', ' Parenchymal or leptomeningeal brain metastases', ' Peripheral neuropathy greater than or equal to grade 2', ' Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.', ' Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.', ' Concomitant Herceptin is not allowed'], 'Results': ['Outcome Measurement: ', ' Time to Disease Progression (Initial Treatment)', ' Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.', ' Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)', 'Results 1: ', ' Arm/Group Title: Gemcitabine Plus Docetaxel', ' Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.', ' Treatment continues until progression of disease at which time crossover treatment begins.', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.28 (7.73 to 10.79)', 'Results 2: ', ' Arm/Group Title: Docetaxel Plus Capecitabine', ' Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.', ' Overall Number of Participants Analyzed: 236', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.88 (7.37 to 11.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 72/237 (30.38%)', ' Anaemia 2/237 (0.84%)', ' Disseminated intravascular coagulation 1/237 (0.42%)', ' Febrile neutropenia 9/237 (3.80%)', ' Leukocytosis 1/237 (0.42%)', ' Leukopenia 6/237 (2.53%)', ' Lymphopenia 1/237 (0.42%)', ' Neutropenia 25/237 (10.55%)', ' Thrombocytopenia 2/237 (0.84%)', ' Atrial fibrillation 0/237 (0.00%)', ' Cardiac failure congestive 2/237 (0.84%)', 'Adverse Events 2:', ' Total: 55/226 (24.34%)', ' Anaemia 1/226 (0.44%)', ' Disseminated intravascular coagulation 0/226 (0.00%)', ' Febrile neutropenia 9/226 (3.98%)', ' Leukocytosis 0/226 (0.00%)', ' Leukopenia 2/226 (0.88%)', ' Lymphopenia 0/226 (0.00%)', ' Neutropenia 7/226 (3.10%)', ' Thrombocytopenia 0/226 (0.00%)', ' Atrial fibrillation 1/226 (0.44%)', ' Cardiac failure congestive 0/226 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
420e4977-ce75-4fab-99e0-3e7db837d521
|
|
Single
|
Results
|
NCT00096356
|
the primary trial results indicate that CoQ10 reduces the PFS of breast cancer patients compared to a placebo by about 8%
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00096356', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 - CoQ10 & Vitamin E', ' CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.', 'INTERVENTION 2: ', ' Arm 2 - Placebo & Vitamin E', ' Placebo-Vitamin E 100 mg/day in 3 doses'], 'Eligibility': ['Inclusion Criteria:', ' Signed consent', ' Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels', ' Total cholesterol > 160mg/dL.', ' Female with primary cancer diagnosis (breast)', ' Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)', ' KPS > 60', ' Bilirubin < 1.5 x ULN', ' SGOT < 2.5 x ULN', ' SGPT < 2.5 x ULN', 'Exclusion Criteria:', ' Recent involuntary weight loss (> 5% of body weight in the past 3 months)', ' Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)', ' Atorvastatin (Lipitor)', ' Cerivastatin', ' Fluvastatin (Lescol)', ' Lovastatin (Mevacor, Altocor, Advicor)', ' Mevastatin', ' Pravastatin (Pravachol)', ' Rosuvastatin', ' Simvastatin (Zocor)', ' Current or planned use of the following medications for fatigue', ' Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)', ' Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)', ' Patients diagnosed with uncontrolled hypertension', ' Breast cancer patients who are male', ' Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.', ' Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)', ' Patients with uncontrolled thyroid dysfunction'], 'Results': ['Outcome Measurement: ', ' Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization', ' POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1 - CoQ10 & Vitamin E', ' Arm/Group Description: CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.', ' Overall Number of Participants Analyzed: 122', ' Least Squares Mean (Standard Error)', ' Unit of Measure: units on a scale 6.96 (0.71)', 'Results 2: ', ' Arm/Group Title: Arm 2 - Placebo & Vitamin E', ' Arm/Group Description: Placebo-Vitamin E 100 mg/day in 3 doses', ' Overall Number of Participants Analyzed: 114', ' Least Squares Mean (Standard Error)', ' Unit of Measure: units on a scale 8.33 (0.79)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/100 (22.00%)', ' ANC 11/100 (11.00%)', ' WBC 4/100 (4.00%)', ' anemia 1/100 (1.00%)', ' hypotension 1/100 (1.00%)', ' L vent sy d 0/100 (0.00%)', ' chest pain 0/100 (0.00%)', ' constipation 1/100 (1.00%)', ' diarrhea 3/100 (3.00%)', ' ileus 1/100 (1.00%)', ' vomiting 1/100 (1.00%)', ' abd pain 0/100 (0.00%)', ' nausea 1/100 (1.00%)', ' allergic reaction 1/100 (1.00%)', ' fatigue 1/100 (1.00%)', 'Adverse Events 2:', ' Total: 15/93 (16.13%)', ' ANC 4/93 (4.30%)', ' WBC 2/93 (2.15%)', ' anemia 0/93 (0.00%)', ' hypotension 0/93 (0.00%)', ' L vent sy d 1/93 (1.08%)', ' chest pain 1/93 (1.08%)', ' constipation 1/93 (1.08%)', ' diarrhea 2/93 (2.15%)', ' ileus 0/93 (0.00%)', ' vomiting 1/93 (1.08%)', ' abd pain 1/93 (1.08%)', ' nausea 3/93 (3.23%)', ' allergic reaction 0/93 (0.00%)', ' fatigue 3/93 (3.23%)', ' fever 1/93 (1.08%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d07b4a30-e74f-468a-8420-7ade791d372d
|
|
Comparison
|
Adverse Events
|
NCT02536339
|
NCT00371345
|
At least one type of respiratory illness was observed in patients from both the primary trial and the secondary trial.
|
Entailment
|
[
0,
3
] |
[
0,
11
] |
{'Clinical Trial ID': 'NCT02536339', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab', ' Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed HER2-positive MBC', ' Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery', ' Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment', ' Stable systemic disease', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' LVEF at least 50%', ' Adequate hematologic, renal, and hepatic function', ' Life expectancy more than 12 weeks', 'Exclusion Criteria:', ' Progression of systemic disease at Screening', ' Leptomeningeal disease', ' History of intolerance or hypersensitivity to study drug', ' Use of certain investigational therapies within 21 days prior to enrollment', ' Current anthracycline use', ' Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use', ' Active infection', ' Pregnant or lactating women', ' Significant history or risk of cardiac disease', ' Symptomatic intrinsic lung disease or lung involvement', ' History of other malignancy within the last 5 years'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response in the CNS, Assessed Using Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria', ' Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. An objective response in the central nervous system (CNS) was a complete response (CR) or partial response (PR) confirmed by repeat assessment, according to RANO-BM criteria. A CR was defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically; for non-target lesions, a CR was the disappearance of all enhancing CNS non-target lesions and no new CNS lesions. A PR was defined as at least a 30% decrease in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD sustained for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; and stable or improved clinically. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.', ' Time frame: From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab', ' Arm/Group Description: Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants With Objective Response (Confirmed CR or PR): 10.8 (3.03 to 25.42)', ' Confirmed Complete Response (CR): 0.0 (0.00 to 9.49)', ' Confirmed Partial Response (PR): 10.8 (3.03 to 25.42)', ' Without Objective Response: 89.2 [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/39 (17.95%)', ' Gastroenteritis viral 1/39 (2.56%)', ' Parainfluenzae virus infection 1/39 (2.56%)', ' Seizure 4/39 (10.26%)', ' Headache 1/39 (2.56%)', ' Hydrocephalus 1/39 (2.56%)', ' Hypertension 1/39 (2.56%)']}
|
{'Clinical Trial ID': 'NCT00371345', 'Intervention': ['INTERVENTION 1: ', ' Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib', ' Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.', 'INTERVENTION 2: ', ' Her2/Neu-amplified Tumor, 100 mg BID', ' Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.'], 'Eligibility': ['Inclusion Criteria:', ' females, 18 or older', ' recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu', ' paraffin-embedded tissue block must be available', ' measurable disease', ' prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)', ' 0, 1 or 2 chemotherapies in the metastatic setting', ' adequate organ function', 'Exclusion Criteria:', ' Metastatic disease confined to bone only', ' Symptomatic central nervous system (CNS) metastasis', ' Concurrent medical condition which may increase the risk of toxicity', ' Unable to take oral medication'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response', ' Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.', ' Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.', 'Results 1: ', ' Arm/Group Title: Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib', ' Arm/Group Description: Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Her2/Neu-amplified Tumor, 100 mg BID', ' Arm/Group Description: Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/70 (28.57%)', ' NAUSEA 2/70 (2.86%)', ' VOMITING 1/70 (1.43%)', ' DIARRHOEA 2/70 (2.86%)', ' ABDOMINAL PAIN 1/70 (1.43%)', ' ABDOMINAL PAIN LOWER 1/70 (1.43%)', ' FATIGUE 2/70 (2.86%)', ' PYREXIA 1/70 (1.43%)', ' OEDEMA PERIPHERAL 1/70 (1.43%)', ' GENERAL PHYSICAL HEALTH DETERIORATION 3/70 (4.29%)', ' PNEUMONIA 1/70 (1.43%)', ' SINUSITIS 1/70 (1.43%)', ' LOBAR PNEUMONIA 1/70 (1.43%)', 'Adverse Events 2:', ' ']}
|
412b2743-8f76-494a-af97-f7bf9541a890
|
Comparison
|
Eligibility
|
NCT00631852
|
NCT00193037
|
Patients may be forced to take part in the secondary trial and the primary trial, even against their consent, as long as it is in their best interests.
|
Contradiction
|
[
0,
8
] |
[
0,
9
] |
{'Clinical Trial ID': 'NCT00631852', 'Intervention': ['INTERVENTION 1: ', ' American Ginseng Root', ' four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery'], 'Eligibility': ['Inclusion Criteria:', ' Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging', ' Surgical patients undergoing lumpectomy, subtotal or total mastectomy', ' 18 years of age or greater', ' female', ' available tissue blocks from diagnostic biopsy', ' negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal', ' must be willing to forego surgery for minimum of 5 days', ' ability and willingness to sign written consent', ' if hypertensive, on stable dose of medication at least 30 days', ' if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days', ' ECOG status < 2 or Karnofsky of 60% or greater', 'Exclusion Criteria:', ' previous or current malignancy, excluding non-melanomic skin cancer', ' evidence of distant metastatic disease', ' history of chemotherapy, biologic or radiotherapy with 6 months of biopsy', ' usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug', ' history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG', ' history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications', ' active bleeding or a pathological condition that carries a high risk of bleeding', ' any swallowing dysfunction', ' uncontrolled intercurrent illness', ' poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)', ' known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.', ' uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)', ' pregnant or breast feeding women Women must be willing to use birth control throughout study duration.', ' current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy', ' current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy', ' current monoamine oxidase inhibitors treatment'], 'Results': ['Outcome Measurement: ', ' Adiponectin', ' Change from baseline to completion of treatment with LEAG.', ' Time frame: mean of 11.8 days', 'Results 1: ', ' Arm/Group Title: American Ginseng Root', ' Arm/Group Description: four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 1308 (11,985)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/16 (6.25%)', ' hemorrhage/ bleeding * [1]1/16 (6.25%)']}
|
{'Clinical Trial ID': 'NCT00193037', 'Intervention': ['INTERVENTION 1: ', ' Arm A -Liposomal Doxorubicin Then Docetaxel', ' Liposomal doxorubicin (Arm A)', ' Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.', ' Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.', 'INTERVENTION 2: ', ' Arm B - Docetaxel Then Liposomal Doxorubicin', ' Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.', ' Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' Prior adjuvant/neoadjuvant treatment allowed', ' Measurable disease', ' Able to perform activities of daily living with minimal assistance', ' Age 18 years or older', ' Adequate bone marrow, liver and kidney function', ' Normal heart function', ' Written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Pre-existing moderate peripheral neuropathy', ' History of significant heart disease', ' Meningeal metastases.', ' Prior chemotherapy for metastatic breast cancer', ' No measurable disease (including bone only, pleural effusions, etc.)', ' Receiving Herceptin therapy.', ' Women who are pregnant or lactating.', ' 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: ', ' Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Arm A -Liposomal Doxorubicin Then Docetaxel', ' Arm/Group Description: Liposomal doxorubicin (Arm A)', ' Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.', ' Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (16 to 42)', 'Results 2: ', ' Arm/Group Title: Arm B - Docetaxel Then Liposomal Doxorubicin', ' Arm/Group Description: Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.', ' Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: percentage of patients 31 (18 to 45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/50 (36.00%)', ' Hypotension 0/50 (0.00%)', ' Bradycardia 0/50 (0.00%)', ' Cardiac Arrest 1/50 (2.00%)', ' Diarrhea 2/50 (4.00%)', ' Pain - Abdominal 1/50 (2.00%)', ' Hemorrhage - GI 1/50 (2.00%)', ' Vomiting 0/50 (0.00%)', ' Nausea 0/50 (0.00%)', ' Dehydration 0/50 (0.00%)', ' Diverticular Abscess 1/50 (2.00%)', ' Failure to Thrive 1/50 (2.00%)', ' Fever 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 22/52 (42.31%)', ' Hypotension 1/52 (1.92%)', ' Bradycardia 1/52 (1.92%)', ' Cardiac Arrest 0/52 (0.00%)', ' Diarrhea 0/52 (0.00%)', ' Pain - Abdominal 0/52 (0.00%)', ' Hemorrhage - GI 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Nausea 1/52 (1.92%)', ' Dehydration 1/52 (1.92%)', ' Diverticular Abscess 0/52 (0.00%)', ' Failure to Thrive 0/52 (0.00%)', ' Fever 1/52 (1.92%)']}
|
fd43feb6-4a55-4de6-b21d-25ff723b0959
|
Comparison
|
Adverse Events
|
NCT01256567
|
NCT01926886
|
The most common adverse event in the primary trial was Febrile neutropenia (14.29%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01256567', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab and Docetaxel Combination', ' Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.', ' Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' The participant is Japanese', ' The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent', ' The participant has measurable and/or non-measurable disease', " The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor Receptor 2 (HER2) negative", ' The participant received neo adjuvant or adjuvant taxane therapy 6 months prior to the study', ' The participant received neo adjuvant or adjuvant biologic therapy 6 weeks prior to the study', ' The participant completed all prior radiotherapy 3 weeks prior to the study registration date', ' The participant received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting 2 weeks prior to the study registration date', " The participant's left ventricular ejection fraction (LVEF) is within normal ranges", ' The participant has adequate hematologic, hepatic, and coagulation function.', ' Eligible participants of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication', 'Exclusion Criteria:', ' The participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. Participants with previous treatment of malignancy is eligible, provided that she has been disease free for >3 years', ' The participant has a known sensitivity to docetaxel', ' The participant has a known sensitivity to agents of similar biologic composition as ramucirumab', ' The participant has a history of chronic diarrheal disease within 6 months prior to the study registration date', ' The participant has received irradiation to a major bone marrow area within 30 days prior to the study registration date', ' The participant has received any experimental agents within 4 weeks prior to the study registration date', ' The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' The participant has Grade 3-4 bleeding within 3 months prior to the study registration date', ' The participant has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy', ' The participant has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders', ' The participant has brain metastases', ' The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness', ' The participant is pregnant or lactating', ' The participant has not fully recovered from effects of prior chemotherapy', ' The participant has undergone major surgery within 28 days prior to the study registration date'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G 3 neutropenia with fever 38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G 3 thrombocytopenia with bleeding requiring platelets; G 3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G 2 hyperbilirubinemia 5 days; QTc >500 milliseconds (ms) or increase 100 ms or arrhythmia; G 4 or uncontrollable hypertension; G 3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.', ' Time frame: Baseline up to data cut off (approximately 48.3 weeks)', 'Results 1: ', ' Arm/Group Title: Ramucirumab and Docetaxel Combination', ' Arm/Group Description: Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.', ' Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants Dose Limiting Toxicity (DLT) during Cycle 1: 2', ' TEAE related to ramucirumab: 7', ' SAE related to ramucirumab: 4', ' TEAE of Grade 3 related to ramucirumab: 6', ' TEAE resulting in ramucirumab discontinuation: 3', ' TEAE with ramucirumab dose modification/delay: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/7 (100.00%)', ' Febrile neutropenia 3/7 (42.86%)', ' Cardiac failure 1/7 (14.29%)', ' Neutrophil count decreased 1/7 (14.29%)', ' Muscular weakness 1/7 (14.29%)', ' Epistaxis 1/7 (14.29%)', ' Interstitial lung disease 1/7 (14.29%)', ' Pleural effusion 2/7 (28.57%)']}
|
{'Clinical Trial ID': 'NCT01926886', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast', ' HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Hormonal therapy will be allowed as per institutional guidelines', ' Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment', ' Participants have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment', ' No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant)', ' Use of concurrent curative radiotherapy will be permitted', 'Exclusion Criteria:', ' History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible', ' Participants with severe dyspnea at rest or requiring supplementary oxygen therapy', ' Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness', ' Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension', ' Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)', ' Pregnant or lactating women', ' Women of childbearing potential and male participants with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment', ' Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment', ' Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma', ' Inadequate bone marrow, hepatic or renal function'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', ' An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.', ' Time frame: Up to 45 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: percentage of participants Emergent AEs: 90.1', ' Emergent SAEs: 7.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/101 (7.92%)', ' Vertigo * 1/101 (0.99%)', ' Infected lymphocele * 1/101 (0.99%)', ' Ejection fraction decreased * 5/101 (4.95%)', ' Lymphoedema * 1/101 (0.99%)']}
|
e1fa68ac-42b4-4223-a362-a89c43562e06
|
Comparison
|
Adverse Events
|
NCT03165955
|
NCT00912340
|
2 patients in the primary trial suffer from DVT, 0 in the secondary trial.
|
Contradiction
|
[
8
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT03165955', 'Intervention': ['INTERVENTION 1: ', ' Oraxol (Oral Paclitaxel Plus HM30181)', ' Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Signed written informed consent', ' Women 18 years of age on day of consent', ' Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist', ' Measurable disease as per RECIST v1.1 criteria', ' Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:', ' Absolute neutrophil count (ANC) 1.5 x 10^9/L', ' Platelet count 100 x 10^9/L', ' Hemoglobin (Hgb) 9 g/dL', ' Adequate liver function', ' Total bilirubin of 1.5 mg/dL', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 x upper limit of normal (ULN) or 5 x ULN if liver metastasis is present', ' Alkaline phosphatase (ALP) 3 x ULN or 5 x ULN if bone metastasis is present', ' Gamma glutamyl transferase (GGT) <10 x ULN', ' Adequate renal function as demonstrated by serum creatinine 1.5 x ULN', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Life expectancy of at least 3 months', ' Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days', ' Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period', ' Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week', ' Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.', ' Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.', 'Exclusion Criteria:', ' Have not recovered to Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)', ' If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment', ' Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome', ' Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria', ' Known CNS metastasis, including leptomeningeal involvement', ' Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer', ' Are currently receiving other medications intended for the treatment of their malignancy', ' Women who are pregnant or breastfeeding', ' Taking prohibited medications:', ' Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements', ' Known allergic reaction or intolerance to study medication components', ' Known allergic reaction or intolerance to contrast media', " Subjects who, in the Investigator's opinion, are not suitable for participation in this study"], 'Results': ['Outcome Measurement: ', ' PK Parameters for paclitaxel_AUC (0-52)', ' PK parameters were summarized using the mean, SD', ' Time frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4', 'Results 1: ', ' Arm/Group Title: Oraxol (Oral Paclitaxel Plus HM30181)', ' Arm/Group Description: Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.', ' Overall Number of Participants Analyzed: 25', ' Mean (Standard Deviation)', ' Unit of Measure: ng*hr/mL Week 1: 3419 (1475)', ' Week 4: 3224 (1150)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/28 (28.57%)', ' Neutropenia 3/28 (10.71%)', ' Hepatitis acute 1/28 (3.57%)', ' Pneumonia 1/28 (3.57%)', ' Septic shock 1/28 (3.57%)', ' Femur fracture 1/28 (3.57%)', ' Infected neoplasm 1/28 (3.57%)', ' Deep vein thrombosis 1/28 (3.57%)']}
|
{'Clinical Trial ID': 'NCT00912340', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', 'INTERVENTION 2: ', ' Everolimus', ' Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Patients will be included in the study based on the following criteria:', ' Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy', ' At least one line of endocrine therapy in the metastatic setting', ' Candidate for hormonal therapy (ER and/or progestin receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)', ' HER2/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH]-negative if IHC 3+) at primary diagnosis', ' Must have a biopsy in the metastatic setting with HER2 expression of 1+ or 2+ by IHC', ' If biopsy of metastatic lesion is performed prior to study entry, HER2 expression by IHC must be 1+ or 2+', ' Histologically confirmed, measurable or evaluable disease; if disease is measurable, Response Evaluation Criteria In Solid Tumors (RECIST) criteria should be used', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', ' Adequate bone marrow function as indicated by the following:', ' Absolute neutrophil count (ANC) > 1500/µL', ' Platelets 100,000/µL', ' Hemoglobin > 10 g/dL', ' Adequate renal function, as indicated by creatinine 1.5x upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin 1.5x ULN', ' International normalized ratio (INR) 1.3 (or 3 on anticoagulants)', ' Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x ULN unless related to primary disease', ' Signed informed consent', ' Adequate birth control', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', 'Exclusion Criteria:', ' Patients will be excluded from the study based on the following criteria:', ' Prior treatment with trastuzumab or other HER2-directed therapies or with an mammalian target of rapamycin (mTOR) inhibitor within 12 months of study entry (when cancer was not definitely hormone refractory)', ' HER2 0 or 3+ by IHC on pre-treatment biopsy of metastatic lesion (if performed)', ' Active infection', ' Uncontrolled central nervous system metastases', ' Life-threatening, visceral metastases', ' Pregnant or lactating women', ' Prior chemotherapy within the last 4 weeks', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)', ' Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction < 50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to trial medications', ' Emotional limitations', ' Prior treatment with any investigational drug within the preceding 4 weeks', ' Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN', ' Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis', ' Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)', ' Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest', ' Taking any of the following agents:', ' Chronic treatment with systemic steroids or another immunosuppressive agent', ' Live vaccines', ' Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Until First Progression', ' Median PFS will be calculated based on time to first progression or death.', ' Time frame: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', ' Overall Number of Participants Analyzed: 24', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.0 (1.6 to 4.1)', 'Results 2: ', ' Arm/Group Title: Everolimus', ' Arm/Group Description: Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.7 (3.9 to 8.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/24 (4.17%)', ' Pericardial effusion *1/24 (4.17%)', ' Other cardiac disorder *0/24 (0.00%)', ' Ejection fraction decrease *0/24 (0.00%)', ' Hypertension *0/24 (0.00%)', ' Salivary gland infection *0/24 (0.00%)', ' Pleural effusion *0/24 (0.00%)', 'Adverse Events 2:', ' Total: 6/30 (20.00%)', ' Pericardial effusion *1/30 (3.33%)', ' Other cardiac disorder *1/30 (3.33%)', ' Ejection fraction decrease *1/30 (3.33%)', ' Hypertension *1/30 (3.33%)', ' Salivary gland infection *1/30 (3.33%)', ' Pleural effusion *2/30 (6.67%)']}
|
6f5570c0-4114-47ee-9611-b2e4be91cf9a
|
Single
|
Results
|
NCT01224678
|
Intervention 2 of the primary trial resulted in a lower percentage change in tumor diameter than intervention 1.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01224678', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Patients receive oral placebo once daily for 12 months.', 'INTERVENTION 2: ', ' Vitamin D', ' Patients receive oral vitamin D (2000 IU) once daily for 12 months.'], 'Eligibility': ['Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.', ' Women with breast density 25% (scattered fibroglandular densities or greater) are eligible.', ' Prior Treatment', ' Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.', ' Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.', ' Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.', ' Vitamin D Use', ' Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.', ' Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.', ' Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.', ' Patients with a history of breast implants or breast reduction are not eligible.', ' Patients with two or more bone fractures in the past five years are not eligible.', ' Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.', ' Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.', ' Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.', ' Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.', ' Required initial laboratory values - Calcium < 10.5 mg/dL'], 'Results': ['Outcome Measurement: ', ' Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms', ' To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients receive oral placebo once daily for 12 months.', ' Overall Number of Participants Analyzed: 46', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -3.4 (7.1)', 'Results 2: ', ' Arm/Group Title: Vitamin D', ' Arm/Group Description: Patients receive oral vitamin D (2000 IU) once daily for 12 months.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -1.4 (11.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/150 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
13b4a3c5-cf6e-4f65-9f94-be927c3ce5ef
|
|
Single
|
Results
|
NCT02581839
|
All participants in the primary trial had a Central Nervous System (CNS) Progression Free Survival (PFS) >= 16 weeks.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT02581839', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.', ' MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician', ' Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician'], 'Eligibility': ['Inclusion Criteria:', ' Female with histologically confirmed breast cancer.', ' Patients must have evidence of metastatic disease (non measurable disease is eligible).', ' Radiologically confirmed metastatic brain lesion by MRI.', ' Brain metastases from breast cancer with or without prior WBRT, STS of surgical resection. Progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT.', ' Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment.', ' No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months.', ' Patients may not be on any cytotoxic chemotherapy or hormonal treatment for breast cancer during protocol treatment. Trastuzumab is allowed in HER2 positive patients).', ' Able to comprehend and willing to sign an Informed Consent Form (ICF)', ' Karnofsky performance status 60', ' No brain radiation therapy > 4 weeks', ' No chemotherapy for > 3 weeks before planned start of protocol treatment', ' Adequate bone marrow, renal, and hepatic function, per local reference laboratory ranges as follows:', ' Absolute neutrophil count (ANC) 1,500/mm3', ' Platelet count 100,000/mm3', ' Hemoglobin 9 g/dL', ' Calculated creatinine clearance (CrCl) 30mL/min (Cockcroft-Gault method)', ' Patients with normal, mild or moderate hepatic dysfunction are eligible.', ' Calcium <10.1 mg/dL (corrected to serum albumin as follows: Corrected Calcium = (0.8 x (4 - patient albumin)) + serum Ca', ' Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment', ' Able to undergo MRI evaluation with and without gadolinium contrast', 'Exclusion Criteria:', ' Patients with the presence of an active infection, abscess or fistula', ' Known leptomeningeal disease or CNS midline shifts.', ' Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.', ' Severe conduction abnormality including significant QTc prolongation >450ms.', ' Patients with grade 3/4 peripheral neuropathy.', ' Patients with pacemaker or an ICD devices.', ' Previous treatment with eribulin mesylate.'], 'Results': ['Outcome Measurement: ', ' Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)', " The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.", ' Time frame: At 12 weeks', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.', ' MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician', ' Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.9 (51 to 99.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Febrile neutropenia * 1/9 (11.11%)', ' Fatigue * 1/9 (11.11%)', ' Lung infection * 1/9 (11.11%)', ' Neutrophil count decreased * 1/9 (11.11%)', ' Platelet count decreased * 1/9 (11.11%)', ' White blood cell decreased * 1/9 (11.11%)', ' Pain in extremity * 1/9 (11.11%)', ' worsening pseudomeningeocele * 1/9 (11.11%)', ' Dyspnea * 1/9 (11.11%)', ' Thromboembolic event * 1/9 (11.11%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6495c223-f7d9-459f-8c57-66a2caac5ee4
|
|
Comparison
|
Intervention
|
NCT01216319
|
NCT03346161
|
the secondary trial and the primary trial are evaluating interventions associated with breast reconstruction for patients that have had mastectomies.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01216319', 'Intervention': ['INTERVENTION 1: ', ' Nipple Reconstruction Cylinder', ' Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder'], 'Eligibility': ['Inclusion Criteria:', ' Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.', ' Patient presents with a desire to obtain nipple reconstruction', ' Patient is at least 18 years of age', ' And other inclusion criteria', 'Exclusion Criteria:', ' Patient is not medically fit enough for surgery under local anesthesia', ' Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)', ' Patient is pregnant, breastfeeding or planning further pregnancy during the study period', ' Patient has physical allergies or cultural objections to the receipt of porcine products', ' And other exclusion criteria'], 'Results': ['Outcome Measurement: ', ' Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)', ' [Not Specified]', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Nipple Reconstruction Cylinder', ' Arm/Group Description: Nipple reconstruction: Biodesign Nipple Reconstruction Cylinder', ' Overall Number of Participants Analyzed: 44', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Nipples Mean (Standard Deviation)Unit of Measure: percentage of projection vs baseline: 37.3 (17.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/50 (2.00%)', ' Metastatic breast cancer 1/50 (2.00%)']}
|
{'Clinical Trial ID': 'NCT03346161', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: BREASTChoice (Decision Tool)', " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", 'INTERVENTION 2: ', ' Arm 2: Enhanced Usual Care (Surgical Care Booklet)', ' Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn\'t have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn\'t have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.'], 'Eligibility': ['Newly diagnosed or recurrent breast cancer', ' Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction', ' Considering or completing a mastectomy.', ' Does not have known distant metastatic disease (stage IV disease) at the time of recruitment', ' Female.', ' English-speaking.', ' At least 18 years of age.', ' Able to understand and willing to sign an IRB-approved written informed consent document.'], 'Results': ['Outcome Measurement: ', ' Percent Correct on the Knowledge Measure (Objective Knowledge Score)', ' To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care', ' Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)', 'Results 1: ', ' Arm/Group Title: Arm 1: BREASTChoice (Decision Tool)', " Arm/Group Description: Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", ' Overall Number of Participants Analyzed: 60', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of answers correct 84.6 (14.2)', 'Results 2: ', ' Arm/Group Title: Arm 2: Enhanced Usual Care (Surgical Care Booklet)', ' Arm/Group Description: Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn\'t have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn\'t have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.', ' Overall Number of Participants Analyzed: 60', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of answers correct 59.7 (18.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 0/60 (0.00%)']}
|
eb61fee2-30fc-42f9-80bd-4d73d6af592c
|
Single
|
Results
|
NCT00091832
|
Both cohorts of the primary trial in a negative (mean) Percent Change From Baseline of Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr).
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00091832', 'Intervention': ['INTERVENTION 1: ', ' Bisphosphonate IV Q4W', ' Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion', 'INTERVENTION 2: ', ' Denosumab 30 mg Q4W', ' Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'], 'Eligibility': ['Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma', ' At least one bone metastasis'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)', ' Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.', ' Time frame: Baseline and Week 13', 'Results 1: ', ' Arm/Group Title: Bisphosphonate IV Q4W', ' Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion', ' Overall Number of Participants Analyzed: 38', ' Mean (Standard Deviation)', ' Unit of Measure: Percent change -10.19 (208.84)', 'Results 2: ', ' Arm/Group Title: Denosumab 30 mg Q4W', ' Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: Percent change -52.87 (95.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/43 (34.88%)', ' Anaemia 0/43 (0.00%)', ' Febrile bone marrow aplasia 0/43 (0.00%)', ' Febrile neutropenia 1/43 (2.33%)', ' Leukopenia 0/43 (0.00%)', ' Neutropenia 1/43 (2.33%)', ' Thrombocytopenia 0/43 (0.00%)', ' Angina pectoris 0/43 (0.00%)', ' Cardiac tamponade 0/43 (0.00%)', ' Cardio-respiratory arrest 0/43 (0.00%)', ' Cardiopulmonary failure 1/43 (2.33%)', ' Pericardial effusion 0/43 (0.00%)', 'Adverse Events 2:', ' Total: 11/42 (26.19%)', ' Anaemia 1/42 (2.38%)', ' Febrile bone marrow aplasia 1/42 (2.38%)', ' Febrile neutropenia 0/42 (0.00%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 0/42 (0.00%)', ' Thrombocytopenia 0/42 (0.00%)', ' Angina pectoris 1/42 (2.38%)', ' Cardiac tamponade 0/42 (0.00%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Cardiopulmonary failure 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
79c698bf-a756-4a73-8075-38c3c5eb7a04
|
|
Single
|
Eligibility
|
NCT00571987
|
Breast implants and Diffuse microcalcifications will not disqualify a patient from entry to 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,
24,
25,
26
] |
[] |
{'Clinical Trial ID': 'NCT00571987', 'Intervention': ['INTERVENTION 1: ', ' Margin Status', ' AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.'], 'Eligibility': ['Inclusion Criteria:', ' Female, 18-100 years old', ' Not pregnant or breastfeeding', ' Pre-study radiologic documentation of:', ' size 5 cm', ' unicentric, unilateral', ' suspicious mass or calcification', ' BIRADS classification IV', ' location of abnormality > 1 cm from skin', ' Ductal or Infiltrating Ductal Carcinoma', ' Grade I-III on final pathology', ' Good general health', ' Zubrod Performance Status of 0,1, or 2', ' No previous chemotherapy', ' No palpable axillary or supraclavicular lymph nodes', ' If prior non-breast malignancy, must have > 5 year disease-free survival', 'Exclusion Criteria:', ' Patient < 18 y/o or > 100 y/o', ' Pregnant or breastfeeding', ' Male', ' Breast implants', ' Multicentric disease or bilateral disease', ' Lesions > 5 cm in diameter', ' Lesions < 1.0 cm from the skin', ' Previous prior radiation to the breast', ' Need for mastectomy', ' Diffuse microcalcifications (as determined by the Investigator)'], 'Results': ['Outcome Measurement: ', ' Number of Patients Requiring 2nd Surgery for Close or Positive Margins', ' A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.', ' Time frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery', 'Results 1: ', ' Arm/Group Title: Margin Status', ' Arm/Group Description: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.', ' Overall Number of Participants Analyzed: 100', ' Measure Type: Number', ' Unit of Measure: participants 22'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/107 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f7be0a6e-6c63-473e-af00-df009f3d7d46
|
|
Comparison
|
Intervention
|
NCT01376349
|
NCT01912612
|
Cohort 2 subjects of the primary trial receive 3.25 mg of vaginal DHEA gel QD more than cohort 1 subjects, of the two cohorts in the secondary trial only the cohort without pain recieves Duloxetine 30 mg daily.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6
] |
{'Clinical Trial ID': 'NCT01376349', 'Intervention': ['INTERVENTION 1: ', ' Arm I Low Dose DHEA', ' Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.', 'INTERVENTION 2: ', ' Arm II High Dose DHEA', ' Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 years', ' Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease). Note: Postmenopausal status will be determined by the following criteria:', ' 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study', ' menopausal status will be determined by an FSH and an estradiol value in the postmenopausal range (generally FSH > 40IU/L and estradiol < 10 pg/ml, depending on laboratory) if:', ' 9 months without a period or', ' post hysterectomy with at least one ovary remaining and less than 55 years old. Note: if age 55 or older with these criteria, then menopausal status does not need to be determined by labs', ' Significant vaginal complaints. Note: Defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention.', ' Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia. The protocol contains more information.', ' Vaginal symptoms must have been present 2 months prior to randomization.', ' Life expectancy > 12 months.', ' Ability to complete questionnaires by themselves or with assistance.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.', ' The patient must provide informed written consent.', ' Willing to return to the enrolling institution for follow-up.', ' Willing to provide blood samples for correlative research purposes.', 'Exclusion Criteria:', ' Initiation or discontinuation of tamoxifen or aromatase inhibitors 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 12-week study.', ' Current diagnosis of an active vaginal infection, if symptoms of vaginal infection, this must be ruled out (ie, foul discharge, fever).', ' Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab is allowed.', ' Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly) are allowed during sexual intercourse.', ' Use of any daily non-hormonal vaginal preparations 1 week prior to study entry.', ' Exception: Daily water-based lubricants for sexual intercourse. Note: Patients who stop agent may be enrolled after one week.', ' Current ( 4 weeks prior to randomization), or planned during the study period, use of any estrogen product or any kind of hormonal vaginal product including bioidentical hormones, estriol or any androgen product.', ' Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie milk is acceptable).', ' On a placebo controlled trial for endocrine therapy.', ' Prior or concurrent pelvic radiation therapy.', ' Prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration (TAH/BSO) is allowed).', ' Diagnosis of any of the following conditions within the past five years:', ' Essential vulvodynia', ' Vulvar vestibulitis', ' Bartholin cyst/abscess', ' History of Bartholin gland surgery', ' Lichen sclerosis', ' Lichen planus of the vulvovaginal region', ' Desquamative vaginitis', ' History or current diagnosis of any of the following conditions:', ' Vulvar or vaginal dysplasia', ' Vaginal prolapse', ' Women of childbearing potential, premenopausal women.'], 'Results': ['Outcome Measurement: ', ' Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks', ' The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).', ' Time frame: At baseline and 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm I Low Dose DHEA', ' Arm/Group Description: Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.', ' Overall Number of Participants Analyzed: 123', ' Median (Full Range)', ' Unit of Measure: change in units on a scale -2 (-4 to 1)', 'Results 2: ', ' Arm/Group Title: Arm II High Dose DHEA', ' Arm/Group Description: Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.', ' Overall Number of Participants Analyzed: 114', ' Median (Full Range)', ' Unit of Measure: change in units on a scale -2 (-4 to 1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/147 (2.04%)', ' Bladder infection 1/147 (0.68%)', ' Breast infection 0/147 (0.00%)', ' Urinary tract infection 0/147 (0.00%)', ' Vaginal infection 1/147 (0.68%)', ' Investigations - Other, specify 0/147 (0.00%)', ' Headache 1/147 (0.68%)', ' Breast pain 0/147 (0.00%)', ' Voice alteration 0/147 (0.00%)', ' Hirsutism 0/147 (0.00%)', ' Rash acneiform 0/147 (0.00%)', 'Adverse Events 2:', ' Total: 7/148 (4.73%)', ' Bladder infection 0/148 (0.00%)', ' Breast infection 0/148 (0.00%)', ' Urinary tract infection 0/148 (0.00%)', ' Vaginal infection 1/148 (0.68%)', ' Investigations - Other, specify 1/148 (0.68%)', ' Headache 1/148 (0.68%)', ' Breast pain 1/148 (0.68%)', ' Voice alteration 0/148 (0.00%)', ' Hirsutism 2/148 (1.35%)', ' Rash acneiform 1/148 (0.68%)']}
|
{'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%)']}
|
6f686de9-f110-4be0-9cd8-1ceb0ce6f073
|
Single
|
Eligibility
|
NCT01004744
|
Patients must have a confirmed pregnancy by positive Hcg test, if they are to take part in the primary trial.
|
Contradiction
|
[
2
] |
[] |
{'Clinical Trial ID': 'NCT01004744', 'Intervention': ['INTERVENTION 1: ', ' Presurgical Oral Anastrozole', ' 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.', ' Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment', ' Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)', ' Age 21 years', ' No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry', ' Signed informed consent', 'Exclusion Criteria:', ' Treatment with other investigational drugs within 6 months of study entry', ' Other serious intercurrent medical illness'], 'Results': ['Outcome Measurement: ', ' Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery', ' The number of subjects who complete oral anastrozole for the length of the study is analyzed. The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery.', ' Time frame: Two weeks', 'Results 1: ', ' Arm/Group Title: Presurgical Oral Anastrozole', ' Arm/Group Description: 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.', ' Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: participants 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2c602b4d-c8a5-4606-8e3a-a87ee7bbc480
|
|
Single
|
Results
|
NCT02463032
|
There was less than a 5% difference in the Percentage of Participants With Objective Response in the GTx-024 9 mg and GTx-024 18 mg group in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT02463032', 'Intervention': ['INTERVENTION 1: ', ' GTx-024 9 mg', ' Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.', 'INTERVENTION 2: ', ' GTx-024 18 mg', ' Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women ( 18 years of age) with metastatic or recurrent locally advanced BC, not amenable to curative treatment by surgery or radiotherapy, with objective evidence of disease progression.', ' Women must have received 1 prior hormonal treatment(s) in the metastatic or adjuvant setting. If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be 6 months. If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be 3 years', ' Histological or cytological confirmation of ER+ BC as assessed by a local laboratory using slides, paraffin blocks, or paraffin sample or by medical history: ER+ (confirmed as ER expression more than or equal to 1% positive tumor nuclei)', ' Human epidermal growth factor receptor 2 (HER2)-negative tumor by local laboratory testing (immunohistochemistry [IHC] 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present)', ' Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue or new biopsy, if archived tissue is unavailable for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible.', ' Postmenopausal women. Postmenopausal status is defined by the National Comprehensive Cancer Network as either:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/mL', ' Age < 55 years and surgical menopause with bilateral oophorectomy a. Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression at the time of screening. Long term use (>6 months prior to screening) is permitted', ' Radiological or clinical evidence (bone scan, computerized tomography [CT], and magnetic resonance Imaging [MRI]) of recurrence or progression within 30 days before randomization', ' Subject must have either measurable disease or bone only non measurable disease, according to RECIST1.1', ' Adequate organ function as shown by:', ' Absolute neutrophil count (ANC) 1,500 cells/mm3', ' Platelet count 100,000 cells/mm3', ' Hemoglobin (Hgb) 9.0 g/dL', ' Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) 2.5 upper limit of the normal range (ULN) (or 5 if hepatic metastases are present)', ' Total serum bilirubin 2.0 × ULN (unless the subject has documented Gilbert Syndrome)', ' Alkaline phosphatase levels 2.5 × ULN ( 5 × ULN in subjects with liver metastasis)', ' Serum creatinine 2.0 mg/dL or 177 µmol/L', ' International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)', ' Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For patients who are normocalcemic, therapy can be initiated at the time the patient initiates study drug', ' Subject is able to swallow capsules', ' Able and willing to give voluntary, written and signed informed consent before any screening procedure and according to local guidelines', 'Exclusion Criteria:', ' Previously received > 1 course of chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic', ' a. Note: Subjects may have received 1 course of chemotherapy prior to surgery for the treatment of locally advanced disease and 1 course of chemotherapy for the treatment of metastatic BC; however, if surgery could not be performed, this will count as the 1 chemotherapy course allowed prior to study', ' Known hypersensitivity to any of the GTx-024 components or subjects previously received treatment with SARM', ' Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone])', ' a. Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 28 days after receiving local therapy (irradiation, surgery, etc.)', ' Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization', ' Currently receiving hormone replacement therapy, unless discontinued prior to screening', ' Subjects positive for Human Immunodeficiency Virus (HIV)', ' Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:', " Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTcB (corrected according to Bazett's formula) interval > 470 msec", ' Serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA', ' Uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)', ' Acute and chronic, active infectious disorders and non malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)', ' Another active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 years', ' Major surgery within 28 days before randomization', ' Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening', ' History of non-compliance to medical regimens', ' Subjects unwilling to or unable to comply with the protocol', ' Subject is currently receiving treatment with any agent listed on the prohibited medication list', ' Treatment with any investigational product within < 4 half-lives for each individual investigational product OR 28 days prior to randomization', ' Current treatment with intravenous bisphosphonate or denosumab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor (AR)+ Subjects', ' To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1, in subjects with estrogen receptor positive/androgen receptor positive (ER+/AR+) BC who have centrally confirmed AR+ status. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or 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; Clinical Benefit Rate (CBR)= CR + PR + SD.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: GTx-024 9 mg', ' Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 16', 'Results 2: ', ' Arm/Group Title: GTx-024 18 mg', ' Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg', ' GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: participants 15'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/72 (8.33%)', ' anemia and marrow failure 0/72 (0.00%)', ' cardiac failure 0/72 (0.00%)', ' hypertension 1/72 (1.39%)', ' myocardial infarction 0/72 (0.00%)', ' diabetes 1/72 (1.39%)', ' nausea 1/72 (1.39%)', ' gastritis 0/72 (0.00%)', ' sepsis 2/72 (2.78%)', ' cellulitis 1/72 (1.39%)', ' pneumonia 0/72 (0.00%)', ' h pylori infection 0/72 (0.00%)', ' hypercalcemia 1/72 (1.39%)', 'Adverse Events 2:', ' Total: 10/64 (15.63%)', ' anemia and marrow failure 1/64 (1.56%)', ' cardiac failure 2/64 (3.13%)', ' hypertension 1/64 (1.56%)', ' myocardial infarction 1/64 (1.56%)', ' diabetes 0/64 (0.00%)', ' nausea 0/64 (0.00%)', ' gastritis 1/64 (1.56%)', ' sepsis 2/64 (3.13%)', ' cellulitis 0/64 (0.00%)', ' pneumonia 1/64 (1.56%)', ' h pylori infection 1/64 (1.56%)', ' hypercalcemia 4/64 (6.25%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ffa913b7-9875-458e-8a28-476f9e788bb0
|
|
Single
|
Adverse Events
|
NCT00193206
|
the primary trial records a total of 7 different types of infections.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00193206', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' Systemic Therapy', ' ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles', ' Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles', ' Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Locally advanced/inflammatory adenocarcinoma of the breast', ' 18 years of age or older', ' Normal heart function', ' Able to perform activities of daily living with minimal assistance', ' No prior chemotherapy for breast cancer', ' Adequate bone marrow, liver and kidney function', ' No evidence or history of significant cardiovascular abnormalities', ' Sentinel node or axillary dissection', ' Sign an informed consent form', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Pregnant or breast feeding', ' History of heart disease with congestive heart failure', ' Heart attack within the previous 6 months', ' Prior chemotherapy or hormone therapy for breast cancer', ' 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', ' For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. 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: Systemic Therapy', ' ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles', ' Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles', ' Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles', ' Overall Number of Participants Analyzed: 116', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 23 19.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/123 (17.89%)', ' Cardiac Ischemia/Infarction [1]1/123 (0.81%)', ' Pain - Chest 2/123 (1.63%)', ' Dehydration 2/123 (1.63%)', ' Death [2]1/123 (0.81%)', ' Weakness 1/123 (0.81%)', ' Pain - Liver 1/123 (0.81%)', ' Infection - Skin [3]3/123 (2.44%)', ' Infection - Gastrointestinal [4]1/123 (0.81%)', ' Infection - Vein [5]2/123 (1.63%)', ' Infection - Pneumonia 1/123 (0.81%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5a4018ea-5d00-4d44-bfa3-a1dfb341b9e5
|
|
Comparison
|
Intervention
|
NCT03456427
|
NCT02685566
|
There are no details concerning the duration or frequency of administration in the intervention sections of the primary trial and the secondary trial
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT03456427', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants: Patient Assisted Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', 'INTERVENTION 2: ', ' All Study Participants: Technologist Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.', 'Exclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.'], 'Results': ['Outcome Measurement: ', ' Percentage of Acceptable Overall Image Quality', ' The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.', 'Time frame: 1 Day', 'Results 1: ', ' Arm/Group Title: All Study Participants: Patient Assisted Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 30 90.9%', ' Image Quality: Unacceptable: 3 9.1%', 'Results 2: ', ' Arm/Group Title: All Study Participants: Technologist Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 33 100.0%', ' Image Quality: Unacceptable: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT02685566', 'Intervention': ['INTERVENTION 1: ', ' FFDM Plus DBT', ' Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', 'INTERVENTION 2: ', ' Full-Field Digital Mammography (FFDM)', ' Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects participating in FMSU004A protocol with known clinical status', 'Exclusion Criteria:', ' Subjects with unknown clinical status not participating in FMSU004A protocol.'], 'Results': ['Outcome Measurement: ', ' Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate', ' This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: FFDM Plus DBT', ' Arm/Group Description: Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', ' Overall Number of Participants Analyzed: 100', ' Mean (95% Confidence Interval)', ' Unit of Measure: probability .805 (0.701 to 0.910)', 'Results 2: ', ' Arm/Group Title: Full-Field Digital Mammography (FFDM)', ' Arm/Group Description: Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', ' Overall Number of Participants Analyzed: 100', ' Mean (95% Confidence Interval)', ' Unit of Measure: probability 0.756 (0.646 to 0.867)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}
|
d8e47fe7-be41-4f74-881b-a80cd3a1e95f
|
Comparison
|
Intervention
|
NCT00236899
|
NCT01153672
|
the primary trial and the secondary trial do not use any of the same drugs in their interventions.
|
Entailment
|
[
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13,
14,
15
] |
[
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{'Clinical Trial ID': 'NCT00236899', 'Intervention': ['INTERVENTION 1: ', ' Treatment Schedule (Weekly)', ' Arm C, Docetaxel and Gemcitabine (Weekly):', ' Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm D, Paclitaxel and Gemcitabine (Weekly):', ' Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', 'INTERVENTION 2: ', ' Treatment Schedule (3 Weekly)', ' Arm A, Docetaxel and Gemcitabine (3 Weekly):', ' Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm B, Paclitaxel and Gemcitabine (3 Weekly):', ' Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic diagnosis of metastatic breast cancer (MBC).', ' Prior neoadjuvant or adjuvant taxanes regimen is allowed if 12 months since completion of the regimen.', ' Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.', ' Patients with measurable disease.', ' Previous hormonal therapy for adjuvant setting or metastatic disease.', 'Exclusion Criteria:', ' Previous chemotherapy for MBC', ' Previous chemotherapy with gemcitabine in any setting of disease', ' Patient candidable to treatment with trastuzumab.'], 'Results': ['Outcome Measurement: ', ' Time to Progressive Disease (TTPD) by Treatment Schedule', ' TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a 20% increase in sum of longest diameter of target lesions.', ' Time frame: Baseline up to 49.84 months', 'Results 1: ', ' Arm/Group Title: Treatment Schedule (Weekly)', ' Arm/Group Description: Arm C, Docetaxel and Gemcitabine (Weekly):', ' Docetaxel: 30 mg/m , 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m , 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm D, Paclitaxel and Gemcitabine (Weekly):', ' Paclitaxel: 80 mg/m , IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m , 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Overall Number of Participants Analyzed: 117', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.33 (6.19 to 10.16)', 'Results 2: ', ' Arm/Group Title: Treatment Schedule (3 Weekly)', ' Arm/Group Description: Arm A, Docetaxel and Gemcitabine (3 Weekly):', ' Docetaxel: 75 mg/m , 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1000 mg/m , 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm B, Paclitaxel and Gemcitabine (3 Weekly):', ' Paclitaxel: 175 mg/m , IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1250 mg/m , 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Overall Number of Participants Analyzed: 124', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.51 (5.93 to 8.33)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/59 (15.25%)', ' Anaemia 0/59 (0.00%)', ' Febrile neutropenia 1/59 (1.69%)', ' Neutropenia 4/59 (6.78%)', ' Thrombocytopenia 0/59 (0.00%)', ' Cardiac failure 0/59 (0.00%)', ' Pericardial effusion 0/59 (0.00%)', ' Diarrhoea 2/59 (3.39%)', ' Intestinal obstruction 0/59 (0.00%)', ' Nausea 1/59 (1.69%)', ' Vomiting 1/59 (1.69%)', ' Asthenia 0/59 (0.00%)', ' Fatigue 1/59 (1.69%)', 'Adverse Events 2:', ' Total: 10/62 (16.13%)', ' Anaemia 1/62 (1.61%)', ' Febrile neutropenia 0/62 (0.00%)', ' Neutropenia 1/62 (1.61%)', ' Thrombocytopenia 1/62 (1.61%)', ' Cardiac failure 1/62 (1.61%)', ' Pericardial effusion 1/62 (1.61%)', ' Diarrhoea 0/62 (0.00%)', ' Intestinal obstruction 0/62 (0.00%)', ' Nausea 0/62 (0.00%)', ' Vomiting 0/62 (0.00%)', ' Asthenia 0/62 (0.00%)', ' Fatigue 0/62 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01153672', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)', ' Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', ' vorinostat: Given PO', ' laboratory biomarker analysis: Correlative studies', ' biopsy: Optional correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' positron emission tomography: Correlative studies', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' gene expression 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; patients need to stop AI for at least one week prior to starting vorinostat treatment on this protocol', ' 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 [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 >= 100,000/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 and magnesium levels within normal limits', ' Calculated creatinine clearance >= 30 mL/min', ' Serum total bilirubin =< 1.5 X ULN', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic 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 [SERM] or downregulating [SERD] i.e. tamoxifen or fulvestrant) within the past 6 weeks', ' Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidespin [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, corrected QT interval (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 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 According to RECIST', ' Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria', ' Time frame: Up to approximately 5 years', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)', ' Arm/Group Description: Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', ' vorinostat: Given PO', ' laboratory biomarker analysis: Correlative studies', ' biopsy: Optional correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' positron emission tomography: Correlative studies', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' gene expression analysis: Correlative studies', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: percentage of evaluable participants 15 (12 to 65)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/8 (25.00%)', ' pancreatitis [1]1/8 (12.50%)', ' Flu-like symptoms [1]1/8 (12.50%)']}
|
e77e15a3-d851-4174-80c3-7b5156e7f987
|
Single
|
Results
|
NCT01806259
|
In total Over 85% patient in the primary trial achieve Recurrence-free Survival after 3 years.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
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8,
9,
10,
11,
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16
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c003dd08-af3b-44cc-b31c-6fbdadfa1d83
|
|
Comparison
|
Adverse Events
|
NCT00455533
|
NCT00767520
|
Throughout both the secondary trial and the primary trial there was only one case of sudden and unexpected death, in cohort 1 of the secondary trial.
|
Entailment
|
[
0,
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2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
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13,
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17,
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20,
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22,
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25
] |
{'Clinical Trial ID': 'NCT00455533', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', 'INTERVENTION 2: ', ' Paclitaxel', ' paclitaxel 80 mg/m^2 administered IV every week for 12 weeks'], 'Eligibility': ['Inclusion criteria', ' Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of 2 cm', ' All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status', ' No prior treatment for breast cancer excluding therapy for DCIS', ' Karnofsky performance status of 80 - 100', ' left ventricular ejection fraction (LVEF) 50% by echocardiogram or multiple gated acquisition (MUGA)', ' Adequate hematologic, hepatic and renal function', ' Exclusion Criteria', ' women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug', ' Women who are pregnant or breastfeeding', ' Inflammatory or metastatic breast cancer', ' Unfit for breast and/or axillary surgery', ' Evidence of baseline sensory or motor neuropathy', ' Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection', ' History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Pathologic Complete Response (pCR)', ' The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.', ' Time frame: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', ' Overall Number of Participants Analyzed: 148', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 24.3 (18.6 to 30.8)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: paclitaxel 80 mg/m^2 administered IV every week for 12 weeks', ' Overall Number of Participants Analyzed: 147', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 25.2 (19.4 to 31.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/145 (11.72%)', ' ANAEMIA 0/145 (0.00%)', ' LEUKOPENIA 2/145 (1.38%)', ' NEUTROPENIA 1/145 (0.69%)', ' LEUKOCYTOSIS 1/145 (0.69%)', ' THROMBOCYTOPENIA 1/145 (0.69%)', ' FEBRILE NEUTROPENIA 1/145 (0.69%)', ' THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)', ' CARDIAC FAILURE 1/145 (0.69%)', ' ATRIAL FIBRILLATION 1/145 (0.69%)', 'Adverse Events 2:', ' Total: 11/144 (7.64%)', ' ANAEMIA 1/144 (0.69%)', ' LEUKOPENIA 0/144 (0.00%)', ' NEUTROPENIA 0/144 (0.00%)', ' LEUKOCYTOSIS 0/144 (0.00%)', ' THROMBOCYTOPENIA 0/144 (0.00%)', ' FEBRILE NEUTROPENIA 1/144 (0.69%)', ' THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)', ' CARDIAC FAILURE 0/144 (0.00%)', ' ATRIAL FIBRILLATION 0/144 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00767520', 'Intervention': ['INTERVENTION 1: ', ' Exemestane + Dasatinib', ' Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Exemestane + Placebo', ' Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis', ' Prior therapy with a non-steroidal aromatase inhibitor', ' Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)', ' Documented breast cancer with tumor 28 days prior to study entry', ' Women who are NOT of childbearing potential', ' Must be able to take oral medication', ' Performance Status 0 or 1', 'Exclusion Criteria:', ' Pleural or pericardial effusion or ascites (of any etiology; Grade 1) within 6 months prior to study entry', ' Any chemotherapy, immunotherapy < 6 months before study entry. Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI', ' Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry', ' Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer', ' Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years', ' Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding', ' Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval > 450 msec at baseline (Fridericia correction)', ' Hematologic abnormality Grade 2', ' Hypocalcemia of Grade 1', " Any Chemistry abnormality of Grade 2 [except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease]", ' Pregnant Women and Women of Childbearing Potential (WOCBP)', ' Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)', ' Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)', ' Potent inhibitors of CYP3A4 isoenzyme', ' Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo', ' PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase ( 20%) in sum of longest diameters from smallest value during study (including baseline).', ' Time frame: Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)', 'Results 1: ', ' Arm/Group Title: Exemestane + Dasatinib', ' Arm/Group Description: Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 79', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 18.1 (15.1 to 24.3)', 'Results 2: ', ' Arm/Group Title: Exemestane + Placebo', ' Arm/Group Description: Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 78', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 16.1 (12.1 to 18.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/79 (27.85%)', ' Anaemia 0/79 (0.00%)', ' Right ventricular dysfunction 1/79 (1.27%)', ' Diarrhoea 1/79 (1.27%)', ' Vomiting 2/79 (2.53%)', ' Abdominal pain 0/79 (0.00%)', ' Colonic obstruction 0/79 (0.00%)', ' Dysphagia 1/79 (1.27%)', ' Nausea 1/79 (1.27%)', ' Mucosal inflammation 1/79 (1.27%)', ' Performance status decreased 1/79 (1.27%)', ' Sudden death 1/79 (1.27%)', 'Adverse Events 2:', ' Total: 13/76 (17.11%)', ' Anaemia 1/76 (1.32%)', ' Right ventricular dysfunction 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Vomiting 2/76 (2.63%)', ' Abdominal pain 1/76 (1.32%)', ' Colonic obstruction 1/76 (1.32%)', ' Dysphagia 0/76 (0.00%)', ' Nausea 1/76 (1.32%)', ' Mucosal inflammation 0/76 (0.00%)', ' Performance status decreased 0/76 (0.00%)', ' Sudden death 0/76 (0.00%)']}
|
8ddf49c7-316e-4c7c-b2dd-423182a37612
|
Single
|
Adverse Events
|
NCT01498458
|
For all adverse event types in the primary trial, at least one case was recorded.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT01498458', 'Intervention': ['INTERVENTION 1: ', ' Pazopanib Plus Capecitabine', ' A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.', ' Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.', ' Diagnosis of advanced or metastatic HER2-negative breast cancer. HER2-negative is defined as HercepTest IHC 0-2+ or FISH negative (ratio < 2.2).', ' At least one prior endocrine or one non-capecitabine-containing chemotherapy treatment for metastatic/advanced disease.', ' Documented progression of either a measurable, or a non-measurable lesion according to the RECIST criteria, or a new lesion.', ' Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.', ' Age => 18 years.', ' Karnofsky Performance Status index => 60%.', ' Laboratory requirements: Absolute neutrophil count (ANC) => 1.5 x 109/L, Platelets => 100 x 109/L, Hemoglobin => 9 g/dL (=> 5.6 mmol/L), Prothrombin time (PT) or international normalised ratio (INR) =< 1.2x UNL (upper normal limit), Partial thromboplastin time (PTT) =< 1.2x UNL, Total bilirubin < 1.5x UNL, ASAT (SGOT) and ALAT (SGPT) =< 2.5x UNL (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x UNL are not permitted), The calculated creatinine clearance should be => 50 mL/min), Urine Protein to Creatinine Ratio (UPC) < 1 (if UPC => 1, then 24-hour urine protein must be < 1 g).', " Normal cardiac function confirmed by ECG; corrected QT interval (QTc) < 480 msec using Bazett's formula.", 'A female either of:Non-childbearing potential i.e., physiologically incapable of becoming pregnant because of history of hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation or postmenopausal status.', " Childbearing potential with a negative serum pregnancy test within 2 weeks prior to registration, preferably as close to the first dose as possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: An intrauterine device with a documented failure rate of less than 1% per year, Vasectomised partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female, Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product, Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).", ' Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.', 'Exclusion Criteria:', ' Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances.', ' Last metastatic treatment with capecitabine, 5-FU, bevacizumab, sunitinib, sorafenib, or other antibodies or tyrosine kinase inhibitors with anti-angiogenic activity. Investigational therapies within 14 days or five half-lives of the drug (whichever is longer) prior to first dose of pazopanib.', ' Any ongoing toxicity from prior anti-cancer therapy that is grade >1 and/or that is progressing in severity, except alopecia.', ' Surgery or tumor embolisation within 28 days prior to the first dose of pazopanib. At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.', ' Concurrent immuno-biological or hormonal therapy for cancer.', ' History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.', ' Life expectancy less than 3 months.', ' History of thyroid autoimmune disease or thyroid disorders with thyroid values out of standard range', " Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: Active peptic ulcer disease, Known intraluminal metastatic lesion/s with risk of bleeding, Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), 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.", ' Severe liver dysfunction', ' Grade 3 or 4 diarrhea.', ' Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: Malabsorption syndrome, Major resection of the stomach or small bowel.', ' Presence of uncontrolled infection.', ' History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA), Poorly controlled hypertension (defined as systolic blood pressure [SBP] of 160 mmHg or diastolic blood pressure [DBP] of 90 mmHg).', ' Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.', ' BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 160/95 mmHg in order for a subject to be eligible for the study (see Section 9.6.1 for details on BP control and re-assessment prior to study enrollment).', ' History of cerebrovascular accident including transient ischemic attack (TIA), 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-coagulating agents for at least 6 weeks are eligible.', ' Evidence of active bleeding or bleeding diathesis including, but not limited to: Prior 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 (procedures such as catheter placement not considered to be major), Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels, Hemoptysis prior to 6 weeks of first dose of study drug, Blood transfusion within 7 days of study entry.', " 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: ', ' Maximum Tolerable Dose (MTD) of Pazopanib', ' The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Pazopanib Plus Capecitabine', ' Arm/Group Description: A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: mg NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/8 (75.00%)', ' Thrombocytopenia 1/8 (12.50%)', ' Hypertension 1/8 (12.50%)', ' Hepatotoxicity 3/8 (37.50%)', ' Pancreatectomy * 1/8 (12.50%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d9e41be5-1e37-4dff-b51a-166576f351d0
|
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