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Comparison
|
Eligibility
|
NCT00438100
|
NCT00662025
|
Patients must have BUN < 20 mg/dL, Platelet count: <90,000/mm3, Leukocyte count of 5,000/mm3 to 8,000/mm3 to be eligible for either the primary trial or the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[
0,
1,
2,
3,
4,
5,
6,
7
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{'Clinical Trial ID': 'NCT00438100', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine Arm', ' Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.', ' Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.', 'INTERVENTION 2: ', ' S-1 Arm', ' S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.', ' S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.'], 'Eligibility': ['Inclusion Criteria:', ' Biopsy-diagnosed breast cancer with metastasis in multiple organs', ' Performance Status (World Health Organization :WHO) 0-2', ' Functions below are maintained in major organs:', ' Leukocyte count: 4,000/mm3 to 12,000/mm3', ' Neutrophil count: >2,000/mm3 or more', ' Platelet count: <100,000/mm3 or more', ' Hemoglobin: >9.5 g/dL', ' Total bilirubin: >1.5 mg/dL', ' AST(GOT): within twice a normal upper value in an institution', ' AST(GPT): within twice a normal upper value in an institution', ' BUN: < 25 mg/dL', ' Creatinine: within a normal upper value in the institution', ' 24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)', " Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85", ' Written informed consent will be obtained for patients for entering this study', 'Exclusion Criteria:', ' Patients with synchronous multiple cancers', ' Complicated with infection', ' Fever from suspected infection', ' Metastasis to the central nerve system', ' A history of ischemic cardiac diseases', ' Active gastrointestinal ulcer', ' Severe nerve disorder', ' Women who are potentially pregnant, pregnant, or breast-feeding', ' Severe drug allergy', ' Severe suppression of the bone marrow', ' Severe renal disorder', ' Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)', ' Being treated with flucytosine', ' Complicated with the infection onset which a study doctor assesses to be inappropriate for this study'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' [Not Specified]', ' Time frame: The follow up period will be two years after the last dose has been administered.', 'Results 1: ', ' Arm/Group Title: Capecitabine Arm', ' Arm/Group Description: Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.', ' Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.', ' Overall Number of Participants Analyzed: 71', ' Median (95% Confidence Interval)', ' Unit of Measure: years 1.2 (0.76 to 2.04)', 'Results 2: ', ' Arm/Group Title: S-1 Arm', ' Arm/Group Description: S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.', ' S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.', ' Overall Number of Participants Analyzed: 65', ' Median (95% Confidence Interval)', ' Unit of Measure: years 1.3 (0.96 to 2.68)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/71 (0.00%)', 'Adverse Events 2:', ' Total: 0/65 (0.00%)']}
|
{'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%)']}
|
c94ad26b-1f5e-4446-a4fe-bb949c5dc561
|
Single
|
Results
|
NCT00244881
|
30% of the primary trial participants had an increased level of CECs after 42 days of treatment.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00244881', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cediranib Maleate)', ' Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed Breast Cancer, stage IV, including:', ' "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer stage IV","10006202"', ' Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer recurrent","10006198"', ' "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Inflammatory carcinoma of breast stage IV","10021979"', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan', ' Patients must have refractory breast cancer, defined as overt clinical tumor progression on most recent treatment with either hormonal therapy, chemotherapy, and/or trastuzumab therapy; patients with up to 3 prior chemotherapy regimens and with any number of biological (hormonal, trastuzumab) regimens for metastatic breast cancer will be eligible', " Life expectancy of greater than 3 months as assessed by the patient's primary oncologist", ' Absolute neutrophil count > 1,500/mcL', ' Platelets > 100,000/mcL', ' Hemoglobin >= 8 g/dL', ' Prothrombin time < institutional upper limit of normal (ULN)', ' Total bilirubin =< 1.5 x ULN', ' AST(SGOT)/ALT(SGPT) =< 2.5 × ULN', ' Creatinine within normal institutional limits', ' Urinalysis with < 1+ proteinuria', ' Troponin T or I within normal institutional limits', ' LVEF >= 45%, as assessed by echocardiogram or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment', ' At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown; however, studies of the agent in rats indicated possible suppression of CYP1A that may be of biological significance; eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of AZD2171 will be determined following review of their case by the Principal Investigator.', ' AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' No therapeutic anti-coagulation; the use of low dose warfarin (1-2 mg/day), intermittent doses of TPA (2 mg x 1), or heparin flushes to prophylax against central venous catheter-associated clots is acceptable', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier', ' Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days', ' Patients may not have been previously treated with an anti-angiogenesis agent', ' \\Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine); these medications will also not be permitted after the start of the study', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; a head CT or MRI must be performed at baseline', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171', ' Any contraindications/barrier to oral medication', " EKG abnormalities of known clinical significance, such as prolonged QT (mean QTc > 470 msec, with Bazett's correction, in screening electrocardiogram or history of familial long QT syndrome); an EKG is required for study entry", ' Uncontrolled intercurrent illness including, but not limited to hypertension, 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 AZD2171 is a VEGF inhibitor with known abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171', ' HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated', ' Patients at increased risk for compromised LVEF requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171 (refer to Appendix J for a listing of these agents)', ' Patients with a New York Heart Association classification of III or IV are excluded (NOTE: patients classified as class II are eligible if controlled on medication and stable with increased monitoring)'], 'Results': ['Outcome Measurement: ', ' Fraction of Patients With Increased Levels of Circulating Endothelial Cells', ' An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).', ' Time frame: After 3 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Treatment (Cediranib Maleate)', ' Arm/Group Description: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/26 (26.92%)', ' Left Ventricular Systolic Dysfunction 1/26 (3.85%)', ' Hypertension 1/26 (3.85%)', ' Vomiting 1/26 (3.85%)', ' Esophagitis 1/26 (3.85%)', ' Gallbladder Abnormality 1/26 (3.85%)', ' Diarrhea 1/26 (3.85%)', ' Dyspnea 1/26 (3.85%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4e31e4f8-a6da-49fc-8bfe-1309674ec2ee
|
|
Single
|
Results
|
NCT00089661
|
On average cohort 1 participants in the primary trial had an increased Rate of Acute Toxicity , whereas those in cohort 2 did not experience any Acute Toxicities.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00089661', 'Intervention': ['INTERVENTION 1: ', ' Denosumab 60 mg Q6M', '[Not Specified]', 'INTERVENTION 2: ', ' Placebo', '[Not Specified]'], 'Eligibility': ['Histologically or cytologically confirmed adenocarcinoma of the breast', ' Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study', ' All treatment pathway must be completed 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)', ' Female > 18 years of age', ' ECOG Performance status 0 and 1', ' Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5', ' Subject is willing and able to provide signed consent before any study-specific procedure', ' Other criteria also apply.'], 'Results': ['Outcome Measurement: ', ' Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12', ' Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Denosumab 60 mg Q6M', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 123', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: Percent Change from Baseline 4.8 (4.3 to 5.4)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 122', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: Percent Change from Baseline -.7 (-1.3 to -.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/120 (9.17%)', ' Acute myocardial infarction 0/120 (0.00%)', ' Atrial fibrillation 1/120 (0.83%)', ' Atrioventricular block second degree 0/120 (0.00%)', ' Cardiac failure congestive 1/120 (0.83%)', ' Myocardial infarction 0/120 (0.00%)', ' Myocardial ischaemia 1/120 (0.83%)', ' Goitre 1/120 (0.83%)', ' Colitis ischaemic 0/120 (0.00%)', ' Diverticulum 0/120 (0.00%)', ' Faecaloma 1/120 (0.83%)', 'Adverse Events 2:', ' Total: 19/129 (14.73%)', ' Acute myocardial infarction 1/129 (0.78%)', ' Atrial fibrillation 0/129 (0.00%)', ' Atrioventricular block second degree 1/129 (0.78%)', ' Cardiac failure congestive 0/129 (0.00%)', ' Myocardial infarction 1/129 (0.78%)', ' Myocardial ischaemia 0/129 (0.00%)', ' Goitre 0/129 (0.00%)', ' Colitis ischaemic 1/129 (0.78%)', ' Diverticulum 1/129 (0.78%)', ' Faecaloma 0/129 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5c00f992-5066-42f2-88d7-566b8b9104b5
|
|
Single
|
Eligibility
|
NCT01527487
|
Patients prescribed Citalopram as an ongoing treatment for depression are not eligible for the primary trial.
|
Entailment
|
[
32,
49
] |
[] |
{'Clinical Trial ID': 'NCT01527487', 'Intervention': ['INTERVENTION 1: ', ' Eribulin+Cyclophosphamide (ErC)', ' Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion', 'INTERVENTION 2: ', ' Docetaxel+Cyclophosphamide (TC)', ' Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive adenocarcinoma of the breast.', ' Primary palpable disease confined to the breast and axilla on physical examination (clinical Stage II or III disease). For patients without clinically suspicious axillary adenopathy, the primary must be >2 cm in diameter by physical examination or imaging studies (clinical T2-3, N0-2, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). Patients who have had axillary node dissection and have pN3a (i.e. 10 involved axillary nodes) are also eligible.', ' Patients entering the trial after undergoing an axillary node dissection will be eligible if they meet other entry criteria.', ' Estrogen receptor (ER) and progesterone receptor (PR) status in the primary tumor known or pending at the time of study registration.', ' Resolution of all acute effects of surgical procedures to grade 1. For patients who had or will have, a sentinel node and/or axillary node dissection, completion at least 1 week prior to the initiation of study treatment with a well-healed wound is required.', ' Bilateral, synchronous breast cancer is allowed if both primary tumors are HER2-negative and at least one meets the specified qualifying tumor or nodal inclusion criteria.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.', ' Patients entering this study must be willing to provide release of tumor tissue collected at baseline during a diagnostic procedure if available, and at the time of future surgical procedure(s) for correlative testing. If tissue is not available, the patient will still be eligible for enrollment to the study.', ' No evidence of metastatic disease, as documented by complete staging workup 8 weeks prior to initiation of study treatment.', ' No prior treatment for this breast cancer with the exception of criterion #3.', ' HER2-negative tumor status defined as:', ' Immunohistochemical (IHC) 0-1+ or', ' IHC 2+ or IHC 3+ confirmed as FISH (Fluorescence in situ hybridization) or SISH (Silver in situ hybridization) negative (defined by ratio <2.2)', ' Adequate hematologic function defined as:', ' Absolute neutrophil count (ANC) 1500/μL', ' Hemoglobin (Hgb) 10 g/dL', ' Platelets 100,000/uL', ' Adequate liver function defined as:', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x the upper limit of normal (ULN)', ' Total bilirubin the institutional ULN', ' Adequate renal function defined as:', ' Serum creatinine 1.5 mg/dL x ULN OR calculated creatinine clearance 50 mL/min by the Cockcroft-Gault method:', ' GRF =(140-age) x (weight/kg) x (0.85 if female) (72 x serum creatinine mg/dL)', ' Other laboratory testing:', ' Serum magnesium the institutional lower limit of normal (LLN)', ' Serum potassium the institutional LLN', ' Female and 18 years of age.', ' Negative serum pregnancy test within <7 days prior to initial trial treatment.', ' Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures that are approved by their study physician while receiving study treatment and continuing for 3 weeks after the last dose of study drug treatment, who are not breastfeeding, and who have a negative serum pregnancy test prior to start of dosing.', ' Willingness and ability to comply with trial and follow-up procedures.', ' Ability to understand the nature of this trial and give written informed consent.', 'Exclusion Criteria:', ' Clinical T4 lesions, including inflammatory breast cancer. Clinical N3 involvement (e.g., ipsilateral, infraclavicular, supraclavicular, and internal mammary nodes).', ' Peripheral neuropathy (motor or sensory) > grade 1 according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).', ' Patient has received radiotherapy for treatment of previous cancer that included 30% of major bone marrow containing areas (e.g., pelvis, lumbar, spine).', ' Known or suspected allergy or hypersensitivity to any of the study drugs (i.e., eribulin, cyclophosphamide, docetaxel) or known hypersensitivity to polysorbate 80.', ' Patients with acute or chronic liver or renal disease or pancreatitis.', ' Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).', ' Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment. However, use of GNRH agonists for the purpose of fertility preservation or suppression of heavy menses is permitted (see Section 5.4.1).', ' Patient has any of the following cardiac diseases currently or within the last 6 months:', ' Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)', " Heart rate-corrected QT interval (QTc) > 480 ms on screening electrocardiogram (ECG) (using Bazett's formula)", ' Unstable angina pectoris', ' Congestive heart failure (New York Heart Association [NYHA] Grade 2', ' Acute myocardial infarction', ' Conduction abnormality not controlled with pacemaker or medication', ' Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).', ' Valvular disease with significant compromise in cardiac function', ' Chronic use of drugs that cause QTc prolongation. Patients must discontinue use of these drugs 7 days prior to the start of study treatment.', ' Presence of other active cancers, or history of treatment for invasive cancer 5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.', ' Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.', ' Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery', ' One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.', ' Time frame: 18 weeks', 'Results 1: ', ' Arm/Group Title: Eribulin+Cyclophosphamide (ErC)', ' Arm/Group Description: Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of surgical patients 18', 'Results 2: ', ' Arm/Group Title: Docetaxel+Cyclophosphamide (TC)', ' Arm/Group Description: Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage of surgical patients 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/54 (7.41%)', ' Febrile Neutropenia 3/54 (5.56%)', ' Sepsis 1/54 (1.85%)', 'Adverse Events 2:', ' Total: 2/22 (9.09%)', ' Febrile Neutropenia 1/22 (4.55%)', ' Sepsis 1/22 (4.55%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4c0ffc50-5cb2-4574-b954-335d142edbe4
|
|
Comparison
|
Adverse Events
|
NCT00810797
|
NCT00828074
|
Skin infections were more common in patients in cohort 1 of the secondary trial, than in cohort 1 of the primary trial.
|
Entailment
|
[
0,
5
] |
[
0,
8
] |
{'Clinical Trial ID': 'NCT00810797', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Exemestane)', ' Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' exemestane: Given orally', ' laboratory biomarker analysis: One year after completion of study treatment', ' quality-of-life assessment: One year after completion of study treatment', ' immunohistochemistry staining method: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed metastatic carcinoma of the breast', ' Hormone receptor (estrogen receptor [ER] and/or progesterone receptor [PR]) positive disease (defined as: ER and/or PR positivity as >= 5% staining), as confirmed by immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue', ' Postmenopausal, as defined by any of the following:', ' Natural menopause, with at least 1 year since last menses', ' Chemotherapy-induced menopause with at least 1 year from last menses and serum luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range', ' History of surgical or radiation-induced ovarian ablation', ' For women =< 56 years old and with a history of hysterectomy but at least one ovary intact, serum LH/FSH and estradiol levels must be within the postmenopausal range', ' Postmenopausal women with disease recurrence while receiving either tamoxifen or a non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant hormonal therapy was taken for 6 months before disease progression) or with disease recurrence following the discontinuation/completion of adjuvant hormonal therapy', ' Postmenopausal women with disease progression following either 0, 1 or 2 prior hormonal therapies for metastatic breast cancer, as long as the subject has had no prior exposure to exemestane (EXE)', ' Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Neutrophil count >= 1.5 X 10^9 cells/L', ' Platelet count >= 100 X 10^9 cells/L', ' Serum creatinine =< 1.5 times upper limit of normal (ULN)', ' Total serum bilirubin =< 1.5 times ULN', ' Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in patients without liver metastases or =< 5 times ULN in patients with liver metastases', ' Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver metastases', ' Subjects must have an estimated life expectancy of greater than 6 months', 'Exclusion Criteria:', ' Prior exposure to EXE, whether in the adjuvant or metastatic setting', ' Prior history of any other cancer with the exception of non-melanoma skin cancer and treated in situ carcinoma of the cervix', ' Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain metastasis allowed but patients must be off decadron, if given for CNS disease)', ' Hormone-receptor negative or unknown breast cancer', ' More than two prior chemotherapy regimen for treatment of metastatic disease (any prior chemotherapy given in the adjuvant setting is permitted)', ' Administration of any other anti-cancer therapy within 2 weeks of initiating study treatment; use of bisphosphonates, however, are permitted for patients with known bone metastases', ' Treatment with any other concurrent investigational agent or anti-tumor drug (chemotherapy, antibody therapy or other biologic agents), will not be permitted', ' Subjects who have had no prior exposure to endocrine therapy', ' Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with the ability to provide informed consent or comply with study procedures'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Estimated using the product-limit method of Kaplan and 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: Until disease progression of death from any cause, up to 3 years', 'Results 1: ', ' Arm/Group Title: Treatment (Exemestane)', ' Arm/Group Description: Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' exemestane: Given orally', ' laboratory biomarker analysis: One year after completion of study treatment', ' quality-of-life assessment: One year after completion of study treatment', ' immunohistochemistry staining method: Correlative studies', ' Overall Number of Participants Analyzed: 36', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.3 (2.0 to 6.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/36 (11.11%)', ' Rectal hemorrhage * 1/36 (2.78%)', ' Disease progression * 1/36 (2.78%)', ' Device related infection * 1/36 (2.78%)', ' Skin infection * 1/36 (2.78%)', ' Hypotension * 1/36 (2.78%)']}
|
{'Clinical Trial ID': 'NCT00828074', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2', ' Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', 'INTERVENTION 2: ', ' Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2', ' Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed stage IV adenocarcinoma of the breast; (unless metastatic disease is documented by computed tomography [CT] scan, magnetic resonance imaging [MRI], or bone scan; also, skin disease that has not been biopsied maybe used if in the investigators clinical opinion this represents metastatic disease)', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan', ' Prior adjuvant therapy, and up to 2 lines of prior chemotherapy (including trastuzumab containing regimens in Her-2 positive patients) for metastatic disease are allowed; prior radiation therapy is allowed, prior hormonal therapy is allowed; the total number of patients enrolled with prior trastuzumab containing regimens will not exceed 10; no more than 50% of enrolled patients will receive the study regimen in a third line setting', ' Life expectancy of greater than 6 months', 'Performance status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2', ' Hemoglobin >= 9.0 g/dl', ' Absolute neutrophil count (ANC) >= 1,500/mm^3', ' Platelet count >= 100,000/mm^3', ' Total bilirubin =< 1.5 times ULN', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal (ULN) (=< 5 x ULN for patients with liver involvement)', ' Creatinine =< 1.5 times ULN', ' International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable', ' Women of child-bearing potential and men 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; women of childbearing potential must have a negative serum pregnancy test performed within 7 days to the start of treatment; 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 document', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior; patients who had bevacizumab within 4 weeks prior to entering the study are allowed', ' Patients may not be receiving any other investigational agents', ' Patients with known brain metastases are excluded from this clinical trial; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements', ' Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management', ' Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months', ' Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug', ' Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks of first dose of study drug', ' Serious non-healing wound, ulcer, or bone fracture', ' Evidence or history of bleeding diathesis or coagulopathy', ' Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug', " Use of St. John's Wort or rifampin (rifampicin)", ' Known or suspected allergy to sorafenib or any agent given in the course of this trial', ' Pregnant women', ' Human immunodeficiency virus (HIV)-positive patients', " Any condition that impairs patient's ability to swallow whole pills", ' Any malabsorption problem', ' Patients who received prior sunitinib are excluded'], 'Results': ['Outcome Measurement: ', ' Number of Participants With at Least One Dose Limiting Toxicity in Phase I', ' Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy.', ' Time frame: 4 weeks from start of treatment, up to 2 years', 'Results 1: ', ' Arm/Group Title: Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2', ' Arm/Group Description: Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 0', 'Results 2: ', ' Arm/Group Title: Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2', ' Arm/Group Description: Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/41 (36.59%)', ' Febrile neutropenia * 0/41 (0.00%)', ' Diarrhea * 1/41 (2.44%)', ' Stomach pain * 1/41 (2.44%)', ' Fever * 2/41 (4.88%)', ' Cytokine release syndrome * 1/41 (2.44%)', ' Infection * 1/41 (2.44%)', ' Skin infection * 2/41 (4.88%)', ' Urinary tract infection * 1/41 (2.44%)', ' Coagulopathy * 0/41 (0.00%)', ' INR increased * 0/41 (0.00%)', ' Lipase increased * 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 2/5 (40.00%)', ' Febrile neutropenia * 1/5 (20.00%)', ' Diarrhea * 0/5 (0.00%)', ' Stomach pain * 0/5 (0.00%)', ' Fever * 0/5 (0.00%)', ' Cytokine release syndrome * 0/5 (0.00%)', ' Infection * 0/5 (0.00%)', ' Skin infection * 0/5 (0.00%)', ' Urinary tract infection * 0/5 (0.00%)', ' Coagulopathy * 1/5 (20.00%)', ' INR increased * 1/5 (20.00%)', ' Lipase increased * 0/5 (0.00%)']}
|
4e3379b9-f971-4ab6-8846-c395f1162bf2
|
Single
|
Eligibility
|
NCT00579826
|
Participants of the primary trial cannot be currently receiving for treatment rheumatoid arthritis, experiencing poorly controlled migraines, receiving hormone replacement therapy or have any prior history of invasive breast cancer in the last 3 years.
|
Contradiction
|
[
0,
2,
6,
8,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00579826', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Letrozole, 2.5 mg daily for 6 months', ' Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.', 'INTERVENTION 2: ', ' Placebo', ' Placebo, daily for 6 months', ' Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Post-menopausal women at high risk for development of breast cancer', ' On a stable dose of hormone replacement therapy', ' have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA', ' Serum level of 25-OH vitamin D of at least 30 ng/ml prior to study entry', ' Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug', 'Exclusion Criteria:', ' Prior history of osteoporosis or osteoporotic fracture.', ' Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.', ' Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs', ' Receiving treatment for rheumatoid arthritis or fibromyalgia', ' Current history of poorly controlled migraines or perimenopausal symptoms', ' Currently receiving other investigational agents.', ' Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.'], 'Results': ['Outcome Measurement: ', ' Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months', ' Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer.', ' Time frame: Baseline to 6 Months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole, 2.5 mg daily for 6 months', ' Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.', ' Overall Number of Participants Analyzed: 28', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of cells stained positive -1.5 (2.8)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo, daily for 6 months', ' Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months.', ' Overall Number of Participants Analyzed: 25', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of cells stained positive -1.1 (3.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9872394c-18b7-4f88-849e-0e2831e6ebf0
|
|
Comparison
|
Eligibility
|
NCT01771666
|
NCT01256567
|
Japanese participants with an ECOG of 2 are eligible for the secondary trial and the primary trial.
|
Contradiction
|
[
0,
7
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01771666', 'Intervention': ['INTERVENTION 1: ', ' ISB and IC-Green Dye', ' The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.'], 'Eligibility': ['Inclusion Criteria:', ' Ability to understand and the willingness to sign a written informed consent document.', ' Signed written informed consent.', ' Women undergoing sentinel lymph node biopsy.', ' Women with breast cancer with known or suspected lymph node involvement.', ' Women undergoing sentinel node identification and completion axillary lymph node dissection.', ' Women of 18 years of age or older.', ' Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.', ' Complete Blood Count (CBC) and basic Metabolic Panel within 6 months', 'Exclusion Criteria:', ' History of liver or kidney failure will not be eligible.', ' Allergies to iodine containing products will not be eligible.', ' Women who are pregnant will not be eligible.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.'], 'Results': ['Outcome Measurement: ', ' Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)', ' Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.', 'Time frame: 1 day', 'Results 1: ', ' Arm/Group Title: ISB and IC-Green Dye', ' Arm/Group Description: The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 34.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)']}
|
{'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%)']}
|
adf3bb50-ec36-467a-987a-f33c10380c60
|
Single
|
Adverse Events
|
NCT01875367
|
One patient in the primary trial suffered a cerebral infarction.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT01875367', 'Intervention': ['INTERVENTION 1: ', ' Arm A: T-IV + T-SC Vial + T-SC Device', ' Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.', 'INTERVENTION 2: ', ' Arm B: T-IV + T-SC Device + T-SC Vial', ' Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Woman, 18 years old or upper.', ' Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:', ' immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)', ' IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)', ' FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.', ' Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.', ' No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.', ' Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.', ' Adequate bone marrow function, liver and kidney', ' Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).', ' The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.', ' The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.', 'Exclusion Criteria:', ' Patients with no advanced breast cancer.', ' Breast cancer patients with tumors HER 2-negative.', ' The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.', ' The patient has uncontrolled brain metastases.', ' Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.', ' Known hypersensitivity to trastuzumab or to any of its components.', ' Patients with severe dyspnea at rest or requiring supplemental oxygen.', ' Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.', ' Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).', ' The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference', ' The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.', ' Time frame: Up to 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm A: T-IV + T-SC Vial + T-SC Device', ' Arm/Group Description: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Subcutaneous: 66 86.8%', ' Intravenous: 6 7.9%', ' No preference: 4 5.3%', 'Results 2: ', ' Arm/Group Title: Arm B: T-IV + T-SC Device + T-SC Vial', ' Arm/Group Description: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.', ' Overall Number of Participants Analyzed: 83', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Subcutaneous: 71 85.5%', ' Intravenous: 5 6.0%', ' No preference: 7 8.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/81 (2.47%)', ' Heart failure 0/81 (0.00%)', ' Fever 1/81 (1.23%)', ' Cold 0/81 (0.00%)', ' Catheter related infection (Bacteriemia) 0/81 (0.00%)', ' Lack of strength in left leg 0/81 (0.00%)', ' Ostenecrosis produced by biphosphonates 0/81 (0.00%)', ' Gastric cancer 0/81 (0.00%)', ' Stroke 0/81 (0.00%)', ' Hematuria 1/81 (1.23%)', ' Nodule in left breast 0/81 (0.00%)', 'Adverse Events 2:', ' Total: 10/85 (11.76%)', ' Heart failure 1/85 (1.18%)', ' Fever 0/85 (0.00%)', ' Cold 1/85 (1.18%)', ' Catheter related infection (Bacteriemia) 1/85 (1.18%)', ' Lack of strength in left leg 1/85 (1.18%)', ' Ostenecrosis produced by biphosphonates 1/85 (1.18%)', ' Gastric cancer 1/85 (1.18%)', ' Stroke 1/85 (1.18%)', ' Hematuria 0/85 (0.00%)', ' Nodule in left breast 1/85 (1.18%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2ef37a06-a1ed-47eb-b8f4-2f97f46293d1
|
|
Single
|
Results
|
NCT00477464
|
59 patients from Arm A of the primary trial achieved a best overall response, classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00477464', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib 1250 mg and Capecitabine 2000 mg/m^2', ' Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.'], 'Eligibility': ['Inclusion criteria:', ' Subjects eligible for enrolment in the study must meet all of the following criteria:', ' Patients who have consent to this study participation and signed into Informed consent form.', ' Subjects must have histologically confirmed invasive breast cancer with stage IIIB, stage IIIC with T4 lesion, or stage IV disease.', ' Documentation of ErbB2 overexpression [IHC3+ or IHC2+ with FISH confirmation] is required based on local laboratory.', ' Subjects must have documented progressive advanced or metastatic breast cancer.', ' Subjects must have refractory breast cancer defined as progression in the locally advanced or metastatic setting or relapse within 6 months of completing adjuvant therapy. Prior therapies must include, but are not limited to:', ' Taxane containing regimen for at least 4 cycles or 2 cycles provided disease progression occurred while on taxane.', ' Anthracycline containing regimen for at least 4 cycles or 2 cycles provided disease progression occurred while on anthracycline.', ' Subjects who relapse >6 months after completion of adjuvant anthracycline-containing chemotherapy, and for whom further anthracycline is not indicated, will be considered to have met the anthracycline prior exposure requirement.', ' Taxanes and anthracyclines may have been administered concurrently or separately.', ' Prior treatment with capecitabine is not permitted.', ' Prior treatment must have contained trastuzumab alone or in combination with other chemotherapy for at least 6 weeks of standard doses in the adjuvant or advanced/metastatic setting.', ' Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.', ' Subjects with stable CNS metastases (asymptomatic, and off systemic steroids and anticonvulsants for at least 3 months) are eligible.', ' Measurable disease according to modified RECIST (Response Evaluation Criteria in Solid Tumors) (see Section 6.2, Efficacy p.49).', ' Subjects must have archived tumor tissue available for biomarker assessment.', ' Female subjects must be 20', ' ECOG Performance Status of 0 or 1.', ' Life expectancy of 12 weeks.', ' Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.', ' Cardiac ejection fraction within the institutional range of normal as measured by ECHO (or MUGA if ECHO is not available). If no institutional range is available, cardiac ejection fraction must be 50%.', ' Adequate hematologic value, hepatic and renal function as defined below. Hematologic ANC (absolute neutrophil count) 1.5×109/L Hemoglobin 9 g/dL Platelets 100× 109/L Hepatic Serum bilirubin 1.5×ULN', " 2.5×ULN if subject has Gilbert's syndrome AST and ALT 5×ULN if documented liver metastases", ' 3×ULN without liver metastases Renal Serum creatinine Creatinine clearance* 50 mL/min', ' Calculated by the Cockcroft and Gault Method', 'Exclusion criteria:', ' Subjects meeting any of the following criteria must not be enrolled in the study:', ' Pregnant or lactating females.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. In addition, subjects with ulcerative colitis are excluded.', ' History of other malignancy. Subjects who have been disease-free for at least 5 years or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', ' Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior anticancer therapy.', ' Active or uncontrolled infection.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure.', ' No prior anti-ErbB1/ErbB2 inhibitor for breast cancer other than trastuzumab.', ' Known history or clinical evidence of leptomeningeal carcinomatosis.', ' Concurrent anticancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine.', ' Bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of study medication. Prophylactic use of bisphosphonate in subjects without bone disease is not permitted, except for prevention of osteoporosis.', ' Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.', ' Participation in other studies or use of other investigational drugs during this study.', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients of lapatinib.', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients.', ' Known dihydropyrimidine dehydrogenase (DPD) deficiency.', " Patients who an investigator judges ineligible to this study in consideration of patient's safety (e.g., complications)."], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Response (Independent Reviewer-assessed)', ' CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A "complete response" is defined as the disappearance of all target or non-target lesions, "partial response" and "disease progression" as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and "stable disease" as neither "partial response" nor "disease progression."', ' Time frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)', 'Results 1: ', ' Arm/Group Title: Lapatinib 1250 mg and Capecitabine 2000 mg/m^2', ' Arm/Group Description: Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 59'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/51 (15.69%)', ' Bone marrow failure 1/51 (1.96%)', ' Left ventricular dysfunction 2/51 (3.92%)', ' Pericardial effusion 1/51 (1.96%)', ' Vertigo 1/51 (1.96%)', ' Dysphagia 1/51 (1.96%)', ' Pulmonary tuberculosis 1/51 (1.96%)', ' Neutrophil count decreased 1/51 (1.96%)', ' Syncope 1/51 (1.96%)', ' Respiratory failure 1/51 (1.96%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
03cb39e4-1d21-47e5-9b09-ebe508eb2a17
|
|
Single
|
Intervention
|
NCT00425672
|
Patients receiving intervention 1 of the primary trial must undergo a 21 day treatment cycle, for a total of 6 courses, unless death occurs .
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT00425672', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', ' ONTAK: Given IV', ' flow cytometry: Correlative studies', ' immunohistochemistry staining method: Correlative studies', ' enzyme-linked immunosorbent assay: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' protein expression analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients with advanced stage refractory breast cancer', ' Progressive or relapsed disease following standard therapy', ' Patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional CT techniques or >= 10 mm with spiral CT scan; measurable (bi-dimensional) chest wall disease will also be allowed', ' Patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible', ' White blood cell count (WBC) > 3.0 THOU/ul', ' ANC > 1.0 THOU/ul', ' Platelets >= 100 THOU/ul', ' Serum creatinine =< 2.0 mg/dL or creatinine clearance (calculated) >= 60 ml/min', ' ALT/AST =< 2.0 x upper limit of normal', ' Total bilirubin =< 1.5 x upper limit of normal', ' Albumin >= 3.0 g/dL', ' Subjects must have a Performance Status Score (ECOG Scale) =< 2', ' Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment', ' Men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ONTAK treatment is discontinued', 'Exclusion Criteria:', ' Prior treatment with ONTAK (DAB389 IL-2) or DAB486 IL-2', ' Known history of hypersensitivity to diphtheria toxin or IL-2', ' Active autoimmune disease', ' Known history of pulmonary disease except controlled asthma', ' History of or pre-existing, cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization', ' Pregnant or breast-feeding women'], 'Results': ['Outcome Measurement: ', ' Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0', ' Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.', ' Time frame: 7 Days after last dose of ONTAK', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', ' ONTAK: Given IV', ' flow cytometry: Correlative studies', ' immunohistochemistry staining method: Correlative studies', ' enzyme-linked immunosorbent assay: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' protein expression analysis: Correlative studies', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/15 (6.67%)', ' Severe Nausea and Vomiting 1/15 (6.67%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
dca6ba74-441e-482f-b667-6c45800ed8c1
|
|
Single
|
Eligibility
|
NCT01702571
|
Patients with incurable and unresectable Locally Advanced Breast Cancer are eligible for the primary trial.
|
Entailment
|
[
0,
4
] |
[] |
{'Clinical Trial ID': 'NCT01702571', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine (All Participants)', ' This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', 'INTERVENTION 2: ', ' Trastuzumab Emtansine (Asian Participants)', ' This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' HER2-positive disease determined locally', ' Histologically or cytologically confirmed invasive breast cancer', ' Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent', ' Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy', ' Measurable and/or non-measurable disease', ' Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2', ' Adequate organ function', ' Use of highly effective contraception as defined by the protocol', 'Exclusion Criteria:', ' History of treatment with trastuzumab emtansine', ' Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not', ' Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0', ' History of other malignancy within the previous 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', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of exposure to cumulative doses of anthracyclines', ' History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.', ' Metastatic central nervous system (CNS) disease only', ' Brain metastases which are symptomatic', ' History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment', ' History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction or unstable angina within 6 months of first study treatment', ' Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnancy or lactation', ' Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events of Primary Interest (AEPIs)', ' The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.', ' Time frame: Baseline up to approximately 7 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine (All Participants)', ' Arm/Group Description: This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', ' Overall Number of Participants Analyzed: 2002', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 23.1 (21.2 to 25.0)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine (Asian Participants)', ' Arm/Group Description: This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', ' Overall Number of Participants Analyzed: 181', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 51.4 (43.9 to 58.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 427/2002 (21.33%)', ' ANAEMIA 13/2002 (0.65%)', ' BONE MARROW FAILURE 1/2002 (0.05%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/2002 (0.05%)', ' FEBRILE NEUTROPENIA 1/2002 (0.05%)', ' THROMBOCYTOPENIA 11/2002 (0.55%)', ' ACUTE CORONARY SYNDROME 3/2002 (0.15%)', ' ANGINA PECTORIS 1/2002 (0.05%)', ' CARDIAC ARREST 1/2002 (0.05%)', ' CARDIAC FAILURE 1/2002 (0.05%)', ' CARDIAC TAMPONADE 1/2002 (0.05%)', 'Adverse Events 2:', ' Total: 36/181 (19.89%)', ' ANAEMIA 0/181 (0.00%)', ' BONE MARROW FAILURE 0/181 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/181 (0.00%)', ' FEBRILE NEUTROPENIA 0/181 (0.00%)', ' THROMBOCYTOPENIA 10/181 (5.52%)', ' ACUTE CORONARY SYNDROME 1/181 (0.55%)', ' ANGINA PECTORIS 0/181 (0.00%)', ' CARDIAC ARREST 0/181 (0.00%)', ' CARDIAC FAILURE 0/181 (0.00%)', ' CARDIAC TAMPONADE 0/181 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
aeecc244-13a9-4944-858e-27ef49585e90
|
|
Comparison
|
Intervention
|
NCT01256008
|
NCT00300781
|
the primary trial is investigating Cognitive behavioural therapy, a type of psychotherapy, in contrast the secondary trial studies Neratinib, a type of chemotherapy.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01256008', 'Intervention': ['INTERVENTION 1: ', ' Stage 1 Clinical Management', ' The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', 'INTERVENTION 2: ', ' Stage 1 CBT', ' The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."], 'Eligibility': ['Inclusion Criteria:', ' Age: 20-65 years;', ' Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;', ' A week after breast cancer surgery;', ' With complaints and symptoms of depression or anxiety', ' HAMD-17 8 points or / and HAMA 8 points;', " Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);", ' Informed consent', 'Exclusion Criteria:', ' Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;', ' Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month', ' Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;', ' Hearing, visual or understanding impairment;', ' Severe depression, suicidal tendencies;', " Can not or will not comply with clinical treatment programs based on the physicians' judgment", ' Exit criteria:', ' Persons with poor compliance during the trial period;', ' Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;', ' Persons who are believed have other circumstances and should be suspended by Physicians'], 'Results': ['Outcome Measurement: ', ' Hamilton Depression Rating Scale (HAMD-17)', ' The scale(HAMD-17) is used to assessed the depression symptoms of patients.', ' The scale range is 0-53.Higher value represents a worse outcome.', ' The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week', ' Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w', 'Results 1: ', ' Arm/Group Title: Stage 1 Clinical Management', ' Arm/Group Description: The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 11.52 (3.789)', ' 2W: 10.23 (3.207)', ' 4W: 9.80 (3.056)', ' 8W: 8.71 (3.601)', ' 12W: 8.01 (3.200)', ' 16W: 7.42 (3.019)', ' 24W: 7.01 (3.317)', 'Results 2: ', ' Arm/Group Title: Stage 1 CBT', ' Arm/Group Description: The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.", ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 13.31 (5.090)', ' 2W: 11.72 (4.976)', ' 4W: 9.72 (4.835)', ' 8W: 7.80 (4.440)', ' 12W: 5.71 (3.979)', ' 16W: 5.13 (4.108)', ' 24W: 4.45 (3.875)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 0/98 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00300781', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 240, Prior Trastuzumab', ' Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.', 'INTERVENTION 2: ', ' Neratinib 240, No Prior Trastuzumab', ' Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV', ' Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)', ' Over-expression of HER2', ' Tumor tissue available and adequate for analysis at screening', ' At least one measurable lesion', 'Exclusion Criteria:', ' Prior treatment with Herceptin (Arm B only)', ' More than 4 prior cytotoxic chemotherapy regimens', ' Subjects with bone or skin as the only site of measurable disease', ' Inadequate cardiac function', ' Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1', ' Active central nervous system metastases', ' Pregnant or breastfeeding women', ' Inability to swallow the HKI-272 capsules'], 'Results': ['Outcome Measurement: ', ' 16-week Progression Free Survival', ' 16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.', ' Time frame: From first dose to 16 weeks', 'Results 1: ', ' Arm/Group Title: Neratinib 240, Prior Trastuzumab', ' Arm/Group Description: Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.2 (45.3 to 71.2)', 'Results 2: ', ' Arm/Group Title: Neratinib 240, No Prior Trastuzumab', ' Arm/Group Description: Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: percentage of participants 77.8 (67.6 to 88.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/66 (28.79%)', ' Anaemia 0/66 (0.00%)', ' Atrioventricular block 0/66 (0.00%)', ' Bradycardia 0/66 (0.00%)', ' Diarrhoea 4/66 (6.06%)', ' Nausea 2/66 (3.03%)', ' Vomiting 3/66 (4.55%)', ' Asthenia 0/66 (0.00%)', ' Fatigue 1/66 (1.52%)', ' Malaise 0/66 (0.00%)', ' Pyrexia 0/66 (0.00%)', ' Disseminated tuberculosis 0/66 (0.00%)', ' Folliculitis 0/66 (0.00%)', ' Hepatitis E 0/66 (0.00%)', 'Adverse Events 2:', ' Total: 17/70 (24.29%)', ' Anaemia 1/70 (1.43%)', ' Atrioventricular block 1/70 (1.43%)', ' Bradycardia 1/70 (1.43%)', ' Diarrhoea 4/70 (5.71%)', ' Nausea 0/70 (0.00%)', ' Vomiting 6/70 (8.57%)', ' Asthenia 1/70 (1.43%)', ' Fatigue 0/70 (0.00%)', ' Malaise 1/70 (1.43%)', ' Pyrexia 1/70 (1.43%)', ' Disseminated tuberculosis 1/70 (1.43%)', ' Folliculitis 1/70 (1.43%)', ' Hepatitis E 1/70 (1.43%)']}
|
741ca5eb-4737-4a35-a9fd-4235d6552b4f
|
Single
|
Results
|
NCT01881230
|
The Gemcitabine group of the primary trial had a median Kaplan-Meier Estimate of Progression-Free Survival more than 2 months shorter than the Carboplatin group
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01881230', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Nab-Paclitaxel + Gemcitabine', ' Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment', 'INTERVENTION 2: ', ' Arm B: Nab-Paclitaxel + Carboplatin', ' Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.'], 'Eligibility': ['Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria are met:', ' Female subjects, age 18 years at the time informed consent is signed', ' Pathologically confirmed adenocarcinoma of the breast', ' Pathologically confirmed as triple negative, source documented, defined as both of the following', ' Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)', ' Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).', ' Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis', " Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy; unless (a) anthracycline treatment was not indicated or was not the best treatment option for the subject in the opinion of the treating physician; and (b) anthracycline treatment remains not indicated or, in the opinion of the treating physician, is not the best treatment option for the subject's metastatic disease.", ' a. Newly diagnosed subjects presenting with TNMBC are eligible for the study if anthracycline treatment is not indicated or is not the best treatment option for the subject in the opinion of the treating physician.', ' Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines', ' Life expectancy 16 weeks from randomization', ' No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy and/or monoclonal antibody therapy are acceptable. Prior treatments must have been discontinued at least 30 days prior to start of study treatment and all related toxicities must have resolved to Grade 1 or less.', ' Prior neoadjuvant or adjuvant chemotherapy, if given, must have been completed at least 6 months before randomization with all related toxicities resolved, and documented evidence of disease progression per RECIST 1.1 guidelines is required.', ' a. If prior neoadjuvant or adjuvant chemotherapy contained taxane, gemcitabine, or platinum agents, the treatment must have completed at least 12 months before randomization', ' Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines', ' At least 30 days from major surgery before randomization, with full recovery', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Subject has the following blood counts at screening:', ' Absolute Neutrophil Count (ANC) 1500/mm^2 ;', ' Platelets 100,000/mm^2 ;', ' Hemoglobin (Hgb) 9 g/dL', ' Subject has the following blood chemistry levels at screening:', ' Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) 2.5 x upper limit of normal range (ULN); if hepatic metastases present 5.0 x ULN', " Total serum bilirubin ULN; or total bilirubin 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome", ' Creatinine clearance > 60 mL/min (by Cockcroft-Gault)', ' Females of child-bearing potential [defined as a sexually mature women who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:', ' Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and', ' Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines', ' Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation', ' Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted', ' Able to adhere to the study visit schedule and other protocol requirements', 'Exclusion Criteria:', ' A subject will not be eligible for inclusion in this study if any of the following criteria apply:', ' Male subjects', ' Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy & monoclonal antibody therapy are acceptable.', ' Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease', ' History of, or known current evidence of brain metastasis, including leptomeningeal involvement.', ' Subjects with bone as the only site of metastatic disease', ' Subjects with regional lymph node as the only site of metastatic disease', ' Serious intercurrent medical or psychiatric illness, including serious active infection', ' History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization', ' History of other primary malignancy in the last 5 years prior to randomization. Subjects with prior breast cancer history are eligible, however, the most recently obtained biopsy must demonstrate triple negative disease (source documented). Subjects with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.', ' Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies which, in the opinion of the investigator, may lead to serious complications', ' Peripheral neuropathy Grade 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0', ' Subjects who have received an investigational product within the previous 4 weeks prior to randomization', ' Subject is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study', ' Pregnant or nursing women', ' Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or any other platin, or nucleoside analogue agents', ' Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study', ' Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study', ' Any condition that confounds the ability to interpret data from the study', ' History of seropositive human immunodeficiency virus (HIV)', ' Subjects who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications'], 'Results': ['Outcome Measurement: ', ' Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.', ' PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.', ' Time frame: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C', 'Results 1: ', ' Arm/Group Title: Arm A: Nab-Paclitaxel + Gemcitabine', ' Arm/Group Description: Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment', ' Overall Number of Participants Analyzed: 61', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.5 (4.1 to 7.0)', 'Results 2: ', ' Arm/Group Title: Arm B: Nab-Paclitaxel + Carboplatin', ' Arm/Group Description: Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.', ' Overall Number of Participants Analyzed: 64', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.3 (5.7 to 10.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/60 (36.67%)', ' Anaemia 2/60 (3.33%)', ' Febrile neutropenia 1/60 (1.67%)', ' Neutropenia 1/60 (1.67%)', ' Pancytopenia 0/60 (0.00%)', ' Thrombocytopenia 0/60 (0.00%)', ' Acute myocardial infarction 0/60 (0.00%)', ' Atrial fibrillation 1/60 (1.67%)', ' Cardiac failure 1/60 (1.67%)', ' Myocardial infarction 0/60 (0.00%)', ' Palpitations 1/60 (1.67%)', ' Pericardial effusion 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 20/64 (31.25%)', ' Anaemia 2/64 (3.13%)', ' Febrile neutropenia 3/64 (4.69%)', ' Neutropenia 2/64 (3.13%)', ' Pancytopenia 0/64 (0.00%)', ' Thrombocytopenia 0/64 (0.00%)', ' Acute myocardial infarction 0/64 (0.00%)', ' Atrial fibrillation 0/64 (0.00%)', ' Cardiac failure 0/64 (0.00%)', ' Myocardial infarction 1/64 (1.56%)', ' Palpitations 0/64 (0.00%)', ' Pericardial effusion 0/64 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b8e0458c-b834-42b5-b5fd-8791f89b0853
|
|
Comparison
|
Adverse Events
|
NCT00382018
|
NCT03012477
|
Between the patients in the primary trial and the secondary trial, only a single one suffered from sepsis.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[
5
] |
{'Clinical Trial ID': 'NCT00382018', 'Intervention': ['INTERVENTION 1: ', ' Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', ' Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.', 'INTERVENTION 2: ', ' Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', ' Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Clinical evidence of metastatic disease (stage IV disease)', ' Newly metastatic disease OR progressive metastatic disease while on hormonal therapy', ' Meets 1 of the following criteria:', ' Measurable disease', ' Bone-only disease* NOTE: *Patients with nonmeasurable disease that does not include bone are not eligible', ' HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay', ' HER-2 positivity is defined as IHC 3+ or FISH+', ' If IHC is indeterminate (2+), FISH must be performed to classify disease', ' Planning to undergo first-line chemotherapy for metastatic disease', ' Patients with brain metastases must have stable disease for > 90 days after completion of prior radiotherapy to the brain', ' No leptomeningeal disease', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Female', ' Menopausal status not specified', ' Zubrod performance status 0-2', ' Not pregnant or nursing', ' Negative pregnancy test', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed', ' Any number of exogenous hormonal therapies for metastatic disease and/or as adjuvant therapy allowed', ' At least 1 year since prior adjuvant chemotherapy', ' At least 2 weeks since prior minor surgery and recovered', ' At least 4 weeks since prior major surgery and recovered', ' No prior chemotherapy for metastatic disease', ' Concurrent hormonal therapy and/or bisphosphonate therapy allowed', ' Concurrent trastuzumab and/or bevacizumab allowed'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.', ' Time frame: Every 3 months until progression then every 6 months for 5 years or until death', 'Results 1: ', ' Arm/Group Title: Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', ' Arm/Group Description: Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.', ' Overall Number of Participants Analyzed: 64', ' Median (95% Confidence Interval)', ' Unit of Measure: months 10.7 (9.1 to 14.8)', 'Results 2: ', ' Arm/Group Title: Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', ' Arm/Group Description: Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.', ' Overall Number of Participants Analyzed: 59', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.5 (8.4 to 16.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/161 (0.00%)', ' Gastrointestinal-Other 0/161 (0.00%)', ' Dehydration 0/161 (0.00%)', ' Renal/Genitourinary-Other 0/161 (0.00%)', 'Adverse Events 2:', ' Total: 1/64 (1.56%)', ' Gastrointestinal-Other 1/64 (1.56%)', ' Dehydration 1/64 (1.56%)', ' Renal/Genitourinary-Other 1/64 (1.56%)']}
|
{'Clinical Trial ID': 'NCT03012477', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin + AZD1775', ' Treatment will consist of one cycle of cisplatin monotherapy (cisplatin 75 mg/m2 IV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days(1 cycle) later.', ' AZD1775 will be administered 200 mg as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.', ' At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3).'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.', ' Either the primary invasive tumor and/or the metastasis must be triple-negative, defined as:', ' hormone-receptor poor, ER- and PR-negative, or staining present in <1% by immunohistochemistry (IHC)', ' HER2-negative: 0 or 1+ by IHC, or FISH<2.0', ' Participants must have at least one lesion that is not within a previously radiated field that is measurable on computerized tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST version 1.1. Bone lesions are not considered measurable by definition. See Section 11 for the evaluation of measurable disease.', 'Prior chemotherapy: Patients may have received 0-1 prior chemotherapeutic regimen for metastatic breast cancer and must have been off treatment with chemotherapy for at least 21 days before enrollment in the study. The number of patients with 0 prior chemotherapeutic regimen will be limited to a maximum of n = 20.', ' Prior biologic therapy: Patients must have discontinued all biologic therapy at least 21 days before participation.', ' Prior radiation therapy: Patients may have received prior radiation therapy in either the metastatic or early-stage setting. Radiation therapy must be completed at least 14 days prior to study participation and patients should have recovered from adverse effects of radiation to grade 1.', ' Age 18', ' ECOG performance status 1', ' Participants must have normal organ and marrow function as defined below:', ' Absolute neutrophil count 1500/mm3', ' Platelets 100,000/mm3', ' Hemoglobin 9 g/dL', ' Total Bilirubin 1.5 mg/dL', ' Serum creatinine 1.5 mg/dL OR measured creatinine clearance (CrCl) 45 mL/min as calculated by the Cockcroft-Gault method OR 24-hour measured urine CrCl 45mL/min', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 times the upper limit of normal. For patients with documented liver metastases, AST/ALT 5.0 times the upper limit of normal.', ' Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment.', ' Availability of a tissue block from initial breast cancer diagnosis and/or metastatic recurrence. If a tissue block is not available, 10-20 unstained slides may be provided as an alternative. If unstained slides will be provided, they should not be sent until specifically requested by the DFCI study coordinator. If archival tumor tissue is not available, a fresh biopsy may be performed.', ' In the first stage of the trial, at least 10 patients with biopsy-accessible disease must be willing to undergo paired research biopsies. These biopsies will occur 5-48 hours after the C1D1 cisplatin dose (ie. C1D2or C1D3) and 5-8hrs (+/- 24hrs) after the last dose of AZD1775 on C2D3. The exact timing of the biopsy relative to receipt of study treatment should be accurately recorded.', ' Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines.', " Research biopsies requiring general anesthesia are not allowed on this protocol unless a biopsy is being obtained simultaneously for clinical reasons, in the judgment of the patients' treating physician.", ' Patients who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to continue protocol therapy. They will not be required to undergo a repeat biopsy attempt.', ' If dosing is delayed placing the biopsy outside of the allowable window, the biopsy should be rescheduled to be within the window. If not feasible, the biopsy should be obtained as close to within the window as possible.', ' Fine needle aspirates (FNA) is not allowed', ' Female subjects of childbearing potential must have a negative serum pregnancy test at screening.', ' The effects of AZD1775 on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use enhanced methods of contraception. All women are considered to be of childbearing potential unless they fulfill one of the following criteria at screening:', ' Post-menopausal defined as age 50 and amenorrheic for at least 12 months OR Women age <50 if they have been amenorrheic for at least 12 months and have a serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) level in the postmenopausal range (per institutional standards).', ' If women have documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, or bilateral tubal ligation, they are considered post-menopausal.', ' Appropriate contraception should be used from the time of screening, throughout the duration of study participation, and for four months after the last dose of AZD1775. Acceptable methods of contraception include abstinence, tubal ligation, intra-uterine devices, and vasectomised partner. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by the male sexual partner for intercourse. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the participants treating physician should be informed immediately. Additionally, male patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing AZD1775. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment.', ' Participant must be able to swallow pills.', ' Participant may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Participants who are receiving any other investigational agents within 21 days of the first dose of study drug.', ' Major surgical procedures <28 days from beginning study treatment.', ' Participants who have received a prior inhibitor of Wee1 kinase activity', ' Participants who have received prior platinum chemotherapy', ' Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Patients with a history of treated central nervous system (CNS) metastases are eligible. Treated brain metastases are defined as those having no evidence of progression for 1 month after treatment, or hemorrhage for 2 weeks after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or CT scan) during the screening period. Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for 2 weeks before the first study drug. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 1 month before day 1 of study treatment will be excluded.', ' Patients with grade >1 neuropathy or grade >1 toxicity (except alopecia or anorexia) from prior therapy', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD1775 or Cisplatin.', ' Participants receiving any medications, substances, or foods (ie, grapefruit juice) listed below are ineligible (Please refer to Section 5.4 for list of restricted co-medications):', ' prescription or non-prescription drugs or other products known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. sensitive substrates of CYP2C8, CYP2C9, CYP2C19, or substrates of these enzymes with narrow therapeutic range', ' inhibitors or substrates of P-gp', ' Participants who have an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association Class III or IV (Appendix B), active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or severe malnutrition. In addition, patients are ineligible if they have a psychiatric illness or a social situation that could limit their ability to comply with the study requirements.', ' Participants who have refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of AZD1775.', ' Pregnant women are excluded from this study because AZD1775 is a Wee1 inhibitor agent with the potential for teratogenic or abortifacient effects.', ' Lactating or breastfeeding women are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD1775, breastfeeding should be discontinued prior to being treated with AZD1775. These potential risks may also apply to other agents used in this study.', ' Known HIV-positive participants are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.', ' Participant with mean resting corrected QT interval (specifically QTc calculated using the Fridericia formula [QTcF]) > 450 msec for males and > 470 msec for females, from 3 electrocardiograms (ECGs) performed within 2-5 minutes apart at study entry, or congenital long QT syndrome.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' The objective response rate (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: Evaluated every 6 weeks from the time of their first treatment, per RECIST 1.1. Duration of therapy will depend on individual response, evidence of disease progression and tolerance, up to 1 year', 'Results 1: ', ' Arm/Group Title: Cisplatin + AZD1775', ' Arm/Group Description: Treatment will consist of one cycle of cisplatin monotherapy (cisplatin 75 mg/m2 IV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days(1 cycle) later.', ' AZD1775 will be administered 200 mg as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.', ' At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3).', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: percentage of participants 26 (13 to 44)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/34 (38.24%)', ' Anemia 3/34 (8.82%)', ' Diarrhea 7/34 (20.59%)', ' Nausea 2/34 (5.88%)', ' Sepsis 1/34 (2.94%)', ' Urinary tract infection 1/34 (2.94%)', ' Alkaline phosphatase increased 1/34 (2.94%)', ' Neutrophil count decreased 2/34 (5.88%)', ' Dehydration 1/34 (2.94%)', ' Headache 1/34 (2.94%)', ' Thromboembolic event 1/34 (2.94%)']}
|
1a112ed3-8318-493b-8973-10de01794892
|
Comparison
|
Intervention
|
NCT00003404
|
NCT00711529
|
the primary trial does not have a Hypnotherapy based intervention, and the secondary trial does not have a Radiotherapy intervention.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00003404', 'Intervention': ['INTERVENTION 1: ', ' Adjuvant Radiotherapy', ' Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.', ' Adjuvant Radiotherapy: Adjuvant radiation therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:', ' Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia', ' Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia', ' Must have been excised with breast-conserving resection and no positive margins', ' Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision', ' No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast', ' Hormone receptor status: Not specified', ' PATIENT CHARACTERISTICS:', ' Age: 18 and over', ' Sex: Female', ' Menopausal status: Not specified', 'Performance status: Not specified', ' Life expectancy: Not specified', ' Hematopoietic: Not specified', ' Hepatic: Not specified', ' Renal: Not specified', ' Other:', ' Not pregnant', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy: Not specified', ' Chemotherapy: Not specified', ' Endocrine therapy: Not specified', ' Radiotherapy: No prior radiotherapy to the ipsilateral breast', ' Surgery: See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Local Recurrence Rate', ' Local recurrence rate of phyllodes tumors', ' Time frame: 36 months after initial excision', 'Results 1: ', ' Arm/Group Title: Adjuvant Radiotherapy', ' Arm/Group Description: Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.', ' Adjuvant Radiotherapy: Adjuvant radiation therapy', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00711529', 'Intervention': ['INTERVENTION 1: ', ' Hypnotherapy', ' Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.', 'INTERVENTION 2: ', ' Gabapentin', ' Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).'], 'Eligibility': ['Inclusion criteria:', ' Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the breast are eligible for participation.', ' Women with non-invasive or pre-invasive lesions of the breast, including but not limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or lobular carcinoma in situ (LCIS) are eligible for participation.', ' Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong family history of breast cancer are eligible.', ' Any woman age 60 years or more who cannot take estrogen therapy because of a real or perceived risk of developing breast cancer are eligible.', ' Women under the age of 60 with a Gail model score of 1.6% or more are eligible.', ' Subjective report of at least one daily hot flash.', ' Able to provide voluntary informed consent.', ' 18 years-old. There will be no upper limit for age inclusion.', ' Karnofsky performance status > 70%.', ' Women with a history of breast cancer must have undergone treatment with curative intent.', ' 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.', ' adequate hematopoietic function (ANC 1500/mm3; Platelets 100,000/mm3; Hemoglobin 8 g/dL)', ' adequate renal and hepatic function [Bilirubin 1.5 times upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) 2.5x ULN, Alkaline phosphatase 2.5x ULN, and Creatinine 2x ULN].', ' No clinical evidence of disease (complete remission).', ' Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated.', ' Patients receiving hormonal therapy in lieu of or following chemotherapy will be eligible to participate.', ' Patients must have access to a compact disk player.', 'Exclusion criteria:', ' History or active secondary cancer within the last 5 years (except for superficial basal cell skin cancers).', ' Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological toxicity.', ' Unable to give informed consent or unable to adhere to protocol.', ' Any serious medical or psychiatric illness likely to interfere with participation in this clinical study, concurrent uncontrolled illness, or ongoing or active infection will be excluded.', ' Any history of alcohol or drug abuse.', ' Allergy to gabapentin.', ' History of seizure disorder.'], 'Results': ['Outcome Measurement: ', ' Number of Daily Hot Flashes', ' Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.', ' Time frame: Baseline', 'Results 1: ', ' Arm/Group Title: Hypnotherapy', ' Arm/Group Description: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.', ' Overall Number of Participants Analyzed: 7', ' Median (Full Range)', ' Unit of Measure: daily hot flashes 5 (2 to 11)', 'Results 2: ', ' Arm/Group Title: Gabapentin', ' Arm/Group Description: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).', ' Overall Number of Participants Analyzed: 8', ' Median (Full Range)', ' Unit of Measure: daily hot flashes 4.5 (2 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: 0/14 (0.00%)']}
|
6044590d-0f89-4a6e-8be7-54ca0c0327d9
|
Single
|
Eligibility
|
NCT02429427
|
Patients with a platelet count of 50 x 109/l are not eligible for the primary trial
|
Entailment
|
[
0,
7
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8d3378f7-caaf-4654-b12a-382a0e911eb1
|
|
Comparison
|
Results
|
NCT01516736
|
NCT00733408
|
the primary trial and the secondary trial have non comparable results as the different in cohort size is too significant.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT01516736', 'Intervention': ['INTERVENTION 1: ', ' LA-EP2006', ' During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.', ' LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.', 'INTERVENTION 2: ', ' Neulasta®', ' During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.', ' Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.'], 'Eligibility': ['Inclusion Criteria:', ' histologically proven breast cancer', ' eligible for six cycles of neoadjuvant or adjuvant chemotherapy', 'Exclusion Criteria:', ' concurrent or prior chemotherapy for breast cancer', ' concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy', ' concurrent prophylactic antibiotics', ' previous therapy with any G-CSF (granulocyte-colony stimulating factor) product', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy', ' Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).', ' Time frame: 21 days (Cycle 1 of chemotherapy treatment)', 'Results 1: ', ' Arm/Group Title: LA-EP2006', ' Arm/Group Description: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.', ' LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.', ' Overall Number of Participants Analyzed: 155', ' Mean (Standard Deviation)', ' Unit of Measure: days FAS: 151 participants', ' 1.36 (1.133)', ' PP: 148 participants', ' 1.34 (1.141)', 'Results 2: ', ' Arm/Group Title: Neulasta ', ' Arm/Group Description: During each chemotherapy cycle eligible patients receive Neulasta s.c. post chemotherapy application.', ' Neulasta : Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.', ' Overall Number of Participants Analyzed: 153', ' Mean (Standard Deviation)', ' Unit of Measure: days FAS: 149 participants', ' 1.19 (0.984)', ' PP: 144 participants', ' 1.19 (0.991)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/155 (18.71%)', ' Febrile neutropenia 16/155 (10.32%)', ' Neutropenia 4/155 (2.58%)', ' Thrombocytopenia 1/155 (0.65%)', ' Anemia 1/155 (0.65%)', ' Atrial fibrillation 0/155 (0.00%)', ' Cardiac arrest 1/155 (0.65%)', ' Cardio-respiratory arrest 1/155 (0.65%)', ' Pericardial hemorrhage 1/155 (0.65%)', ' Eye irritation 0/155 (0.00%)', ' Abdominal pain 3/155 (1.94%)', 'Adverse Events 2:', ' Total: 32/153 (20.92%)', ' Febrile neutropenia 19/153 (12.42%)', ' Neutropenia 6/153 (3.92%)', ' Thrombocytopenia 1/153 (0.65%)', ' Anemia 0/153 (0.00%)', ' Atrial fibrillation 1/153 (0.65%)', ' Cardiac arrest 0/153 (0.00%)', ' Cardio-respiratory arrest 0/153 (0.00%)', ' Pericardial hemorrhage 0/153 (0.00%)', ' Eye irritation 1/153 (0.65%)', ' Abdominal pain 5/153 (3.27%)']}
|
{'Clinical Trial ID': 'NCT00733408', 'Intervention': ['INTERVENTION 1: ', ' Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)', ' Be receiving first-line therapy for metastatic disease', ' Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration', ' OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL', ' Subjects with brain metastases as their first site of disease recurrence may be eligible if treated by definitive radiation (stereotactic radiosurgery or whole brain) with clinically controlled neurologic symptoms for a period of 21 days prior to study treatment', ' Bilirubin =< 1.5 mg/dL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Platelets > 100,000 cells/mm^3', ' Hemoglobin > 9.0 g/dL', ' Absolute neutrophil count (ANC) >= 1,500 cells/mm^3', ' Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable', ' If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy', ' Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)', ' Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines', 'Exclusion Criteria:', ' Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane', ' Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids', ' Pre-existing nephritic syndrome', ' Serious intercurrent medical or psychiatric illness including serious active infection', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) grade II or greater congestive heart failure', ' History of myocardial infarction or unstable angina within 6 months prior to study enrollment', ' History of stroke or transient ischemic attack within 6 months prior to study enrollment', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study', ' Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Proteinuria at screening as demonstrated by either:', ' Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR', ' Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is < 1.0 to be eligible; if the UPC ratio is >= 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =< 1 g of protein in 24 hours for the patient to be eligible)', ' Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' 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. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.', ' Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years', 'Results 1: ', ' Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO', ' Overall Number of Participants Analyzed: 55', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.2 to 11.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/55 (9.09%)', ' Infection 2/55 (3.64%)', ' Pain * 1/55 (1.82%)', ' Muscle Weakness * 1/55 (1.82%)', ' Dyspnea 1/55 (1.82%)']}
|
f701473d-e034-4a06-9829-d20cc483162c
|
Single
|
Results
|
NCT00450866
|
In the primary trial a cohort 1 has a higher percentage of patients with progression free survival at 3 months after treatment, than cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT00450866', 'Intervention': ['INTERVENTION 1: ', ' Epothilone B: Group A', ' Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.', 'INTERVENTION 2: ', ' Epothilone B: Group B', ' Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed carcinoma of the breast', ' CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal disease), meeting 1 of the following criteria:', ' Recurrent or progressive CNS metastases after whole brain radiotherapy', ' If only evaluable site of CNS progression has been previously treated with stereotactic radiosurgery, radiation necrosis must be excluded by radiographic (e.g., positron emission tomography scan or magnetic resonance spectroscopy) or histologic assessment', ' Newly diagnosed, untreated, asymptomatic brain or leptomeningeal metastases', ' Patient must be neurologically stable, as demonstrated by a stable dose of steroids and anticonvulsants for 1 week prior to obtaining baseline gadolinium-enhanced MRI of the brain and/or 1 week prior to beginning study treatment', ' No CNS complications requiring urgent neurosurgical intervention (e.g., resection or shunt placement)', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' Karnofsky performance status 60-100%', ' Life expectancy 3 months', ' Absolute neutrophil count > 1,500/mm^3', ' Hemoglobin > 9.0 g/dL', ' Platelet count > 100,000/mm^3 (red blood cell transfusion and repeat evaluation allowed)', ' Bilirubin < 1.5 times upper limit of normal (ULN)', ' AST and ALT < 2.5 times ULN', ' Alkaline phosphatase < 2.5 times ULN', ' Creatinine < 1.5 times ULN', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 3 months after completion of study therapy', ' No known hypersensitivity to epothilones', ' No peripheral neuropathy > grade 1', ' No unresolved diarrhea within the past 7 days', ' Grade 0 diarrhea required at study entry', ' No concurrent serious medical illness (e.g., HIV positivity or active hepatitis B or C)', ' No severe cardiac insufficiency (e.g., New York Heart Association class III-IV heart disease) with uncontrolled and/or unstable cardiac or coronary artery disease', ' No active or suspected acute or chronic uncontrolled infection, including abscess or fistulae', ' No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix', ' No history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits', ' No contraindications to MRI, including any of the following:', ' Pacemaker', ' Ferromagnetic implants', ' Claustrophobia', ' Extreme obesity', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' More than 2 weeks since prior noncytotoxic drugs (e.g., small molecule-targeted drugs) and recovered', ' More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered', ' More than 3 weeks since prior intracranial surgery and recovered', ' More than 4 weeks since prior radiotherapy and recovered', ' More than 4 weeks since prior major surgery', ' More than 28 days since prior investigational compounds or drugs', ' No prior epothilones', ' No concurrent known diarrheagenic agents', ' No other concurrent anticancer agents, including investigational agents, biological agents, or chemotherapy', ' No other concurrent experimental therapies', ' Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed', ' No concurrent Coumadin® or other agents containing warfarin', ' Low dose Coumadin® ( 1 mg) for prophylactic maintenance of indwelling lines or ports allowed', ' No concurrent radiotherapy for central metastases (e.g., vertebral or mediastinal metastases)', ' Concurrent radiotherapy for local peripheral metastases not being used as marker lesions allowed', ' No concurrent prophylactic hematopoietic growth factors during course 1', ' No concurrent herbal or nontraditional medications'], 'Results': ['Outcome Measurement: ', ' Central Nervous System (CNS) Progression-free Survival(PFS)', ' The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.', ' PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.', ' Time frame: 3 months after treatment', 'Results 1: ', ' Arm/Group Title: Epothilone B: Group A', ' Arm/Group Description: Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: participants 12', 'Results 2: ', ' Arm/Group Title: Epothilone B: Group B', ' Arm/Group Description: Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/55 (32.73%)', ' Anemia * 1/55 (1.82%)', ' Neutropenia * 1/55 (1.82%)', ' Dehydration * 6/55 (10.91%)', ' Diarrhea * 8/55 (14.55%)', ' Hemorrhage, upper GI * 1/55 (1.82%)', ' Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) * 1/55 (1.82%)', ' Nausea * 1/55 (1.82%)', ' Pain - Abdomen NOS (not otherwise specified) * 1/55 (1.82%)', ' Ulcer, GI - Duodenum * 1/55 (1.82%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3889cecd-aa2d-4f58-857e-11d7209f9cf4
|
|
Single
|
Results
|
NCT00338286
|
No participants of the primary trial had a Progression Free Survival over 1 year.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00338286', 'Intervention': ['INTERVENTION 1: ', ' Standard of Care (SOC)', " Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.", 'INTERVENTION 2: ', ' Epoetin Alfa', ' Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed (e.g., slide of tissue) breast cancer', ' HER2/NEU positive or negative', ' Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy', ' Received 1st and 2nd line chemotherapy', ' Hemoglobin (Hb) <= 11g/dL at the time of randomization', ' planned to receive at least 2 more cycles of chemotherapy', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group score 0 or 1', ' At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year', 'Exclusion Criteria:', ' Active second cancer', ' no recent history of clinically relevant thrombovascular event', ' Current treatment with anticoagulants', ' Brain metastasis or CNS involvement', ' Anemia secondary to another cause', ' Recent (within prior 1 months) use of an ESA', ' Patient pregnant or breast feeding', ' Progressive disease during adjuvant/neoadjuvant chemotherapy', ' Rapidly progressive or life-threatening metastatic disease', ' Concomitant endocrine therapy', ' Patient in whom the only site of metastasis was local and was successfully treated surgically.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.', ' Time frame: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)', 'Results 1: ', ' Arm/Group Title: Standard of Care (SOC)', " Arm/Group Description: Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.", ' Overall Number of Participants Analyzed: 1048', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.4 (7.1 to 7.6)', 'Results 2: ', ' Arm/Group Title: Epoetin Alfa', ' Arm/Group Description: Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.', ' Overall Number of Participants Analyzed: 1050', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.4 (6.9 to 7.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 229/1045 (21.91%)', ' Agranulocytosis * 0/1045 (0.00%)', ' Anaemia * 15/1045 (1.44%)', ' Bone Marrow Failure * 0/1045 (0.00%)', ' Febrile Neutropenia * 29/1045 (2.78%)', ' Leukopenia * 9/1045 (0.86%)', ' Neutropenia * 55/1045 (5.26%)', ' Neutrophilia * 1/1045 (0.10%)', ' Pancytopenia * 3/1045 (0.29%)', ' Thrombocytopenia * 12/1045 (1.15%)', ' Acute Myocardial Infarction * 2/1045 (0.19%)', 'Adverse Events 2:', ' Total: 251/1051 (23.88%)', ' Agranulocytosis * 1/1051 (0.10%)', ' Anaemia * 10/1051 (0.95%)', ' Bone Marrow Failure * 1/1051 (0.10%)', ' Febrile Neutropenia * 40/1051 (3.81%)', ' Leukopenia * 10/1051 (0.95%)', ' Neutropenia * 52/1051 (4.95%)', ' Neutrophilia * 0/1051 (0.00%)', ' Pancytopenia * 7/1051 (0.67%)', ' Thrombocytopenia * 18/1051 (1.71%)', ' Acute Myocardial Infarction * 2/1051 (0.19%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
19d0c9de-02ad-4a8e-937b-e9d0f0cc8051
|
|
Comparison
|
Adverse Events
|
NCT00789581
|
NCT02445586
|
the secondary trial reported more cases of Haematemesis, but the primary trial had more total cases of DIASTOLIC DYSFUNCTION across both its cohorts.
|
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
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT00789581', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', ' Ixabepilone (Ixempra): 40 mg/m2', 'INTERVENTION 2: ', ' Paclitaxel', ' Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', 'Paclitaxel (Taxol): 80 mg/m2'], 'Eligibility': ['Inclusion Criteria:', ' Female patients greater than or equal to18 years of age.', ' Histologically confirmed invasive unilateral breast cancer (regardless of', ' histology).', ' Early-stage breast cancer, defined as:', ' Node-positive disease: >0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR', ' Node-negative, with primary tumor >1.0 cm (T1c-T3).', ' Definitive loco-regional surgery must have been completed as specified', ' below:', ' Patients must have undergone either breast conservation surgery', ' (i.e., lumpectomy) or total mastectomy.', ' Surgical margins of the resected section must be histologically free of', ' invasive adenocarcinoma and ductal carcinoma in situ.', ' Surgical margins involved with lobular carcinoma in situ (LCIS) will not', ' be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.', ' Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below:', ' Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.', ' Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.', ' Patients with synchronous bilateral cancers are eligible only if:', ' All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.', ' Eligibility based on the highest stage grouping.', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the', ' following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2).', ' Estrogen receptor negative (<10% staining by IHC for estrogen receptor).', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.', ' Patient must be <= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).', ' MammoSite brachytherapy radiation is acceptable if it is performed', ' immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter.', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count (ANC) >1500/mm3', ' Platelet count >=100,000/mm3', ' Hemoglobin >9 g/dL', ' Adequate liver function, defined by:', ' AST and ALT <=2.5 x the upper limit of normal (ULN)', ' Total bilirubin <=1.5 x ULN (unless the patient has grade 1 bilirubin', " elevation due to Gilbert's disease or a similar syndrome involving slow", ' conjugation of bilirubin).', ' Adequate renal function, defined by:', ' Serum creatinine <=1.5 x ULN', ' Complete staging work-up <=12 weeks prior to initiation of study treatment', ' with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan.', ' Adequate cardiac function, defined by a left ventricular ejection fraction', ' (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).', ' Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).', ' Patients with previous history of invasive cancers (including breast cancer)', ' are eligible if definitive treatment was completed more than 5 years prior to', ' initiating current study treatment, and there is no evidence of recurrent disease.', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.', ' Patient must be accessible for treatment and follow-up.', ' Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.', ' All patients must be able to understand the investigational nature of the', ' study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' Women who are pregnant or breastfeeding.', ' History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.', ' Any evidence or suspicion of metastatic disease other than ipsilateral', ' axillary lymph nodes.', ' Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).', ' Previous anthracycline chemotherapy.', ' Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of', ' study treatment until the end of treatment with ixabepilone.', ' Previous treatment for this breast cancer (including neoadjuvant', ' chemotherapy).', ' Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).', ' Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0.', ' Cardiac disease, including: congestive heart failure (CHF) > Class II per', ' New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.', ' History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or', ' a drug formulated in CremophorEL such as paclitaxel.', ' Use of any investigational agent within 30 days of administration of the first dose of study drug.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Concurrent severe, uncontrolled infection or intercurrent illness including,', ' but not limited to, ongoing or active infection, or psychiatric illness/social', ' situations that would limit compliance with study requirements.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Inability to comply with study and/or follow-up procedures.'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.', ' Time frame: up to 5.25 years (63 months)', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', ' Ixabepilone (Ixempra): 40 mg/m2', ' Overall Number of Participants Analyzed: 306', ' Measure Type: Number', ' Unit of Measure: percentage of participants 3-year DFS: 88.6 (84.3 to 91.8)', ' 5-year DFS: 87.1 (82.6 to 90.5)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', 'Paclitaxel (Taxol): 80 mg/m2', ' Overall Number of Participants Analyzed: 308', ' Measure Type: Number', ' Unit of Measure: percentage of participants 3-year DFS: 88.8 (84.6 to 91.9)', ' 5-year DFS: 84.7 (79.7 to 88.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 58/305 (19.02%)', ' FEBRILE NEUTROPENIA * 12/305 (3.93%)', ' NEUTROPENIA * 4/305 (1.31%)', ' ANAEMIA * 2/305 (0.66%)', ' LEUKOPENIA * 1/305 (0.33%)', ' PANCYTOPENIA * 1/305 (0.33%)', ' THROMBOCYTOPENIA * 1/305 (0.33%)', ' DISSEMINATED INTRAVASCULAR COAGULATION * 0/305 (0.00%)', ' ATRIAL FIBRILLATION * 1/305 (0.33%)', ' DIASTOLIC DYSFUNCTION * 1/305 (0.33%)', ' PERICARDIAL EFFUSION * 1/305 (0.33%)', 'Adverse Events 2:', ' Total: 50/304 (16.45%)', ' FEBRILE NEUTROPENIA * 12/304 (3.95%)', ' NEUTROPENIA * 1/304 (0.33%)', ' ANAEMIA * 0/304 (0.00%)', ' LEUKOPENIA * 0/304 (0.00%)', ' PANCYTOPENIA * 0/304 (0.00%)', ' THROMBOCYTOPENIA * 0/304 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION * 1/304 (0.33%)', ' ATRIAL FIBRILLATION * 1/304 (0.33%)', ' DIASTOLIC DYSFUNCTION * 0/304 (0.00%)', ' PERICARDIAL EFFUSION * 0/304 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02445586', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.'], 'Eligibility': ['Inclusion Criteria:', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner', ' Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible', ' Known and documented HER2-positive', ' Known and documented LVEF of at least 50 percent (%)', ' Adequate organ function', ' A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease', ' Pregnant or lactating women', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting', ' History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant', ' The number of participants with serious adverse events was counted in the four following categories for number of events reported per participant: greater than or equal to ( ) 1, 1, greater than (>) 1, or 0 serious adverse events. Participants with multiple occurrences of events (the 1 and >1 serious adverse event categories) were only counted once per category.', ' Time frame: From Baseline until end of study (up to approximately 3 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Arm/Group Description: Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 Serious Adverse Event: 31 59.6%', ' 1 Serious Adverse Event: 17 32.7%', ' >1 Serious Adverse Events: 14 26.9%', ' 0 Serious Adverse Events: 21 40.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/52 (59.62%)', ' Febrile neutropenia 2/52 (3.85%)', ' Left ventricular dysfunction 2/52 (3.85%)', ' Sinus tachycardia 1/52 (1.92%)', ' Congenital arterial malformation 1/52 (1.92%)', ' Diarrhoea 5/52 (9.62%)', ' Salivary hypersecretion 1/52 (1.92%)', ' Enteritis 1/52 (1.92%)', ' Abdominal pain 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Stomatitis 1/52 (1.92%)', ' Haematemesis 1/52 (1.92%)']}
|
cb023dbc-3e99-4c32-a857-7f8d49ef5a96
|
Single
|
Eligibility
|
NCT00193180
|
A female patient over the age of 18 suffering from Cirrhosis cannot take part in the primary trial.
|
Entailment
|
[
0,
6,
8,
16
] |
[] |
{'Clinical Trial ID': 'NCT00193180', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' No more than one prior chemotherapy regimen for metastatic breast cancer', ' Able to perform activities of daily living with minimal assistance', ' Adequate bone marrow, liver and kidney function', ' Age 18 years or older', ' Give written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Moderate to severe peripheral neuropathy', ' Uncontrolled blood pressure or uncontrolled heart beat irregularities', ' Diabetes Mellitus with fasting blood sugar greater than 200 mg %', ' Significant heart disease within the prior 6 months', ' Severe or uncontrolled medical disease', ' Active uncontrolled infection', ' Known chronic liver disease', ' Known diagnosis of HIV infection', ' Pregnant or breast feeding females', ' 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)', ' Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (4.3 to 28.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/37 (48.65%)', ' Febrile neutropenia 1/37 (2.70%)', ' Hemoglobin 1/37 (2.70%)', ' Leukocytes 1/37 (2.70%)', ' Neutrophils 1/37 (2.70%)', ' Cardiac ischemia/infarction 2/37 (5.41%)', ' Cardiac ischemia/infarction - rheumatic heart failure 1/37 (2.70%)', ' Dehydration 1/37 (2.70%)', ' Gastrointestinal - Other (diverticular abscess) 1/37 (2.70%)', ' Gastritis 1/37 (2.70%)', ' Mucositis 1/37 (2.70%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1d0ce237-70eb-45b4-9c77-f0b70d410387
|
|
Comparison
|
Eligibility
|
NCT00256243
|
NCT00721630
|
Patients wanting to take part in the secondary trial must be at a specific location, this is not necessary for the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00256243', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy With GM-CSF', ' Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.'], 'Eligibility': ['Eligibility Criteria:', ' Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.', ' Patients must meet one of the criteria defined below (indicate one):', ' a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.', ' b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.', ' Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.', ' Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % must be greater than the institutional lower limit of normal.', ' Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.', ' Patients must have an Absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.', ' Patients must have a performance status of 0-2 by Zubrod criteria', ' Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.', ' All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.'], 'Results': ['Outcome Measurement: ', ' Clinical Response Rate', " Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.", ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Chemotherapy With GM-CSF', ' Arm/Group Description: Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 47 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/38 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00721630', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine + Lapatinib', ' The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.', ' capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).'], 'Eligibility': ['Inclusion Criteria:', ' Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.', ' Clinical evidence of metastatic breast cancer.', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).', ' Progressive disease following treatment with trastuzumab for metastatic breast cancer or as adjuvant therapy (either single-agent or combination therapy)', ' Prior therapy inclusion:', ' No more than two prior chemotherapy regimens allowed for advanced stage disease', ' No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if >6 months prior to treatment on study.', ' No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' No more than 450mg/m2 cumulative dose of prior doxorubicin', ' At least 3 weeks since prior chemotherapy or radiation therapy', ' Age or = to 18. Because no dosing or adverse event data are currently available on the use of lapatinib 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, 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.', ' Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.', ' Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of corticosteroids and anticonvulsants.', ' ECOG performance status < or = to 2', ' Life expectancy of greater than 12 weeks', ' Patients must have normal organ and marrow function as defined below:', ' leukocytes or = to 3,000/μL', ' absolute neutrophil count or = 1,500/μL', ' platelets or = 100,000/μL', ' total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT) or = 2.5x institutional upper limit of normal serum creatinine within normal institutional limits', ' Cardiac ejection fraction at or above the lower limit of normal of 50% as measured by multigated radionuclide angiography (MUGA) scan. If LVEF is greater than 70%, and ECHO should be performed as well. Baseline and on treatment scans should be performed using the same modality and preferably at the same institution.', ' Ability to understand and the willingness to sign a written informed. consent document.', ' Able to swallow and retain oral medication.', 'Exclusion Criteria:', ' Patients may not be 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 lapatinib or capecitabine.', ' Known DPD deficiency.', ' Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months of study entry, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because lapatinib is member of the 4- anilinoquinazoline class of kinase inhibitors with 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 lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib.', ' HIV-positive patients 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.', " 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,uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).", ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors:', ' Medications that inhibit or induce CYP3A4 are prohibited. Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator.', ' Renal function as measured by creatinine clearance < 30ml/min', ' Patients are permitted to participate in other non-therapeutic clinical trials while receiving treatment on this study (ie, experimental imaging, minor procedures necessary for tissue acquisition on study)'], 'Results': ['Outcome Measurement: ', ' Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Capecitabine + Lapatinib', ' Arm/Group Description: The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.', ' capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Partial Response: 5 21.7%', ' Stable Disease >/= 6 months: 6 26.1%', ' Stable disease <6 months: 11 47.8%', ' Progression of disease: 1 4.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/23 (39.13%)', ' Anemia 1/23 (4.35%)', ' Diarrhea 1/23 (4.35%)', ' Nausea 1/23 (4.35%)', ' Fracture 1/23 (4.35%)', ' ALT 1/23 (4.35%)', ' AST 1/23 (4.35%)', ' INR 1/23 (4.35%)', ' PTT 1/23 (4.35%)', ' Glucose, high 1/23 (4.35%)', ' Limb Pain 1/23 (4.35%)', ' Ataxia 2/23 (8.70%)', ' Neurology - Other 1/23 (4.35%)', ' Seizure 1/23 (4.35%)', ' Syncope 1/23 (4.35%)', ' Confusion 1/23 (4.35%)']}
|
93290529-38b1-444b-9ac8-fa32b98821c5
|
Single
|
Eligibility
|
NCT00436917
|
Patients with Scoliosis with a Cobb angle exceeding 20 degrees at the lumbar spine, or with a prior surgery at the lumbosacral spine are excluded from the primary trial, as these constitute contraindications to spine dual energy x-ray absorptiometry (DXA).
|
Entailment
|
[
39,
40,
41
] |
[] |
{'Clinical Trial ID': 'NCT00436917', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid', ' 4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of localized breast cancer', ' Stage I-IIIA disease', ' Adequately treated breast cancer', ' No clinical or radiological evidence of recurrent or metastatic disease', ' Baseline total lumbar spine or femoral neck bone mineral density T-score < -2.0 standard deviation (e.g., a patient with a T score of -2.1 is eligible)', ' Hormone-receptor status:', ' Estrogen receptor and/or progesterone receptor-positive breast cancer', ' PATIENT CHARACTERISTICS:', ' Female', ' Postmenopausal, defined by 1 of the following criteria:', ' Age > 55 years with cessation of menses', ' Age 55 years with spontaneous cessation of menses for > 1 year', ' Age 55 years with spontaneous cessation of menses for 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND has postmenopausal estradiol levels', ' Bilateral oophorectomy', ' ECOG performance status 0-2', ' Life expectancy 5 years', ' WBC 3,000/mm³ OR granulocyte count 1,500/mm³', ' Platelet count 100,000/mm³', ' Alkaline phosphatase 3 times upper limit of normal (ULN)', ' AST 3 times ULN', ' Creatinine < 2.0 mg/dL', ' Creatinine clearance 45 mL/min', ' No hypercalcemia (i.e., calcium level > 1 mg/dL above ULN) OR hypocalcemia (i.e., calcium level > 0.5 mg/dL below lower limit of normal) within the past 6 months', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No other nonmalignant systemic diseases, including any of the following:', ' Uncontrolled infection', ' Uncontrolled diabetes mellitus', ' Uncontrolled thyroid dysfunction', " Disease affecting bone metabolism (hyperparathyroidism, hypercortisolism, Paget's disease, osteogenesis imperfecta)", ' Malabsorption syndrome', ' No uncontrolled seizure disorders associated with falls', ' No known hypersensitivity to zoledronate or other bisphosphonates, letrozole, calcium, or vitamin D', ' No concurrent active dental problems, including any of the following:', ' Infection of the teeth or jawbone (maxillary or mandibular)', ' Dental or fixture trauma', ' Prior or current diagnosis of osteonecrosis of the jaw', ' Exposed bone in the mouth', ' Slow healing after dental procedures', ' No contraindication to spine dual energy x-ray absorptiometry (DXA) as defined by any of the following:', ' History of surgery at the lumbosacral spine, with or without implantable devices', ' Scoliosis with a Cobb angle > 15 degrees at the lumbar spine', ' Immobility, hyperostosis, or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan', ' Disease of the spine that would preclude the proper acquisition of a lumbar spine DXA', ' No condition that would preclude study follow-up or compliance', ' No psychiatric illness that would preclude giving informed consent', ' PRIOR CONCURRENT THERAPY:', ' More than 3 weeks since prior and no other concurrent oral bisphosphonates', ' No prior intravenous bisphosphonates', ' No prior aromatase inhibitor therapy', ' More than 6 months since prior anabolic steroids or growth hormone', ' More than 2 weeks since prior and no concurrent inhibitor of osteoclastic bone resorption (e.g., calcitonin, mithramycin, or gallium nitrate)', ' More than 30 days since prior systemic investigational drug and/or device', ' More than 7 days since prior topical investigational drug', ' More than 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extraction, implants)', ' Concurrent short-term corticosteroid therapy allowed', ' No concurrent sodium fluoride, parathyroid hormone, or tibolone', ' No other concurrent investigational drug or device'], 'Results': ['Outcome Measurement: ', ' Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)', ' Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.', ' Time frame: Baseline and 1 year', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid', ' Arm/Group Description: 4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)', ' Overall Number of Participants Analyzed: 30', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percentage of the baseline value 2.66 (1.27 to 4.62)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/52 (1.92%)', ' Musculoskeletal disorder 1/52 (1.92%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
dad5ecc6-afcf-496c-8193-778a100c0318
|
|
Single
|
Eligibility
|
NCT00976989
|
Patients with LVEF greater than or equal to 60% are eligible for the primary trial.
|
Entailment
|
[
0,
4
] |
[] |
{'Clinical Trial ID': 'NCT00976989', 'Intervention': ['INTERVENTION 1: ', ' T+P Concomitant Anthracycline-based Chemotherapy', ' 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.', 'INTERVENTION 2: ', ' T+P Sequential Anthracycline-based Chemotherapy', ' FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.'], 'Eligibility': ['Inclusion Criteria:', ' female participants, age >/=18 years', ' advanced, inflammatory or early stage unilateral invasive breast cancer', ' HER2-positive breast cancer', ' baseline left ventricular ejection fraction (LVEF) >/=55%', 'Exclusion Criteria:', ' metastatic disease (Stage IV) or bilateral breast cancer', ' previous anticancer therapy or radiotherapy for any malignancy', ' other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma', ' clinically relevant cardiovascular disease', ' current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent'], 'Results': ['Outcome Measurement: ', ' Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator', ' Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.', ' Time frame: From baseline up to approximately 3.5 years', 'Results 1: ', ' Arm/Group Title: T+P Concomitant Anthracycline-based Chemotherapy', ' Arm/Group Description: 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.', ' Overall Number of Participants Analyzed: 72', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: T+P Sequential Anthracycline-based Chemotherapy', ' Arm/Group Description: FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.', ' Overall Number of Participants Analyzed: 75', ' Measure Type: Number', ' Unit of Measure: percentage of participants 2.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/72 (31.94%)', ' Febrile Neutropenia 10/72 (13.89%)', ' Neutropenia 2/72 (2.78%)', ' Leukopenia 2/72 (2.78%)', ' Thrombocytopenia 0/72 (0.00%)', ' Left ventricular dysfunction 1/72 (1.39%)', ' Cardiovascular disorder 0/72 (0.00%)', ' Conduction disorder 0/72 (0.00%)', ' Diarrhoea 1/72 (1.39%)', ' Vomiting 0/72 (0.00%)', ' Nausea 0/72 (0.00%)', ' Small intestinal obstruction 0/72 (0.00%)', 'Adverse Events 2:', ' Total: 18/75 (24.00%)', ' Febrile Neutropenia 4/75 (5.33%)', ' Neutropenia 3/75 (4.00%)', ' Leukopenia 0/75 (0.00%)', ' Thrombocytopenia 0/75 (0.00%)', ' Left ventricular dysfunction 3/75 (4.00%)', ' Cardiovascular disorder 0/75 (0.00%)', ' Conduction disorder 0/75 (0.00%)', ' Diarrhoea 3/75 (4.00%)', ' Vomiting 2/75 (2.67%)', ' Nausea 1/75 (1.33%)', ' Small intestinal obstruction 0/75 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d0efe29c-1d76-4129-9cf5-2955564d1370
|
|
Comparison
|
Adverse Events
|
NCT01048099
|
NCT02502864
|
the primary trial recorded 2.38% more total adverse events than the secondary trial
|
Entailment
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT01048099', 'Intervention': ['INTERVENTION 1: ', ' Patients Treated', ' Patients who received study treatment'], 'Eligibility': ['Inclusion Criteria:', ' Part I', ' Women with HER2-negative breast cancer, as defined by FISH testing. (FISH testing may have been performed on the primary tumor, or subsequently on a biopsy of a metastatic lesion.)', ' Patients should be currently receiving chemotherapy, or scheduled to start chemotherapy (second-line or subsequent), for HER2-negative metastatic breast cancer.', ' To begin protocol treatment, patients must have progressed after at least 1 previous chemotherapy regimen for metastatic breast cancer.', ' Patients who are ER/PR positive or negative are eligible. ER/PR positive patients should be refractory to hormonal therapy, or not good candidates for hormonal therapy due to clinical features.', ' ECOG performance status of 0, 1 or 2.', ' Adequate recovery from recent surgery; 1 week must have elapsed from the time of a minor surgery; 4 weeks must have elapsed from the time of a major surgery.', ' Patients must have measurable disease per RECIST criteria.', ' Laboratory values as follows: Absolute neutrophil count (ANC) 1500/μL Hemoglobin (Hgb) 10 g/dL Platelets 100,000/L AST or ALT and alkaline phosphatase (ALP) must be <2.5 x ULN, or <5 x ULN in patients with liver metastases. Total bilirubin <1.5 x the institutional ULN Serum creatinine <1.5 x institutional ULN or calculated creatinine clearance 45 mL/min', ' Patients from Part 1 who have HER2 overexpression/activation identified by the PRO Onc Assay may enter the treatment portion of Part 2, if they meet all Part 2 eligibility criteria.', ' Life expectancy of 12 weeks.', ' Patient must be accessible for treatment and follow-up.', ' Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.', ' Part II', ' Women with HER2-negative breast cancer, as defined by FISH testing. (FISH testing may have been performed on the primary tumor, or subsequently on a biopsy of a metastatic lesion.)', ' Patients should be currently receiving chemotherapy, or scheduled to start chemotherapy, for HER2-negative metastatic breast cancer.', ' Patients who are ER/PR positive or negative are eligible. ER/PR positive patients should be refractory to hormonal therapy, or not good candidates for hormonal therapy due to clinical features.', ' ECOG performance status of 0, 1 or 2.', ' Adequate recovery from recent surgery; 1 week must have elapsed from the time of a minor surgery; 4 weeks must have elapsed from the time of a major surgery.', ' Patients must have measurable disease per RECIST criteria.', ' Laboratory values as follows:', ' Absolute neutrophil count (ANC) 1500/μL', ' Hemoglobin (Hgb) 10 g/dL', ' Platelets 100,000/uL', ' AST or ALT and alkaline phosphatase (ALP) must be <2.5 x ULN, or <5 x ULN in patients with liver metastases.', ' Total bilirubin <1.5 x the institutional ULN', ' Serum creatinine <1.5 x institutional ULN or calculated creatinine clearance 45 mL/min', ' Life expectancy of 12 weeks.', ' Patient must be accessible for treatment and follow-up.', ' Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.', ' Patients who are eligible for HER2-targeted treatment will begin this treatment at the first time a treatment change is necessary (i.e. at the next progression of metastatic breast cancer). This may occur immediately after PRO Onc assay results are received, or may be several months later, for patients responding well to their current chemotherapy.', ' Patients must continue to meet all inclusion and exclusion criteria for the Part 2 screening population at the time they are ready to start HER2-targeted treatment.', ' Ejection fraction 50%, as measured by echocardiogram (ECHO) or MUGA.', 'Exclusion Criteria:', ' Part I:', ' Patients currently responding to hormonal therapy.', ' Previous treatment with any HER2-targeted agent.', ' Patients with meningeal metastases.', ' Patients who are not considered likely candidates for subsequent therapy after next progression of metastatic breast cancer.', ' Women who are pregnant or lactating.', ' Patients with New York Heart Association class II or greater congestive heart failure.', ' Any of the following 6 months prior to starting study treatment:', ' myocardial infarction;', ' severe unstable angina;', ' ongoing cardiac dysrhythmia', ' Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Use of any non-approved or investigational agent 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Part II', ' Patients currently responding to hormonal therapy.', ' Previous treatment with any HER2-targeted agent.', ' Patients with meningeal metastases.', ' Patients with active brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 4 weeks have elapsed since treatment. Ideally, patients should not still require use of seizure medication or steroids.', ' Patients who are not considered likely candidates for subsequent therapy after next progression of metastatic breast cancer.', ' Women who are pregnant or lactating.', ' Patients with New York Heart Association class II or greater congestive heart failure.', ' Any of the following 6 months prior to starting study treatment:', ' myocardial infarction;', ' severe unstable angina;', ' ongoing cardiac dysrhythmia.', ' Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Use of any non-approved or investigational agent 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS 5 years.'], 'Results': ['Outcome Measurement: ', ' Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)', ' The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression/activation as detected by PRO Onc Assay.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Patients Treated', ' Arm/Group Description: Patients who received study treatment', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: percentage of participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/14 (35.71%)', ' Ileus 1/14 (7.14%)', ' General disorders and administration site conditions - Other, disease progression 2/14 (14.29%)', ' Infections and infestations - Other, pneumonia 1/14 (7.14%)', ' Acute kidney injury 1/14 (7.14%)']}
|
{'Clinical Trial ID': 'NCT02502864', 'Intervention': ['INTERVENTION 1: ', ' Standard of Care + Surveys', ' Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.'], 'Eligibility': ['Inclusion Criteria:', ' Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)', ' Age >/= 65 years (Senior adult focused study given increased risk for toxicity)', ' Participants must be female', ' Eastern Cooperative Oncology Group (ECOG) performance status <2', ' Must have normal organ and marrow function', ' No pre-existing neuropathy grade > 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0', ' Be postmenopausal (defined as amenorrheic for at least 12 months)', ' Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.', 'Exclusion Criteria:', ' Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements', ' Have psychiatric illness that would limit compliance with study requirements', ' Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide', ' Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.', ' Not willing to follow protocol requirements or to give informed consent'], 'Results': ['Outcome Measurement: ', ' Rate of Achieving Targeted Area Under the Curve (AUC)', ' Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg*hr/L) within 4 cycles of therapy in patients > 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.', ' Time frame: Cycle 4 - Up to 6 months', 'Results 1: ', ' Arm/Group Title: Standard of Care + Surveys', ' Arm/Group Description: Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants AUC mg*hr/L: 2.5-3.7: 5 62.5%', ' AUC mg*hr/L: <2.5: 3 37.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Fatigue * 1/9 (11.11%)', ' Non-cardiac chest pain * 1/9 (11.11%)', ' Sepsis * 1/9 (11.11%)', ' Urinary tract infection * 1/9 (11.11%)', ' Syncope * 1/9 (11.11%)', ' Anxiety * 1/9 (11.11%)', ' Thromboembolic event * 1/9 (11.11%)']}
|
63ec91be-7e12-431e-84b0-ca401bfb157b
|
Single
|
Results
|
NCT00373256
|
Cohort 1 of the primary trial included 250 patients being treated with Sunitinib and Paclitaxel for a duration of 18 months or until death, and the mean PFS for this group was just under 7 and a half months.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00373256', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib + Paclitaxel', ' Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.', 'INTERVENTION 2: ', ' Bevacizumab + Paclitaxel', ' Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of advanced breast cancer.', ' Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.', ' ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.', 'Exclusion Criteria:', ' No prior treatment with cytotoxics in the advanced disease setting.', ' HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.', ' Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4', ' Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death', 'Results 1: ', ' Arm/Group Title: Sunitinib + Paclitaxel', ' Arm/Group Description: Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.', ' Overall Number of Participants Analyzed: 242', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.4 (6.9 to 8.5)', 'Results 2: ', ' Arm/Group Title: Bevacizumab + Paclitaxel', ' Arm/Group Description: Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.', ' Overall Number of Participants Analyzed: 243', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.2 (7.7 to 13.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 89/235 (37.87%)', ' Anaemia 3/235 (1.28%)', ' Febrile neutropenia 12/235 (5.11%)', ' Leukopenia 1/235 (0.43%)', ' Neutropenia 6/235 (2.55%)', ' Pancytopenia 2/235 (0.85%)', ' Thrombocytopenia 2/235 (0.85%)', ' Atrial fibrillation 1/235 (0.43%)', ' Cardiac failure congestive 1/235 (0.43%)', ' Cardiogenic shock 1/235 (0.43%)', ' Cardiovascular disorder 0/235 (0.00%)', 'Adverse Events 2:', ' Total: 85/242 (35.12%)', ' Anaemia 1/242 (0.41%)', ' Febrile neutropenia 3/242 (1.24%)', ' Leukopenia 0/242 (0.00%)', ' Neutropenia 2/242 (0.83%)', ' Pancytopenia 0/242 (0.00%)', ' Thrombocytopenia 0/242 (0.00%)', ' Atrial fibrillation 2/242 (0.83%)', ' Cardiac failure congestive 1/242 (0.41%)', ' Cardiogenic shock 0/242 (0.00%)', ' Cardiovascular disorder 1/242 (0.41%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fd5af11f-7270-49d5-924a-755ff399c463
|
|
Single
|
Intervention
|
NCT02186015
|
Women in cohort B of the primary trial with serum 25 (OH)D greater than or equal to 30 ng/ml did not receive weekly supplementation of cholecalciferol.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT02186015', 'Intervention': ['INTERVENTION 1: ', ' Cholecalciferol', ' Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.', 'INTERVENTION 2: ', ' No Cholecalciferol', ' Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.'], 'Eligibility': ['Inclusion Criteria:', ' Metastatic breast cancer (Stage IV)', ' Histologically confirmed estrogen receptor positive disease', ' Female', ' Serum 25(OH) <30 ng/ml', ' Age 18 years', ' Pre or post-menopausal', ' ECOG Performance status 0-2', ' Adequate organ function as defined as GFR> 30 mls/min and serum calcium 10.4 mg/dl', ' Any race/ethnicity', ' English speaking', ' No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician', ' Willingness to sign a written informed consent and complete questionnaires', ' Cease ingestion of vitamin D supplementation not study related', 'Exclusion Criteria:', ' Women with Stage I-III breast cancer', ' Serum 25(OH)D levels 30 ng/ml', ' Untreated CNS involvement', ' History of kidney stones', ' History of renal failure', ' History of hyperparathyroidism', ' History of hypersensitivity to vitamin D', ' Non-English speaking', ' Currently pregnant or lactating, or anticipating pregnancy', ' Unwilling to cease ingestion of calcium supplements (>1000 mg/d)', ' Unwilling or unable to complete informed consent or study questionnaires', ' Psychiatric or other clinical conditions that preclude study compliance', ' Other important medical or safety considerations at the discretion of the investigator and/or study physician, including non-compliance with the study therapy or other activities'], 'Results': ['Outcome Measurement: ', ' Change in Serum 25(OH)D', " Change in laboratory serum value of 25(OH)D at 8 weeks post-supplementation for participants who received weekly supplementation of 50,000 IUs of vitamin D3. Change is expressed as laboratory serum value of 25(OH)D at 8 weeks minus baseline. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.", ' Time frame: 0, 8 weeks', 'Results 1: ', ' Arm/Group Title: Cholecalciferol', ' Arm/Group Description: Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.', ' Overall Number of Participants Analyzed: 10', ' Median (Inter-Quartile Range)', ' Unit of Measure: ng/ml 32 (22 to 40)', 'Results 2: ', ' Arm/Group Title: No Cholecalciferol', ' Arm/Group Description: Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.', ' Overall Number of Participants Analyzed: 0', ' Median (Inter-Quartile Range)', ' Unit of Measure: ng/ml '], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/11 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f07e932e-1d79-4e1f-9ac2-ed9e2db1c276
|
|
Single
|
Adverse Events
|
NCT00924352
|
One patient in the primary trial had abnormally low levels of AST, ALT and ANC.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00924352', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone + Dasatinib', ' Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.', ' Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.', ' Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.'], 'Eligibility': ['Inclusion Criteria:', ' A patient must meet each of the following criteria to be considered eligible for inclusion in this study:', ' Patient has the ability to understand and the willingness to sign a written informed consent including form according to institutional guidelines.', ' Patient has histologically-proven breast cancer.', ' Patient has locally recurrent or metastatic disease, measurable or non- measurable by RECIST criteria.', ' Patient has HER2-negative disease or disease that is refractory to HER2- directed therapy.', ' Patient is female or male 18 years of age.', ' Patient has(ECOG)performance status of 2.', ' Patient must have received at least 1 but no more than 2 prior chemotherapy regimens for locally recurrent or metastatic disease. Patients may have received neoadjuvant and/or adjuvant chemotherapy. These prior regimens can not have included ixabepilone or dasatinib. A line of chemotherapy will be defined as one or more agents used continuously or discontinuously (i.e., allowing a break or chemo holiday) without the addition of a new agent. Hormonal therapy will not be considered a line of therapy.', ' Prior chemotherapy must have been completed at least 3 weeks prior to study treatment start (6 weeks for nitrosoureas and mitomycin), and the patient must have recovered from all associated toxicities (except for alopecia and neuropathy grade 1 according to CTCAE, v3.0 classification).', ' Radiation therapy, immunotherapy, biologic therapy, and hormonal/endocrine therapy must have been completed at least 2 weeks prior to study treatment start. Any major surgery must have been completed at least 4 weeks prior to study treatment start.', ' Patient has adequate organ, metabolic and bone marrow function as follows:', ' Total bilirubin 1.0 × institutional ULN', ' AST, ALT 2.5 × institutional ULN', ' Serum sodium, potassium, calcium, magnesium, and phosphate institutional LLN. (Hypokalemia or hypomagnesemia must be corrected prior to dasatinib administration.)', ' Serum creatinine < 1.5 × institutional ULN', ' Hematologic function: - ANC 1500/mm3. -Platelet count 100,000/mm3. - Hemoglobin 10.0 g/dL', ' PT and PTT < 1.5 x institutional ULN', ' Ability to take oral medication (dasatinib must be swallowed whole).', ' Concomitant medications:', " Patient agrees to discontinue St John's Wort at least 5 days prior to starting dasatinib therapy and while receiving dasatinib therapy.", ' Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.', ' The use of CYP3A4 inducers, inhibitors, and substrates; medications that prolong QT interval; antacids; H2 blockers and proton pump inhibitors; and medications that inhibit platelet function and anticoagulation should be avoided during dasatinib therapy. These are restricted therapies that are permitted with caution when medically indicated.', ' Women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study treatment.', ' Patients of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study treatment is stopped.', 'Exclusion Criteria:', ' A patient who meets any of the following criteria will be considered not eligible for inclusion in this study:', ' Patient has had prior treatment with ixabepilone, dasatinib, or both.', ' Patient has had more than 2 prior lines of chemotherapy for locally recurrent or metastatic breast cancer. A line of chemotherapy will be defined as one or more agents used continuously or discontinuously (i.e., allowing a break or chemo holiday) without the addition of a new agent. Hormonal therapy will not be considered a line of therapy.', ' Patient has received a cumulative dose of > 360 mg/m2 of doxorubicin or > 600 mg/m2 of epirubicin.', ' Prior radiation must not have included 30% of major bone marrow containing areas (pelvis, lumbar spine).', ' Patients with CTC grade 2 or greater neuropathy (motor or sensory) at study entry.', ' Patient has evidence CNS or brain metastases, unless CNS or brain metastases have been treated and stable for > 3 months.', ' Patient has psychiatric illness or social situation that would limit or prohibit compliance with study requirements.', ' Patient has an inability to take oral medication or inability to absorb oral medication.', ' Patient has had any invasive cancer other than the one being treated in this study within 3 years with the exception of surgically cured nonmelanoma skin cancer; in situ carcinoma of the cervix; in situ carcinoma of the breast.', ' Patient is receiving concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for cancer).', ' Patient has other serious medical conditions as judged by the Principal Investigator.', ' Patient has a concurrent medical condition which may increase the risk of toxicity.', ' Patient has a pleural or pericardial effusion of any grade.', ' Patient has cardiac symptoms including any of the following:', ' Uncontrolled angina, congestive heart failure or myocardial infarction within 6 months of study entry.', ' Diagnosed congenital long QT syndrome.', ' Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).', ' Prolonged QTc on pre-entry ECG (> 450 msec).', ' Hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.', ' Patient has a history of significant bleeding disorder unrelated to cancer, including:', " Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).", ' Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).', ' Ongoing or recent ( 3 months) significant GI bleeding.', ' Patient is taking any of the following concomitant medications at study entry:', ' a. Category I drugs that are generally accepted to have a risk of causing Torsades de pointes including (Patients must discontinue drug 7 days prior to starting dasatinib.):', ' quinidine, procainamide, disopyramide.', ' amiodarone, sotalol, ibutilide, dofetilide.', ' erythromycin, clarithromycin.', ' chlorpromazine,haloperidol,mesoridazine, thioridazine,pimozide .', ' cisapride,bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,halofantrine, levomethadyl, pentamidine,sparfloxacin, lidoflazine.', ' Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone or dasatinib. Ixabepilone is contraindicated in patients who have a known, prior, severe (CTC grade 3 or 4) history of hypersensitivity reaction to a drug formulated in Cremophor® EL (polyoxyethylated castor oil).', ' Patient has received any investigational agent or therapy within 30 days prior to study treatment start.', ' Patient is unwilling or unable to comply with study requirements.', ' Women who:', ' are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study treatment, or', ' have a positive pregnancy test at baseline, or', ' are pregnant or breastfeeding.', ' Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.'], 'Results': ['Outcome Measurement: ', ' Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)', ' The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which 1 of 6 patients experienced DLT, and above which 2 of 6 patients experienced DLT.', ' Time frame: MTD was assessed during the first cycle of combination therapy (days 1-28).', 'Results 1: ', ' Arm/Group Title: Ixabepilone + Dasatinib', ' Arm/Group Description: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.', ' Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.', ' Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: mg daily 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/56 (19.64%)', ' Febrile Neutropenia * 3/56 (5.36%)', ' Neutropenia * 1/56 (1.79%)', ' Pancytopenia * 1/56 (1.79%)', ' Atrial Fibrillation * 1/56 (1.79%)', ' Coronary Artery Disease * 1/56 (1.79%)', ' Constipation * 1/56 (1.79%)', ' Chest Pain * 1/56 (1.79%)', ' Non-Cardiac Chest Pain * 1/56 (1.79%)', ' Edema due to Cardiac Disease * 1/56 (1.79%)', ' Cellulitis * 1/56 (1.79%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6a5ee728-7db9-4ec0-b98c-0500e9a6187e
|
|
Comparison
|
Intervention
|
NCT02297412
|
NCT02667626
|
Cohort 2 of the secondary trial and the primary trial are control groups, receiving a placebo tablet PO BID.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT02297412', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Minocycline Hydrochloride)', ' Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Arm II (Placebo)', ' Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Ability to complete questionnaires by themselves or with assistance', ' Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)', 'Exclusion Criteria:', ' Any of the following:', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception', ' Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause', ' History of allergic or other adverse reactions to minocycline', ' Prior exposure to neurotoxic chemotherapy', ' Diagnosis of fibromyalgia', ' Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids', ' History of allergic or other adverse reactions to tetracycline'], 'Results': ['Outcome Measurement: ', ' Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)', ' Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.', ' Time frame: Up to 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm I (Minocycline Hydrochloride)', ' Arm/Group Description: Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 20', ' Median (Full Range)', ' Unit of Measure: scores on a scale 96.0 (54.4 to 100.0)', 'Results 2: ', ' Arm/Group Title: Arm II (Placebo)', ' Arm/Group Description: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 20', ' Median (Full Range)', ' Unit of Measure: scores on a scale 84.3 (46.5 to 99.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/22 (13.64%)', ' Lung infection 1/22 (4.55%)', ' Lymphocyte count decreased 2/22 (9.09%)', ' Rash maculo-papular 0/22 (0.00%)', 'Adverse Events 2:', ' Total: 1/23 (4.35%)', ' Lung infection 0/23 (0.00%)', ' Lymphocyte count decreased 0/23 (0.00%)', ' Rash maculo-papular 1/23 (4.35%)']}
|
{'Clinical Trial ID': 'NCT02667626', 'Intervention': ['INTERVENTION 1: ', ' SCPR Intervention', ' Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.', ' Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence', 'INTERVENTION 2: ', ' Control', ' Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.', ' Control: Web-based resource lists and text-based study adherence reminders'], 'Eligibility': ['Inclusion:', ' Breast cancer (Stages 0-III) diagnosis', ' Breast cancer diagnosis age 45 years', ' 5 years since breast cancer diagnosis', ' Current age 18 to 50 years', ' Completed treatment with surgery, radiation and chemotherapy (if applicable)', ' Able to read English', ' Able to consent to the study', ' Access to an Internet connection', ' Exclusion:', ' Women who are pregnant at recruitment'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a 50% Decrease in Hot Flash Score', ' 50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.', ' Time frame: Baseline and 24 weeks', 'Results 1: ', ' Arm/Group Title: SCPR Intervention', ' Arm/Group Description: Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.', ' Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence', ' Overall Number of Participants Analyzed: 86', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 50 58.1%', 'Results 2: ', ' Arm/Group Title: Control', ' Arm/Group Description: Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.', ' Control: Web-based resource lists and text-based study adherence reminders', ' Overall Number of Participants Analyzed: 96', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 53 55.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/86 (0.00%)', 'Adverse Events 2:', ' Total: 0/96 (0.00%)']}
|
a495df61-260d-479c-8d5f-d586f295c672
|
Single
|
Intervention
|
NCT01105650
|
Participants in cohort 1 of the primary trial weighing less than 45 kg receive 4 million units/m^2 less of IL-2, than participants over 45 kg, but all participants will be administered IL-2 3 times per week for 6 doses.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6
] |
[] |
{'Clinical Trial ID': 'NCT01105650', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: CsA', ' Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', 'INTERVENTION 2: ', ' Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2', ' Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', 'Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 2 prior salvage chemotherapy regimens (directed at recurrent/metastatic disease).', ' OR', ' Diagnosis of metastatic breast cancer (female or male) that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:', ' If estrogen receptor or progesterone receptor positive must have progressed on prior hormonal therapy and/or', ' if HER2-neu positive must have progressed on trastuzumab, lapatinib, or similar agent', ' Women with a history of both cancers are eligible for this study provided that they currently meet eligibility for one of the diseases. Women who have had another malignancy and have been disease free for at least 3 year, or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.', ' Measurable disease per disease specific Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - patients with bone as their only site of disease will not be eligible.', ' If history of brain metastases must be stable for at least 3 months after treatment - A brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases.', ' Available related HLA-haploidentical natural killer (NK) cell donor (by at least class I serologic typing at the A&B locus)', ' Age 18 years or older', ' Karnofsky performance status > or = 50%', ' Adequate organ function as determined by the following criteria within 14 days of study enrollment', ' Bone marrow: platelets > or = 80,000 x 10^9/L and hemoglobin > or = 9 g/dL, unsupported by transfusions; absolute neutrophil count (ANC) > or = 1000 x 10^9/L, unsupported by growth colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)', ' Renal function: creatinine (Cr) < or = 2.0 mg/dL', ' Liver function: Aspartate aminotransferase (AST), Alanine transaminase (ALT), total bilirubin, alkaline phosphatase < 5 times upper limit of institutional normal (ULN)', ' Cardiac: Left ventricular ejection fraction >40% (within 28 days of treatment start)', 'Pulmonary function: >50% corrected Carbon Monoxide Diffusing Capacity (DLCO) and Forced Expiratory Volume in One Second (FEV1), if presence of pleural effusion due to metastatic disease >40% corrected DLCO and FEV1 is acceptable (within 28 days of treatment start)', ' Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to Day 0', ' At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen', ' Voluntary written informed consent', 'Exclusion Criteria:', ' Pregnant or nursing - The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Participants of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy and agree to use adequate birth control during study treatment', ' Active infection - subjects must be afebrile, off antibiotics, and with no uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or biopsies) are allowed'], 'Results': ['Outcome Measurement: ', ' Response Rate', ' Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.', ' Time frame: Month 3', 'Results 1: ', ' Arm/Group Title: Arm 1: CsA', ' Arm/Group Description: Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2', ' Arm/Group Description: Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', 'Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Atrial flutter0/3 (0.00%)', ' Hearing impairmed0/3 (0.00%)', ' Vestibular disorder0/3 (0.00%)', ' Blurred vision0/3 (0.00%)', ' Abdominal pain1/3 (33.33%)', ' Death NOS3/3 (100.00%)', ' Fever0/3 (0.00%)', ' Acute kidney injury0/3 (0.00%)', ' Dyspnea1/3 (33.33%)', ' Respiratory failure0/3 (0.00%)', 'Adverse Events 2:', ' Total: 3/3 (100.00%)', ' Atrial flutter0/3 (0.00%)', ' Hearing impairmed1/3 (33.33%)', ' Vestibular disorder1/3 (33.33%)', ' Blurred vision1/3 (33.33%)', ' Abdominal pain0/3 (0.00%)', ' Death NOS2/3 (66.67%)', ' Fever0/3 (0.00%)', ' Acute kidney injury1/3 (33.33%)', ' Dyspnea0/3 (0.00%)', ' Respiratory failure0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
917afeec-5152-4424-89e3-7f3ffad6378f
|
|
Single
|
Eligibility
|
NCT01617668
|
Patients must have healthy kidneys, liver and bone marrow to participate in the primary trial.
|
Entailment
|
[
0,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT01617668', 'Intervention': ['INTERVENTION 1: ', ' LCL161 + Paclitaxel (Gene Expression Signature Positive)', ' Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.', 'INTERVENTION 2: ', ' Paclitaxel Only (Gene Expression Signature Positive)', ' Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of invasive triple negative breast cancer', ' Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening', ' Candidates for mastectomy or breast-conserving surgery', ' Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm)', ' Regional nodes N0-N2', ' Absence of distant metastatic disease', ' ECOG performance status 0-1', ' Adequate bone marrow function', ' Adequate liver function and serum transaminases', ' Adequate renal function', 'Exclusion Criteria:', ' Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline); locally recurrent breast cancer', ' Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months', ' Uncontrolled cardiac disease', ' Patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug', ' Impaired GI function that may affect the absorption of LCL161', ' Pregnant or breast feeding (lactating) women', ' Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy', ' pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: LCL161 + Paclitaxel (Gene Expression Signature Positive)', ' Arm/Group Description: Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.', ' Overall Number of Participants Analyzed: 51', ' Median (95% Confidence Interval)', ' Unit of Measure: Percentage of Participants 24.9 (14.5 to 37.8)', 'Results 2: ', ' Arm/Group Title: Paclitaxel Only (Gene Expression Signature Positive)', ' Arm/Group Description: Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.', ' Overall Number of Participants Analyzed: 50', ' Median (95% Confidence Interval)', ' Unit of Measure: Percentage of Participants 23.4 (13.3 to 36.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 45/106 (42.45%)', ' Anaemia 1/106 (0.94%)', ' Disseminated intravascular coagulation 1/106 (0.94%)', ' Febrile neutropenia 1/106 (0.94%)', ' Lymph node pain 1/106 (0.94%)', ' Neutropenia 2/106 (1.89%)', ' Sinus tachycardia 1/106 (0.94%)', ' Abdominal pain upper 0/106 (0.00%)', ' Diarrhoea 2/106 (1.89%)', ' Nausea 1/106 (0.94%)', ' Chills 2/106 (1.89%)', ' Feeling cold 1/106 (0.94%)', 'Adverse Events 2:', ' Total: 7/103 (6.80%)', ' Anaemia 1/103 (0.97%)', ' Disseminated intravascular coagulation 0/103 (0.00%)', ' Febrile neutropenia 1/103 (0.97%)', ' Lymph node pain 0/103 (0.00%)', ' Neutropenia 0/103 (0.00%)', ' Sinus tachycardia 0/103 (0.00%)', ' Abdominal pain upper 1/103 (0.97%)', ' Diarrhoea 0/103 (0.00%)', ' Nausea 0/103 (0.00%)', ' Chills 0/103 (0.00%)', ' Feeling cold 0/103 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
19f84eca-6bb1-4d32-a9b0-b2dd7c3f22e6
|
|
Comparison
|
Eligibility
|
NCT02244580
|
NCT01901146
|
Patients with undetermined estrogen receptor status can be accepted by both the primary trial and the secondary trial.
|
Contradiction
|
[
0,
3
] |
[
0,
5,
7
] |
{'Clinical Trial ID': 'NCT02244580', 'Intervention': ['INTERVENTION 1: ', ' Luminal A', ' Patients subtyped as Luminal A with DDFS determined 5 years after randomisation', 'INTERVENTION 2: ', ' Combined Subtype', ' Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation'], 'Eligibility': ['Inclusion Criteria:', ' Invasive breast cancer verified in a histological biopsy', ' Age 65 or younger', ' Estrogen receptor (ER), PgR and HER2 expression have been determined', ' No distant metastases present (M0)', ' The patient provides a written informed consent for study participation', ' The estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over >35% within the first 10 years from the diagnosis)', 'Exclusion Criteria:', ' Patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes', ' The WHO performance status is moderate/poor, Z >1', ' The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x 109/L', ' Any physical or mental disorder that is considered to prohibit administration of chemotherapy', ' Cardiac failure; severe cardiac arrythmia requiring regular medication'], 'Results': ['Outcome Measurement: ', ' 5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™', ' Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))', ' Time frame: 5 year from the date of patient randomisation', 'Results 1: ', ' Arm/Group Title: Luminal A', ' Arm/Group Description: Patients subtyped as Luminal A with DDFS determined 5 years after randomisation', ' Overall Number of Participants Analyzed: 769', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 92', 'Results 2: ', ' Arm/Group Title: Combined Subtype', ' Arm/Group Description: Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation', ' Overall Number of Participants Analyzed: 769', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 82'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT01901146', 'Intervention': ['INTERVENTION 1: ', ' ABP 980', ' Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.', 'INTERVENTION 2: ', ' Trastuzumab', ' Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Females 18 years of age', ' Histologically confirmed invasive breast cancer', ' Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection', ' Planning neoadjuvant chemotherapy', ' HER2 positive disease', ' Measurable disease in the breast after diagnostic biopsy, defined as longest diameter 2.0 cm', ' Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry', ' Normal bone marrow function', ' Normal hepatic function', ' Normal renal function', ' Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures', ' Inclusion Criteria for Randomization:', ' Left ventricular ejection fraction (LVEF) of 55% by 2D echocardiogram', ' Complete all 4 cycles of run-in chemotherapy', 'Exclusion Criteria:', ' Bilateral breast cancer', ' Presence of known metastases', ' Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer', ' Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix', ' Pre-existing clinically significant ( grade 2) peripheral neuropathy', ' Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension', ' Severe dyspnea at rest requiring supplementary oxygen therapy', ' History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)', ' Recent infection requiring a course of systemic anti-infectives that were completed 14 days before enrollment (with the exception of uncomplicated urinary tract infection)', ' Woman of childbearing potential who is pregnant or is breast feeding', ' Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment', ' Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study', ' Other investigational procedures while participating in this study are excluded', ' Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients', ' Subject previously has enrolled and/or has been randomized in this study', ' Subject likely to not be available to complete all protocol required study visits or procedures', ' History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Pathologic Complete Response', ' Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).', ' Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.', ' Time frame: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase', 'Results 1: ', ' Arm/Group Title: ABP 980', ' Arm/Group Description: Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m paclitaxel Q3W for 4 cycles.', ' Overall Number of Participants Analyzed: 358', ' Measure Type: Number', ' Unit of Measure: percentage of participants 48.0', 'Results 2: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m paclitaxel Q3W for 4 cycles.', ' Overall Number of Participants Analyzed: 338', ' Measure Type: Number', ' Unit of Measure: percentage of participants 40.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/364 (4.95%)', ' Febrile neutropenia 3/364 (0.82%)', ' Atrial fibrillation 1/364 (0.27%)', ' Cardio-respiratory arrest 1/364 (0.27%)', ' Sinus bradycardia 1/364 (0.27%)', ' Ventricular extrasystoles 0/364 (0.00%)', ' Enterocolitis 0/364 (0.00%)', ' Faecaloma 0/364 (0.00%)', ' Gastric ulcer perforation 0/364 (0.00%)', ' Gastrointestinal toxicity 0/364 (0.00%)', ' Pancreatitis acute 0/364 (0.00%)', 'Adverse Events 2:', ' Total: 5/361 (1.39%)', ' Febrile neutropenia 0/361 (0.00%)', ' Atrial fibrillation 0/361 (0.00%)', ' Cardio-respiratory arrest 0/361 (0.00%)', ' Sinus bradycardia 0/361 (0.00%)', ' Ventricular extrasystoles 0/361 (0.00%)', ' Enterocolitis 0/361 (0.00%)', ' Faecaloma 0/361 (0.00%)', ' Gastric ulcer perforation 0/361 (0.00%)', ' Gastrointestinal toxicity 1/361 (0.28%)', ' Pancreatitis acute 0/361 (0.00%)']}
|
f5aa1aa3-7be3-4518-8cc5-df2394e70e96
|
Single
|
Results
|
NCT03584009
|
Participants in the primary trial administered with Fulvestrant 500mg via intramuscular injection had a higher % of clinical benefit than participants who were administered an additional 800mg of Venetoclax orally.
|
Entailment
|
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{'Clinical Trial ID': 'NCT03584009', 'Intervention': ['INTERVENTION 1: ', ' Venetoclax + Fulvestrant', ' Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).', 'INTERVENTION 2: ', ' Fulvestrant', ' Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).'], 'Eligibility': ['Inclusion Criteria:', ' Histological or cytological confirmation of estrogen receptor-positive (ER+) invasive carcinoma of the breast. ER+, HER2- negative invasive carcinoma of the breast with evaluable sample for BCL-2 IHC value at the time of screening. Participants who were originally diagnosed with HER2-positive breast cancer that converted to HER2-negative MBC are not eligible.', ' Evidence of metastatic or locally advanced disease not amenable to surgical or local therapy with curative intent.', ' Be postmenopausal or pre- or perimenopausal women amenable to being treated with the luteinizing hormone-releasing hormone (LHRH) agonist goserelin.', ' Participants must not have received more than two prior lines of hormonal therapy in the locally advanced or metastatic setting. In addition, at least one line of treatment must be a CDK4/6i AND participants must have experienced disease recurrence or progression during or after CDK4/6i therapy, which must have been administered for a minimum of 8 weeks prior to progression.', ' Participants for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at the time of entry into the study, as per national or local treatment guidelines.', ' Women of childbearing potential (i.e., not postmenopausal for at least 12 months or surgically sterile) must have had a negative serum pregnancy test result at screening, within 14 days prior to the first study drug administration.', ' For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 2 years after the last dose of study drug (or based on the local prescribing information for fulvestrant). Women must refrain from donating eggs during this same period.', ' Willing to provide tumor biopsy sample.', ' Had at least one measurable lesion via RECIST v1.1.', ' Had an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.', ' Had adequate organ and marrow function.', ' Had a life expectancy > 3 months.', ' To full fill the coagulation requirements for patient with or without therapeutic anticoagulation.', 'Exclusion criteria:', ' Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), venetoclax, or any agent whose mechanism of action is to inhibit BCL-2.', ' Pregnant, lactating, or intending to become pregnant during the study.', ' Known untreated or active Central Nervous System (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control.', ' Prior chemotherapy in the locally advanced or metastatic setting regardless of the duration of the treatment.', ' Any anti-cancer therapy received within 21 days of the first dose of study drug, including chemotherapy, radiotherapy, hormonal therapy, immunotherapy, antineoplastic vaccines, or other investigational therapy. (Radiotherapy with palliative intent to non-target sites is allowed).', ' Concurrent radiotherapy to any site or prior radiotherapy within 21 days of Cycle 1 Day 1 or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) or prior radiotherapy to > 25% of bone marrow.', ' Current severe, uncontrolled, systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic or infectious disease.', ' Any major surgery within 28 days of the first dose of study drug or anticipation of the need for major surgery during the course of study treatment.', ' Consumption of one or more of the following within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges including marmalade containing Seville oranges; Star fruit (carambola).', ' Administration within 7 days prior first dose of study treatment of Steroid therapy for anti-neoplastic intent, Strong or moderate CYP3A inhibitors or Strong or moderate CYP3A inducers.', ' Need for current chronic corticosteroid therapy (> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids).', ' Known infection with (human immunodeficiency virus) HIV or human T-cell leukemia virus 1.', ' Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day).', ' Positive test results for hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at screening. Participants who were positive for HCV antibody should have been negative for HCV by PCR to be eligible for study participation. Participants with a past or resolved hepatitis B virus (HBV) infection (defined as having a positive total HBcAb and negative hepatitis B surface antigen [HbsAg]) may be included if HBV DNA is undetectable. These participants should have been willing to undergo monthly DNA testing.', ' Participants who had a positive HCV antibody test are eligible for the study if a PCR assay is negative for HCV RNA.', ' History of other malignancies within the past 5 years except for treated skin basal cell carcinoma, squamous cell carcinoma, non-malignant melanoma <= 1.0 mm without ulceration, localized thyroid cancer, or cervical carcinoma in-situ.', ' Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study.', ' Cardiopulmonary dysfunction.', " Other medical or psychiatric conditions that, in the opinion of the investigatory, may interfere with the participant's participation in the study.", ' Inability or unwillingness to swallow pills or receive intramuscular (IM) injections.', ' History of malabsorption syndrome or other condition that would interfere with enteral absorption.', " History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).", ' Concurrent hormone replacement therapy.', ' Inability to comply with study and follow-up procedures.', ' History or active cardiopulmonary dysfunction.', ' Known hypersensitivity to any of the study medications (fulvestrant, venetoclax) or to any of the excipients.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1', ' Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir). In addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm.', ' Time frame: Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)', 'Results 1: ', ' Arm/Group Title: Venetoclax + Fulvestrant', ' Arm/Group Description: Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 11.8 (4.44 to 23.87)', 'Results 2: ', ' Arm/Group Title: Fulvestrant', ' Arm/Group Description: Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 13.7 (5.70 to 26.26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/50 (8.00%)', ' Pyrexia 1/50 (2.00%)', ' Lower respiratory tract infection 1/50 (2.00%)', ' Urosepsis 1/50 (2.00%)', ' Ejection fraction decreased 1/50 (2.00%)', ' Flank pain 0/50 (0.00%)', ' Bone pain 0/50 (0.00%)', ' Pleural effusion 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 2/51 (3.92%)', ' Pyrexia 0/51 (0.00%)', ' Lower respiratory tract infection 0/51 (0.00%)', ' Urosepsis 0/51 (0.00%)', ' Ejection fraction decreased 0/51 (0.00%)', ' Flank pain 1/51 (1.96%)', ' Bone pain 1/51 (1.96%)', ' Pleural effusion 1/51 (1.96%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45338f7c-5aaa-40fb-8503-7c943e1f3a29
|
|
Comparison
|
Intervention
|
NCT00429507
|
NCT00038467
|
Unlike the secondary trial, the primary trial does not administer any medication orally.
|
Entailment
|
[
0,
1,
2
] |
[
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5
] |
{'Clinical Trial ID': 'NCT00429507', 'Intervention': ['INTERVENTION 1: ', ' Samarium 153-EDTMP + Stem Cell Transplant', ' Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IV breast cancer metastatic to bone and/or bone marrow only.', ' Age between 18 and 65 years.', ' Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1', ' Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.', ' Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.', ' White blood cell count (WBC) >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.', ' Adequate pulmonary function defined as forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for hemoglobin) >/= 50% of predicted.', ' Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.', ' Serum total bilirubin < 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (SGPT) < 3x ULN', ' Creatinine clearance of >/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.', ' Ability to understand the study and provide informed consent.', 'Exclusion Criteria:', ' Any metastatic disease or history of metastatic disease other than skeletal metastases', ' Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.', ' Previous strontium-89 or samarium-153 treatment for any skeletal involvement.', ' Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.', ' Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.', ' Life expectancy severely limited by concomitant illness (less than 6 months).', ' Prior nephrectomy.', ' History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.', ' Uncontrolled arrhythmia or symptomatic cardiac disease.', ' Current gross hematuria in urinalysis (UA) in the absence of vaginal bleeding.', ' Evidence of HIV-seropositivity.', ' Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.', ' Use of any investigational agent within 30 days preceding enrollment.', ' Pregnant or lactating women.', ' Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.', ' Myelodysplastic syndrome.', ' Subject weight of more than 125 kg.'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' Time to progression is measured as the time from study entry to the development of disease progression.', ' Time frame: 7.5 Years, Study period was March 2007 to November 2014.', 'Results 1: ', ' Arm/Group Title: Samarium 153-EDTMP + Stem Cell Transplant', ' Arm/Group Description: Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.', ' Overall Number of Participants Analyzed: 12', ' Median (Full Range)', ' Unit of Measure: Days 317 (105 to 1339)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00038467', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.', 'INTERVENTION 2: ', ' Tamoxifen', ' Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'], 'Eligibility': ['Inclusion Criteria:', ' postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease', 'Exclusion Criteria:', ' unresectable breast cancer', ' ER negative primary tumor'], 'Results': ['Outcome Measurement: ', ' Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study', ' DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.', ' Time frame: Baseline up to Month 36', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.', ' Overall Number of Participants Analyzed: 2352', ' Measure Type: Number', ' Unit of Measure: probability of DFS 0.90 (0.89 to 0.92)', 'Results 2: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.', ' Overall Number of Participants Analyzed: 2372', ' Measure Type: Number', ' Unit of Measure: probability of DFS 0.86 (0.85 to 0.88)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 383/2320 (16.51%)', ' Anaemia * 2/2320 (0.09%)', ' Disseminated intravascular coagulation * 1/2320 (0.04%)', ' Granulocytopenia * 0/2320 (0.00%)', ' Hypofibrinogenaemia * 0/2320 (0.00%)', ' Iron deficiency anaemia * 1/2320 (0.04%)', ' Lymphadenitis * 1/2320 (0.04%)', ' Lymphadenopathy * 0/2320 (0.00%)', ' Thrombocytopenia * 1/2320 (0.04%)', ' Acute myocardial infarction * 5/2320 (0.22%)', 'Adverse Events 2:', ' Total: 439/2338 (18.78%)', ' Anaemia * 4/2338 (0.17%)', ' Disseminated intravascular coagulation * 0/2338 (0.00%)', ' Granulocytopenia * 1/2338 (0.04%)', ' Hypofibrinogenaemia * 1/2338 (0.04%)', ' Iron deficiency anaemia * 0/2338 (0.00%)', ' Lymphadenitis * 0/2338 (0.00%)', ' Lymphadenopathy * 1/2338 (0.04%)', ' Thrombocytopenia * 5/2338 (0.21%)', ' Acute myocardial infarction * 0/2338 (0.00%)']}
|
0964be32-f9e7-49ec-ad22-b030d483702a
|
Single
|
Eligibility
|
NCT01527487
|
Patients prescribed Citalopram as an ongoing treatment for depression are not eligible for the primary trial, as Psychological illnesses are not permitted.
|
Contradiction
|
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[] |
{'Clinical Trial ID': 'NCT01527487', 'Intervention': ['INTERVENTION 1: ', ' Eribulin+Cyclophosphamide (ErC)', ' Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion', 'INTERVENTION 2: ', ' Docetaxel+Cyclophosphamide (TC)', ' Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive adenocarcinoma of the breast.', ' Primary palpable disease confined to the breast and axilla on physical examination (clinical Stage II or III disease). For patients without clinically suspicious axillary adenopathy, the primary must be >2 cm in diameter by physical examination or imaging studies (clinical T2-3, N0-2, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). Patients who have had axillary node dissection and have pN3a (i.e. 10 involved axillary nodes) are also eligible.', ' Patients entering the trial after undergoing an axillary node dissection will be eligible if they meet other entry criteria.', ' Estrogen receptor (ER) and progesterone receptor (PR) status in the primary tumor known or pending at the time of study registration.', ' Resolution of all acute effects of surgical procedures to grade 1. For patients who had or will have, a sentinel node and/or axillary node dissection, completion at least 1 week prior to the initiation of study treatment with a well-healed wound is required.', ' Bilateral, synchronous breast cancer is allowed if both primary tumors are HER2-negative and at least one meets the specified qualifying tumor or nodal inclusion criteria.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.', ' Patients entering this study must be willing to provide release of tumor tissue collected at baseline during a diagnostic procedure if available, and at the time of future surgical procedure(s) for correlative testing. If tissue is not available, the patient will still be eligible for enrollment to the study.', ' No evidence of metastatic disease, as documented by complete staging workup 8 weeks prior to initiation of study treatment.', ' No prior treatment for this breast cancer with the exception of criterion #3.', ' HER2-negative tumor status defined as:', ' Immunohistochemical (IHC) 0-1+ or', ' IHC 2+ or IHC 3+ confirmed as FISH (Fluorescence in situ hybridization) or SISH (Silver in situ hybridization) negative (defined by ratio <2.2)', ' Adequate hematologic function defined as:', ' Absolute neutrophil count (ANC) 1500/μL', ' Hemoglobin (Hgb) 10 g/dL', ' Platelets 100,000/uL', ' Adequate liver function defined as:', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x the upper limit of normal (ULN)', ' Total bilirubin the institutional ULN', ' Adequate renal function defined as:', ' Serum creatinine 1.5 mg/dL x ULN OR calculated creatinine clearance 50 mL/min by the Cockcroft-Gault method:', ' GRF =(140-age) x (weight/kg) x (0.85 if female) (72 x serum creatinine mg/dL)', ' Other laboratory testing:', ' Serum magnesium the institutional lower limit of normal (LLN)', ' Serum potassium the institutional LLN', ' Female and 18 years of age.', ' Negative serum pregnancy test within <7 days prior to initial trial treatment.', ' Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures that are approved by their study physician while receiving study treatment and continuing for 3 weeks after the last dose of study drug treatment, who are not breastfeeding, and who have a negative serum pregnancy test prior to start of dosing.', ' Willingness and ability to comply with trial and follow-up procedures.', ' Ability to understand the nature of this trial and give written informed consent.', 'Exclusion Criteria:', ' Clinical T4 lesions, including inflammatory breast cancer. Clinical N3 involvement (e.g., ipsilateral, infraclavicular, supraclavicular, and internal mammary nodes).', ' Peripheral neuropathy (motor or sensory) > grade 1 according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).', ' Patient has received radiotherapy for treatment of previous cancer that included 30% of major bone marrow containing areas (e.g., pelvis, lumbar, spine).', ' Known or suspected allergy or hypersensitivity to any of the study drugs (i.e., eribulin, cyclophosphamide, docetaxel) or known hypersensitivity to polysorbate 80.', ' Patients with acute or chronic liver or renal disease or pancreatitis.', ' Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).', ' Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment. However, use of GNRH agonists for the purpose of fertility preservation or suppression of heavy menses is permitted (see Section 5.4.1).', ' Patient has any of the following cardiac diseases currently or within the last 6 months:', ' Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)', " Heart rate-corrected QT interval (QTc) > 480 ms on screening electrocardiogram (ECG) (using Bazett's formula)", ' Unstable angina pectoris', ' Congestive heart failure (New York Heart Association [NYHA] Grade 2', ' Acute myocardial infarction', ' Conduction abnormality not controlled with pacemaker or medication', ' Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).', ' Valvular disease with significant compromise in cardiac function', ' Chronic use of drugs that cause QTc prolongation. Patients must discontinue use of these drugs 7 days prior to the start of study treatment.', ' Presence of other active cancers, or history of treatment for invasive cancer 5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.', ' Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.', ' Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery', ' One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.', ' Time frame: 18 weeks', 'Results 1: ', ' Arm/Group Title: Eribulin+Cyclophosphamide (ErC)', ' Arm/Group Description: Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of surgical patients 18', 'Results 2: ', ' Arm/Group Title: Docetaxel+Cyclophosphamide (TC)', ' Arm/Group Description: Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion', ' Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage of surgical patients 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/54 (7.41%)', ' Febrile Neutropenia 3/54 (5.56%)', ' Sepsis 1/54 (1.85%)', 'Adverse Events 2:', ' Total: 2/22 (9.09%)', ' Febrile Neutropenia 1/22 (4.55%)', ' Sepsis 1/22 (4.55%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
73cfc4ea-afc0-465b-a403-c1bd771ded33
|
|
Single
|
Eligibility
|
NCT00876395
|
Patients suffering from Ulcerative colitis are excluded from the primary trial.
|
Entailment
|
[
9,
15
] |
[] |
{'Clinical Trial ID': 'NCT00876395', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Paclitaxel + Trastuzumab', ' Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', 'INTERVENTION 2: ', ' Placebo + Paclitaxel + Trastuzumab', ' Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'], 'Eligibility': ['Inclusion Criteria:', ' Adult Women ( 18 years old).', ' Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.', ' Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.', ' HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).', ' Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.', ' Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.', ' Documentation of negative pregnancy test.', ' Organ functions at time of inclusion.', 'Exclusion Criteria:', ' Prior mTOR inhibitors for the treatment of cancer.', ' Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).', ' Radiotherapy to 25% of the bone marrow within 4 weeks prior to randomization', ' History of central nervous system metastasis.', ' Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.', ' Serious peripheral neuropathy.', ' Cardiac disease or dysfunction.', ' Uncontrolled hypertension.', 'HIV.', 'Pregnant,'], 'Results': ['Outcome Measurement: ', " Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population", ' PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.', ' Time frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Paclitaxel + Trastuzumab', ' Arm/Group Description: Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', ' Overall Number of Participants Analyzed: 480', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.95 (14.55 to 17.91)', 'Results 2: ', ' Arm/Group Title: Placebo + Paclitaxel + Trastuzumab', ' Arm/Group Description: Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.49 (12.29 to 17.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 173/472 (36.65%)', ' Anaemia 6/472 (1.27%)', ' Febrile neutropenia 4/472 (0.85%)', ' Iron deficiency anaemia 1/472 (0.21%)', ' Leukopenia 2/472 (0.42%)', ' Neutropenia 2/472 (0.42%)', ' Thrombocytopenia 4/472 (0.85%)', ' Acute myocardial infarction 1/472 (0.21%)', ' Aortic valve incompetence 0/472 (0.00%)', ' Atrial fibrillation 2/472 (0.42%)', ' Cardiac arrest 1/472 (0.21%)', 'Adverse Events 2:', ' Total: 40/238 (16.81%)', ' Anaemia 0/238 (0.00%)', ' Febrile neutropenia 1/238 (0.42%)', ' Iron deficiency anaemia 0/238 (0.00%)', ' Leukopenia 0/238 (0.00%)', ' Neutropenia 2/238 (0.84%)', ' Thrombocytopenia 0/238 (0.00%)', ' Acute myocardial infarction 0/238 (0.00%)', ' Aortic valve incompetence 1/238 (0.42%)', ' Atrial fibrillation 0/238 (0.00%)', ' Cardiac arrest 0/238 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
75b67d63-9727-418d-afd5-c0fb867417b5
|
|
Single
|
Adverse Events
|
NCT01671319
|
1/42 patients in cohort 2 of the primary trial fainted.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT01671319', 'Intervention': ['INTERVENTION 1: ', ' Dose Dense TC + Pegfilgrastim', ' Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle', ' docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle'], 'Eligibility': ['Inclusion Criteria:', ' histologically confirmed invasive carcinoma of the female breast, status post definitive surgery (lumpectomy or mastectomy plus nodal evaluation if feasible). Patients must initiate therapy with ddTC within 84 days of the last breast or axillary surgery performed for curative intent', ' candidate for chemotherapy by the treating oncologist', ' Patients with pN2 or pN3 disease are NOT explicitly excluded. However, patients with N2 or N3 disease MUST be reviewed with the PI or study chair before being enrolled on the study as TC would not normally be considered adequate therapy for such patients.', ' Patients with bilateral, synchronous invasive breast cancer are eligible as long as both primary tumors meet the eligibility criteria.', ' Patients with estrogen-receptor (ER) and/or progesterone receptor (PR) negative, positive, or unknown tumors are eligible.', ' Patients with HER2 positive, negative or unknown disease are eligible for this trial. Patients whose tumors are HER2 positive by either immunohistochemistry (IHC) 3+ staining or demonstrate gene amplification by FISH should receive trastuzumab, following completion of adjuvant cytotoxic therapy with 4 cycles of ddTC.', ' There must be negative surgical margins for invasive cancer and DCIS. LCIS is acceptable at the margin.', ' Patients with multi-centric breast cancer are eligible as long as all known disease is resected from the breast with negative margins.', ' Age >18 years.', ' ECOG performance status 1', ' Women of childbearing potential should have a negative urine or blood beta-HCG, and must agree to contraception if engaging in sexual activity. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women must not be pregnant or nursing as the chemotherapy drugs used in this study may cause harm to a fetus or newborn.', ' Ability to understand and the willingness to sign a written informed consent document.', ' Platelets >/=100,000/μl within 4 weeks of registration.', ' Absolute neutrophil count (ANC) >/= 1,500/μl within 4 weeks of registration.', ' Total bilirubin within normal institutional limits within 4 weeks of registration.', ' Alkaline phosphatase (alk phos) 2.5 X institutional Upper Limit of Normal (ULN) within 4 weeks of registration.', ' AST (SGOT)/ALT(SGPT) 1.5X ULN', ' Creatinine within normal institutional limits OR Creatinine clearance>/= 60 mL/min/1.73 m2 for patients with creatinine levels above normal', ' If patient has received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indications (not for treatment of this cancer), they have been discontinued prior to enrollment.', 'Exclusion Criteria:', ' Patient has received previous trastuzumab, chemotherapy, hormonal therapy, or other anti-cancer agents (including investigational agents) for this malignancy.', ' Patient will be receiving GNRH agonists such as goserelin (Zoladex) or leuprolide acetate (Lupron) concomitantly with chemotherapy for the purpose of preventing breast cancer recurrence.', ' Patient has inflammatory breast cancer (pT4d) or metastatic breast cancer.', ' Patient has 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.', ' Patient has pre-existing persistent neuropathy.', ' The patient has received prior chemotherapy or radiotherapy or any malignancy within the past 2 years.', ' Patient has received prior docetaxel or cyclophosphamide within the past 5 years.', ' Patient has known contraindication or hypersensitivity to docetaxel, cyclophosphamide or pegfilgrastim.'], 'Results': ['Outcome Measurement: ', ' Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy', ' Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.', ' Time frame: 4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks', 'Results 1: ', ' Arm/Group Title: Dose Dense TC + Pegfilgrastim', ' Arm/Group Description: Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle', ' docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: participants 37'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/42 (9.52%)', ' Perforation, GI 1/42 (2.38%)', ' Febrile neutropenia 1/42 (2.38%)', ' Syncope 1/42 (2.38%)', ' Rash/desquamation 1/42 (2.38%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
94cd9451-35a4-4035-a7de-2d385f771607
|
|
Single
|
Adverse Events
|
NCT00068341
|
More patients in cohort 1 of the primary trial experienced febrile neutropenia than in cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21
] |
[] |
{'Clinical Trial ID': 'NCT00068341', 'Intervention': ['INTERVENTION 1: ', ' Arm I: HER2+', '(Pre-Op TCH)', 'INTERVENTION 2: ', ' Arm II: HER2+', ' (Pre-Op TC, Post-Op Herceptin)'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed infiltrating adenocarcinoma of the breast', ' Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.', ' No prior radiation to the involved breast', ' ECOG (Electrocochleography) performance status 0-2', ' Age 18 years to 80 years', ' Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl', ' All liver function tests < upper limit of normal', ' Serum creatinine < 2.0 mg/dl', ' Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram', ' HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]', ' If female of childbearing potential, pregnancy test is negative', ' If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study', ' Informed consent has been obtained', 'Exclusion Criteria:', ' Non-confirmed infiltrating adenocarcinoma breast cancer', ' Evidence of metastasis', ' Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin', ' Prior radiation to the involved breast', ' Recent breast cancer drug therapy within last 5 years of any form', ' History of allergy to polysorbate or castor oil', ' Ongoing active infection', ' Concurrent life-limiting disease with a life expectancy of less than one year', ' Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix', ' Pregnancy, nursing, fertile women who do not use birth control device', ' Inability to give informed consent', ' Patients with pre-existing peripheral neuropathy > grade 2'], 'Results': ['Outcome Measurement: ', ' Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.', ' Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).', ' Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Arm I: HER2+', ' Arm/Group Description: (Pre-Op TCH)', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: participants DFS (Disease Free Survival): 13', ' OS (overall survival): 13', 'Results 2: ', ' Arm/Group Title: Arm II: HER2+', ' Arm/Group Description: (Pre-Op TC, Post-Op Herceptin)', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: participants DFS (Disease Free Survival): 8', ' OS (overall survival): 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/15 (40.00%)', ' diarrhea and dehydration * 0/15 (0.00%)', ' Severe Dehydration * 1/15 (6.67%)', ' hypokalemia * 1/15 (6.67%)', ' pain, swelling, mastectomy site cellulitis * 0/15 (0.00%)', ' death progressive disease * 0/15 (0.00%)', ' divetricular abscess * 0/15 (0.00%)', ' fever * 1/15 (6.67%)', ' febrile neutropenia * 3/15 (20.00%)', ' Neutropenia * 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 4/14 (28.57%)', ' diarrhea and dehydration * 0/14 (0.00%)', ' Severe Dehydration * 0/14 (0.00%)', ' hypokalemia * 0/14 (0.00%)', ' pain, swelling, mastectomy site cellulitis * 0/14 (0.00%)', ' death progressive disease * 1/14 (7.14%)', ' divetricular abscess * 0/14 (0.00%)', ' fever * 0/14 (0.00%)', ' febrile neutropenia * 2/14 (14.29%)', ' Neutropenia * 0/14 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
18310f83-54ca-4530-92f1-7c41419ab69e
|
|
Single
|
Adverse Events
|
NCT00567190
|
There was the same number of anemic patinets in both cohorts of the primary trial.
|
Entailment
|
[
0,
2,
12,
14
] |
[] |
{'Clinical Trial ID': 'NCT00567190', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab + Docetaxel', ' Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.', 'INTERVENTION 2: ', ' Placebo + Trastuzumab + Docetaxel', ' Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Participants with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; participants with de novo Stage IV disease are eligible)', ' Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC)', ' Left ventricular ejection fraction (LVEF) 50 percent (%) at baseline (within 42 days of randomization)', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment', 'Exclusion Criteria:', ' History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC, which must be stopped prior to randomization)', ' History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting', ' History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than (<)12 months', ' History of persistent Grade 2 hematologic toxicity resulting from previous adjuvant therapy', ' Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0, Grade 3 at randomization', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' Computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain is mandatory in cases of clinical suspicion of brain metastases', ' History of exposure to cumulative doses of anthracyclines', ' Current uncontrolled hypertension or unstable angina', ' History of congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception: atrial fibrillation or paroxysmal supraventricular tachycardia)', ' History of myocardial infarction within 6 months of randomization', ' History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy', ' Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy', ' Inadequate organ function, as defined in the protocol, within 28 days prior to randomization', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment', ' Pregnant or lactating women', ' History of receiving any investigational treatment within 28 days of randomization', ' Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)', ' Receipt of IV antibiotics for infection within 14 days of randomization', ' Current chronic daily treatment with corticosteroids (excluding inhaled steroids)', ' Known hypersensitivity to any of the study drugs', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) Determined by an Independent Review Facility', ' PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of 1 new lesion. For non-target lesions, PD was defined as the appearance of 1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.', ' Time frame: Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Docetaxel', ' Arm/Group Description: Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.', ' Overall Number of Participants Analyzed: 402', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 18.5 (15 to 23)', 'Results 2: ', ' Arm/Group Title: Placebo + Trastuzumab + Docetaxel', ' Arm/Group Description: Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.', ' Overall Number of Participants Analyzed: 406', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 12.4 (10 to 13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 116/396 (29.29%)', ' Anaemia 3/396 (0.76%)', ' Febrile neutropenia 20/396 (5.05%)', ' Granulocytopenia 1/396 (0.25%)', ' Leukopenia 1/396 (0.25%)', ' Neutropenia 19/396 (4.80%)', ' Atrial fibrillation 3/396 (0.76%)', ' Cardiac failure congestive 0/396 (0.00%)', ' Coronary artery disease 0/396 (0.00%)', ' Left ventricular dysfunction 7/396 (1.77%)', ' Myocardial infarction 3/396 (0.76%)', 'Adverse Events 2:', ' Total: 160/408 (39.22%)', ' Anaemia 3/408 (0.74%)', ' Febrile neutropenia 46/408 (11.27%)', ' Granulocytopenia 0/408 (0.00%)', ' Leukopenia 0/408 (0.00%)', ' Neutropenia 18/408 (4.41%)', ' Atrial fibrillation 0/408 (0.00%)', ' Cardiac failure congestive 2/408 (0.49%)', ' Coronary artery disease 1/408 (0.25%)', ' Left ventricular dysfunction 6/408 (1.47%)', ' Myocardial infarction 0/408 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4fa6b99e-0e70-465d-8b24-b728979b3689
|
|
Single
|
Eligibility
|
NCT00627978
|
Women with leptomeningeal metastases are unfortunately excluded from the primary trial, as it would prevent them from giving informed consent to study entry.
|
Contradiction
|
[
18,
19
] |
[] |
{'Clinical Trial ID': 'NCT00627978', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' Participants are treated with Ixabepilone.', ' ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours', 'INTERVENTION 2: ', ' Control', ' No treatment with Ixabepilone'], 'Eligibility': ['Inclusion Criteria', ' Ability to understand and the willingness to sign a written informed consent document.', ' Histologic or cytologic diagnosis of adenocarcinoma originating in the breast.', ' Evidence that the cancer is metastatic or locally advanced and not curable by local measures (i.e., surgery, radiation).', ' NOTE: There is no limit on number of prior chemotherapy regimens received.', ' Karnofsky performance status (KPS) score of 70 - 100; (Appendix 1).', ' Life expectancy of at least 12 weeks.', ' Adequate recovery of drug related toxicities from prior systemic therapy (recovery to < = Grade 1 except for Grade 2 fatigue and alopecia).', ' Adequate recovery from recent surgery and radiation therapy. At least one week must have elapsed from the time of a minor surgery and/or focal/palliative radiation therapy; at least 3 weeks for major surgery and other radiation therapy.', ' Women or Men, age > = 18 years.', ' Patients must have normal organ and marrow function as defined below:', ' Hematologic function with absolute neutrophils 1,500/mm3 and/or platelets > 125,000/mm3', ' Hepatic function with serum bilirubin less than 1.5 times the upper institutional limits of normal, ALT 2.5 times the upper institutional limits of normal ( 5 times the upper institutional limits of normal if documented hepatic metastases are present)', ' Renal function with serum creatinine 1.5 times the upper limit of normal', ' Women of childbearing potential (WOCBP) and men with partners who are of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.', ' WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.', ' - WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.', ' Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Exclusion Criteria', ' Patients with known and active brain and/or leptomeningeal metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.', ' CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.', ' Prior treatment with ixabepilone.', ' Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, 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.', ' Known history of HIV infection.', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.', ' Patients may not be receiving any other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone.', ' Known prior severe hypersensitivity reactions to agents containing CremophorEL.', ' Patients may not be receiving any prohibited therapies and/or medications.', ' Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.'], 'Results': ['Outcome Measurement: ', ' Axons With Abnormal Morphology', ' Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.', ' Time frame: Baseline and Over 7 cycles of treatment, approximately 21 weeks', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Participants are treated with Ixabepilone.', ' ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of axons Axons grade 0 (normal) or 1 morphology baseline: 52', ' Axons grade 0 (normal) or 1 morphology Cycle 7: 2', ' Axons grade 3 or 4 morphology baseline: 24', ' Axons grade 3 or 4 morphology Cycle 7: 79', 'Results 2: ', ' Arm/Group Title: Control', ' Arm/Group Description: No treatment with Ixabepilone', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: percentage of axons Axons grade 0 (normal) or 1 morphology baseline: 82', ' Axons grade 0 (normal) or 1 morphology Cycle 7: NA [1]', ' Axons grade 3 or 4 morphology baseline: 15.5', ' Axons grade 3 or 4 morphology Cycle 7: NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e0fac0a4-a5ab-4089-8986-f601586506af
|
|
Single
|
Eligibility
|
NCT01847001
|
Spanish women with a heart rate of at most 50 beats per minute are eligible for the primary trial.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT01847001', 'Intervention': ['INTERVENTION 1: ', ' Propranolol + Neoadjuvant Chemotherapy', ' Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.', ' Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and', ' Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).', ' If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab.', ' After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor.', ' DOT imaging will be done at 4 additional time points, including beo.', ' Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' English or Spanish speaking women age 18', ' Heart Rate > 60 bpm', ' Systolic Blood Pressure > 100 mm/Hg', ' Deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or Abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of Adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.', ' Echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) with ejection fraction > 50%.', ' Patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (HER2) +/- breast cancer are eligible', ' If a patient has HER2-positive breast cancer, Herceptin and Perjeta will be given along with taxane therapy', ' Any stage invasive breast cancer provided the primary breast tumor size is 1 cm', ' Agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)', ' Agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. The biopsy prior to Taxol #1 is optional.', 'Exclusion Criteria:', ' Patients failing to meet the inclusion criteria', ' Corrected QT interval (QTc) prolongation as defined by > 470 milliseconds on electrocardiogram (ECG)', ' First-degree Atrioventricular (AV) block on ECG in which P-R interval lengthened > 200 milliseconds; Second Degree; or Third Degree', ' On beta-blocker treatment. If discontinued, patients must have been off beta-blockers for at least 3 months.', ' History of asthma, given concern for β-blockade in this population'], 'Results': ['Outcome Measurement: ', ' Mean Adherence to Propranolol', ' Propranolol adherence was documented biweekly by pill counts and drug diary checks.', ' Time frame: Approximately 6 months', 'Results 1: ', ' Arm/Group Title: Propranolol + Neoadjuvant Chemotherapy', ' Arm/Group Description: Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.', ' Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and', ' Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).', ' If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab.', ' After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor.', ' DOT imaging will be done at 4 additional time points, including beo.', ' Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.', ' Overall Number of Participants Analyzed: 10', ' Mean (Full Range)', ' Unit of Measure: Percentage of propanolol adherence 96 (89 to 100)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/10 (10.00%)', ' Colitis * [1]1/10 (10.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
85210693-996a-4ab9-92f4-62060571da21
|
|
Single
|
Adverse Events
|
NCT00148668
|
Cohort 1 and 2 of the primary trial recorded the same number of patients with Neutropenia.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00148668', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Herceptin/navelbine', 'INTERVENTION 2: ', ' Arm 2', ' Taxotere/carboplatin/herceptin'], 'Eligibility': ['Inclusion Criteria:', ' Patients with stage II or III breast cancer', ' HER-2 positive tumors', ' Older than 18 years of age', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.', ' ANC > 1,500/mm3', ' Hemoglobin > 9gm/dl', ' Platelets > 100,000mm3', ' Creatinine < 2mg/dl', ' Glucose < 200mg/dl', ' Bilirubin < 1.5 x ULN', 'Exclusion Criteria:', ' Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.', ' Pregnant or breast-feeding women', ' Serious illness, or medical or psychiatric condition', ' Uncontrolled infections', ' Active or severe cardiovascular or pulmonary disease', ' Patients with left ventricular ejection fraction < 50%', ' Peripheral neuropathy of any etiology that exceeds grade 1', ' Prior history of malignancy', ' Uncontrolled diabetes'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer', ' Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Herceptin/navelbine', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 17', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Taxotere/carboplatin/herceptin', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants 31'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/41 (12.20%)', ' Neutropenia 4/41 (9.76%)', ' Febrile Neutropenia 0/41 (0.00%)', ' SGPT (ALT) 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 5/40 (12.50%)', ' Neutropenia 4/40 (10.00%)', ' Febrile Neutropenia 1/40 (2.50%)', ' SGPT (ALT) 0/40 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f0fbdbf4-af12-4cde-a5f1-a56cc60658f4
|
|
Comparison
|
Adverse Events
|
NCT01310231
|
NCT00093808
|
1 patient in the secondary trial developed an eating disorder, there were no cases of this happening in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT01310231', 'Intervention': ['INTERVENTION 1: ', ' Metformin', ' Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Number of cycles: Until progression or unacceptable toxicity develops.', 'INTERVENTION 2: ', ' Placebo', ' Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Number of cycles: until progression or unacceptable toxicity develops.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven invasive breast cancer with metastatic spread outside of breast, ipsilateral axillary and supraclavicular nodal areas (Histological confirmation of metastases is not required) OR, Locally advanced breast cancer that is refractory to initial anticancer treatment.', ' A decision has been made to administer single or multiple agent first or second line chemotherapy that includes one of the following agents: anthracycline, taxane, platinum, capecitabine.', ' Age: 18 to 75 years at the time of registration', ' Invasive breast cancer, any ER or PgR status', ' ECOG performance status 0-2', ' Life expectancy of at least 6 months', " Adequate hepatic and renal function (SGOT and ALT < 1.8 X upper limit of normal for the institution, alkaline phosphatase 2X upper limit of normal for the institution, bilirubin within normal limits for the institution (expect in patients with Gilbert's syndrome who will be eligible regardless of bilirubin) and creatinine 130 umol/L)", ' Blood counts: Neutrophils must be at least 1,000/mm3 and Platelets 75,000/mm3.', ' Ability to understand and to provide written informed consent for the study', ' Absence of any psychological, familial, sociological, or other patient related factors that might preclude compliance with the study protocol', ' Measurable or non measurable (but evaluable) tumour must be present - radiologic or clinical evaluation must have been performed within 4 weeks prior to registration.', 'Exclusion Criteria:', ' More than one previous line(s) of chemotherapy for metastatic disease - if prior chemotherapy has been administered, the last date of treatment must have been given at least 3 weeks prior to registration [any adjuvant systemic treatment is acceptable]', ' If prior hormone therapy (as adjuvant or metastatic therapy) has been administered, it must have been stopped at least 3 weeks prior to registration', ' Radiotherapy to a target or non target lesion within 4 weeks of registration', ' Known CNS metastases', ' History of cardiac failure', ' Known hypersensitivity or allergy to metformin', ' History of or known diabetes or baseline fasting glucose 7.0 mmol/L', ' History of lactic or other metabolic acidosis', ' Use of metformin within 3 months of registration', ' Current or planned pregnancy or lactation in women of child-bearing potential. Patients of childbearing potential must have a negative serum pregnancy test.', ' Fertile patients must agree to use an effective method of contraception while on study treatment; which could include IUD, condoms or other barrier methods of birth control', ' Habitual alcohol intake of more than three drinks daily', ' Concurrent use of any biguanide medication (other than metformin as a study medication)', ' Patients with grade 2 diarrhea at baseline, malabsorption syndrome or unable to swallow oral medication', ' Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for 5 years.', ' Use of any investigational agent within 28 days prior to registration.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival.', ' Scans will be repeated every 9 weeks. Local follow up for survival will continue until all patients have died or for a maximum total follow up of 3 years, which ever occurs first. The two study arms will be compared in an intent to treat fashion using Cox proportional hazard analysis, with the stratification variables included in the model. Treatment discontinuation for toxicity or other reasons will be considered an event.', ' Time frame: From date of randomization to first documented progression or death, which ever occurs first, assessed up to 3 years.', 'Results 1: ', ' Arm/Group Title: Metformin', ' Arm/Group Description: Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Number of cycles: Until progression or unacceptable toxicity develops.', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: months 5.4 (1.04)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).', ' Number of cycles: until progression or unacceptable toxicity develops.', ' Overall Number of Participants Analyzed: 18', ' Mean (Standard Deviation)', ' Unit of Measure: months 6.3 (1.68)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/22 (13.64%)', ' ascites with hyponatraemia 0/22 (0.00%)', ' febrile neutropenia with respiratory infection 1/22 (4.55%)', ' urosepsis 1/22 (4.55%)', ' febrile neutropenia with urinary tract infection 0/22 (0.00%)', ' dyspnoea 1/22 (4.55%)', ' hypoxia 0/22 (0.00%)', ' thromboembolism 0/22 (0.00%)', 'Adverse Events 2:', ' Total: 4/17 (23.53%)', ' ascites with hyponatraemia 1/17 (5.88%)', ' febrile neutropenia with respiratory infection 0/17 (0.00%)', ' urosepsis 0/17 (0.00%)', ' febrile neutropenia with urinary tract infection 1/17 (5.88%)', ' dyspnoea 0/17 (0.00%)', ' hypoxia 1/17 (5.88%)', ' thromboembolism 1/17 (5.88%)']}
|
{'Clinical Trial ID': 'NCT00093808', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine + Vinorelbine + Trastuzumab', ' Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive breast cancer', ' Metastatic disease', ' HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR positive for amplification by fluorescent in situ hybridization', ' Testing may be performed in the primary tumor or the metastatic site', ' Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease', ' Measurable disease', ' At least one measurable lesion 2.0 cm by CT scan or MRI OR 1.0 cm by spiral CT scan', ' The following are considered non-measurable disease:', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast disease', ' Lymphangitis cutis/pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' No bone metastases as the only evidence of metastasis', ' Previously treated CNS metastases allowed provided disease has been stable for the past 3 months', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female or male', ' Performance status', ' ECOG 0-2', ' Life expectancy', ' At least 12 weeks', ' Hematopoietic', ' Absolute neutrophil count 1,500/mm^3', ' Hemoglobin 8.0 g/dL', ' Platelet count 100,000/mm^3', ' No known uncontrolled coagulopathy', ' Hepatic', ' Bilirubin 3.0 times the upper limit of normal (ULN)', ' One of the following must be true:', ' AST or ALT 5 times ULN AND alkaline phosphatase normal', ' Alkaline phosphatase 5 times ULN AND AST or ALT normal', ' Alkaline phosphatase 2.5 times ULN AND AST or ALT 1.5 times ULN', ' INR 1.5 times ULN', ' Renal', ' Calcium 11.5 mg/dL', ' Creatinine 1.5 times ULN', ' Creatinine clearance 30 mL/min', ' Cardiovascular', ' LVEF 50% by MUGA or echocardiogram', ' No clinically significant (i.e., active) cardiac disease', ' No congestive heart failure', ' No symptomatic coronary artery disease', ' No myocardial infarction within the past 12 months', ' No cardiac arrhythmia not controlled with medication', ' Gastrointestinal', ' Able to take oral medication', ' No lack of physical integrity of the upper gastrointestinal tract', ' No clinically significant malabsorption syndrome', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after study participation', ' No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically similar agents', ' No prior unanticipated severe reaction to fluoropyrimidine therapy', ' No know hypersensitivity to fluorouracil', ' No known dihydropyrimidine dehydrogenase deficiency', ' No history of uncontrolled seizures or CNS disorders', ' No clinically significant psychiatric disability that would preclude giving informed consent or study compliance', ' No other serious uncontrolled infection or disease', ' No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior adjuvant trastuzumab (Herceptin^®) allowed as adjuvant or first-line therapy for metastatic disease', ' No concurrent immunotherapy', ' Chemotherapy', ' See Disease Characteristics', ' No more than 1 prior chemotherapy regimen in the advanced or metastatic (non-adjuvant) setting', ' No prior continuous ( 24 hours) fluorouracil infusion', ' No prior capecitabine', ' No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)', ' Endocrine therapy', ' At least 1 day since prior hormonal therapy', ' No concurrent hormonal therapy', ' Radiotherapy', ' More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal column, sternum, or ribs)', ' No concurrent radiotherapy', ' Surgery', ' More than 4 weeks since prior major surgery', ' No prior organ allografts requiring immunosuppressive therapy', ' Other', ' More than 4 weeks since prior investigational drugs', ' No concurrent sorivudine or its chemically related analogues (e.g., brivudine)', ' No concurrent allopurinol, metronidazole, or cimetidine', ' No other concurrent cytotoxic agents', ' No other concurrent investigational drugs', ' No other concurrent anticancer therapy'], 'Results': ['Outcome Measurement: ', ' Confirmed Response Rate', ' A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Capecitabine + Vinorelbine + Trastuzumab', ' Arm/Group Description: Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: proportion of patients 0.67 (0.51 to 0.80)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/46 (19.57%)', ' Febrile neutropenia 1/46 (2.17%)', ' Cardiac disorder 1/46 (2.17%)', ' Diarrhea 1/46 (2.17%)', ' Upper gastrointestinal hemorrhage 1/46 (2.17%)', ' Chest pain 1/46 (2.17%)', ' Fatigue 1/46 (2.17%)', ' Neutrophil count decreased 2/46 (4.35%)', ' Platelet count decreased 1/46 (2.17%)', ' Anorexia 1/46 (2.17%)', ' Dehydration 1/46 (2.17%)', ' Serum potassium increased 1/46 (2.17%)']}
|
6a37e999-4b7e-4654-b9ac-7776a0720040
|
Comparison
|
Adverse Events
|
NCT00423917
|
NCT00082641
|
the primary trial and the secondary trial both report cases of confusion in all their patient cohorts.
|
Contradiction
|
[
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%)']}
|
a625ff4b-9c91-4ab8-a78b-df833d15759a
|
Single
|
Adverse Events
|
NCT00082641
|
At least one patient in the primary trial suffered from a life threatening bone fracture.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b25e7c40-a1db-4ae7-9613-0f65ddb4c040
|
|
Single
|
Adverse Events
|
NCT00856492
|
Cohort 1 of the primary trial recorded no deaths and no cases of Anemia.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00856492', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', ' Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).', 'INTERVENTION 2: ', ' Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', ' Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or pathologically confirmed breast cancer meeting one of the following criteria:', ' Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)', ' Inflammatory disease meeting the following two clinicopathologic criteria:', " Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%", ' A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself', ' HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH*', ' 2+ by DAKO or IHC allowed provided FISH* negative', ' NOTE: *A negative FISH test ratio is < 1.8 or FISH HER2 gene copy < 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry', ' Hormone receptor status known', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Zubrod performance status 0-2', ' Granulocyte count > 1,500/mm^3', ' ANC 1,500/mm^3', ' Platelet count > 100,000/mm^3', ' Hemoglobin 9.0 g/dL', ' Serum creatinine 1.5 times upper limit of normal (ULN)', ' Bilirubin 1.5 mg/dL', ' ALT and AST 3 times ULN', ' Alkaline phosphatase 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Urine protein:creatinine ratio 0.5 OR urine protein < 1,000 mg on 24-hour urine collection', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome)', ' QTc < 500 msec by EKG', ' LVEF normal by MUGA or ECHO (for patients with hypertension or for patients > 60 years of age)', ' NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)', ' No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:', ' Myocardial infarction (including severe/unstable angina)', ' Coronary/peripheral artery bypass graft', ' Symptomatic congestive heart failure', ' Pulmonary embolism', ' No poorly controlled hypertension, defined as recurrent or persistent ( 24 hours) elevated blood pressure (i.e., systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg)', ' No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer', ' Peripheral neuropathy < grade 2', ' PRIOR CONCURRENT THERAPY:', ' No prior tyrosine kinase inhibitors', ' More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer', ' At least 7 days since prior hormonal therapy', ' At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice', " No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)", ' No other concurrent therapy for the treatment of breast cancer except for bisphosphonates', ' No concurrent brachytherapy'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response Rate', ' Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.', ' Time frame: pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)', 'Results 1: ', ' Arm/Group Title: Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', ' Arm/Group Description: Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).', ' Overall Number of Participants Analyzed: 98', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 35.7%', 'Results 2: ', ' Arm/Group Title: Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', ' Arm/Group Description: Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab', ' Overall Number of Participants Analyzed: 113', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 24 21.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/96 (22.92%)', ' Anemia 1/96 (1.04%)', ' Febrile neutropenia 4/96 (4.17%)', ' Heart failure 1/96 (1.04%)', ' Abdominal pain 1/96 (1.04%)', ' Dysphagia 1/96 (1.04%)', ' Mucositis oral 1/96 (1.04%)', ' Nausea 1/96 (1.04%)', ' Vomiting 2/96 (2.08%)', ' Death NOS 0/96 (0.00%)', ' Pain 1/96 (1.04%)', ' Catheter related infection 1/96 (1.04%)', ' Enterocolitis infectious 0/96 (0.00%)', 'Adverse Events 2:', ' Total: 3/60 (5.00%)', ' Anemia 1/60 (1.67%)', ' Febrile neutropenia 1/60 (1.67%)', ' Heart failure 1/60 (1.67%)', ' Abdominal pain 0/60 (0.00%)', ' Dysphagia 0/60 (0.00%)', ' Mucositis oral 0/60 (0.00%)', ' Nausea 0/60 (0.00%)', ' Vomiting 0/60 (0.00%)', ' Death NOS 1/60 (1.67%)', ' Pain 0/60 (0.00%)', ' Catheter related infection 0/60 (0.00%)', ' Enterocolitis infectious 1/60 (1.67%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
25f1f3b8-15ed-4339-bf56-1cf1e0c2909f
|
|
Single
|
Results
|
NCT01268150
|
The Eribulin Mesylate group in the primary trial had a higher proportion of patients with complete response (CR) or partial response (PR) than the control group.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01268150', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.'], 'Eligibility': ['Key Inclusion Criteria', ' Females age 18 years or older at the time of informed consent', ' Have histologically or cytologically proven adenocarcinoma of the breast', ' Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors', ' (RECIST) criteria v 1.1', ' Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.', ' Life expectancy of greater than 24 weeks', ' Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2', ' At least 12 months since prior neoadjuvant or adjuvant chemotherapy', ' At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions', ' Adequate renal function', ' Adequate bone marrow function', ' Adequate liver function', ' Key Exclusion Criteria', ' Subjects who meet any of the following criteria will be excluded from participation in this study:', ' Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer', ' Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer', ' Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin', ' Inflammatory breast cancer', ' Clinically significant cardiovascular impairment', ' Subjects with known CNS disease are not eligible, except for those with treated brain metastasis.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen', ' Currently pregnant or breast-feeding.', ' Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR', ' Time frame: Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 28.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/56 (30.36%)', ' Febrile neutropenia 3/56 (5.36%)', ' Leukopenia 1/56 (1.79%)', ' Neutropenia 3/56 (5.36%)', ' Pericardial effusion 1/56 (1.79%)', ' Supraventricular tachycardia 1/56 (1.79%)', ' Intestinal perforation 1/56 (1.79%)', ' Small intestinal obstruction 1/56 (1.79%)', ' Bronchitis 1/56 (1.79%)', ' Pyelonephritis 1/56 (1.79%)', ' Sepsis 1/56 (1.79%)', ' Urinary tract infection 1/56 (1.79%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c0ddffa9-4a88-4ee1-8525-a77e887c3d85
|
|
Comparison
|
Eligibility
|
NCT00129389
|
NCT00304096
|
Patients with permanent sensory loss, interfering with daily activities are excluded from the primary trial, but may still be eligible for the secondary trial.
|
Entailment
|
[
22,
30
] |
[
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,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53
] |
{'Clinical Trial ID': 'NCT00129389', 'Intervention': ['INTERVENTION 1: ', ' Arm A: FAC', ' FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.', 'INTERVENTION 2: ', ' Arm B: FAC-wP', ' FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be Human Epidermal Growth Factor Receptor 2 (HER2) negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:', ' Tumor size > 2 cm; and/or', ' ER and Progesterone Receptor (PgR) negative; and/or', ' Histological grade 2-3; and/or', ' Age < 35 years old.', ' Time window between surgery and study randomization must be less than 60 days.', ' Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.', ' Patients must not present evidence of metastatic disease.', ' Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.', ' Status of HER2 in primary tumor, known before randomization. Patients with Immunohistochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.', ' Age >= 18 and <= 70 years old.', ' Performance status (Karnofsky index) >= 80.', ' Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).', ' Laboratory results (within 14 days prior to randomization):', ' Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100x 10^9/l; hemoglobin >= 10 mg/dl;', ' Hepatic function: total bilirubin <= 1 upper normal limit (UNL); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of AST and ALT > 1.5 UNL are associated with alkaline phosphatase > 2.5 UNL, patient is not eligible.', ' Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.', ' Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week time window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests, as clinically indicated.', ' Patients able to comply with treatment and study follow-up.', ' Negative pregnancy test done in the 14 previous days to randomization.', 'Exclusion Criteria:', ' Prior systemic therapy for breast cancer.', ' Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.', ' Any T4 or N1-3 or M1 tumor.', ' HER2 positive breast cancer (IHC 3+ or positive FISH result).', ' Pre-existing grade >=2 motor or sensorial neurotoxicity by the National Cancer Institute Common Toxicity Criteria (NCICTC) v-2.0.', ' Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.', ' History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.', ' Active uncontrolled infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.', ' Concomitant treatment with other therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS) Event', ' DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm A: FAC', ' Arm/Group Description: FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.', ' Overall Number of Participants Analyzed: 974', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 98 10.1%', 'Results 2: ', ' Arm/Group Title: Arm B: FAC-wP', ' Arm/Group Description: FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)', ' Overall Number of Participants Analyzed: 951', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 71 7.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 60/974 (6.16%)', ' Febrile neutropenia * [1]31/974 (3.18%)', ' Neutropenia * [2]6/974 (0.62%)', ' Neutropenia * [1]3/974 (0.31%)', ' Neutropenia * [3]2/974 (0.21%)', ' Leukocytes * [4]1/974 (0.10%)', ' Hemoglobin * [1]0/974 (0.00%)', ' Thrombosis/embolism * [1]1/974 (0.10%)', ' Thrombosis/embolism * [2]0/974 (0.00%)', ' Cardiac-ischemia/infarction * [2]0/974 (0.00%)', 'Adverse Events 2:', ' Total: 61/951 (6.41%)', ' Febrile neutropenia * [1]18/951 (1.89%)', ' Neutropenia * [2]1/951 (0.11%)', ' Neutropenia * [1]1/951 (0.11%)', ' Neutropenia * [3]1/951 (0.11%)', ' Leukocytes * [4]0/951 (0.00%)', ' Hemoglobin * [1]1/951 (0.11%)', ' Thrombosis/embolism * [1]3/951 (0.32%)', ' Thrombosis/embolism * [2]3/951 (0.32%)', ' Cardiac-ischemia/infarction * [2]1/951 (0.11%)']}
|
{'Clinical Trial ID': 'NCT00304096', 'Intervention': ['INTERVENTION 1: ', ' Stratum 1: Received Hormonal Therapy', ' Participants received hormonal therapy', 'INTERVENTION 2: ', ' Stratum 2: Had Not Received Hormonal Therapy', ' Participants had not received hormonal therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed adenocarcinoma of the breast', ' Stage III or IV disease', ' Primary or recurrent disease', ' Invasive lobular carcinoma allowed', ' HLA-A1, -A2, -A3, or -A31 positive', ' Underwent and recovered from prior primary therapy', ' Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months', ' Must have at least one undissected axillary and/or inguinal lymph node basin', ' No history of brain metastases', ' Hormone receptor status', ' Estrogen receptor-positive or -negative tumor', ' PATIENT CHARACTERISTICS:', ' ECOG performance status of 0 or 1', ' Body weight > 110 lbs (without clothes)', ' Male or female', ' Menopausal status not specified', ' Absolute neutrophil count > 1000/mm^3', ' Platelet count > 100,000/mm^3', ' Hemoglobin > 9 g/dL', ' Hemoglobin A1c < 7%', ' AST and ALT 2.5 x upper limit of normal (ULN)', ' Bilirubin 2.5 x ULN', ' Alkaline phosphatase 2.5 x ULN', ' Creatinine 1.5 x ULN', ' HIV negative', ' Hepatitis C negative', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No known or suspected allergies to any component of the vaccine', ' No active infection requiring antibiotics', ' No New York Heart Association class III or IV heart disease', ' No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:', ' Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms', ' Clinical evidence of vitiligo', ' Other forms of depigmenting illness', ' Mild arthritis requiring nonsteroidal antiinflammatory drugs', ' No medical contraindication or potential problem that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' More than 4 weeks since prior surgery', ' More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy', ' More than 4 weeks since prior and no concurrent allergy desensitization injections', ' More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids', ' No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)', ' Prior or concurrent topical corticosteroids allowed', ' More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)', ' More than 4 weeks since prior and no concurrent other investigational medication', ' More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents', ' Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed', ' No prior vaccination with any synthetic peptides in this protocol', ' Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered 2 weeks prior to or 2 weeks after study vaccine', ' Short term therapy for acute conditions not related to breast cancer allowed', ' No concurrent illegal drugs'], 'Results': ['Outcome Measurement: ', ' The Number of Participants Who Experienced Dose-limiting Adverse Events', ' Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity', ' Time frame: 30 days post administration of last vaccine', 'Results 1: ', ' Arm/Group Title: Stratum 1: Received Hormonal Therapy', ' Arm/Group Description: Participants received hormonal therapy', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: Stratum 2: Had Not Received Hormonal Therapy', ' Arm/Group Description: Participants had not received hormonal therapy', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Fever [1]1/6 (16.67%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)', ' Fever [1]0/5 (0.00%)']}
|
64ea58e5-e28f-42bc-818e-31bbf347080c
|
Single
|
Intervention
|
NCT01905592
|
the primary trial only defines intervention dosage for cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT01905592', 'Intervention': ['INTERVENTION 1: ', " Physician's Choice", ' Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.', 'INTERVENTION 2: ', ' Niraparib', ' Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops'], 'Eligibility': ['Inclusion Criteria:', ' Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation.', ' Histologically or cytologically confirmed HER2-negative metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent.', ' Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy.', ' Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting.', ' a. Hormone receptor positive patients must also have hormone resistant disease; either relapsed while on adjuvant endocrine treatment, or within one year of completing adjuvant endocrine treatment, or progression on at least one line of endocrine treatment for advanced cancer.', ' ECOG performance status 0-2', ' Adequate bone marrow, kidney and liver function', 'Exclusion Criteria:', ' Patients with platinum resistant cancer', ' Symptomatic uncontrolled brain metastases', ' Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval', ' Known hypersensitivity to the components of niraparib', ' Invasive cancer other than breast cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)', ' Pregnant or breast feeding patients', ' Immunocompromised patients', ' Known active Hepatitis B or C', ' Prior treatment with a PARP inhibitor', ' Known history of myelodysplastic syndrome (MDS).', ' known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) - Central Review Assessment', " The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of patients with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCAmut breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version 1.1 as determined by central review assessment.", ' Time frame: From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years', 'Results 1: ', " Arm/Group Title: Physician's Choice", ' Arm/Group Description: Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.', ' Overall Number of Participants Analyzed: 71', ' Median (95% Confidence Interval)', ' Unit of Measure: months 3.1 (1.6 to 7.2)', 'Results 2: ', ' Arm/Group Title: Niraparib', ' Arm/Group Description: Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops', ' Overall Number of Participants Analyzed: 135', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.1 (2.9 to 4.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/65 (6.15%)', ' Thrombocytopenia * 0/65 (0.00%)', ' Anaemia * 20/65 (0.00%)', ' Febrile neutropenia * 20/65 (0.00%)', ' Leukopenia * 20/65 (0.00%)', ' Neutropenia * 20/65 (0.00%)', ' Pericardial effusion * 20/65 (0.00%)', ' Tachycardia * 20/65 (0.00%)', ' Nausea * 0/65 (0.00%)', ' Vomiting * 21/65 (1.54%)', ' Constipation * 20/65 (0.00%)', ' Abdominal pain * 20/65 (0.00%)', 'Adverse Events 2:', ' Total: 33/134 (24.63%)', ' Thrombocytopenia * 10/134 (7.46%)', ' Anaemia * 29/134 (6.72%)', ' Febrile neutropenia * 21/134 (0.75%)', ' Leukopenia * 21/134 (0.75%)', ' Neutropenia * 21/134 (0.75%)', ' Pericardial effusion * 21/134 (0.75%)', ' Tachycardia * 21/134 (0.75%)', ' Nausea * 5/134 (3.73%)', ' Vomiting * 23/134 (2.24%)', ' Constipation * 22/134 (1.49%)', ' Abdominal pain * 21/134 (0.75%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7a0f4365-9775-4f1d-a1c7-4630b41b43ea
|
|
Single
|
Eligibility
|
NCT01073865
|
Females over the age of 18, whose last period was 2 weeks prior are eligible for the primary trial.
|
Entailment
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT01073865', 'Intervention': ['INTERVENTION 1: ', ' Zoladex 10.8 mg', ' ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks', 'INTERVENTION 2: ', ' Zoladex 3.6 mg', ' ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Female 20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 10 pg/mL and FSH 30 mIU/mL within 4 weeks of randomisation.', ' Hormone sensitivity (ER positive) of primary or secondary tumour tissue.', ' Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.', 'Exclusion Criteria:', ' Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer', ' Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation', ' Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Progression-free Survival (PFS) at 24 Weeks', ' A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.', ' Time frame: 24 weeks after the first dosing', 'Results 1: ', ' Arm/Group Title: Zoladex 10.8 mg', ' Arm/Group Description: ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks', ' Overall Number of Participants Analyzed: 109', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 67 61.5%', 'Results 2: ', ' Arm/Group Title: Zoladex 3.6 mg', ' Arm/Group Description: ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks', ' Overall Number of Participants Analyzed: 113', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 68 60.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/108 (3.70%)', ' ANAEMIA 1/108 (0.93%)', ' ENTEROCOLITIS 0/108 (0.00%)', ' PERIODONTAL DISEASE 0/108 (0.00%)', ' VOMITING 0/108 (0.00%)', ' CHEST PAIN 1/108 (0.93%)', ' PNEUMONIA 0/108 (0.00%)', ' TETANUS 1/108 (0.93%)', ' HYPERURICAEMIA 0/108 (0.00%)', ' DECREASED APPETITE 0/108 (0.00%)', ' MUSCULAR WEAKNESS 0/108 (0.00%)', ' PAIN IN EXTREMITY 1/108 (0.93%)', ' DYSPNOEA 0/108 (0.00%)', 'Adverse Events 2:', ' Total: 8/113 (7.08%)', ' ANAEMIA 1/113 (0.88%)', ' ENTEROCOLITIS 1/113 (0.88%)', ' PERIODONTAL DISEASE 1/113 (0.88%)', ' VOMITING 1/113 (0.88%)', ' CHEST PAIN 0/113 (0.00%)', ' PNEUMONIA 1/113 (0.88%)', ' TETANUS 0/113 (0.00%)', ' HYPERURICAEMIA 1/113 (0.88%)', ' DECREASED APPETITE 1/113 (0.88%)', ' MUSCULAR WEAKNESS 1/113 (0.88%)', ' PAIN IN EXTREMITY 0/113 (0.00%)', ' DYSPNOEA 3/113 (2.65%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
64dcb690-ef14-4cf2-85e5-670eb0645d7f
|
|
Single
|
Results
|
NCT01566721
|
More patients in cohort 2 of the primary trial had At Least 1 Adverse Event (AE) During the Treatment Period than in cohort 1.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01566721', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: SC Herceptin by Needle/Syringe', ' Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.', 'INTERVENTION 2: ', ' Cohort B: SC Herceptin by SID', ' Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Screening left ventricular ejection fraction (LVEF) greater than or equal to ( ) 55%', 'Exclusion Criteria:', ' Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent', ' History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years', ' Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed', ' Metastatic disease', ' Inadequate bone marrow, hepatic, or renal function', ' Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy', ' History of severe allergic or immunological reactions, such as difficult-to-control asthma', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period', ' Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.', ' Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)', 'Results 1: ', ' Arm/Group Title: Cohort A: SC Herceptin by Needle/Syringe', ' Arm/Group Description: Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.', ' Overall Number of Participants Analyzed: 1864', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.6', 'Results 2: ', ' Arm/Group Title: Cohort B: SC Herceptin by SID', ' Arm/Group Description: Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.', ' Overall Number of Participants Analyzed: 709', ' Measure Type: Number', ' Unit of Measure: percentage of participants 89.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 242/1864 (12.98%)', ' Febrile neutropenia * 39/1864 (2.09%)', ' Neutropenia * 9/1864 (0.48%)', ' Febrile bone marrow aplasia * 2/1864 (0.11%)', ' Anaemia * 3/1864 (0.16%)', ' Leukocytosis * 2/1864 (0.11%)', ' Leukopenia * 2/1864 (0.11%)', ' Pancytopenia * 1/1864 (0.05%)', ' Thymus enlargement * 1/1864 (0.05%)', ' Lymphadenopathy * 0/1864 (0.00%)', ' Thrombocytopenia * 0/1864 (0.00%)', 'Adverse Events 2:', ' Total: 84/709 (11.85%)', ' Febrile neutropenia * 14/709 (1.97%)', ' Neutropenia * 6/709 (0.85%)', ' Febrile bone marrow aplasia * 2/709 (0.28%)', ' Anaemia * 0/709 (0.00%)', ' Leukocytosis * 0/709 (0.00%)', ' Leukopenia * 0/709 (0.00%)', ' Pancytopenia * 0/709 (0.00%)', ' Thymus enlargement * 0/709 (0.00%)', ' Lymphadenopathy * 0/709 (0.00%)', ' Thrombocytopenia * 0/709 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
cacd1b1b-510e-421b-9adb-c5715f281794
|
|
Single
|
Adverse Events
|
NCT02502864
|
The maximum number of occurences for an adverse event in the primary trial was 3.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT02502864', 'Intervention': ['INTERVENTION 1: ', ' Standard of Care + Surveys', ' Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.'], 'Eligibility': ['Inclusion Criteria:', ' Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)', ' Age >/= 65 years (Senior adult focused study given increased risk for toxicity)', ' Participants must be female', ' Eastern Cooperative Oncology Group (ECOG) performance status <2', ' Must have normal organ and marrow function', ' No pre-existing neuropathy grade > 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0', ' Be postmenopausal (defined as amenorrheic for at least 12 months)', ' Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.', 'Exclusion Criteria:', ' Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements', ' Have psychiatric illness that would limit compliance with study requirements', ' Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide', ' Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.', ' Not willing to follow protocol requirements or to give informed consent'], 'Results': ['Outcome Measurement: ', ' Rate of Achieving Targeted Area Under the Curve (AUC)', ' Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg*hr/L) within 4 cycles of therapy in patients > 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.', ' Time frame: Cycle 4 - Up to 6 months', 'Results 1: ', ' Arm/Group Title: Standard of Care + Surveys', ' Arm/Group Description: Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants AUC mg*hr/L: 2.5-3.7: 5 62.5%', ' AUC mg*hr/L: <2.5: 3 37.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Fatigue * 1/9 (11.11%)', ' Non-cardiac chest pain * 1/9 (11.11%)', ' Sepsis * 1/9 (11.11%)', ' Urinary tract infection * 1/9 (11.11%)', ' Syncope * 1/9 (11.11%)', ' Anxiety * 1/9 (11.11%)', ' Thromboembolic event * 1/9 (11.11%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c3e5a015-e8b5-4281-828c-deb1f7fc7e3a
|
|
Single
|
Results
|
NCT01401166
|
All patients in cohort 1 of the primary trial had a Preferred Method of Drug Administration.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT01401166', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: SC (SID) Then IV Herceptin', ' Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.', 'INTERVENTION 2: ', ' Cohort 1: IV Then SC (SID) Herceptin', ' Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed HER2-positive primary breast cancer', ' No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)', ' Completed neo-adjuvant chemotherapy prior to entry, if received', ' At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', 'Exclusion Criteria:', ' History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years', ' Inadequate bone marrow function', ' Impaired liver function', ' Inadequate renal function', ' Serious cardiovascular disease', ' Human immunodeficiency virus or hepatitis B or C infection', ' Prior maximum cumulative dose of doxorubicin greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or equivalent'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants by Preferred Method of Drug Administration', ' The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.', ' Time frame: Week 24', 'Results 1: ', ' Arm/Group Title: Cohort 1: SC (SID) Then IV Herceptin', ' Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.', ' Overall Number of Participants Analyzed: 117', ' Measure Type: Number', ' Unit of Measure: percentage of participants SC Herceptin: 95.7', ' IV Herceptin: 4.3', ' No Preference: 0.0', 'Results 2: ', ' Arm/Group Title: Cohort 1: IV Then SC (SID) Herceptin', ' Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.', ' Overall Number of Participants Analyzed: 119', ' Measure Type: Number', ' Unit of Measure: percentage of participants SC Herceptin: 87.4', ' IV Herceptin: 9.2', ' No Preference: 3.4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/242 (1.65%)', ' Left ventricular dysfunction * 0/242 (0.00%)', ' Adverse drug reaction * 0/242 (0.00%)', ' Chest pain * 0/242 (0.00%)', ' Cholelithiasis * 0/242 (0.00%)', ' Breast abscess * 0/242 (0.00%)', ' Device related infection * 1/242 (0.41%)', ' Influenza * 0/242 (0.00%)', ' Postoperative wound infection * 0/242 (0.00%)', ' Pyelonephritis * 0/242 (0.00%)', 'Adverse Events 2:', ' Total: 2/241 (0.83%)', ' Left ventricular dysfunction * 0/241 (0.00%)', ' Adverse drug reaction * 0/241 (0.00%)', ' Chest pain * 0/241 (0.00%)', ' Cholelithiasis * 0/241 (0.00%)', ' Breast abscess * 0/241 (0.00%)', ' Device related infection * 0/241 (0.00%)', ' Influenza * 1/241 (0.41%)', ' Postoperative wound infection * 0/241 (0.00%)', ' Pyelonephritis * 0/241 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7926bfa3-cf49-4589-8143-0a0826336b67
|
|
Comparison
|
Intervention
|
NCT00975676
|
NCT00632489
|
the primary trial does not explicitly state the dosage of Triptorelin for either of its patient cohorts. On the other hand, the secondary trial gives details of doses used for LBH589, Capecitabine and Lapatinib.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00975676', 'Intervention': ['INTERVENTION 1: ', ' Triptorelin Plus Tamoxifen', ' Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.', 'INTERVENTION 2: ', ' Triptorelin Plus Exemestane', ' Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed resected breast cancer', ' Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required', ' Randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane', ' Hormone receptor status:', ' Estrogen receptor- and/or progesterone receptor-positive tumor', ' PATIENT CHARACTERISTICS:', ' Premenopausal', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Estrogen Levels (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S]) at Different Time Points During the First 4 Years of Treatment With Triptorelin (Trip) in Combination With Either Tamoxifen (T) or Exemestane (E), IBCSG 24-02 SOFT-EST Substudy', ' Estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.', ' Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization', 'Results 1: ', ' Arm/Group Title: Triptorelin Plus Tamoxifen', ' Arm/Group Description: Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.', ' Overall Number of Participants Analyzed: 26', ' Mean (Standard Deviation)', ' Unit of Measure: pg/mL Estradiol (E2) levels at baseline (0 months): 26 participants', ' 109.81 (119.151)', ' Estradiol (E2) levels at 3 months: 25 participants', ' 4.876 (7.123)', ' Estradiol (E2) levels at 6 months: 24 participants', ' 3.761 (2.02)', ' Estradiol (E2) levels at 12 months: 20 participants', ' 4.013 (2.765)', ' Estradiol (E2) levels at 18 months: 20 participants', ' 7.306 (16.325)', ' Estradiol (E2) levels at 24 months: 15 participants', ' 4.453 (3.347)', ' Estradiol (E2) levels at 36 months: 14 participants', ' 3.704 (2.138)', ' Estradiol (E2) levels at 48 months: 14 participants', ' 5.914 (8.959)', ' Estrone (E1) levels at baseline (0 months): 26 participants', ' 60.27 (52.4)', ' Estrone (E1) levels at 3 months: 25 participants', ' 17.8 (6.73)', ' Estrone (E1) levels at 6 months: 24 participants', ' 18.66 (7.54)', ' Estrone (E1) levels at 12 months: 21 participants', ' 19.05 (8.4)', ' Estrone (E1) levels at 18 months: 20 participants', ' 18.64 (9.35)', ' Estrone (E1) levels at 24 months: 15 participants', ' 18.96 (7.63)', ' Estrone (E1) levels at 36 months: 14 participants', ' 19.49 (7.32)', ' Estrone (E1) levels at 48 months: 14 participants', ' 19.14 (7.24)', ' Estrone sulfate (E1S) levels at baseline (0 months): 26 participants', ' 1437 (1825.06)', ' Estrone sulfate (E1S) levels at 3 months: 25 participants', ' 281.4 (183.44)', ' Estrone sulfate (E1S) levels at 6 months: 24 participants', ' 259 (167.23)', ' Estrone sulfate (E1S) levels at 12 months: 21 participants', ' 278.5 (236.38)', ' Estrone sulfate (E1S) levels at 18 months: 20 participants', ' 281.8 (160.6)', ' Estrone sulfate (E1S) levels at 24 months: 14 participants', ' 242.6 (96.75)', ' Estrone sulfate (E1S) levels at 36 months: 14 participants', ' 249.4 (113.27)', ' Estrone sulfate (E1S) levels at 48 months: 13 participants', ' 231.1 (93.46)', 'Results 2: ', ' Arm/Group Title: Triptorelin Plus Exemestane', ' Arm/Group Description: Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.', ' Overall Number of Participants Analyzed: 83', ' Mean (Standard Deviation)', ' Unit of Measure: pg/mL Estradiol (E2) levels at baseline (0 months): 81 participants', ' 96.55 (151.235)', ' Estradiol (E2) levels at 3 months: 67 participants', ' 3.973 (8.439)', ' Estradiol (E2) levels at 6 months: 66 participants', ' 3.672 (8.006)', ' Estradiol (E2) levels at 12 months: 68 participants', ' 2.486 (5)', ' Estradiol (E2) levels at 18 months: 65 participants', ' 2.527 (6.204)', ' Estradiol (E2) levels at 24 months: 62 participants', ' 2.52 (6.566)', ' Estradiol (E2) levels at 36 months: 60 participants', ' 1.654 (2.764)', ' Estradiol (E2) levels at 48 months: 50 participants', ' 9.073 (57.307)', ' Estrone (E1) levels at baseline (0 months): 81 participants', ' 65.42 (78.12)', ' Estrone (E1) levels at 3 months: 67 participants', ' 2.93 (3.33)', ' Estrone (E1) levels at 6 months: 66 participants', ' 2.73 (3.12)', ' Estrone (E1) levels at 12 months: 68 participants', ' 3.71 (6.35)', ' Estrone (E1) levels at 18 months: 65 participants', ' 8.47 (33.42)', ' Estrone (E1) levels at 24 months: 62 participants', ' 4.69 (9.16)', ' Estrone (E1) levels at 36 months: 60 participants', ' 4.93 (9.16)', ' Estrone (E1) levels at 48 months: 50 participants', ' 8.53 (35.07)', ' Estrone sulfate (E1S) levels at baseline (0 months): 81 participants', ' 1371 (1763.84)', ' Estrone sulfate (E1S) levels at 3 months: 67 participants', ' 56.02 (133.71)', ' Estrone sulfate (E1S) levels at 6 months: 66 participants', ' 54.7 (97.66)', ' Estrone sulfate (E1S) levels at 12 months: 68 participants', ' 47.31 (130.45)', ' Estrone sulfate (E1S) levels at 18 months: 64 participants', ' 63.52 (175.19)', ' Estrone sulfate (E1S) levels at 24 months: 59 participants', ' 73.56 (258.29)', ' Estrone sulfate (E1S) levels at 36 months: 60 participants', ' 53.27 (151.03)', ' Estrone sulfate (E1S) levels at 48 months: 46 participants', ' 112 (556.81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT00632489', 'Intervention': ['INTERVENTION 1: ', ' LBH589 With Capecitabine', ' MTD, LBH589 with Capecitabine', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.', 'INTERVENTION 2: ', ' LBH589 and Lapatinib', ' LBH589 and Lapatinib', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented metastatic or locally unresectable, incurable malignancy for which capecitabine is clinically appropriate.', ' Male or female patients aged 18 years old.', ' Maximum of 3 prior regimens in a metastatic setting allowed and may include other targeted agents, immunotherapy and chemotherapy.', ' Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.', ' Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.', ' Baseline MUGA or ECHO must demonstrate LVEF > than the lower limits of the institutional normal.', ' Laboratory values as follows:', ' ANC > 1500/μL', ' Hgb > 9 g/dL', ' Platelets > 100,000/uL', ' Bilirubin < 1.5 mg/dL', ' AST/SGOT < 2.5 x ULN or < 5.0 x ULN and ALT/SGPT in patients with liver metastases', ' Creatinine < 1.5 mg/dL or calculated creatinine clearance > 50 ml/min', ' Albumin > 3 g/dL', ' Potassium > lower limit of normal (LLN)', ' Phosphorous > LLN', ' Calcium > LLN', ' Magnesium > LLN', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment and must commit to begin two acceptable methods of birth control, one highly effective method of birth control and one additional effective method at the same time before starting treatment.', ' Life expectancy > 12 weeks.', ' Accessible for treatment and follow-up.', ' All patients must be able to understand the nature of the study and give written informed consent prior to study entry.', ' Additional Breast Cancer Patient Subset (Part 2 and Part 3) Inclusion Criteria:', ' Incurable carcinoma of the breast, with measurable locally recurrent or metastatic disease.', ' ICH 3+ overexpression or FISH amplification documented by a local laboratory in primary or metastatic tumor tissue.', ' Prior treatment with an anthracycline, taxane, and trastuzumab or not a candidate for such treatment. Patient may have received these drugs in combination or in sequence for the treatment of locally advanced or metastatic disease and/or adjuvant therapy.', 'Exclusion Criteria:', ' Prior treatment with an HDAC inhibitor or current treatment with valproic acid.', ' Previous treatment with capecitabine.', ' Impaired cardiac function including any of the following:', ' Screening ECG with a QTc > 450 msec.', ' Congenital long QT syndrome.', ' History of sustained ventricular tachycardia.', ' Any history of ventricular fibrillation or torsades de pointes.', ' Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate > 50 beats per minute are eligible.', ' Myocardial infarction or unstable angina within 6 months of study entry.', ' Congestive heart failure (NY Heart Association class III or IV).', ' Right bundle branch block and left anterior hemiblock (bifascicular block).', ' Atrial fibrillation or flutter.', ' Ongoing therapy with antiarrhythmics or other medications associated with QTc prolongation.', ' Uncorrected hypokalemia or hypomagnesaemia.', ' Uncontrolled hypertension (systolic blood pressure [BP] 180 or diastolic BP > 100 mm Hg) or uncontrolled cardiac arrhythmias.', ' Active CNS disease, including meningeal metastases.', ' Known diagnosis of human immunodeficiency virus (HIV) infection.', ' Unresolved diarrhea > CTCAE grade 1.', ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.', ' Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.', ' Patients with known hypersensitivity to 5-fluorouracil chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting study drug or patients that have not recovered from side effects of previous therapy.', ' Patient is < 5 years free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.', ' Concomitant use of any anti-cancer therapy or radiation therapy.', ' Pregnant or breast feeding or female of reproductive potential not using two effective methods of birth control.', ' Male patients whose sexual partners are women of childbearing potential not using effective birth control.', " Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).", ' Other concurrent severe, uncontrolled infection or 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.', ' Patients taking any medications listed in "Prohibited Medications" for both capecitabine and lapatinib .', ' Patients with uncontrolled coagulopathy (PT and/or PTT > 1.2 x ULN; patient must also be on stable dose of anticoagulant for a defined medical indication).', ' Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible.', ' Additional Breast Cancer Patient Subset (Part 2 and Part 3) Exclusion Criteria:', ' 1. Prior treatment with lapatinib'], 'Results': ['Outcome Measurement: ', ' To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil', ' MTD for Capecitabine, BID', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: LBH589 With Capecitabine', ' Arm/Group Description: MTD, LBH589 with Capecitabine', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: mg/m2 100', 'Results 2: ', ' Arm/Group Title: LBH589 and Lapatinib', ' Arm/Group Description: LBH589 and Lapatinib', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: mg/m2 '], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/15 (40.00%)', ' Constipation 1/15 (6.67%)', ' General disorders and administration site conditions - Other, disease progression 2/15 (13.33%)', ' General disorders and administration site conditions - Other, failure to thrive 0/15 (0.00%)', ' Infections and infestations - Other, unspecified 1/15 (6.67%)', ' Platelet count decreased 1/15 (6.67%)', ' Dehydration 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 3/5 (60.00%)', ' Constipation 0/5 (0.00%)', ' General disorders and administration site conditions - Other, disease progression 1/5 (20.00%)', ' General disorders and administration site conditions - Other, failure to thrive 1/5 (20.00%)', ' Infections and infestations - Other, unspecified 0/5 (0.00%)', ' Platelet count decreased 0/5 (0.00%)', ' Dehydration 1/5 (20.00%)', ' Dysarthria 0/5 (0.00%)']}
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1e0da2b7-b91e-4b83-bcb6-7bfafff7e39b
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Comparison
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Adverse Events
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NCT00887575
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NCT01610284
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Cohort 1 of the secondary trial had more than 50x the number of patients as cohort 1 of the primary trial.
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Contradiction
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00887575', 'Intervention': ['INTERVENTION 1: ', ' Phase II- Sunitinib/Paclitaxel/Carboplatin', ' Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, age 18 years', ' Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast', ' Triple-negative tumors are defined as:', ' For HER2-negative:', ' Fluorescence in situ hybridization (FISH)-negative (defined by ratio <2.2) OR', ' Immunohistochemical (IHC) 0, IHC 1+, OR', ' IHC 2+ or IHC 3+ and FISH-negative (defined by ratio <2.2)', ' For ER- and PR-negative: <10% tumor staining by immunohistochemistry (IHC)', ' Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). T1N0M0 lesions are excluded. Patients with metastatic disease are excluded.', ' Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. Patients with lesions measurable only by imaging will require repeat imaging after 3 cycles and prior to surgery', ' Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2', ' Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)', ' Resolution of all acute effects of surgical procedures to grade 1.', ' For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound is required', ' Adequate hematologic function with:', ' Absolute neutrophil count (ANC) >1500/μL', ' Platelets 100,000/μL', ' Hemoglobin 10 g/dL', ' Adequate hepatic and renal function with:', ' Serum bilirubin the institutional upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x institutional ULN', ' Alkaline phosphatase 2.5 x institutional ULN', ' Serum creatinine 1.5 x ULN or calculated creatinine clearance 40 mL/min', ' Left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA) or echocardiogram (ECHO)', ' Bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria', ' Knowledge of the investigational nature of the study and ability to provide consent for study participation', ' Ability and willingness to comply with study visits, treatment, testing, and other study procedures', 'Exclusion Criteria:', ' Previous treatment for this breast cancer', ' Previous treatment with paclitaxel or carboplatin', ' Previous treatment with sunitinib or other angiogenic inhibitors (including, but not limited to bevacizumab, sorafenib, thalidomide)', ' Any of the following within the 12 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, or pulmonary embolus', ' Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy)', ' Ongoing cardiac dysrhythmias grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec', ' Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of starting study treatment. An interval of at least 1week is required following minor surgical procedures, with the exception of placement of a vascular access device', ' Grade 3 hemorrhage within 4 weeks of starting study treatment', ' Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication', ' Known human immunodeficiency virus (HIV) infection or other serious infection', ' Concomitant treatment with drugs having proarrhythmic potential including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide', " Concurrent use of the potent CYP3A4 inhibitors ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole and CYP3A4 inducers rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, and dexamethasone. Use of dexamethasone for study premedication is allowed. Grapefruit and grapefruit juice is prohibited. Alternative therapies should be used when available. If use of a potent CYP3A4 inhibitor or inducer is necessary, this must be approved by the Study Chair", ' Known or suspected hypersensitivity to drugs containing Cremophor®EL (polyoxyethylated castor oil) such as cyclosporine or teniposide', ' Pregnancy or breast-feeding. Negative serum pregnancy test is required within 7 days prior to first study treatment (Day 1, Cycle ) for all women of childbearing potential. Patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for three months after the last dose of study treatment. Patients must agree to not breast-feed while receiving study treatment', ' Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment', ' History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease', ' Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study', ' Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible, but will have maintenance sunitinib interrupted while receiving radiation', ' Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study'], 'Results': ['Outcome Measurement: ', ' Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin', ' Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.', ' Time frame: at weeks 26-30', 'Results 1: ', ' Arm/Group Title: Phase II- Sunitinib/Paclitaxel/Carboplatin', ' Arm/Group Description: Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/41 (7.32%)', ' ANEMIA 1/41 (2.44%)', ' FEBRILE NEUTROPENIA 1/41 (2.44%)', ' LEUKOPENIA 1/41 (2.44%)', ' NEUTROPENIA 2/41 (4.88%)', ' THROMBOCYTOPENIA 2/41 (4.88%)', ' DIARRHEA 1/41 (2.44%)', ' DYSPEPSIA 1/41 (2.44%)', ' FLATULENCE 1/41 (2.44%)', ' MUCOSITIS 1/41 (2.44%)', ' NAUSEA 2/41 (4.88%)', ' VOMITING 2/41 (4.88%)', ' EDEMA 1/41 (2.44%)', ' FATIGUE 2/41 (4.88%)', ' PHARYNGITIS 1/41 (2.44%)']}
|
{'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%)']}
|
a81e4dbe-e9cf-4f2b-b2f7-b1bf6d630c42
|
Comparison
|
Adverse Events
|
NCT01269346
|
NCT01597193
|
Cohort 1 of the primary trial and Cohort 1 of the secondary trial have the same total number of adverse events.
|
Contradiction
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT01269346', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate in Combination With Trastuzumab', ' Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.', ' Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.'], 'Eligibility': ['Key Inclusion criteria:', ' Age 18 years or older', ' Histologically or cytologically proven adenocarcinoma of the breast', ' Subjects who have locally recurrent or metastatic disease with at least one measurable lesion', ' HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2', ' At least 12 months since prior neoadjuvant or adjuvant chemotherapy', ' At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions', ' Adequate renal function', ' Adequate bone marrow function', ' Adequate liver function', ' Adequate cardiac function', ' Key Exclusion criteria:', ' Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.', ' Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer', ' Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin', ' Inflammatory breast cancer', ' Prior history of hypertensive crisis or hypertensive encephalopathy', ' Clinically significant cardiovascular impairment', ' Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.', ' Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen', ' History of bleeding diasthesis', ' Currently pregnant or breast-feeding.', ' Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', " The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.", ' Time frame: Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate in Combination With Trastuzumab', ' Arm/Group Description: Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.', ' Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 71.2 (56.92 to 82.87)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/52 (28.85%)', ' Anaemia * 1/52 (1.92%)', ' Febrile neutropenia 24/52 (7.69%)', ' Neutropenia 28/52 (15.38%)', ' Cardiac failure chronic 21/52 (1.92%)', ' Vomiting 23/52 (5.77%)', ' Diarrhoea 21/52 (1.92%)', ' Gastric ulcer 21/52 (1.92%)', ' Gastritis 21/52 (1.92%)', ' Nausea 21/52 (1.92%)', ' Fatigue 21/52 (1.92%)', ' Pyrexia 21/52 (1.92%)', ' Gastroenteritis 21/52 (1.92%)']}
|
{'Clinical Trial ID': 'NCT01597193', 'Intervention': ['INTERVENTION 1: ', ' Dose Escalation: Enzalutamide 80 mg', ' Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'INTERVENTION 2: ', ' Dose Escalation: Enzalutamide 160 mg', ' Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed breast cancer with accompanying pathology report;', ' Submit unstained representative tumor specimen, either as a paraffin block (preferred) or 10 unstained slides', ' Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);', ' Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;', ' Estimated life expectancy of at least 3 months', 'Exclusion Criteria:', ' Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;', ' Pregnant or lactating;', ' Known or suspected brain metastasis or leptomeningeal disease;', ' History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;', ' For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.'], 'Results': ['Outcome Measurement: ', ' Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)', ' DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug.', ' Time frame: Baseline up to Day 35', 'Results 1: ', ' Arm/Group Title: Dose Escalation: Enzalutamide 80 mg', ' Arm/Group Description: Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16.7', 'Results 2: ', ' Arm/Group Title: Dose Escalation: Enzalutamide 160 mg', ' Arm/Group Description: Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/7 (28.57%)', ' Anaemia * 0/7 (0.00%)', ' Iron Deficiency Anaemia * 0/7 (0.00%)', ' Pericardial Effusion * 0/7 (0.00%)', ' Adrenal Insufficiency * 1/7 (14.29%)', ' Abdominal Pain * 0/7 (0.00%)', ' Gastritis Erosive * 0/7 (0.00%)', ' Urosepsis * 0/7 (0.00%)', ' Pneumonia * 0/7 (0.00%)', ' Urinary Tract Infection * 0/7 (0.00%)', ' Enterocolitis infectious * 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 1/8 (12.50%)', ' Anaemia * 1/8 (12.50%)', ' Iron Deficiency Anaemia * 0/8 (0.00%)', ' Pericardial Effusion * 0/8 (0.00%)', ' Adrenal Insufficiency * 0/8 (0.00%)', ' Abdominal Pain * 0/8 (0.00%)', ' Gastritis Erosive * 0/8 (0.00%)', ' Urosepsis * 0/8 (0.00%)', ' Pneumonia * 0/8 (0.00%)', ' Urinary Tract Infection * 0/8 (0.00%)', ' Enterocolitis infectious * 0/8 (0.00%)']}
|
36957dd8-fe28-4b70-b651-8f6ea7d1d0e9
|
Single
|
Adverse Events
|
NCT01111825
|
There were no observed cases of Constipation, Diarrhoea, Nausea or Febrile neutropenia within patient cohorts 1 and 2 of the primary trial.
|
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,
28,
29
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1aee22c7-96f2-4ea6-909a-48741f87ba07
|
|
Single
|
Intervention
|
NCT00513695
|
paclitaxel is the only drug in the primary trial given by IV.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00513695', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Neoadjuvant Chemotherapy Before Surgery)', ' Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.', ' sunitinib malate: Given PO', ' paclitaxel: Given IV', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given PO', ' filgrastim: Given SC', ' therapeutic conventional surgery: Undergo surgery', ' laboratory biomarker analysis: Correlative studies', ' flow cytometry: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Be informed of the investigational nature of the study and all pertinent aspects of the trial and must sign and give written consent in accordance with institutional and federal guidelines', " Have a histologically-confirmed diagnosis of breast cancer that is locally advanced or inflammatory; inflammatory breast cancer is defined as erythema and peau d'orange involving half or more of the breast with a histologic diagnosis of breast cancer; the finding of focal dermal lymphatic involvement on histology does not constitute inflammatory breast cancer", ' Have selected stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0 or T0-2, N2, M0) disease judged primarily unresectable by an experienced breast surgeon or otherwise deemed appropriate candidates for neoadjuvant treatment or stage IIIB (T4, any N, M0) or stage IIIC (any T, N3, M0) disease', ' Patients must have a performance status of 0-2 by Zubrod criteria', ' Absolute neutrophil count (ANC) >= 1,500 cells/mm^3', ' Platelet count >= 100,000 cells/mm^3', ' Serum creatinine =< 1.5 x institutional upper limit of normal (IULN)', ' Bilirubin =< 2.0', ' Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT)/alkaline phosphatase =< 2.0 x IULN', ' Have a multi gated acquisition scan (MUGA) or echocardiogram scan performed within 3 months prior to enrollment and have a left ventricular ejection fraction (LVEF) % greater than the institutional lower limit of normal', ' Be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures', 'Exclusion Criteria:', ' Have evidence of distant metastases', ' Have tumors that overexpress human epidermal growth factor receptor 2 (HER2)/neu as evidenced by 3+ staining by immunohistochemistry or gene amplification by fluorescent in situ hybridization (FISH)', ' Have received any prior chemotherapy or hormonal therapy for breast cancer', ' Have received prior radiation therapy or prior definitive surgery for breast cancer', ' Have a clinical diagnosis of congestive heart failure or angina pectoris or any of the following within the 6 months prior to study drug administration:, myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or pulmonary embolism', ' Have ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 grade >= 2', ' Have uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)', ' Have pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication', ' Have a known, active infection', ' Have any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, any in situ cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission or any other cancer from which the patient has been disease-free for 5 years', ' Human immunodeficiency virus (HIV) positive', ' Are receiving or planning to receive any concurrent anticancer therapy while receiving protocol treatment', ' Are receiving or planning to receive concurrent treatment on another clinical trial (supportive care trials or non-treatment trials, e.g. quality of life (QOL) are allowed; participation in the companion imaging trial, dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) and fludeoxyglucose F 18 positron emission tomography (FDG PET) with Kinetic Analysis to Monitor Breast Cancer Response to Neoadjuvant Sunitinib and Metronomic Chemotherapy is also allowed)', ' Be pregnant or breast feeding; female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; all female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate', ' Have other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study'], 'Results': ['Outcome Measurement: ', ' Microscopic Pathologic CR (pCR) Rate', ' Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.', ' Time frame: At the time of surgery', 'Results 1: ', ' Arm/Group Title: Treatment (Neoadjuvant Chemotherapy Before Surgery)', ' Arm/Group Description: Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.', ' sunitinib malate: Given PO', ' paclitaxel: Given IV', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given PO', ' filgrastim: Given SC', ' therapeutic conventional surgery: Undergo surgery', ' laboratory biomarker analysis: Correlative studies', ' flow cytometry: Correlative studies', ' Overall Number of Participants Analyzed: 63', ' Measure Type: Number', ' Unit of Measure: percent of evaluable participants 27 (18 to 39)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 47/68 (69.12%)', ' Neutropenia (ANC)47/68 (69.12%)', ' Leucopenia23/68 (33.82%)', ' Anemia15/68 (22.06%)', ' Diarrhea3/68 (4.41%)', ' Nausea1/68 (1.47%)', ' Fatigue3/68 (4.41%)', ' Pain2/68 (2.94%)', ' ALT elevation4/68 (5.88%)', ' Sensory Neuropathy3/68 (4.41%)', ' Mucositis7/68 (10.29%)', 'Rash1/68 (1.47%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d677707e-9ca9-4801-8fcd-7960a9f4f30a
|
|
Comparison
|
Intervention
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NCT03252145
|
NCT00904033
|
None of the subjects in the primary trial are required to injest any pills, whereas both cohorts of the secondary trial must take a weekly tablet.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6
] |
{'Clinical Trial ID': 'NCT03252145', 'Intervention': ['INTERVENTION 1: ', ' Manual Lymph Drainage', ' Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.', 'INTERVENTION 2: ', ' Negative Pressure', ' PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.'], 'Eligibility': ['INCLUSION CRITERIA:', ' To be included women must be:', ' Be over 18 years of age;', ' Have had cancer treatment that included a surgical procedure, radiation therapy (RT), and/or chemotherapy (CTX);', ' Have completed active cancer treatment at least 1 year prior to study enrollment;', ' Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment;', ' Have arm lymphedema on one side only;', ' Have confirmed LE based on bioimpedance measurements with an L-Dex® score of >7.1 (note - this is very mild lymphedema);', ' Have stable arm LE. LE will be considered "stable" if during the 3 months prior to study enrollment there was no arm infection requiring antibiotics, no change in ability to perform activities of daily living related to LE, and no subjective report of significant persistent changes in limb volume;', ' Be mentally and physically able to participate in the study;', ' Be able to attend the sessions at the University of California, San Francisco (UCSF) Parnassus campus;', ' Read and understand English;', ' Be able to understand a written informed consent document and the willingness to sign it', ' EXCLUSION CRITERIA', ' Women cannot have:', ' Bilateral upper extremity LE;', ' Current infection or lymphangitis involving the affected arm;', ' Current recurrence of their breast cancer (BC) (local or distant)', ' Pre-existing LE prior to their BC diagnosis;', ' A condition that precludes measurement of LE using Bioimpedance Spectroscopy (BIS), including pregnancy;', ' Current venous thrombosis in either upper extremity or be on current anticoagulant therapy;', ' Extremity edema due to heart failure'], 'Results': ['Outcome Measurement: ', ' Recruitment Rates', ' The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.', ' Time frame: At 4 weeks', 'Results 1: ', ' Arm/Group Title: Manual Lymph Drainage', ' Arm/Group Description: Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: rate of recruitment 32.5', 'Results 2: ', ' Arm/Group Title: Negative Pressure', ' Arm/Group Description: PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb', ' PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: rate of recruitment 37.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00904033', 'Intervention': ['INTERVENTION 1: ', ' No Exercise', ' Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week', 'INTERVENTION 2: ', ' Exercise', ' Exercise Arm: Exercise consisting of progressive walking and resistance band training', ' Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise'], 'Eligibility': ['Inclusion Criteria:', ' Must be female.', ' Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.', ' Must provide informed consent.', ' Must be willing to discontinue use of calcium and/or vitamin D supplements.', ' Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.', ' Must have a functional capacity rating of 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.', " Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 12-week supplementation of calcitriol 45 μg. Participants assigned to either of the calcitriol treatment arms will be instructed to stop taking calcium and/or vitamin D supplements.", ' Must be less than five years from the diagnosis of breast cancer and have received chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation therapy, if received, must have been completed prior to study enrollment. Hormonal therapy may be ongoing.', 'Exclusion Criteria:', ' Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.', ' Patients who had a myocardial infarction within the past year.', " Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.", ' Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.', ' Patients with hypercalcemia (corrected serum Ca > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.', ' Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.', ' Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.', ' Patients with a known sensitivity to calcitriol.', ' Women who are pregnant or lactating.', ' Previously verified diagnosed of osteoporosis.', ' Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.', ' Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.', ' Women currently using oral contraception.', ' Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).', ' Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.'], 'Results': ['Outcome Measurement: ', ' Bone Resorption (Exercise)', ' Bone Resorption using Serum NTx (Exercise comparison)', ' Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE).', ' Time frame: Week 12', 'Results 1: ', ' Arm/Group Title: No Exercise', ' Arm/Group Description: Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week', ' Overall Number of Participants Analyzed: 20', ' Least Squares Mean (Standard Error)', ' Unit of Measure: nm BCE 13.8 (1.656)', 'Results 2: ', ' Arm/Group Title: Exercise', ' Arm/Group Description: Exercise Arm: Exercise consisting of progressive walking and resistance band training', ' Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise', ' Overall Number of Participants Analyzed: 19', ' Least Squares Mean (Standard Error)', ' Unit of Measure: nm BCE 14.7 (1.033)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}
|
5335a9c9-bae1-42e9-9428-eb0eded62d7f
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Single
|
Results
|
NCT01307891
|
Abraxane + Tigatuzumab group of the primary trial has 10% more patients with either Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions than the Abraxane Alone group.
|
Entailment
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[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01307891', 'Intervention': ['INTERVENTION 1: ', ' Abraxane + Tigatuzumab', ' Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', 'INTERVENTION 2: ', ' Abraxane Alone', ' Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have pathologically documented Stage IV breast cancer. If blocks (paraffin-embedded tissue) from original diagnosis are available, they will be obtained to confirm the diagnosis and for correlative studies. Fifteen slides can be obtained from the block if the block is not available to be sent or released.', ' Tumor must be HER-2-neu negative (defined as 0 or 1+ staining by immunohistochemistry or gene amplification ratio less than or equal to 2.0, by fluorescent in situ hybridization - FISH), estrogen and progesterone receptors negative (<10%).', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)', ' Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions (chest wall, breast, skin, subcutaneous, superficial lymph nodes, bones and liver metastases) must agree to biopsy.', ' Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines.', ' If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons and excess tissue that would otherwise have been discarded is then used for research purposes. If a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol.', ' Patients with reasonably accessible lesions as described above, who will not agree with the biopsy, will not be enrolled in the trial.', ' Patients with NO reasonably accessible lesions as described above can be enrolled in the trial.', ' Prior Therapy:', ' There is no restriction as to the number of prior regimens for metastatic disease as long as patients have adequate performance status. Patients with no prior chemotherapy for metastatic disease and patients who have received prior therapy with taxanes for metastatic disease (taxol or taxotere) are eligible. Stratification will be used for randomization of these two categories (no prior chemotherapy for metastatic disease or prior taxane therapy for metastatic disease).', ' Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry.', ' Patients must have completed radiation therapy at least 7 days prior to beginning protocol treatment.', ' Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, and may not have any pre- existing treatment-related toxicities in excess of grade 1. Patients must have < grade 2 pre-existing peripheral neuropathy.', ' Patients may receive bisphosphonates; however, if used, bone lesions may not be used for progression or response.', ' At least 18 years of age (19 in Alabama).', ' Life expectancy of greater than 12 weeks.', ' ECOG performance status < or equal to 2.', ' Patients must have normal organ and marrow function as defined below:', ' Absolute neutrophil count: > or equal to 1,500/mcL,', ' Hemoglobin: > or equal to 9 mg/dL,', ' Platelets: > or equal to 100,000/mcL,', ' Total bilirubin: < or equal to 1.5 X institutional upper limit of normal,', ' AST(SGOT)/ALT(SGPT): < or equal to 2.5 X institutional upper limit of normal without liver metastases, OR < or equal to 5 X institutional upper limit of normal if documented liver metastases,', ' Creatinine: < or equal to 2.0 mg/dL, OR calculated creatinine clearance greater than or equal to 50 mL/min (calculated by the Cockcroft and Gault method).', ' Ability to understand and the willingness to sign a written informed consent document.', ' Both men and women are eligible.', ' Use of an effective means of contraception in subjects of child-bearing potential.', ' Negative serum or urine beta-HCG pregnancy test at screening for patients with childbearing potential.', 'Exclusion Criteria:', ' Patients may not be receiving any other investigational agents.', ' Prior use of Abraxane for metastatic disease or in the adjuvant setting.', ' Metastatic lesions identifiable only by PET.', ' Patients may not be receiving concurrent chemotherapy for treatment of metastatic disease.', ' Active brain metastases: evidence of progression < or equal to 3 months after local therapy (patients should be asymptomatic and off corticosteroids and anticonvulsants for at least 3 months prior to study entry).', ' Patients with brain metastases must have at least one site of measurable disease outside of the central nervous system.', ' Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, history of recent myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant or lactating women are excluded. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study.', ' A prior invasive malignant disease within five years except for skin cancer (squamous cell or basal cell carcinoma).', ' Patients with known history of HIV or Hepatitis B because of potential for added toxicity from treatment regimen.', ' Dementia or altered mental status that would prohibit the understanding of informed consent.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Abraxane + Tigatuzumab', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (14.9 to 45.0)', 'Results 2: ', ' Arm/Group Title: Abraxane Alone', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of patients 38 (18 to 61.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/39 (7.69%)', ' Neutropenia 1/39 (2.56%)', ' Bilateral Pulmonary Thromboembolism 0/39 (0.00%)', ' Fever 1/39 (2.56%)', ' Empyema associated with a permanent thoracic catheter 1/39 (2.56%)', 'Adverse Events 2:', ' Total: 3/21 (14.29%)', ' Neutropenia 1/21 (4.76%)', ' Bilateral Pulmonary Thromboembolism 1/21 (4.76%)', ' Fever 1/21 (4.76%)', ' Empyema associated with a permanent thoracic catheter 0/21 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e6c0f7af-b549-4aad-8f3c-15f367a04a50
|
|
Single
|
Adverse Events
|
NCT00929240
|
There are no cases of Febrile bone marrow aplasia in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
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22,
23
] |
[] |
{'Clinical Trial ID': 'NCT00929240', 'Intervention': ['INTERVENTION 1: ', ' Maintenance Phase: Bevacizumab', " During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.", 'INTERVENTION 2: ', ' Maintenance Phase: Bevacizumab + Capecitabine', " During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first."], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' HER2-negative metastatic breast cancer', ' candidates for taxane-based chemotherapy;', ' ECOG performance status of 0 or 1.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic breast cancer;', ' prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;', ' prior radiotherapy for treatment of metastatic disease;', ' chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)', ' Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.', ' Time frame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years', 'Results 1: ', ' Arm/Group Title: Maintenance Phase: Bevacizumab', " Arm/Group Description: During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.", ' Overall Number of Participants Analyzed: 94', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.3', 'Results 2: ', ' Arm/Group Title: Maintenance Phase: Bevacizumab + Capecitabine', " Arm/Group Description: During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.", ' Overall Number of Participants Analyzed: 91', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 78/284 (27.46%)', ' Febrile neutropenia * 28/284 (9.86%)', ' Neutropenia * 217/284 (5.99%)', ' Leukopenia * 23/284 (1.06%)', ' Anaemia * 22/284 (0.70%)', ' Thrombocytopenia * 20/284 (0.00%)', ' Myocardial infarction * 20/284 (0.00%)', ' Arrhythmia * 21/284 (0.35%)', ' Atrial fibrillation * 1/284 (0.35%)', ' Coronary artery disease * 20/284 (0.00%)', ' Left ventricular dysfunction * 21/284 (0.35%)', 'Adverse Events 2:', ' Total: 7/92 (7.61%)', ' Febrile neutropenia * 0/92 (0.00%)', ' Neutropenia * 20/92 (0.00%)', ' Leukopenia * 20/92 (0.00%)', ' Anaemia * 20/92 (0.00%)', ' Thrombocytopenia * 20/92 (0.00%)', ' Myocardial infarction * 20/92 (0.00%)', ' Arrhythmia * 20/92 (0.00%)', ' Atrial fibrillation * 0/92 (0.00%)', ' Coronary artery disease * 20/92 (0.00%)', ' Left ventricular dysfunction * 20/92 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1fc3aeac-3bc0-4a47-8222-ea267a822804
|
|
Single
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Intervention
|
NCT00320411
|
the primary trial participants must take 6 tablets of Lapatinib Monotherapy (1500g) PO once daily.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00320411', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib Monotherapy', ' Lapatinib: 1500 mg (six 250 mg tablets) orally once daily'], 'Eligibility': ['Inclusion Criteria:', ' A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:', ' Life expectancy of 16 weeks from the start of lapatinib therapy;', ' Signed informed consent obtained from the patient;', ' Subjects must have histologically confirmed breast cancer with advanced (Stage IIIb, IIIc with T4 lesion) or metastatic disease (including recurrent patients);', ' Subjects must meet the following criteria regarding prior therapy:', ' Anthracyclines, taxanes:', ' If anthracycline- and taxane-containing regimens are administered sequentially;', ' Subjects should have been provided with at least 2 cycles each and at least 4 cycles in total.', ' If anthracycline- and taxane-containing regimen are administered concurrently;', ' Subjects should have been provided with at least 4 cycles in total. or', ' Subjects should have been provided with at least 2 cycles in total and provided progressive disease occurred.', ' If anthracycline- and taxane-containing regimen are administered separately;', ' Subjects should have been provided with at least 4 cycles each. or', ' Subjects should have been provided with at least 2 cycles each and provided progressive disease occurred each regimen.', ' Trastuzumab:', ' Prior treatment must contain trastuzumab alone or in combination with other chemotherapy for at least 6 weeks of standard doses.', ' Subjects must meet the following criteria regarding ErbB2 expression (defined by the following status before undergoing trastuzumab therapy.)', ' Patients with ErbB2 overexpression:', ' 3+ by IHC, or FISH+', ' 2+ by IHC and FISH+ are also eligible. However, patients with "2+ by IHC" who have previously been treated with trastuzumab should undergo FISH before study entry, if they have not had this test performed before, and are considered eligible only if their tumours are categorised as FISH+.', ' Documentation of tumor progression or relapse after the most recent treatment is required.', ' Archived tumor tissue must be available to compare tumor response with intra-tumoral expression levels of biomarkers (ErbB1 and ErbB2).', ' Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors); (See "6.3. Efficacy")', ' A female, 20 and 74 years (at the time of giving consent), is eligible to enter and participate in this study if she is of:', ' Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are post-menopausal, i.e., at least 1 year has past since the last menstrual period); or is', ' The subject has a negative serum pregnancy test at screening, and agrees to one of the following from 2 weeks prior to administration of the first dose of lapatinib until 28 days after the final dose of lapatinib＊.', ' Complete abstinence from intercourse:', ' Consistent and correct use of one of the following acceptable methods of birth control:', ' Injectable progestogen;', ' Any intrauterine device (IUD);', ' Oral contraceptives (either combined or Progestogen only);', ' Barrier methods including diaphragm or condom with a spermicide.', ' At least 3 weeks since the last dose of prior last chemotherapy, immunotherapy, biologic therapy, hormonal therapy, or radiotherapy (except for local radiation therapy to pain relief) for cancer or since the date of completion of surgery (except for minor surgical procedures) before beginning treatment with lapatinib, except for trastuzumab which must be discontinued at least 2 weeks prior to beginning of study drug. Subjects must have recovered or stabilized sufficiently from side effects associated with prior therapy;', ' Prior to enrollment, radiation therapy is allowed to a limited field (e.g. painful bone mets, painful lumps), if it is not the sole site of measurable and/or assessable disease. Patients must have completed treatment and adequately recovered, in particular from bone marrow suppression.', ' Subjects who are not on bisphosphonate therapy. Bisphosphonates initiated prior to study medication are allowed; however, initiation of bisphosphonate following the first dose of study medication is not allowed. Prophylactic use of bisphosphonates is only permitted for treatment of osteoporosis.', ' Subjects with stable CNS metastasis (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are also eligible;', ' ECOG Performance Status of 0 to 2;', ' Able to swallow and retain oral medication;', " Left ventricular ejection fraction (LVEF), measured by echocardiogram (ECHO), above the institutional's lower limit of normal (LVEF of 50% in such case as normal range of LVEF is not provided by institution).", ' Subjects must have adequate organ function as defined below:', ' Myelofunction:', ' Neutrophil count 1500 /mm3 Hemoglobin 9 g/dL (at least 2 weeks after blood transfusion if needed) Platelet count 100,000 /mm3', ' Hepatic function:', ' Albumin 2.5 g/dL Total bilirubin 1.5xULN AST, ALT: 3xULN (without liver metastases), 5xULN (if documented liver metastases)', ' Renal function:', ' Serum creatinine 1.5 mg/dL, or creatinine clearance 40 mL/min (calculated by the Cockcroft and Gault Method)', ' Subjects who can visit the hospital once weekly (±3 days) at least in the first month after the start of lapatinib therapy and then every 4 weeks (±1 week) until the last assessment.', 'Exclusion Criteria:', ' A subject will not be eligible for inclusion in this study if any of the following criteria apply:', ' Pregnant or lactating females;', ' Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;', ' History of other malignancy. Subjects who have been disease free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;', " Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety * [* Grade 3 (according to NCI-CTCAE Version 3.0), as a general rule];", ' Active or uncontrolled infection;', ' Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;', ' Known history of or clinical evidence of leptomeningeal carcinomatosis;', ' Participated in a clinical study within the past 28 days of the first dose of lapatinib;', ' Prior therapy with an ErbB1inhibitor (e.g., gefinitib) and/or ErbB2 inhibitor other than trastuzumab;', ' Has taken/received prohibited inhibitors (including foods) of CYP3A4 within 7 days prior to the first dose of study medication or has taken/received prohibited inducers inducers (including foods) of CYP3A4 within 14 days prior to the first dose of study medication(Refer to Appendix 7).', ' The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients', ' Patients ineligible for participation in the study in the judgment of the investigator/sub investigator.'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.', ' Time frame: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.', 'Results 1: ', ' Arm/Group Title: Lapatinib Monotherapy', ' Arm/Group Description: Lapatinib: 1500 mg (six 250 mg tablets) orally once daily', ' Overall Number of Participants Analyzed: 58', ' Measure Type: Number', ' Unit of Measure: participants Complete response: 1', ' Partial response: 8', ' Stable disease: 18', ' Progressive disease: 29', 'Unknown: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/58 (24.14%)', ' Ventricular dysfunction 1/58 (1.72%)', ' Nausea 1/58 (1.72%)', ' Diarrhea 1/58 (1.72%)', ' Vomiting 1/58 (1.72%)', ' Malaise 1/58 (1.72%)', ' Disease progression 1/58 (1.72%)', ' Hepatic function abnormal 2/58 (3.45%)', ' Hepatomegaly 1/58 (1.72%)', ' Pneumonia 2/58 (3.45%)', ' Cellulitis 1/58 (1.72%)', ' Lymphocyte count decreased 1/58 (1.72%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9e664bcb-38cc-4ca6-9738-28d96248b7f2
|
|
Single
|
Adverse Events
|
NCT02924883
|
In the primary trial, all cases of Enteritis, Vertigo and Anaemia occurred in cohort 2.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
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16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
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27
] |
[] |
{'Clinical Trial ID': 'NCT02924883', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine + Placebo', ' Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)', 'INTERVENTION 2: ', ' Trastuzumab Emtansine + Atezolizumab', ' Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)'], 'Eligibility': ['Inclusion Criteria:', ' Archival tumor samples must be obtained from primary and/or metastatic sites', ' Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression', ' HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies', ' Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic BC', ' Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)', ' Progression must have occurred during or after most recent treatment for locally advanced/metastatic BC or within 6 months after completing adjuvant therapy', ' Participants must have measurable disease that is evaluable as per RECIST v1.1', ' Eastern Cooperative Oncology Group Performance Status of 0 or 1', ' Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause', ' Use of highly effective method of contraception as defined by the protocol', 'Exclusion Criteria:', ' Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents', ' Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria', ' Radiation therapy within 2 weeks prior to Cycle 1, Day 1', ' History of exposure to the cumulative doses of anthracyclines', ' History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence', ' Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites', ' Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment', ' Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus', ' Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)', ' Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization', ' Participants with known central nervous system disease', ' Leptomeningeal disease', ' History of autoimmune disease', ' Prior allogeneic stem cell or solid organ transplantation', ' Active tuberculosis', ' Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study', ' Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization', ' Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial', ' Participants who are breastfeeding, or intending to become pregnant during the study'], 'Results': ['Outcome Measurement: ', " Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)", ' PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.', ' Time frame: Baseline up to approximately 15 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine + Placebo', ' Arm/Group Description: Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)', ' Overall Number of Participants Analyzed: 69', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.8 (4.0 to 11.1)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine + Atezolizumab', ' Arm/Group Description: Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)', ' Overall Number of Participants Analyzed: 133', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.2 (5.8 to 10.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 52/133 (39.10%)', ' Thrombocytopenia 2/133 (1.50%)', ' Anaemia 1/133 (0.75%)', ' Disseminated intravascular coagulation 0/133 (0.00%)', ' Atrial thrombosis 1/133 (0.75%)', ' Cardiac failure 0/133 (0.00%)', ' Vertigo 0/133 (0.00%)', ' Vomiting 3/133 (2.26%)', ' Nausea 1/133 (0.75%)', ' Colitis 1/133 (0.75%)', ' Constipation 1/133 (0.75%)', ' Enteritis 0/133 (0.00%)', ' Abdominal pain 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 16/67 (23.88%)', ' Thrombocytopenia 0/67 (0.00%)', ' Anaemia 0/67 (0.00%)', ' Disseminated intravascular coagulation 1/67 (1.49%)', ' Atrial thrombosis 0/67 (0.00%)', ' Cardiac failure 1/67 (1.49%)', ' Vertigo 1/67 (1.49%)', ' Vomiting 0/67 (0.00%)', ' Nausea 1/67 (1.49%)', ' Colitis 0/67 (0.00%)', ' Constipation 0/67 (0.00%)', ' Enteritis 1/67 (1.49%)', ' Abdominal pain 2/67 (2.99%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1b8403ac-7eb3-41cb-8b7e-a89af3492805
|
|
Single
|
Eligibility
|
NCT03004534
|
Participants with T2 N1 M0 breast carcinoma are eligible for the primary trial.
|
Entailment
|
[
5,
6,
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT03004534', 'Intervention': ['INTERVENTION 1: ', ' Presurgical Molecular Assessment', ' Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.', ' darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.'], 'Eligibility': ['Inclusion Criteria:', ' Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.', ' Female 18 years old.', ' Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which Neoadjuvant Systemic Therapy (NAST) is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.', ' Known ER, PgR and HER2 statuses.', ' Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: patinets with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):', ' T1 with T 1.0cm, T2 or T3 by at least one radiographic or clinical measurement', ' Either clinically positive (N1 only) or clinically negative axillary nodes (N0)', ' M0', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.', ' Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:', ' Hematology: Hemoglobin 9.0 g/dl; ANC 1.5 × 109/L; Platelet count 100 × 109/L', " Liver function: ALT and AST 2.5 × ULN; Total bilirubin 1.5 × ULN (or 3 times ULN for patients with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)", ' Renal function: Creatinine 2.0 × ULN', ' No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the day of the first intake of darolutamide.', ' Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of darolutamide.', ' For WoCBP* negative serum pregnancy test within 7 days of enrollment.', ' Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.', ' Note: WoCBP are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as: Bilateral oophorectomy; Age 60; Age < 60 and amenorrheic for 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.', 'Exclusion Criteria:', ' Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.', ' Bilateral invasive BC.', ' Patient that underwent excisional biopsy of the primary tumor.', ' Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and or refusal of patient to undergo corresponding biopsy in case NAST is planned.', ' Prior or concurrent systemic anticancer therapy for BC treatment(immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).', ' Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.', ' Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).', ' Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.', ' Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.', ' Use of other investigational drug within 28 days of enrollment.', ' Major surgery* within 28 days before enrollment.', ' Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A patient with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.', ' Severe or uncontrolled concurrent disease, infection or comorbidity.', ' Known active viral hepatitis, HIV or chronic liver disease.', ' Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.', ' Any contraindication to oral agents or gastrointestinal disorder or procedure which expects to interfere significantly with absorption of protocol treatment.', " History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.", ' Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.', ' Known allergy to darolutamide or any of the excipients.', ' Pregnant or lactating darolutamide. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability.'], 'Results': ['Outcome Measurement: ', ' Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.', ' Androgen Receptor (AR) was assessed on the collected samples.', ' Time frame: 1 year, 6 months', 'Results 1: ', ' Arm/Group Title: Presurgical Molecular Assessment', ' Arm/Group Description: Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.', ' darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Androgen Receptor - Up: 7 20.6%', ' Androgen Receptor - Unchanged: 12 35.3%', ' Androgen Receptor - Down: 15 44.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ad853675-40ed-4a65-a401-d09ac3153570
|
|
Single
|
Results
|
NCT00493636
|
Cohort 1 of the primary trial had a longer median, maximum and minimum pfs than cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21
] |
[] |
{'Clinical Trial ID': 'NCT00493636', 'Intervention': ['INTERVENTION 1: ', ' A (Sorafenib + Gemcitabine or Capecitabine)', ' Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', 'INTERVENTION 2: ', ' B (Placebo + Gemcitabine or Capecitabine)', ' Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast.', ' Measurable or evaluable locally advanced or metastatic disease.', ' Age 18 years.', ' Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.', ' Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.', ' No more than one prior chemotherapy regimen for locally advanced or metastatic disease.', ' Prior hormonal therapy allowed provided it has been discontinued prior to randomization.', ' Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.', ' ECOG Performance Status of 0 or 1.', ' Adequate bone marrow, liver, and renal function', ' Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.', ' Patients must be able and willing to sign a written informed consent.', ' Patients must be able to swallow and retain oral medication.', 'Exclusion Criteria:', ' Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.', ' Patients with active brain metastases.', ' Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.', ' Prior use of gemcitabine/capecitabine or sorafenib.', ' Evidence or history of bleeding diathesis or coagulopathy.', ' Serious, non-healing wound, ulcer, or bone fracture.', " Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.", ' Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.', ' Clinically significant cardiac disease', ' Uncontrolled hypertension', ' Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.', ' Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks of randomization.', ' Any other hemorrhage/bleeding event NCI-CTCAE Grade 3 within 4 weeks of randomization.', ' Active clinically serious infection > NCI-CTCAE Grade 2.', ' Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).', ' Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years prior to randomization.', ' Known or suspected allergy to sorafenib or gemcitabine/capecitabine.', " Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.", ' Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.', ' Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.', ' Women who are pregnant or breast-feeding.', ' Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.', ' Inability to comply with protocol and/or not willing or not available for follow-up assessments.', " Any condition which in the investigator's opinion makes the patient unsuitable for the study participation."], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' [Not Specified]', ' Time frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.', 'Results 1: ', ' Arm/Group Title: A (Sorafenib + Gemcitabine or Capecitabine)', ' Arm/Group Description: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', ' Overall Number of Participants Analyzed: 81', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 103 (83 to 128)', 'Results 2: ', ' Arm/Group Title: B (Placebo + Gemcitabine or Capecitabine)', ' Arm/Group Description: Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', ' Overall Number of Participants Analyzed: 79', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 81 (48 to 95)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/79 (40.51%)', ' Febrile neutropenia * 2/79 (2.53%)', ' Neutropenia * 0/79 (0.00%)', ' Vomiting * 3/79 (3.80%)', ' Abdominal pain * 1/79 (1.27%)', ' Nausea * 2/79 (2.53%)', ' Diarrhea * 2/79 (2.53%)', ' Constipation * 0/79 (0.00%)', ' Stomatitis * 2/79 (2.53%)', ' Disease progression * 2/79 (2.53%)', ' Pyrexia * 1/79 (1.27%)', ' Fatigue * 3/79 (3.80%)', ' Mucosal inflammation * 2/79 (2.53%)', 'Adverse Events 2:', ' Total: 28/77 (36.36%)', ' Febrile neutropenia * 0/77 (0.00%)', ' Neutropenia * 2/77 (2.60%)', ' Vomiting * 2/77 (2.60%)', ' Abdominal pain * 3/77 (3.90%)', ' Nausea * 2/77 (2.60%)', ' Diarrhea * 1/77 (1.30%)', ' Constipation * 2/77 (2.60%)', ' Stomatitis * 0/77 (0.00%)', ' Disease progression * 2/77 (2.60%)', ' Pyrexia * 3/77 (3.90%)', ' Fatigue * 0/77 (0.00%)', ' Mucosal inflammation * 0/77 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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b43bee02-cc3f-4dc8-b13f-8a93de5dc422
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Single
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Results
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NCT00050011
|
the primary trial results show that Zoledronic Acid Upfront is a better treatment than Zoledronic Acid Delayed-start for increasing Lumbar Spine (L1-L4) Bone Mineral Density (BMD).
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Entailment
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{'Clinical Trial ID': 'NCT00050011', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Upfront', ' Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', 'INTERVENTION 2: ', ' Zoledronic Acid Delayed-start', ' In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Postmenopausal status defined by one of the following :', ' women equal to or greater than 55 years with cessation of menses', ' spontaneous cessation of menses within the past 1 year, but amenorrheic in women less than or equal to 55 years (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved', ' bilateral oophorectomy (prior to the diagnosis of breast cancer).', ' Adequately diagnosed and treated breast cancer defined as:', ' Patients with breast cancer whose tumor can be removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery and who receive appropriate additional local treatments such as radiotherapy according to best practice.', ' Patients must be at the end of their local treatment without evidence of local residual disease.', ' Patients must have no clinical or radiological evidence of distant metastasis.', ' Hormone receptor positive defined as:', ' ER and/or PR greater than or equal to1 0 fmol/mg cytosol protein; or greater than or equal to 10% of the tumor cells positive by', ' immunohistochemical evaluation.', ' Patients with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD are eligible.', ' Patients who will receive adjuvant chemotherapy are eligible for participation. Adjuvant chemotherapy must be completed prior to randomization.', ' The date of randomization must not be more than the following:', ' 12 weeks from completion of surgery;', ' 12 weeks after completion of adjuvant chemotherapy;', " 12 weeks after completion of surgery and radiation therapy; however the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", " 12 weeks after completion of chemotherapy and radiation therapy; however, the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", ' Patients who have undergone neoadjuvant chemotherapy are eligible.', ' No prior treatment with Femara.', 'Exclusion criteria:', ' Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization.', ' Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.', ' Patients with a history of fracture with low-intensity or no associated trauma.', ' Patients who have started adjuvant hormonal therapy or who have completed adjuvant hormonal therapy prior to randomization.', ' Patients who have received any endocrine therapy within the past 12 months (other than neoadjuvant tamoxifen or toremifene, insulin and/or oral anti-diabetic medications, and thyroid hormone replacement). Hormone replacement therapy must be discontinued prior to randomization.', ' Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months.', ' Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be discontinued within 3 weeks of baseline evaluations.', ' Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting, is acceptable).', ' Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months.', ' Patients with prior use of Tibolone within the last 6 months.', ' Any prior use of PTH for more than 1 week.', ' Prior use of systemic sodium fluoride for > 3 months during the past 2 years.', ' Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.', ' Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.', ' Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded.', ' Uncontrolled seizure disorders associated with falls.', ' Patients with abnormal renal function as evidenced by a serum creatinine equal to or greater than 3 mg/dL (265.2 mmol/L).', " History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months prior to study entry.", ' Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.', ' Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days.', ' Additional Exclusion Criteria: (for Spine DXA)', ' History of surgery at the lumbosacral spine, with or without implantable devices.', ' Scoliosis with a Cobb angle >15 degree at the lumbar spine.', ' Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan.', ' Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.', ' Additional protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)', ' Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.', ' Time frame: Baseline, 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Upfront', ' Arm/Group Description: Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 253', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD 1.955 (3.3658)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Delayed-start', ' Arm/Group Description: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 256', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD -2.325 (3.9542)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 83/300 (27.67%)', ' Anaemia 2/300 (0.67%)', ' Granulocytopenia 1/300 (0.33%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 0/300 (0.00%)', ' Acute coronary syndrome 1/300 (0.33%)', ' Acute myocardial infarction 2/300 (0.67%)', ' Angina pectoris 2/300 (0.67%)', ' Aortic valve stenosis 1/300 (0.33%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 0/300 (0.00%)', 'Adverse Events 2:', ' Total: 71/300 (23.67%)', ' Anaemia 0/300 (0.00%)', ' Granulocytopenia 0/300 (0.00%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 1/300 (0.33%)', ' Acute coronary syndrome 0/300 (0.00%)', ' Acute myocardial infarction 1/300 (0.33%)', ' Angina pectoris 1/300 (0.33%)', ' Aortic valve stenosis 0/300 (0.00%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 1/300 (0.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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62258901-8207-413d-913f-a04682635add
|
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Single
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Results
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NCT02657889
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Both the primary trial cohorts reported identical results.
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Entailment
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[
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{'Clinical Trial ID': 'NCT02657889', 'Intervention': ['INTERVENTION 1: ', ' Phase 1: Niraparib 200mg + Pembrolizumab', ' Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.', 'INTERVENTION 2: ', ' Phase 1: Niraparib 300mg + Pembrolizumab', ' Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.'], 'Eligibility': ['Main Inclusion Criteria:', ' Patient has histologically proven advanced (unresectable) or metastatic cancer as outlined below according to study phase and disease type:', ' Phase 1 patients (breast or ovarian cancer)', ' Patients with advanced or metastatic breast cancer must have disease that is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative (ie, TNBC). Patients with advanced or metastatic disease may have up to 4 lines of cytotoxic therapy. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.', " Patients must have any epithelial (ie, serous, endometroid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have received up to 5 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.", ' Phase 2 patients (breast or ovarian cancer)', ' Patients with advanced or metastatic breast cancer must have TNBC. Patients with advanced or metastatic disease may have received up to 2 lines of cytotoxic therapy. Adjuvant and/or neoadjuvant therapies are not counted in the number of lines of therapy. TNBC patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration.', " Patients must have with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have had up to 4 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant, adjuvant, and the combination of both will be considered as one line of therapy.", ' Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation', ' Measurable lesions by RECIST v1.1', ' Eastern Cooperative Oncology Group (ECOG) 0 or 1', ' Adequate organ function', ' Able to take oral medications', ' Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment', ' Male patient agrees to use an adequate method of contraception', ' Main Exclusion Criteria:', ' Patients with primary platinum refractory ovarian cancer (ie, progressive disease on or within 6 months of first-line platinum therapy)', ' Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Note: Patients previously treated for brain metastases may be able to participate provided they are stable', ' Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer', ' Poor medical risk', " Condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.", ' Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study', ' Immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment', ' Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)', ' Known active hepatitis B or hepatitis C', ' Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment', ' Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent', ' Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor', ' Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening', ' Known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)'], 'Results': ['Outcome Measurement: ', ' Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)', ' DLTs are defined as: Any treatment-related Grade 3 non-hematologic clinical (non-laboratory) AE Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if: - Medical intervention is required to treat the patient, or - The abnormality leads to hospitalization, or - The abnormality persists for 7 days. Any treatment-related hematologic toxicity specifically defined as: - Thrombocytopenia Grade 4 for 7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion; - Neutropenia Grade 4 for 7 days, or Grade 3 or 4 associated with infection or febrile neutropenia; - Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion. Any treatment-related AE leading to niraparib dose interruption per the following criteria: - A dose interruption for a non-DLT lab abnormality lasting 14 days. - A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered.', ' Time frame: During Cycle 1, ie, during the first 21 days of treatment', 'Results 1: ', ' Arm/Group Title: Phase 1: Niraparib 200mg + Pembrolizumab', ' Arm/Group Description: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase 1: Niraparib 300mg + Pembrolizumab', ' Arm/Group Description: Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/7 (85.71%)', ' Anemia * 1/7 (14.29%)', ' Febrile neutropenia * 0/7 (0.00%)', ' Leukopenia * 0/7 (0.00%)', ' Neutropenia * 1/7 (14.29%)', ' Pancytopenia * 0/7 (0.00%)', ' Thrombocytopenia * 1/7 (14.29%)', ' Cardiac failure congestive * 0/7 (0.00%)', ' Cardiac tamponade * 0/7 (0.00%)', ' Pericardial effusion * 0/7 (0.00%)', ' Tachycardia * 0/7 (0.00%)', ' Adrenal insufficiency * 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 4/7 (57.14%)', ' Anemia * 0/7 (0.00%)', ' Febrile neutropenia * 0/7 (0.00%)', ' Leukopenia * 0/7 (0.00%)', ' Neutropenia * 0/7 (0.00%)', ' Pancytopenia * 1/7 (14.29%)', ' Thrombocytopenia * 3/7 (42.86%)', ' Cardiac failure congestive * 0/7 (0.00%)', ' Cardiac tamponade * 0/7 (0.00%)', ' Pericardial effusion * 0/7 (0.00%)', ' Tachycardia * 0/7 (0.00%)', ' Adrenal insufficiency * 0/7 (0.00%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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d23aee47-e80f-42fe-b095-9cd81f9e0ed3
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Single
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Results
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NCT00524303
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The Trastuzumab arm of the primary trial had 9% better results than the Lapatinib arm.
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Entailment
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{'Clinical Trial ID': 'NCT00524303', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', 'INTERVENTION 2: ', ' Lapatinib', ' Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'], 'Eligibility': ['Inclusion Criteria:', ' Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA).', ' Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2).', ' ErbB2 overexpressing breast cancer, defined as one of the following definitions:', ' 3+ staining by immunohistochemistry (IHC),', ' a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus', ' a FISH ratio of more than 2.2.', ' Have either measurable or evaluable disease.', ' Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (Refer to Section 11.4).', ' Have LVEF within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.', ' Be deemed able to tolerate 8 cycles of preoperative chemotherapy, including 4 cycles with an anthracycline (epirubicin).', ' Must be willing to undergo 2 mandatory core biopsies (4 passes each) after diagnosis to obtain tissue for biologic expression profiling. Any subject with clinically palpable residual disease may undergo an optional third biopsy to allow identification of presumed pathways of resistance to therapy. This information might be useful in providing the subject with options for other targeted therapies if definitive surgery confirms residual disease. Definitive local therapy with surgery and radiation therapy as indicated will be performed after completion of 12 weeks of paclitaxel-based chemotherapy.', ' Are able to swallow and retain oral medication (intact pill).', ' Are able to complete all screening assessments as outlined in the protocol.', ' Have adequate organ function as defined in Table 4:', ' Table 1 Baseline Laboratory Values', ' Hematologic:', ' ANC (absolute neutrophil count) >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L', ' Hepatic:', ' albumin >2.5 g/dL serum bilirubin <1.25 x ULN AST / ALT <3 x ULN if no documented liver metastases AST / ALT <3 x ULN with documented liver metastases', ' Renal:', ' serum creatinine <2.0 mg/dL', ' OR - calculated creatinine clearance >40 mL/min', ' Are subjects aged >18 years with any menopausal status:', ' Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal)', ' Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:', " Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide.", ' Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer [Albain, 2002]. Progestogen may also affect the proliferative rate of endocrine-responsive tumors.', 'Exclusion Criteria:', ' Have received any prior chemotherapy.', ' Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.', ' Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.', ' 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 active cardiac disease, defined as one or more of the following:', ' History of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction <6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient', ' Are pregnant or breastfeeding.', ' Have received concurrent treatment with an investigational agent or participate in another clinical trial.', ' Have received concurrent treatment with prohibited medications (refer to Section 5.8.2 for details on prohibited medications).', ' Have 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 any of the agents used in this study or their excipients.', ' Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy', ' A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.', ' Time frame: Week 26', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 54.0', 'Results 2: ', ' Arm/Group Title: Lapatinib', ' Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 45.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/32 (21.88%)', ' Febrile nuetropenia 3/32 (9.38%)', ' Neutropenia 3/32 (9.38%)', ' Anaemia 1/32 (3.13%)', ' Diarrhoea 0/32 (0.00%)', ' Vomiting 0/32 (0.00%)', ' Nausea 0/32 (0.00%)', ' Stomatitis 0/32 (0.00%)', ' Pyrexia 0/32 (0.00%)', ' Chest discomfort 0/32 (0.00%)', ' Cellilitis 0/32 (0.00%)', ' Diverticulitis 0/32 (0.00%)', ' Gastroenteritis 0/32 (0.00%)', 'Adverse Events 2:', ' Total: 7/34 (20.59%)', ' Febrile nuetropenia 0/34 (0.00%)', ' Neutropenia 0/34 (0.00%)', ' Anaemia 0/34 (0.00%)', ' Diarrhoea 2/34 (5.88%)', ' Vomiting 1/34 (2.94%)', ' Nausea 0/34 (0.00%)', ' Stomatitis 0/34 (0.00%)', ' Pyrexia 3/34 (8.82%)', ' Chest discomfort 0/34 (0.00%)', ' Cellilitis 1/34 (2.94%)', ' Diverticulitis 1/34 (2.94%)', ' Gastroenteritis 0/34 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d23eb56e-c232-4754-94aa-903bc174cb35
|
|
Single
|
Eligibility
|
NCT00562718
|
Patients with breast implants are always excluded from the primary trial.
|
Contradiction
|
[
6
] |
[] |
{'Clinical Trial ID': 'NCT00562718', 'Intervention': ['INTERVENTION 1: ', ' Surgery and Chemotherapy', ' Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.', ' capecitabine', ' adjuvant therapy', 'radiation therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria:', ' T3 or T4 primary tumor', ' 4 or more involved axillary lymph nodes (N2 nodal stage)', ' Completed surgical excision', ' No immediate reconstruction with autologous flap reconstruction', " Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion", ' No residual breast cancer', ' Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified', ' Candidate for radiotherapy', ' Must not require bilateral radiotherapy', ' No metastatic (stage IV) breast cancer by AJCC staging criteria', ' Hormone receptor status not specified', ' No CNS disorders', ' PATIENT CHARACTERISTICS:', ' Life expectancy 6 months', ' Karnofsky performance status 70-100%', ' Menopausal status not specified', ' Ambulatory', ' Hemoglobin > 9 g/dL', ' Platelet count > 100,000/mm³', ' ANC > 1,500/mm³', ' Serum AST, ALT, and alkaline phosphatase 2 times upper limit of normal (ULN)', ' Total bilirubin normal', ' Creatinine clearance > 50 mL/min', ' Negative pregnancy test', ' Not pregnant or nursing', ' Fertile patients must use effective contraception during study and for 30 days after the last study drug administration', ' No serious, uncontrolled, concurrent infection(s)', ' No diabetes with current or history of delayed wound healing or skin ulcers', ' No autoimmune connective tissue disorder', ' No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency', ' No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer', ' No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months', ' No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following:', ' Uncontrolled seizures', ' Psychiatric disability judged by the investigator to be clinically significant', ' Physically intact upper gastrointestinal tract', ' No malabsorption syndrome', ' No uncompensated coagulopathy', ' No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy', ' Able to read and speak English', ' PRIOR CONCURRENT THERAPY:', ' Fully recovered from surgery and chemotherapy with completely healed surgical wounds', ' At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®)', " Concurrent trastuzumab allowed at the physician's discretion", ' More than 4 weeks since prior participation in any investigational drug study', ' At least 4 weeks since prior and no concurrent sorivudine or brivudine', ' More than 2 weeks since prior major surgery', ' No prior capecitabine', ' No prior radiotherapy to the chest or ipsilateral lymphatics', ' No concurrent hormonal therapy during course of chemotherapy or radiation therapy', ' No concurrent allopurinol or cimetidine', ' Concurrent coumadin is allowed'], 'Results': ['Outcome Measurement: ', ' Overall Safety', ' Primarily Grade 1 and 2 toxicities attributable to capecitabine', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Surgery and Chemotherapy', ' Arm/Group Description: Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.', ' capecitabine', ' adjuvant therapy', ' radiation therapy', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of participants 12.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/39 (15.38%)', ' Radiation Dermatitis 6/39 (15.38%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1c0dcd29-4a04-4b78-abbf-b047d4c29597
|
|
Single
|
Adverse Events
|
NCT01298193
|
More than 20% of patients in cohort 1 of the primary trial experienced adverse events.
|
Contradiction
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT01298193', 'Intervention': ['INTERVENTION 1: ', ' Observational Phase (First Cycle):', ' Observational phase (first cycle):', ' Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 [5-HT3] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).', ' Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).'], 'Eligibility': ['Inclusion Criteria:', ' Female patient 18 years of age.', ' Patient has a histological confirmed early-stage (I to III) breast cancer.', ' Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent.', ' Patient is naive to moderate or highly emetogenic chemotherapy per "Hesketh" criteria.', ' Patient is scheduled to receive of chemotherapy with Docetaxel-Cyclophosphamide (Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2) administered every 21 days.', ' Patient has a predicted life expectancy 4 months.', ' Functional State 0-1 Eastern Cooperative Oncology Group (ECOG) Scale (see Appendix 12.2).', ' Patient has an adequate organ function including the following:', ' Bone marrow reserve: Absolute Neutrophil Count >1500/mm3 and white blood cell (WBC) count >3000/mm3; Platelet Count >100.000/mm3', ' Hepatic: aspartate aminotransferase (AST) <2.5 x upper limit of normal; alanine aminotransferase (ALT) <2.5 x upper limit of normal; Bilirubin within the normal limit.', ' Renal: Creatinine <1.5 x upper limit of normal.', ' Premenopausal female patients must demonstrate a negative serum and/or urine pregnancy test within 3 days of study drug administration, and agree to use a double-barrier form of contraception for at least 14 days prior to, throughout and for at least 14 days following the last dose of study medication. Women taking oral contraceptive agents must agree to add a barrier form of contraception. Abstinence is also considered an acceptable form of contraception. (Note: A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who has either: 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea); 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or 3) bilateral tubal ligation.)', ' Patient is able to read, understand and complete study questionnaires.', 'Exclusion Criteria:', ' Patient is scheduled to receive any chemotherapy treatment different to the Docetaxel-Cyclophosphamide chemotherapy.', ' Patient has received or will receive radiation therapy to the abdomen, chest or pelvis in the month prior to the study enter.', ' Patient has vomited in the 24 hours prior to Treatment Day 1.', ' Patient has a history of treatment with emetogenic chemotherapy of moderate or high level per "Hesketh" (classification of emetogenic chemotherapy agents).', ' Patient has an active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.', ' Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.', ' Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.', ' Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.', ' Patient has a history of hypersensitivity to aprepitant, 5-HT3 antagonists, or dexamethasone.', ' Patient is pregnant or breast feeding.', ' Patient has participated in a study with aprepitant or has taken a non approved (investigational) drug within the last 4 weeks.', ' Patient is taking systemic corticosteroid therapy at any dose; topical and inhaled corticosteroids are permitted.', ' Patient is taking, or will be taking within 28 days of Day 1 of cycle 2 (cycle in which patients will start taking aprepitant) the following CYP3A4 inducers:', ' phenytoin or carbamazepine', ' barbiturates', ' rifampicin or rifabutin', " St. John's Wort", ' Patient is taking, or will be taking within 7 days of Day 1 of cycle 2 the following CYP3A4 substrates:', ' terfenadine', ' cisapride', ' astemizole', ' pimozide', ' Patient is taking, or will be taking within the 7 days of Day 1 of cycle 2 the following CYP3A4 inhibitors:', ' clarithromycin', ' ketoconazole, itraconazole', ' Patient will be taking an antiemetic within 48 hours of Day 1 of cycle 2. Prohibited antiemetics include:', ' 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron or palonosetron)', ' phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine)', ' butyrophenones (e.g., haloperidol or droperidol)', ' benzamides (e.g., metoclopramide or alizapride)', ' domperidone', ' cannabinoids', ' herbal therapies with potential antiemetic properties', ' scopolamine', ' cyclizine', ' Patient has used benzodiazepines or opiates, except for single daily doses of triazolam, temazepam or midazolam in the 48 hours prior to Day 1 of cycle 2. Continuation of chronic benzodiazepines or opiate therapy is permitted provided it was initiated at least 48 hours before enrollment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Response (CR)', ' Complete response is defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.', ' Time frame: Up to 21 days after cycle 1 of chemotherapy treatment', 'Results 1: ', ' Arm/Group Title: Observational Phase (First Cycle):', ' Arm/Group Description: Observational phase (first cycle):', ' Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 [5-HT3] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).', ' Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).', ' Overall Number of Participants Analyzed: 185', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 161 87.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/185 (16.76%)', ' Anemic Shock [1]1/185 (0.54%)', ' Febrile Neutropenia [2]13/185 (7.03%)', ' Febrile Neutropenia 2/185 (1.08%)', ' Febrile neutropenia [3]3/185 (1.62%)', ' Neutrophil Count Decreased [2]2/185 (1.08%)', ' Neutrophil Count Decreased [3]2/185 (1.08%)', ' Neutrophil Count Decreased [4]2/185 (1.08%)', ' Colon Diverticulitis 1/185 (0.54%)', ' Vomiting [2]1/185 (0.54%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b1a17048-dfe8-4173-ae80-6ec273244848
|
|
Single
|
Results
|
NCT01808573
|
the primary trial Patients receiving Neratinib Plus Capecitabine had a PFS much longer than the study time frame of 38 months.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01808573', 'Intervention': ['INTERVENTION 1: ', ' Neratinib Plus Capecitabine', ' neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.', 'INTERVENTION 2: ', ' Lapatinib Plus Capecitabine', ' lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Aged 18 years at signing of informed consent.', ' Histologically confirmed MBC, current stage IV.', ' Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.', ' Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.', 'Exclusion Criteria:', ' Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.', ' Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.'], 'Results': ['Outcome Measurement: ', ' Centrally Assessed Progression Free Survival', ' Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.', ' Time frame: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.', 'Results 1: ', ' Arm/Group Title: Neratinib Plus Capecitabine', ' Arm/Group Description: neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.', ' Overall Number of Participants Analyzed: 307', ' Mean (95% Confidence Interval)', ' Unit of Measure: months 8.8 (7.8 to 9.8)', 'Results 2: ', ' Arm/Group Title: Lapatinib Plus Capecitabine', ' Arm/Group Description: lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.', ' Overall Number of Participants Analyzed: 314', ' Mean (95% Confidence Interval)', ' Unit of Measure: months 6.6 (5.9 to 7.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/303 (33.99%)', ' Anaemia 1/303 (0.33%)', ' Febrile neutropenia 1/303 (0.33%)', ' Neutropenia 1/303 (0.33%)', ' Acute myocardial infarction 0/303 (0.00%)', ' Atrial fibrillation 1/303 (0.33%)', ' Cardiac arrest 0/303 (0.00%)', ' Cardiac tamponade 1/303 (0.33%)', ' Cardiomyopathy 1/303 (0.33%)', ' Palpitations 2/303 (0.66%)', ' Pericardial effusion 1/303 (0.33%)', ' Tachycardia 0/303 (0.00%)', 'Adverse Events 2:', ' Total: 93/311 (29.90%)', ' Anaemia 2/311 (0.64%)', ' Febrile neutropenia 3/311 (0.96%)', ' Neutropenia 0/311 (0.00%)', ' Acute myocardial infarction 1/311 (0.32%)', ' Atrial fibrillation 0/311 (0.00%)', ' Cardiac arrest 1/311 (0.32%)', ' Cardiac tamponade 1/311 (0.32%)', ' Cardiomyopathy 0/311 (0.00%)', ' Palpitations 0/311 (0.00%)', ' Pericardial effusion 1/311 (0.32%)', ' Tachycardia 1/311 (0.32%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
33652443-0bb4-493e-adfe-f5032b96b13d
|
|
Single
|
Eligibility
|
NCT00228943
|
Clinically anxious patients are not able to participate in the primary trial.
|
Contradiction
|
[
8,
9
] |
[] |
{'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']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
74dba58a-8f5d-478b-a886-0e9758847fe3
|
|
Single
|
Results
|
NCT02131064
|
less than 60 participants in the TCH + P group of the primary trial achieved Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT02131064', 'Intervention': ['INTERVENTION 1: ', ' TCH + P', ' Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).', 'INTERVENTION 2: ', ' T-DM1 + P', ' Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cm', ' HER2-positive breast cancer', ' Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive', ' Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system', ' Known hormone receptor status of the primary tumor', ' Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Baseline Left Ventricular Ejection Fraction (LVEF) >/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)', ' Effective contraception as defined by protocol', 'Exclusion Criteria:', ' Stage IV (metastatic) breast cancer', ' Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer', ' Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer', ' Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes', ' Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy', ' History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years', ' Treatment with any investigational drug within 28 days prior to randomization', ' Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0', " Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study", ' Current pregnancy or breastfeeding'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples', ' tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.', ' Time frame: Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)', 'Results 1: ', ' Arm/Group Title: TCH + P', ' Arm/Group Description: Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).', ' Overall Number of Participants Analyzed: 221', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 56.1 (49.29 to 62.76)', 'Results 2: ', ' Arm/Group Title: T-DM1 + P', ' Arm/Group Description: Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).', ' Overall Number of Participants Analyzed: 223', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 44.4 (37.76 to 51.18)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 70/219 (31.96%)', ' Anaemia * 0/219 (0.00%)', ' Febrile neutropenia * 26/219 (11.87%)', ' Neutropenia * 7/219 (3.20%)', ' Thrombocytopenia * 1/219 (0.46%)', ' Cardiac failure * 2/219 (0.91%)', ' Sinus tachycardia * 1/219 (0.46%)', ' Left ventricular dysfunction * 2/219 (0.91%)', ' Abdominal pain * 1/219 (0.46%)', ' Abdominal pain upper * 1/219 (0.46%)', ' Colitis * 3/219 (1.37%)', 'Adverse Events 2:', ' Total: 30/223 (13.45%)', ' Anaemia * 3/223 (1.35%)', ' Febrile neutropenia * 3/223 (1.35%)', ' Neutropenia * 0/223 (0.00%)', ' Thrombocytopenia * 1/223 (0.45%)', ' Cardiac failure * 1/223 (0.45%)', ' Sinus tachycardia * 0/223 (0.00%)', ' Left ventricular dysfunction * 0/223 (0.00%)', ' Abdominal pain * 0/223 (0.00%)', ' Abdominal pain upper * 0/223 (0.00%)', ' Colitis * 0/223 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5344044c-127d-4a39-80dc-277538b5ad33
|
|
Single
|
Adverse Events
|
NCT00820872
|
Hyperglycemia was the most common adverse event in cohort 1 of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00820872', 'Intervention': ['INTERVENTION 1: ', ' Group 1', ' Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the following criteria:', ' Nonmetastatic disease', ' Operable and adequately excised', ' Patients with nonresectable deep margin invasion are eligible provided they have had or will receive radiotherapy to the region', ' Patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumor bed', ' Node-positive OR -negative and determined eligible to receive adjuvant trastuzumab (Herceptin®)', ' No positive or suspicious internal mammary nodes by SNS that have not been or will not be irradiated', ' No supraclavicular lymph node involvement (confirmed by fine needle aspiration or biopsy)', ' Over expression and/or amplification of HER2 in the invasive component of the primary tumor, according to one of the following:', ' 3+ over-expression by IHC (> 30% of invasive tumor cells)', ' 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification', ' HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)', ' Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0 HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in 30% or less neoplastic cells) by IHC not allowed', ' Hormone receptor status known (estrogen receptor with or without progesterone receptor)', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-1', ' Hemoglobin 10.0 g/dL', ' ANC 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Serum creatinine 2.0 times upper limit of normal (ULN)', ' AST and ALT 2.5 times ULN', ' Alkaline phosphatase 2.5 times ULN', ' Bilirubin 1.5 times ULN ( 2.0 times ULN if known Gilbert syndrome)', ' Baseline LVEF 50% measured by ECHO or MUGA scan', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No serious cardiac illness or medical condition including, but not limited to, any of the following:', ' History of documented congestive heart failure (any NYHA class) or systolic dysfunction (LVEF < 50%)', ' High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade atrioventricular-block [second degree or higher], or supraventricular arrhythmias that are not adequately rate-controlled)', ' Angina pectoris requiring antianginal medication', ' Clinically significant valvular heart disease', ' Evidence of transmural infarction on ECG', ' Poorly controlled hypertension (any reading of systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)', ' No other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions or illness', ' None of the following:', ' Ulcerative colitis', ' Malabsorption syndrome', ' Any disease significantly affecting gastrointestinal function', ' Inability to swallow oral medication', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior mediastinal irradiation except internal mammary-node irradiation for the present breast cancer', ' No prior anti-HER2 therapy for any reason', ' No prior biologic or immunotherapy for breast cancer', ' No prior resection of the stomach or small bowel', ' No other concurrent anticancer therapy including chemotherapeutic agents, biologic agents, or radiotherapy', ' No concurrent anticancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the study chair', ' No concurrent CYP3A4 inhibitors or inducers', ' No concurrent epoetin alfa, including darbepoetin alfa', ' No concurrent oprelvekin'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0', ' [Not Specified]', ' Time frame: Up to 10 years', 'Results 1: ', ' Arm/Group Title: Group 1', ' Arm/Group Description: Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin ) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: percentage of patients 43'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/30 (33.33%)', ' Hemoglobin decreased 2/30 (6.67%)', ' Abdominal pain 1/30 (3.33%)', ' Colitis 1/30 (3.33%)', ' Diarrhea 7/30 (23.33%)', ' Nausea 2/30 (6.67%)', ' Rectal hemorrhage 1/30 (3.33%)', ' Fatigue 1/30 (3.33%)', ' Skin infection 1/30 (3.33%)', ' Neutrophil count decreased 1/30 (3.33%)', ' Platelet count decreased 3/30 (10.00%)', ' Dehydration 1/30 (3.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ed43519d-9954-4e0f-9d42-39a3ed81e4a5
|
|
Single
|
Adverse Events
|
NCT00929240
|
There are no cases of Febrile neutropenia in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[] |
{'Clinical Trial ID': 'NCT00929240', 'Intervention': ['INTERVENTION 1: ', ' Maintenance Phase: Bevacizumab', " During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.", 'INTERVENTION 2: ', ' Maintenance Phase: Bevacizumab + Capecitabine', " During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first."], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' HER2-negative metastatic breast cancer', ' candidates for taxane-based chemotherapy;', ' ECOG performance status of 0 or 1.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic breast cancer;', ' prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;', ' prior radiotherapy for treatment of metastatic disease;', ' chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)', ' Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.', ' Time frame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years', 'Results 1: ', ' Arm/Group Title: Maintenance Phase: Bevacizumab', " Arm/Group Description: During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.", ' Overall Number of Participants Analyzed: 94', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.3', 'Results 2: ', ' Arm/Group Title: Maintenance Phase: Bevacizumab + Capecitabine', " Arm/Group Description: During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.", ' Overall Number of Participants Analyzed: 91', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 78/284 (27.46%)', ' Febrile neutropenia * 28/284 (9.86%)', ' Neutropenia * 217/284 (5.99%)', ' Leukopenia * 23/284 (1.06%)', ' Anaemia * 22/284 (0.70%)', ' Thrombocytopenia * 20/284 (0.00%)', ' Myocardial infarction * 20/284 (0.00%)', ' Arrhythmia * 21/284 (0.35%)', ' Atrial fibrillation * 1/284 (0.35%)', ' Coronary artery disease * 20/284 (0.00%)', ' Left ventricular dysfunction * 21/284 (0.35%)', 'Adverse Events 2:', ' Total: 7/92 (7.61%)', ' Febrile neutropenia * 0/92 (0.00%)', ' Neutropenia * 20/92 (0.00%)', ' Leukopenia * 20/92 (0.00%)', ' Anaemia * 20/92 (0.00%)', ' Thrombocytopenia * 20/92 (0.00%)', ' Myocardial infarction * 20/92 (0.00%)', ' Arrhythmia * 20/92 (0.00%)', ' Atrial fibrillation * 0/92 (0.00%)', ' Coronary artery disease * 20/92 (0.00%)', ' Left ventricular dysfunction * 20/92 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8d2fde27-a5e8-40ee-a35d-3d4697198a4e
|
|
Single
|
Results
|
NCT00676663
|
The the primary trial placebo group performed worse than the test group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00676663', 'Intervention': ['INTERVENTION 1: ', ' Exemestane 25 mg + Placebo', ' Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.', 'INTERVENTION 2: ', ' Exemestane 25 mg + Entinostat 5 mg', ' Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patients', ' Histologically or cytologically confirmed estrogen receptor positive (ER+) breast cancer', ' Relapsed or progressed on prior treatment with aromatase inhibitor (AI)', ' Metastatic disease must be measurable', ' Patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment', ' Patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior AI', ' Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1', ' Laboratory parameters: a)Hemoglobin 9.0 g/dL; platelets 100.0 x 10^9/L; Absolute Neutrophil Count (ANC ) 1.5 x 10^9/L without the use of hematopoietic growth factors b)Creatinine less than 2.5 times the upper limit of normal for the institution c)Aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of normal for the institution', ' Able to understand and give written informed consent and comply with study procedures', 'Exclusion Criteria:', ' Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting', ' Progressive disease after less than 3 months treatment with most recent AI for patients with metastatic disease', ' Rapidly progressive, life-threatening metastases', ' Any palliative radiotherapy to the measurable lesion', ' Previous treatment with SNDX-275 or any other histone deacetylase (HDAC) inhibitor including valproic acid', ' Allergy to benzamides or inactive components of the study drug', ' A history of allergies to any active or inactive ingredients of exemestane', ' Any concomitant medical condition that precludes adequate study treatment compliance', ' Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study', ' Patient is currently receiving treatment with valproic acid, Zolinza (vorinostat) or any other HDAC inhibitor or deoxyribonucleic acid (DNA) methyltransferase inhibitor or any systemic anticancer treatment (with the exception of Lupron)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.', ' Time frame: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)', 'Results 1: ', ' Arm/Group Title: Exemestane 25 mg + Placebo', ' Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 66', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.27 (1.81 to 3.68)', 'Results 2: ', ' Arm/Group Title: Exemestane 25 mg + Entinostat 5 mg', ' Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 64', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.28 (3.26 to 5.36)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/66 (12.12%)', ' Anemia group 1/66 (1.52%)', ' Leukopenia group 1/66 (1.52%)', ' Thrombocytopenia group 1/66 (1.52%)', ' Atrial tachycardia 0/66 (0.00%)', ' Constipation 1/66 (1.52%)', ' Enterocutaneous fistula 1/66 (1.52%)', ' Ileus 0/66 (0.00%)', ' Oesophagitis 0/66 (0.00%)', ' Pancreatic mass 1/66 (1.52%)', ' Pancreatitis acute 0/66 (0.00%)', ' Asthenia 1/66 (1.52%)', ' Pyrexia 1/66 (1.52%)', 'Adverse Events 2:', ' Total: 10/63 (15.87%)', ' Anemia group 1/63 (1.59%)', ' Leukopenia group 0/63 (0.00%)', ' Thrombocytopenia group 0/63 (0.00%)', ' Atrial tachycardia 1/63 (1.59%)', ' Constipation 0/63 (0.00%)', ' Enterocutaneous fistula 0/63 (0.00%)', ' Ileus 1/63 (1.59%)', ' Oesophagitis 1/63 (1.59%)', ' Pancreatic mass 0/63 (0.00%)', ' Pancreatitis acute 1/63 (1.59%)', ' Asthenia 0/63 (0.00%)', ' Pyrexia 0/63 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fc0da76b-e5b5-44e3-abaf-6231fff493c3
|
|
Single
|
Results
|
NCT00119262
|
cohorts 1 and 2 of the primary trial both had 3 patients that suffered from Congestive Heart Failure.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00119262', 'Intervention': ['INTERVENTION 1: ', ' Arm A (ddBAC > BT > B)', ' Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab', 'INTERVENTION 2: ', ' Arm B (ddAC > BT > B)', ' Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast with involvement of at least one axillary or internal mammary lymph node on routine histologic examination with hematoxylin and eosin staining; NOTE: patients with axillary or internal mammary node involvement only demonstrated by immunohistochemistry are not eligible', ' Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy; NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy', ' Margins of lumpectomy or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible', ' (ARM A ONLY) Interval between last surgery for breast cancer (lumpectomy, mastectomy, sentinel node biopsy, axillary dissection or re-excision of lumpectomy margins) and D1 must be > 28 days and =< 84 days', ' ECOG performance status of 0-2', ' Absolute neutrophil count >= 1000/mm^3', ' Platelet count >= 100,000/mm^3', ' Total bilirubin =< 1.5 mg/dL', ' AST =< 2 upper limit of normal', ' Serum creatinine =< 1.5 mg/dL', ' Urine protein: creatinine ratio < 1.0', ' PT INR =< 1.5', ' PTT =< 1.5 x normal', ' LVEF >= institutional limits of normal by MUGA or ECHO', " Prior to registration the investigator must specify if radiation is planned; patients who have undergone a lumpectomy must receive radiation; post-mastectomy radiation is at the investigator's discretion", ' Patients with HER2+ (3+ by IHC or FISH+) breast cancer are not eligible and should be treated with a trastuzumab-based adjuvant therapy', ' Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher TMN stage tumor meets the eligibility criteria for this trial', ' Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes (N2) at diagnosis', ' Patients must not have received prior cytotoxic chemotherapy, hormonal therapy or radiation for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed; NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly prior raloxifene use is allowed but must be discontinued at study entry', ' Patients must not have had a major surgical procedure within 4 weeks of entry; NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery', ' Patients must not have clinically significant cardiovascular disease including:', ' New York Heart Association (NYHA) grade II or greater congestive heart failure', ' Grade II or greater peripheral vascular disease', ' Uncontrolled hypertension defined as SBP > 160 or DBP > 90', ' Any prior history of cerebrovascular disease including TIA or stroke', ' Patients must not require therapeutic anticoagulation; patients with a history of deep venous thrombosis or pulmonary embolism are not eligible; NOTE: prophylactic use of anticoagulants to maintain patency of a vascular assess device is permitted', ' Patients may not require regular use of aspirin (daily for >= 10 days at doses of > 325 mg/day) or regular therapeutic doses of other nonsteroidal anti-inflammatory agents known to inhibit platelet function; additionally, patients using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal); NOTE: regular use of Cox-2 inhibitors is permitted; NOTE: low-dose aspirin is permitted', ' Patients must not have a non-healing wound or fracture; patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months are excluded', ' Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies', ' Patients who have experienced myocardial infarction or unstable angina within 12 months are excluded', ' Patients who have had experienced an arterial thrombotic event within 12 months are excluded', ' Patients must not have uncontrolled or clinical significant arrhythmia', ' Women must not be pregnant or breast-feeding due to the potential harmful effects of bevacizumab on the developing fetus; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy', ' Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception while on study and for at least 3-4 months after the last dose of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Congestive Heart Failure Rate', ' Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.', ' Time frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry', 'Results 1: ', ' Arm/Group Title: Arm A (ddBAC > BT > B)', ' Arm/Group Description: Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab', ' Overall Number of Participants Analyzed: 103', ' Measure Type: Number', ' Unit of Measure: percentage of participants 2.9 (0.6 to 8.3)', 'Results 2: ', ' Arm/Group Title: Arm B (ddAC > BT > B)', ' Arm/Group Description: Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab', ' Overall Number of Participants Analyzed: 120', ' Measure Type: Number', ' Unit of Measure: percentage of participants 2.5 (0.5 to 7.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 71/103 (68.93%)', ' Anemia 1/103 (0.97%)', ' Hemolysis 1/103 (0.97%)', ' Febrile neutropenia 4/103 (3.88%)', ' Cardiac-Ischemia 1/103 (0.97%)', ' Left ventricular diastolic dysfunction 1/103 (0.97%)', ' Left ventricular systolic dysfunction 4/103 (3.88%)', ' Diarrhea w/o prior colostomy 2/103 (1.94%)', ' Muco/stomatitis (symptom), oral cavity 3/103 (2.91%)', 'Adverse Events 2:', ' Total: 65/120 (54.17%)', ' Anemia 4/120 (3.33%)', ' Hemolysis 0/120 (0.00%)', ' Febrile neutropenia 5/120 (4.17%)', ' Cardiac-Ischemia 0/120 (0.00%)', ' Left ventricular diastolic dysfunction 2/120 (1.67%)', ' Left ventricular systolic dysfunction 4/120 (3.33%)', ' Diarrhea w/o prior colostomy 0/120 (0.00%)', ' Muco/stomatitis (symptom), oral cavity 3/120 (2.50%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1a32e1c1-31b1-40e5-bbb6-84041ef796fe
|
|
Single
|
Adverse Events
|
NCT02291913
|
One patient in the primary trial suffered from an inflammation of the esophagus.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT02291913', 'Intervention': ['INTERVENTION 1: ', ' Everolimus', ' Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.', ' Everolimus', ' Exemestane: Anti-estrogen therapy', ' Tamoxifen: Anti-estrogen therapy', ' Fulvestrant: Anti-estrogen therapy', ' Anastrozole: Anti-estrogen therapy', ' Letrozole: Anti-estrogen therapy', ' Toremifine: Anti-estrogen therapy'], 'Eligibility': ['Inclusion Criteria:', ' Histologic diagnosis of unresectable, locally recurrent or MBC.', ' ER and/or PR-positive tumors with staining by immunohistochemistry (IHC) based on the most recent biopsy.', ' Only 1 previous chemotherapy regimen for MBC. Patients progressing while receiving adjuvant endocrine therapy or progressing <12 months from completion of adjuvant endocrine therapy are eligible.', ' Progressed on anti-estrogen therapy (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy) defined as:', ' Recurrence while on, or within 12 months of end of anti-estrogen therapy for early stage breast cancer, or', ' Progression while on, or within one month of anti-estrogen therapy for locally advanced or metastatic breast cancer.', ' Note: No washout for anti-estrogen therapy required. Anti-estrogen therapy does not have to be the last treatment prior to study entry.', ' Post-menopausal or pre/peri-menopausal women on tamoxifen. LHRH agonists may be used to render ovarian suppression with postmenopausal ranges of estradiol or FSH per institutional guidelines.', ' HER2-negative breast cancer, defined as follows:', ' Fluorescent In Situ Hybridization (FISH)-negative (FISH ratio <2.0), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.0).', ' Measureable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or evaluable bone lesions, lytic or mixed, in absence of measureable disease by RECIST criteria.', ' Adequate hematologic, hepatic and renal function.', ' International normalized ratio (INR) 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy).', ' Age 18 years.', ' ECOG Performance Status score of 0-2.', ' Life expectancy of 12 weeks.', 'Exclusion Criteria:', ' Previous therapy or known intolerance/hypersensitivity with any approved or investigational mTOR inhibitor (e.g., temsirolimus, everolimus, sirolimus).', ' Patients who are 21 days after their most recent chemotherapy and have not recovered from side effects.', ' Use of an investigational drug 21 days or 5 half-lives (whichever is shorter) prior to the first dose of everolimus. For investigational drugs for which 5 half-lives is 21 days, a minimum of 10 days between termination of the investigational drug and administration of everolimus is required.', ' Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered 28 days or limited field radiation for palliation 7 days for metastatic disease prior to first dose of everolimus or has not recovered from side effects of such therapy.', ' Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 2 weeks have elapsed since treatment. Patients are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs) during the study and should not be receiving chronic corticosteroid therapy for CNS metastases.', ' Patients with known active hepatitis B (HBV) or hepatitis C (HCV) infection. Patients with risk factors for hepatitis must have HBV DNA and HCV RNA testing by PCR, and are ineligible if these tests are positive.', ' Patients receiving immunization with attenuated live vaccines within 1 week of study entry or during study period.', ' NOTE: There are additional inclusion/exclusion criteria. The study center will determine patient eligibility and respond to any questions.'], 'Results': ['Outcome Measurement: ', ' Median Progression Free Survival (PFS)', ' PFS is defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, or death on study. Participants who are alive and free from disease progression will be censored at the date of last radiologic tumor assessment. Participants who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. Participants who do not have a post-baseline tumor assessment will be censored at the date of first treatment (Day 1).', ' Time frame: up to 3 years', 'Results 1: ', ' Arm/Group Title: Everolimus', ' Arm/Group Description: Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.', ' Everolimus', ' Exemestane: Anti-estrogen therapy', ' Tamoxifen: Anti-estrogen therapy', ' Fulvestrant: Anti-estrogen therapy', ' Anastrozole: Anti-estrogen therapy', ' Letrozole: Anti-estrogen therapy', ' Toremifine: Anti-estrogen therapy', ' Overall Number of Participants Analyzed: 36', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.2 (4.1 to 10.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/48 (31.25%)', ' Anemia * 1/48 (2.08%)', ' Cardiac failure congestive * 1/48 (2.08%)', ' Constipation * 2/48 (4.17%)', ' Esophagitis * 1/48 (2.08%)', ' Gastrointestinal hemorrhage * 1/48 (2.08%)', ' Non-Cardiac chest pain * 1/48 (2.08%)', ' Pain * 1/48 (2.08%)', ' Cholecystitis * 1/48 (2.08%)', ' Diverticulitis * 1/48 (2.08%)', ' Cellulitis * 1/48 (2.08%)', ' Gastroenteritis * 1/48 (2.08%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9a31db67-e28a-4114-a308-e899f9c22813
|
|
Comparison
|
Eligibility
|
NCT00996632
|
NCT01644890
|
Emily has an Inoperable breast cancer, she is eligible for both the secondary trial and the primary trial.
|
Entailment
|
[
0,
3
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00996632', 'Intervention': ['INTERVENTION 1: ', ' Ultrasonic', ' Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)', 'INTERVENTION 2: ', ' Conventional', ' Patients were operated by a conventional diatherm knife'], 'Eligibility': ['Inclusion Criteria:', ' Operable breast cancer', 'Exclusion Criteria:', ' Inoperable breast cancer', ' BMI > 25', ' Neoadiuvant radioterapy', ' Carcinomastitis', ' Previous phlebitis of omolateral arm', 'Collagen disease'], 'Results': ['Outcome Measurement: ', ' Drainage Volume', ' volume in milliliters of axillary drainage', ' Time frame: discharge day', 'Results 1: ', ' Arm/Group Title: Ultrasonic', ' Arm/Group Description: Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)', ' Overall Number of Participants Analyzed: 38', ' Mean (Standard Deviation)', ' Unit of Measure: milliliters 182.6 (267.1)', 'Results 2: ', ' Arm/Group Title: Conventional', ' Arm/Group Description: Patients were operated by a conventional diatherm knife', ' Overall Number of Participants Analyzed: 56', ' Mean (Standard Deviation)', ' Unit of Measure: milliliters 525.2 (629.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT01644890', 'Intervention': ['INTERVENTION 1: ', ' NK105', ' received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', 'INTERVENTION 2: ', ' Paclitaxel', ' received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent of the patient signed by herself.', ' Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.', ' Aged 20 to 74 at the time of informed consent.', 'Exclusion Criteria:', ' Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.', ' Assessment period was from the day of randomisation until the first observation of lesion progression or death', ' Time frame: Baseline, every 6 weeks of study treatment period, and end of study,', 'Results 1: ', ' Arm/Group Title: NK105', ' Arm/Group Description: received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', ' Overall Number of Participants Analyzed: 211', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.4 (7.0 to 9.9)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', ' Overall Number of Participants Analyzed: 211', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.5 (6.9 to 11.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 34/214 (15.89%)', ' Leukocytosis 0/214 (0.00%)', ' Atrial fibrillation 0/214 (0.00%)', ' Cardiac failure congestive 0/214 (0.00%)', ' Pericardial effusion 1/214 (0.47%)', ' Cataract 0/214 (0.00%)', ' Macular fibrosis 0/214 (0.00%)', ' Constipation 2/214 (0.93%)', ' Diarrhoea 2/214 (0.93%)', ' Enterocolitis 0/214 (0.00%)', ' Ileus 1/214 (0.47%)', ' Nausea 3/214 (1.40%)', 'Adverse Events 2:', ' Total: 27/213 (12.68%)', ' Leukocytosis 1/213 (0.47%)', ' Atrial fibrillation 1/213 (0.47%)', ' Cardiac failure congestive 1/213 (0.47%)', ' Pericardial effusion 0/213 (0.00%)', ' Cataract 1/213 (0.47%)', ' Macular fibrosis 1/213 (0.47%)', ' Constipation 1/213 (0.47%)', ' Diarrhoea 1/213 (0.47%)', ' Enterocolitis 1/213 (0.47%)', ' Ileus 0/213 (0.00%)', ' Nausea 0/213 (0.00%)']}
|
f948a2d1-2e22-47c8-9345-0eb68569bd3f
|
Single
|
Eligibility
|
NCT00479674
|
Patients that have previously been trated with bevacizumab are not eligible for the primary trial, unless they have also received carboplatin 2 weeks prior to study entry.
|
Contradiction
|
[
22,
24
] |
[] |
{'Clinical Trial ID': 'NCT00479674', 'Intervention': ['INTERVENTION 1: ', ' Abraxane, Carboplatin, Bevacizumab', ' Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15', ' Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..', ' Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.', ' Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.'], 'Eligibility': ['Inclusion Criteria:', ' Tissue block containing tumor to confirm metastatic breast cancer is required;', ' Measurable disease according to RECIST criteria', ' "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as 10% of cells staining or Allred 2;', ' Aged 18 years or older;', ' Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy 3 months;', ' Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;', ' 2 weeks between surgery and study enrollment ( 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;', ' Laboratory tests performed within 14 days of study entry:', ' Granulocytes 1,500/µL;', ' Platelets 100,000/µL;', ' Hemoglobin 9 gm/dL;', ' Total bilirubin institutional upper limit of normal (ULN);', ' Aspartate transaminase (AST) and alanine aminotransferase (ALT) 5 times ULN;', ' Alkaline phosphatase 2.5 times ULN;', ' Estimated creatinine clearance 60 mL/min.', ' left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA)/Echocardiogram;', ' Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;', ' Cognitive and communication skills to comply with study and/or follow-up procedures;', ' No reproductive potential:', ' If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.', 'If post-menopausal: Amenorrhea for 12 months.', 'Exclusion Criteria:', ' Pregnant or breast feeding;', ' Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;', ' Known hypersensitivity to any component of any study drug;', ' Active infection;', ' Current neuropathy grade 2;', ' central nervous system (CNS) metastases as determined by head CT with contrast;', ' History of bleeding within the past 6 months or active bleeding disorder;', ' Serious non-healing wound, ulcer or bone fracture;', ' Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;', ' Inadequately controlled hypertension (defined as systolic blood pressure < 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;', ' Proteinuria (defined as urine protein: creatinine (UPC) ratio 1.0 or urine dipstick 2+.', ' Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;', ' Uncontrolled serious contraindicated medical condition or psychiatric illness.'], 'Results': ['Outcome Measurement: ', ' Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.', ' Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Abraxane, Carboplatin, Bevacizumab', ' Arm/Group Description: Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15', ' Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..', ' Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.', ' Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants Complete Response: 18 (8 to 34)', ' Partial Response: 69 (52 to 83)', ' Stable Disease: 8 (2 to 21)', ' Progressive Disease: 5 (1 to 17)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/41 (53.66%)', ' Anemia 1/41 (2.44%)', ' Dyspepsia 1/41 (2.44%)', ' Mucositis oral 1/41 (2.44%)', ' Nausea 3/41 (7.32%)', ' Vomiting 1/41 (2.44%)', ' Pain 3/41 (7.32%)', ' Allergic reaction 1/41 (2.44%)', ' Infections and infestations - Other, specify: [1]1/41 (2.44%)', ' Vascular access complication 3/41 (7.32%)', ' Alanine aminotransferase increased 1/41 (2.44%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e3265040-8316-4f62-969c-27af396ba18c
|
|
Single
|
Eligibility
|
NCT00656019
|
Candidates with hyperparathyroidism are automatically excluded from the primary trial.
|
Entailment
|
[
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT00656019', 'Intervention': ['INTERVENTION 1: ', ' Normal Vitamin D Levels', ' No additional Vitamin D administered', 'INTERVENTION 2: ', ' Low-normal Vitamin D Levels', ' 2000 IU dose of Vitamin D per day administered orally'], 'Eligibility': ['INCLUSION CRITERIA:', ' Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.', ' Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.', ' No prior therapy for breast cancer within the past 5 years.', ' 18 years of age or older.', ' Ability to understand and the willingness to sign a written informed consent document.', 'EXCLUSION CRITERIA:', ' History of parathyroid disease, hypercalcemia, or kidney stones.', ' Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.', ' History of renal failure requiring dialysis or kidney transplantation.', ' Pregnant or nursing', ' Receiving supplemental calcium > 1200 mg calcium per day during study.', ' Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.', ' Locally-advanced breast cancer', ' Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy', ' Plans for preoperative radiation therapy', ' Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.', ' Any condition potentially interfering with subjects ability to comply with taking study medication.', ' Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.', ' Current participation in another research study that would increase risk to subject, in the opinion of the investigators'], 'Results': ['Outcome Measurement: ', ' Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer', ' Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes', ' Time frame: 10 days to 4 weeks post diagnosis.', 'Results 1: ', ' Arm/Group Title: Normal Vitamin D Levels', ' Arm/Group Description: No additional Vitamin D administered', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Low-normal Vitamin D Levels', ' Arm/Group Description: 2000 IU dose of Vitamin D per day administered orally', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)', 'Adverse Events 2:', ' Total: 0/19 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6c25e195-47cd-48af-bb51-5b5c44772baa
|
|
Single
|
Results
|
NCT00171340
|
the primary trial results imply that Zoledronic Acid 4 mg Upfront causes a +ve Change in Bone Mineral Density, whereas Zoledronic Acid 4 mg Delayed causes a loss in Bone Mineral Density (within a certain patient demographic).
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00171340', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid 4 mg Upfront', ' Zolendronic 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: ', ' Zoledronic Acid 4 mg Delayed', ' Zolendronic 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 or recently postmenopausal', ' Recent surgery for breast cancer', ' Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status', ' No prior treatment with letrozole', ' Other protocol-defined inclusion criteria may apply.', 'Exclusion Criteria:', ' Metastatic disease', ' Invasive bilateral disease', ' Clinical or radiological evidence of existing fracture in spine or hip', ' Prior treatment with IV bisphosphonates in the past 12 months', ' Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)', ' Use of Tibolone within 6 months', ' Prior use of parathyroid hormone for more than 1 week', ' Previous or concomitant malignancy', ' Abnormal renal function', ' History of disease effecting bone metabolism', ' Other protocol-defined exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.', ' Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).', ' Time frame: Baseline, 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid 4 mg Upfront', ' Arm/Group Description: Zolendronic 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: 423', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage change in BMD 2.208 (3.4194)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid 4 mg Delayed', ' Arm/Group Description: Zolendronic 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: 418', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage change in BMD -3.617 (4.2151)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 133/525 (25.33%)', ' Anaemia 1/525 (0.19%)', ' Febrile neutropenia 1/525 (0.19%)', ' Acute myocardial infarction 2/525 (0.38%)', ' Angina pectoris 3/525 (0.57%)', ' Angina unstable 1/525 (0.19%)', ' Aortic valve incompetence 1/525 (0.19%)', ' Arrhythmia 0/525 (0.00%)', ' Atrial fibrillation 1/525 (0.19%)', ' Atrioventricular block complete 0/525 (0.00%)', ' Cardiac arrest 0/525 (0.00%)', 'Adverse Events 2:', ' Total: 124/535 (23.18%)', ' Anaemia 1/535 (0.19%)', ' Febrile neutropenia 0/535 (0.00%)', ' Acute myocardial infarction 0/535 (0.00%)', ' Angina pectoris 2/535 (0.37%)', ' Angina unstable 0/535 (0.00%)', ' Aortic valve incompetence 1/535 (0.19%)', ' Arrhythmia 1/535 (0.19%)', ' Atrial fibrillation 4/535 (0.75%)', ' Atrioventricular block complete 1/535 (0.19%)', ' Cardiac arrest 2/535 (0.37%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
382747d3-69df-41be-a771-4218407ce5d3
|
|
Single
|
Results
|
NCT00376688
|
Most the primary trial subjects experienced a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00376688', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Temsirolimus)', ' Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Temsirolimus: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic or recurrent breast cancer not amenable to local therapy (surgery and radiation) (histologic/cytologic confirmation of recurrence preferred, but not required)', ' Either the primary or metastatic tumor must be positive for estrogen receptor (>= 1% by immunohistochemical staining) and/or progesterone receptor (>= 1% by immunohistochemical staining) and/or human epidermal growth factor receptor (HER2neu) (3+ immunohistochemical staining or fluorescence in situ hybridization [FISH] positive)', ' Patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' There are no limitations on the number of prior therapy regimens; however, patients who have had prior exposure to rapamycin or any other mechanistic target of rapamycin (mTOR) inhibitor are excluded from the trial', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Absolute neutrophil count >= 1,500/uL', ' Platelets >= 100,000/uL', ' Total bilirubin =< institutional upper limit of normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional upper limit of normal', ' Creatinine =< 2.0 x normal institutional upper limit of normal', ' Cholesterol =< 350 mg/dL (fasting)', ' Triglycerides =< 400 mg/dL (fasting)', ' Albumin >= 3.3 mg/dL', ' Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of child-bearing potential must have a negative pregnancy test prior to treatment on study; breastfeeding should be discontinued if the mother is treated with temsirolimus', ' Ability to understand and the willingness to sign a written informed consent document', ' Tissue for correlative studies must be available and the subject must agree to use of tissue for these studies', 'Exclusion Criteria:', ' Patients must be off of hormonal agents used for the treatment of breast cancer for one week with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist', ' Patients should have recovered from the adverse effects of prior chemotherapy; in general, this will mean that the patient would have been due or overdue for the next dose of the prior regimen: three weeks should have elapsed for a regimen administered once every three weeks, etc', ' Radiotherapy should have been completed', ' Three weeks should have elapsed since prior therapy with monoclonal antibodies', ' Patients may not be receiving any other investigational agents or herbal preparations; patients may not be taking corticosteroids except in low doses as replacement for adrenal insufficiency or for short -term (less than 5 days) use for other reasons', ' Patients with known brain metastases are not permitted on study unless the metastases have been controlled by prior surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for at least 4 weeks', " Patients cannot be receiving enzyme-inducing antiepileptic drugs (enzyme-inducing antiepileptic drugs [EIAEDs]; e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels; use of agents that potently inhibit CYP3A (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited; CCI-779 can inhibit CYP2D6, and may decrease metabolism (and increase drug levels) of drugs that are substrates for CYP2D6, such as codeine; the appropriateness of use of such agents is left to physician discretion; if there is any doubt about eligibility based on concomitant medication, the study chair, Dr Fleming, should be contacted; all concomitant medications must be recorded", ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study', ' Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin) are not eligible for this trial'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)', ' Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.', ' Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;', ' Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits', ' Time frame: Up to 24 months', 'Results 1: ', ' Arm/Group Title: Treatment (Temsirolimus)', ' Arm/Group Description: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Temsirolimus: Given IV', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Number', ' Unit of Measure: percentage of participants 9.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/31 (29.03%)', ' Abdominal pain * [1]2/31 (6.45%)', ' Nausea * [2]2/31 (6.45%)', ' Vomiting * [3]2/31 (6.45%)', ' Death NOS * [4]3/31 (9.68%)', ' Platelet count decreased * [5]2/31 (6.45%)', ' Dyspnea * [6]5/31 (16.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d05ec90a-f267-44be-aaa6-3be960a0d50c
|
|
Comparison
|
Adverse Events
|
NCT02301988
|
NCT00728949
|
The only types of adverse events recorded by both the secondary trial and the primary trial is Diarrhoea and various pains .
|
Entailment
|
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18,
19,
20,
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[
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{'Clinical Trial ID': 'NCT02301988', 'Intervention': ['INTERVENTION 1: ', ' Ipatasertib + Paclitaxel', ' Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).', 'INTERVENTION 2: ', ' Placebo + Paclitaxel', ' Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).'], 'Eligibility': ['Inclusion Criteria:', ' Premenopausal or postmenopausal women', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in largest diameter (cT1-3) by MRI', ' Adequate hematologic and organ function within 14 days before the first study treatment', ' Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor', ' For female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment', 'Exclusion Criteria:', ' Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancer', ' Any prior treatment for the current primary invasive breast cancer', ' Participants with cT4 or cN3 stage breast tumors', ' Metastatic (Stage IV) breast cancer', ' Bilateral invasive breast cancer', ' Multicentric breast cancer', ' Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants)', ' pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.', ' Time frame: Surgery visit (at approximately Weeks 14 to 19)', 'Results 1: ', ' Arm/Group Title: Ipatasertib + Paclitaxel', ' Arm/Group Description: Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants 17.1 (9.82 to 27.25)', 'Results 2: ', ' Arm/Group Title: Placebo + Paclitaxel', ' Arm/Group Description: Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).', ' Overall Number of Participants Analyzed: 75', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.3 (6.58 to 22.86)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/76 (13.16%)', ' Sickle cell anaemia with crisis 1/76 (1.32%)', ' Diarrhoea 1/76 (1.32%)', ' Pyrexia 1/76 (1.32%)', ' Chest pain 1/76 (1.32%)', ' Complication associated with device 1/76 (1.32%)', ' General physical health deterioration 0/76 (0.00%)', ' Device related infection 2/76 (2.63%)', ' Pneumonia 1/76 (1.32%)', ' Atypical pneumonia 1/76 (1.32%)', ' Dehydration 1/76 (1.32%)', 'Adverse Events 2:', ' Total: 3/75 (4.00%)', ' Sickle cell anaemia with crisis 0/75 (0.00%)', ' Diarrhoea 0/75 (0.00%)', ' Pyrexia 1/75 (1.33%)', ' Chest pain 0/75 (0.00%)', ' Complication associated with device 0/75 (0.00%)', ' General physical health deterioration 1/75 (1.33%)', ' Device related infection 0/75 (0.00%)', ' Pneumonia 1/75 (1.33%)', ' Atypical pneumonia 0/75 (0.00%)', ' Dehydration 0/75 (0.00%)']}
|
{'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%)']}
|
37301690-9b68-48de-b280-6307e632043e
|
Comparison
|
Eligibility
|
NCT00356148
|
NCT01856543
|
Women of any age can participate in the primary trial, but only adults can be eligible for the secondary trial.
|
Entailment
|
[
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%)']}
|
{'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%)']}
|
b61e798c-d38f-4c72-91bb-4d3e28b6184c
|
Comparison
|
Eligibility
|
NCT00201760
|
NCT00127933
|
Patients must have an infiltrating breast carcinoma to participate in the secondary trial or the primary trial.
|
Entailment
|
[
0,
1
] |
[
0,
3
] |
{'Clinical Trial ID': 'NCT00201760', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 Gemcitabine/Cisplatin/Trastuzumab', ' Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).', ' Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.', ' Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.', ' Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.', 'INTERVENTION 2: ', ' Arm 2 Gemcitabine / Trastuzumab', ' Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).', ' Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.', ' Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.'], 'Eligibility': ['Eligibility Criteria:', ' Must have invasive metastatic breast cancer', ' Tumor must be Her 2/neu 3+ by IHC (must be confirmed by Ohio State University pathology)or positive FISH', ' Histological confirmation of invasive breast cancer either from the original diagnosis and/or diagnosis of metastatic disease.', ' Tumor must be detectable clinically or radiographically (a positive bone scan is allowed as the only site of disease). Unidimensional measurements must be obtained whenever possible). Bone marrow only disease is not eligible for enrollment on this study.', ' No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG or ECHO. Patients must have normal LV function and LVEF(left ventricular ejection fraction)> 50% as demonstrated by either echo or muga within the proceeding 4 weeks.', ' Must have adequate renal and hepatic function documented by a serum creatinine < 1.5 x the institutional upper limit of normal (ULN), serum bilirubin <1.5 x ULN and liver enzymes (AST, ALT, or alkaline phosphatase) < 2 x ULN (< 5 x ULN if hepatic metastasis) within 21 days prior to registration.', ' Patients must have an ANC (absolute neutrophil count) > 1.5, platelets > 100,000, Hemoglobin >9.0 within 21 days of registration.', ' If patients are on bisphosphonates at the time of registration, with a stable creatinine over the preceding 2 months, then they may continue bisphosphonates during the study.', ' No more than one prior Trastuzumab/chemotherapy or Trastuzumab/biotherapy combination for metastatic disease. Additional Trastuzumab therapy may have been given in the adjuvant setting. Prior hormonal therapy is allowed for either adjuvant or metastatic disease.', ' Must be >3 weeks since administration of last chemotherapy prior to initiation of treatment on this trial. Prior trastuzumab may have been administered within one week of initiation of treatment on this trial if the last dose was 2 mg/kg. Any prior trastuzumab dosing greater than 2 mg/kg requires a 3 week washout period.', ' Patients may have received prior cisplatin or carboplatin for metastatic disease.', ' No CNS(central nervous system)metastasis disease.', ' No active infection at time of registration.', ' Pregnant or nursing women may not participate in trial.', ' Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.', ' ECOG (Eastern Cooperative Oncology Group)performance status < 2 at the time of registration.', ' Patients may participate in a non-treatment related protocol while participating in this study.', ' No other active malignancy is allowed. Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years is allowed.'], 'Results': ['Outcome Measurement: ', ' Disease Progression', ' Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Arm 1 Gemcitabine/Cisplatin/Trastuzumab', ' Arm/Group Description: Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).', ' Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.', ' Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.', ' Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 20.0%', 'Results 2: ', ' Arm/Group Title: Arm 2 Gemcitabine / Trastuzumab', ' Arm/Group Description: Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).', ' Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.', ' Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/5 (20.00%)', ' Nausea/vomiting/diarrhea 1/5 (20.00%)', ' Pneumonia 1/5 (20.00%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)', ' Nausea/vomiting/diarrhea 0/5 (0.00%)', ' Pneumonia 0/5 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00127933', 'Intervention': ['INTERVENTION 1: ', ' HER2-Neu Negative', ' Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1', ' HER2-neu negative: capecitabine + docetaxel', ' Duration: Four 3-week treatment cycles', 'INTERVENTION 2: ', ' HER2-Neu Positive', ' Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly', ' HER2-neu positive: capecitabine + docetaxel + trastuzumab', ' Duration: Four 3-week treatment cycles'], 'Eligibility': ['Inclusion Criteria:', ' women >=18 years of age;', ' newly diagnosed;', ' infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.', 'Exclusion Criteria:', ' evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;', ' previous systemic or local primary treatment.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery', ' Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.', ' Time frame: at the time of definitive surgery; after four 3-week cycles (3-4 months)', 'Results 1: ', ' Arm/Group Title: HER2-Neu Negative', ' Arm/Group Description: Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1', ' HER2-neu negative: capecitabine + docetaxel', ' Duration: Four 3-week treatment cycles', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: percentage of participants 15.8 (9.7 to 25.4)', 'Results 2: ', ' Arm/Group Title: HER2-Neu Positive', ' Arm/Group Description: Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly', ' HER2-neu positive: capecitabine + docetaxel + trastuzumab', ' Duration: Four 3-week treatment cycles', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of participants 50.0 (31.9 to 71.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/122 (12.30%)', ' febrile neutropenia 4/122 (3.28%)', ' Neutropenia 0/122 (0.00%)', ' Angina unstable 1/122 (0.82%)', ' Coronary artery disease 1/122 (0.82%)', ' Myocardial infarction 1/122 (0.82%)', ' Diarrhoea 2/122 (1.64%)', ' Colitis 1/122 (0.82%)', ' Pyrexia 2/122 (1.64%)', ' Chest pain 1/122 (0.82%)', ' Pneumonia 1/122 (0.82%)', ' Catheter site cellulitis 1/122 (0.82%)', 'Adverse Events 2:', ' Total: 7/34 (20.59%)', ' febrile neutropenia 1/34 (2.94%)', ' Neutropenia 1/34 (2.94%)', ' Angina unstable 0/34 (0.00%)', ' Coronary artery disease 0/34 (0.00%)', ' Myocardial infarction 0/34 (0.00%)', ' Diarrhoea 0/34 (0.00%)', ' Colitis 0/34 (0.00%)', ' Pyrexia 0/34 (0.00%)', ' Chest pain 0/34 (0.00%)', ' Pneumonia 1/34 (2.94%)', ' Catheter site cellulitis 0/34 (0.00%)', ' Infection 1/34 (2.94%)']}
|
3ca27248-0728-4b10-b940-6e2603acef30
|
Comparison
|
Eligibility
|
NCT00248170
|
NCT01299038
|
Ae-Cha is a 32 year old Korean woman with an inoperable breast cancer, she is ineligible for both the secondary trial and the primary trial.
|
Entailment
|
[
0,
1
] |
[
6,
10
] |
{'Clinical Trial ID': 'NCT00248170', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' 2.5 mg by mouth (p.o.) once daily', 'INTERVENTION 2: ', ' Anastrozole', ' 1 mg p.o. once daily'], 'Eligibility': ['Inclusion Criteria:', ' Recent primary surgery for breast cancer', ' Early stage breast cancer', ' Postmenopausal', ' Hormone receptor positive', ' Positive lymph node involvement', 'Exclusion Criteria:', ' Metastatic disease', ' Presence of contralateral breast cancer including DCIS', ' Progression', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival', ' Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.', ' Time frame: 84 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: 2.5 mg by mouth (p.o.) once daily', ' Overall Number of Participants Analyzed: 2061', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (84.14 to NA)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: 1 mg p.o. once daily', ' Overall Number of Participants Analyzed: 2075', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 486/2049 (23.72%)', ' Anaemia 4/2049 (0.20%)', ' Autoimmune haemolytic anaemia 0/2049 (0.00%)', ' Haemorrhagic anaemia 1/2049 (0.05%)', ' Lymphadenopathy 0/2049 (0.00%)', ' Pancytopenia 0/2049 (0.00%)', ' Acute coronary syndrome 1/2049 (0.05%)', ' Acute myocardial infarction 3/2049 (0.15%)', ' Adams-Stokes syndrome 1/2049 (0.05%)', ' Angina pectoris 8/2049 (0.39%)', ' Angina unstable 1/2049 (0.05%)', 'Adverse Events 2:', ' Total: 520/2062 (25.22%)', ' Anaemia 3/2062 (0.15%)', ' Autoimmune haemolytic anaemia 1/2062 (0.05%)', ' Haemorrhagic anaemia 0/2062 (0.00%)', ' Lymphadenopathy 2/2062 (0.10%)', ' Pancytopenia 1/2062 (0.05%)', ' Acute coronary syndrome 1/2062 (0.05%)', ' Acute myocardial infarction 4/2062 (0.19%)', ' Adams-Stokes syndrome 0/2062 (0.00%)', ' Angina pectoris 8/2062 (0.39%)', ' Angina unstable 2/2062 (0.10%)']}
|
{'Clinical Trial ID': 'NCT01299038', 'Intervention': ['INTERVENTION 1: ', ' Rosuvastatin 20mg', ' Rosuvastatin 20mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', 'INTERVENTION 2: ', ' Rosuvastatin 40mg', ' Rosuvastatin 40mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Metastatic adenocarcinoma of the breast (Stage IV)', ' Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)', ' Minimum age 18 years', ' ECOG Performance status of 0, 1 or 2', ' Normal organ and marrow function as defined in the protocol', 'Exclusion Criteria:', ' Participants may not be receiving any other study agents', ' Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks', ' Any statin therapy within the last 3 weeks', ' Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)', ' Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors', ' Conditions predisposing to renal failure secondary to rhabdomyolysis', ' Recent history of heavy alcohol use as judged by the treating physician', ' Known to be pregnant (testing not required) or nursing', ' History of rhabdomyolysis on statin therapy', ' Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'], 'Results': ['Outcome Measurement: ', ' Mean Change of Tissue Factor Bearing Microparticles', ' Comparison of plasma microparticle concentration between baseline and week 4', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: Rosuvastatin 20mg', ' Arm/Group Description: Rosuvastatin 20mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', ' Overall Number of Participants Analyzed: 8', ' Mean (Standard Deviation)', ' Unit of Measure: microparticles per microliter 102 (586)', 'Results 2: ', ' Arm/Group Title: Rosuvastatin 40mg', ' Arm/Group Description: Rosuvastatin 40mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: microparticles per microliter -618 (624)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}
|
c2da6504-96a1-4669-b609-16731a5330d3
|
Single
|
Adverse Events
|
NCT01262027
|
Less than 5% of patients in the primary trial suffered an adverse event.
|
Entailment
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT01262027', 'Intervention': ['INTERVENTION 1: ', ' Dovitinib', ' Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Patients have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.', ' Patients have stage IV disease with local or distant relapse', ' Patients have negative HER2 expression by IHC (defined as 0 or1+), or fluorescence in situ hybridization (FISH). If HER2 is 2+, negative HER2 expression must be confirmed by FISH.', ' Patients are able to swallow and retain oral medication.', ' Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Patients have received two or more standard chemotherapies for metastatic disease and have relapsed.', ' Patients have ability and willingness to sign written informed consent.', ' Patients are 18 years of age or older.', ' Female patients of childbearing potential (A female not free from menses > 2 years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study. Highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device. Highly effective contraception must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.', ' Female patients of childbearing potential must have negative serum pregnancy test </=14 days prior to starting study treatment.', ' If Patients have been treated with anti-vascular endothelial growth factor (VEGF) agents, such as Bevacizumab, last dose must be > 4 weeks.', ' Patients have biopsy tissue of the metastatic disease (including chest wall or regional nodes) available (paraffin blocks or up to 20 unstained slides), if no biopsy tissue available, a biopsy (or thoracentesis if patient has pleural effusion only) of the metastatic disease will be performed to confirm the diagnoses.', ' Serum total bilirubin must be within Upper Limited Normal (T. Bilirubin upper limit of normal (ULN)=1.0 mg/dl)', ' AST and ALT must be < 2.5 x ULN(with or without liver metastases).', 'Exclusion Criteria:', ' Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy and biological therapy) while taking study medication.', ' Cirrhosis of liver, or known hepatitis B or C infection have hepatic impairment Child-Pugh Score of B or worse.', ' Absolute neutrophil count (ANC) < 1.5', ' Patients have an active infection and require IV or oral antibiotics.', ' Impaired cardiac function or clinically significant cardiac diseases, including any of the following: a) History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation; b) Clinically significant resting bradycardia (< 50 beats per minute); c) left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (which ever is higher). d) Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE); e) Uncontrolled hypertension defined by an SBP>150 and/or a diastolic blood pressure (DBP)>100 mm Hg with or without anti-hypertensive medication.', ' History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.', ' Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients safety.', ' Patients with only locally or regionally confined disease without evidence of metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants', ' Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Dovitinib', ' Arm/Group Description: Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 0', ' Stable Disease (SD): 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/22 (4.55%)', ' Blood bilirubin increased 1/22 (4.55%)', ' Alkaline phosphatase increased 1/22 (4.55%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
646959e4-25d0-4eb1-b7b0-2d7b1e02e132
|
|
Comparison
|
Intervention
|
NCT01293032
|
NCT00849472
|
None of the patients in the primary trial or the secondary trial are required to undergo radiotherapy or surgery.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01293032', 'Intervention': ['INTERVENTION 1: ', ' Group 2 (RS 11-25)', ' Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy', ' The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines', ' The patient must be female', ' The patient must be greater than or equal to 18 years old', ' The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1', ' The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy', ' The primary breast tumor must be >= 2 cm by physical exam or imaging', ' Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.', ' The tumor must have been determined to be HER2-negative as follows:', ' Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or', ' Chromogenic in situ hybridization (CISH) is performed, the result must indicate a HER2 gene copy number of < 6 per nucleus; or', ' Immunohistochemistry (IHC) 0-1+; or', ' IHC 2+ and FISH-negative or CISH-negative', ' The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as > 10% tumor staining by immunohistochemistry', ' The patient must have been evaluated by a treating physician, reviewed and discussed by the multi-disciplinary breast team, and considered to be a candidate for chemotherapy', 'Exclusion Criteria:', ' FNA alone to diagnose the primary tumor', ' Excisional biopsy or lumpectomy performed prior to randomization', ' Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration', ' Tumors clinically staged as including inflammatory breast cancer', ' Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible)', ' Definitive clinical or radiologic evidence of metastatic disease (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization)', ' Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are eligible)', ' HER2 test result of IHC 3+, regardless of FISH results, if performed', ' Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)', ' History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization', ' Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to registration', ' Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy', ' Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)', ' Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements', ' Use of any investigational product within 30 days prior to registration'], 'Results': ['Outcome Measurement: ', ' The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment', ' The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.', ' Time frame: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Group 2 (RS 11-25)', ' Arm/Group Description: Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.15 (0.051 to 0.319)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT00849472', 'Intervention': ['INTERVENTION 1: ', ' AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib', ' Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of tumor and blood samples required for the FB-6 correlative science studies', ' The ECOG performance status must be 0 or 1', ' Patients must have the ability to swallow oral medication.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Patients must have clinical stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla measuring at least 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' Adequate organ function', " LVEF assessment by 2-D echocardiogram or MUGA scan performed within 3 months prior to study entry must be greater or equal to 50% regardless of the facility's LLN.", ' ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.', ' The TSH level must be within normal limits for the laboratory.', 'Exclusion Criteria:', ' Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by FISH or CISH (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.', ' FNA alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to study entry.', ' Surgical axillary staging procedure prior to study entry.', ' Definitive clinical or radiologic evidence of metastatic disease.', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.', ' Contralateral invasive breast cancer at any time.', ' Non-breast malignancies unless the patient is considered to be disease-free for 5 or more years prior to study entry and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Requirement for chronic use of any of the prohibited medications or substances', ' Previous therapy with anthracyclines, taxanes, or pazopanib for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.', ' Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM.', ' Any sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy', ' History of hepatitis B or C.', ' Symptomatic pancreatitis or asymptomatic greater or equal to grade 2 elevation of amylase or lipase as per NCI CTCAE v3.0.', ' History of documented pancreatitis.', ' Uncontrolled hypertension defined as systolic BP greater than 140 mmHg or diastolic BP greater greater than 90 mmHg, with or without anti-hypertensive medication.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' Cardiac disease that would preclude the use of any of the drugs included in the FB-6 treatment regimen.', ' History of TIA or CVA.', ' History of any arterial thrombotic event within 12 months prior to study entry.', ' Pulmonary embolism or DVT within 6 months prior to study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months prior to study entry, exclusive of menorrhagia in premenopausal women.', ' Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' History of GI perforation, abdominal fistulae, or intra-abdominal abscess.', ' Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function.', " Sensory/motor neuropathy greater or equal to grade 2, as defined by the NCI's CTCAE v3.0.", ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of study therapy and for at least 3 months following the last dose of pazopanib.', ' Pregnancy or lactation at the time of study entry.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Known immediate or delayed hypersensitivity reaction to doxorubicin, cyclophosphamide, paclitaxel, pazopanib, or drugs chemically related to pazopanib.', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes', ' pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.', ' Time frame: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)', 'Results 1: ', ' Arm/Group Title: AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib', ' Arm/Group Description: Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.', ' Overall Number of Participants Analyzed: 93', ' Measure Type: Number', ' Unit of Measure: Participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/101 (14.85%)', ' Anaemia 1/101 (0.99%)', ' Febrile neutropenia 1/101 (0.99%)', ' Myocardial ischaemia 1/101 (0.99%)', ' Nausea 1/101 (0.99%)', ' Vomiting 1/101 (0.99%)', ' Pyrexia 2/101 (1.98%)', ' Herpes zoster 1/101 (0.99%)', ' Infection 2/101 (1.98%)', ' Perineal abscess 1/101 (0.99%)', ' Cellulitis 1/101 (0.99%)', ' Thermal burn 1/101 (0.99%)', ' Alanine aminotransferase increased 1/101 (0.99%)']}
|
0e6eebe9-46c2-4fa5-b9ed-e0997044960b
|
Single
|
Results
|
NCT00950742
|
100% of participants in the Afatinib 30mg + Herceptin group of the primary trial suffer Dose Limiting Toxicities.
|
Entailment
|
[
0,
1,
2,
3,
10,
11,
12,
13,
8,
15
] |
[] |
{'Clinical Trial ID': 'NCT00950742', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 20mg + Herceptin', ' Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.', 'INTERVENTION 2: ', ' Afatinib 30mg + Herceptin', ' Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.'], 'Eligibility': ['Inclusion criteria:', ' Female patients aged >18 years.', ' Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.', 'Exclusion criteria:', ' Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT)', ' Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.', ' Time frame: 28 days', 'Results 1: ', ' Arm/Group Title: Afatinib 20mg + Herceptin', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: Participants 4', 'Results 2: ', ' Arm/Group Title: Afatinib 30mg + Herceptin', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Number', ' Unit of Measure: Participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/16 (18.75%)', ' Diarrhoea 1/16 (6.25%)', ' Renal failure acute 1/16 (6.25%)', ' Pulmonary embolism 1/16 (6.25%)', 'Adverse Events 2:', ' Total: 0/2 (0.00%)', ' Diarrhoea 0/2 (0.00%)', ' Renal failure acute 0/2 (0.00%)', ' Pulmonary embolism 0/2 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a781374c-99e1-47ee-a266-bff9267c2ed1
|
|
Single
|
Results
|
NCT01151046
|
The placebo group in the primary trial had a much lower Median PFS than the MM-121 cohort.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01151046', 'Intervention': ['INTERVENTION 1: ', ' MM-121 + Exemestane', ' MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day', 'INTERVENTION 2: ', ' Placebo + Exemestane', ' Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day'], 'Eligibility': ['Inclusion Criteria:', ' Locally advanced or metastatic breast cancer', ' Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer', ' 18 years of age', 'Exclusion Criteria:', ' Received prior treatment with exemestane', ' Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)', ' Symptomatic CNS disease'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).', ' Time frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks', 'Results 1: ', ' Arm/Group Title: MM-121 + Exemestane', ' Arm/Group Description: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day', ' Overall Number of Participants Analyzed: 56', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 15.9 (9.3 to 30.3)', 'Results 2: ', ' Arm/Group Title: Placebo + Exemestane', ' Arm/Group Description: Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day', ' Overall Number of Participants Analyzed: 59', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 10.7 (8.1 to 16.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/56 (12.50%)', ' Febrile Neutropenia * 1/56 (1.79%)', ' Cardiovascular insufficiency * 1/56 (1.79%)', ' Tacchycardia * 0/56 (0.00%)', ' Abdominal Pain (Upper) * 0/56 (0.00%)', ' Gastritis * 0/56 (0.00%)', ' Nausea * 2/56 (3.57%)', ' Vomiting * 1/56 (1.79%)', ' Chest Pain * 1/56 (1.79%)', ' Disease Progression * 1/56 (1.79%)', ' Pneumonia * 0/56 (0.00%)', ' Hepatic Failure * 2/56 (3.57%)', 'Adverse Events 2:', ' Total: 11/59 (18.64%)', ' Febrile Neutropenia * 0/59 (0.00%)', ' Cardiovascular insufficiency * 0/59 (0.00%)', ' Tacchycardia * 1/59 (1.69%)', ' Abdominal Pain (Upper) * 1/59 (1.69%)', ' Gastritis * 1/59 (1.69%)', ' Nausea * 0/59 (0.00%)', ' Vomiting * 0/59 (0.00%)', ' Chest Pain * 0/59 (0.00%)', ' Disease Progression * 1/59 (1.69%)', ' Pneumonia * 1/59 (1.69%)', ' Hepatic Failure * 0/59 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9aea5a84-bced-4441-b8b8-154c307f5a03
|
|
Single
|
Adverse Events
|
NCT00917735
|
One patient in cohort 2 of the primary trial died in a motorcycle crash.
|
Contradiction
|
[
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21
] |
[] |
{'Clinical Trial ID': 'NCT00917735', 'Intervention': ['INTERVENTION 1: ', ' Green Tea Extract', ' Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.', 'INTERVENTION 2: ', ' Sugar Pill', ' Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Healthy postmenopausal women aged 50-70 years', ' "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts', ' Willing to avoid consumption of green tea for 1 year', 'Exclusion Criteria:', ' Positive serological markers of hepatitis B or hepatitis C infections', ' Elevated levels of liver enzymes', ' Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors', ' Current smoker of cigarettes or other tobacco products', ' BMI <19 or >40 kg/m2', ' Weight change > 10 lbs during the previous year', ' History of breast cancer or proliferative breast disease', ' Regular consumption of > 7 alcoholic drinks/wk', ' Regular consumption of green tea (>1 cup/wk)', ' Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors', ' Participation in any weight loss or weight gain studies', ' Currently taking Methotrexate or Enbrel', ' History of ovarian cancer', ' Any form of cancer in the last 5 years', ' Presence of implants'], 'Results': ['Outcome Measurement: ', ' Mammographic Density', ' Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.', ' Time frame: Baseline and month 12', 'Results 1: ', ' Arm/Group Title: Green Tea Extract', ' Arm/Group Description: Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 28.9 mg catechins including 210.7 11.0 mg of EGCG.', ' Overall Number of Participants Analyzed: 462', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 22.71 (21.39 to 24.10)', ' Percent mammographic density at month 12: 22.09 (20.77 to 23.50)', 'Results 2: ', ' Arm/Group Title: Sugar Pill', ' Arm/Group Description: Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.', ' Overall Number of Participants Analyzed: 470', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percent Percent mammographic density at baseline: 21.84 (20.59 to 23.17)', ' Percent mammographic density at month 12: 21.13 (19.88 to 22.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/538 (2.23%)', ' Hypertension 0/538 (0.00%)', ' Acoustic Neuroma 1/538 (0.19%)', ' Diarrhea 0/538 (0.00%)', ' Colitis 1/538 (0.19%)', ' Elevated ALT or AST enzyme 7/538 (1.30%)', ' Diagnosis of Uterine Cancer 0/538 (0.00%)', ' Motorcycle accident 0/538 (0.00%)', ' Fall 0/538 (0.00%)', ' Surgery 3/538 (0.56%)', 'Adverse Events 2:', ' Total: 8/537 (1.49%)', ' Hypertension 1/537 (0.19%)', ' Acoustic Neuroma 0/537 (0.00%)', ' Diarrhea 1/537 (0.19%)', ' Colitis 0/537 (0.00%)', ' Elevated ALT or AST enzyme 0/537 (0.00%)', ' Diagnosis of Uterine Cancer 2/537 (0.37%)', ' Motorcycle accident 1/537 (0.19%)', ' Fall 1/537 (0.19%)', ' Surgery 2/537 (0.37%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
deb77d34-76a5-4e6e-bc9d-176cc30eca07
|
|
Single
|
Adverse Events
|
NCT00068341
|
More patients in cohort 1 of the primary trial experienced death progressive disease than in cohort 2.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21
] |
[] |
{'Clinical Trial ID': 'NCT00068341', 'Intervention': ['INTERVENTION 1: ', ' Arm I: HER2+', '(Pre-Op TCH)', 'INTERVENTION 2: ', ' Arm II: HER2+', ' (Pre-Op TC, Post-Op Herceptin)'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed infiltrating adenocarcinoma of the breast', ' Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.', ' No prior radiation to the involved breast', ' ECOG (Electrocochleography) performance status 0-2', ' Age 18 years to 80 years', ' Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl', ' All liver function tests < upper limit of normal', ' Serum creatinine < 2.0 mg/dl', ' Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram', ' HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]', ' If female of childbearing potential, pregnancy test is negative', ' If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study', ' Informed consent has been obtained', 'Exclusion Criteria:', ' Non-confirmed infiltrating adenocarcinoma breast cancer', ' Evidence of metastasis', ' Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin', ' Prior radiation to the involved breast', ' Recent breast cancer drug therapy within last 5 years of any form', ' History of allergy to polysorbate or castor oil', ' Ongoing active infection', ' Concurrent life-limiting disease with a life expectancy of less than one year', ' Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix', ' Pregnancy, nursing, fertile women who do not use birth control device', ' Inability to give informed consent', ' Patients with pre-existing peripheral neuropathy > grade 2'], 'Results': ['Outcome Measurement: ', ' Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.', ' Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).', ' Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Arm I: HER2+', ' Arm/Group Description: (Pre-Op TCH)', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: participants DFS (Disease Free Survival): 13', ' OS (overall survival): 13', 'Results 2: ', ' Arm/Group Title: Arm II: HER2+', ' Arm/Group Description: (Pre-Op TC, Post-Op Herceptin)', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: participants DFS (Disease Free Survival): 8', ' OS (overall survival): 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/15 (40.00%)', ' diarrhea and dehydration * 0/15 (0.00%)', ' Severe Dehydration * 1/15 (6.67%)', ' hypokalemia * 1/15 (6.67%)', ' pain, swelling, mastectomy site cellulitis * 0/15 (0.00%)', ' death progressive disease * 0/15 (0.00%)', ' divetricular abscess * 0/15 (0.00%)', ' fever * 1/15 (6.67%)', ' febrile neutropenia * 3/15 (20.00%)', ' Neutropenia * 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 4/14 (28.57%)', ' diarrhea and dehydration * 0/14 (0.00%)', ' Severe Dehydration * 0/14 (0.00%)', ' hypokalemia * 0/14 (0.00%)', ' pain, swelling, mastectomy site cellulitis * 0/14 (0.00%)', ' death progressive disease * 1/14 (7.14%)', ' divetricular abscess * 0/14 (0.00%)', ' fever * 0/14 (0.00%)', ' febrile neutropenia * 2/14 (14.29%)', ' Neutropenia * 0/14 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
bfe97430-fcec-4c4a-9621-51f6ec05d8d3
|
|
Single
|
Results
|
NCT01421017
|
the primary trial studies the effects of CTX/IMQ/RT and IMQ+RT on Systemic Tumor Response Rates 9 weeks after the start of treatment.
|
Entailment
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT01421017', 'Intervention': ['INTERVENTION 1: ', ' IMQ+RT', ' This arm has been closed as of 6/4/2014.', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', 'Imiquimod', 'INTERVENTION 2: ', ' CTX/IMQ/RT', ' Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Patients with biopsy-confirmed breast cancer.', ' Patients with at least measurable skin metastases and distant, measurable metastases (outside of skin) by Response Evaluation Criteria in Solid Tumors (RECIST). For patients without distant measurable metastases, an area of the skin metastases designated to not receive local therapy can be substituted. Patients with multiple (>= 2) metastatic sites (skin involvement not required), with at least one site measurable by RECIST, will be eligible for the CTX/RT cohort.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group performance status 0-2.', ' Patients must agree to tumor fine-needle aspiration required by protocol.', ' Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) can be continued if distant metastases are non-responsive (i.e. no complete response or partial response) on that regimen for >= 8 weeks as assessed by the investigator.', ' Patients must have adequate organ and bone marrow function as defined below:', ' absolute neutrophil count >= 1,300/microliter', ' hemoglobin >= 9.0 grams/deciliter', ' platelets >= 75,000/microliter', ' total bilirubin =< 1.5 X institutional upper limit of normal', ' AST (aspartate aminotransferase) =< 2.5 X institutional upper limit of normal', ' ALT (alanine aminotransferase) =< 2.5 X institutional upper limit of normal', ' creatinine =< 2 X institutional upper limit of normal if patient has chronic renal insufficiency and creatinine has been stable for > 4 months)', ' Informed consent.', 'Exclusion Criteria:', ' Brain metastases unless resected or irradiated and stable >= 4 weeks.', ' Concurrent treatment with other investigational agents.', ' Patients who have received any local therapy (radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery) other than biopsy to the target area within 4 weeks prior to first dosing of study agent.', ' Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.', ' Patients with an uncontrolled bleeding disorder.', ' Patients (with skin metastases only) who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.', ' Patients with known immunodeficiency or receiving immunosuppressive therapies.', ' History of allergic reactions to imiquimod or its excipients.', ' Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnancy or lactation.', ' Women of childbearing potential not using a medically acceptable means of contraception.'], 'Results': ['Outcome Measurement: ', ' Systemic Tumor Response Rates (Complete Response+Partial Response)', ' The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).', ' Time frame: 9 weeks from the start of the treatment of RT', 'Results 1: ', ' Arm/Group Title: IMQ+RT', ' Arm/Group Description: This arm has been closed as of 6/4/2014.', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: proportion of tumors .25 (.06 to .57)', 'Results 2: ', ' Arm/Group Title: CTX/IMQ/RT', ' Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: proportion of tumors .083 (.002 to .38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/12 (16.67%)', ' Blurred Vision *0/12 (0.00%)', ' Breast Pain *1/12 (8.33%)', ' Fever *1/12 (8.33%)', ' Tumor Pain *2/12 (16.67%)', ' Headache *0/12 (0.00%)', ' Pain in extremity *0/12 (0.00%)', ' Breast Infection *1/12 (8.33%)', ' Skin Infection *1/12 (8.33%)', ' Neosplasms Benign *1/12 (8.33%)', ' Dysarthria *0/12 (0.00%)', ' Pleural Effusion *0/12 (0.00%)', 'Adverse Events 2:', ' Total: 3/12 (25.00%)', ' Blurred Vision *0/12 (0.00%)', ' Breast Pain *0/12 (0.00%)', ' Fever *0/12 (0.00%)', ' Tumor Pain *0/12 (0.00%)', ' Headache *1/12 (8.33%)', ' Pain in extremity *1/12 (8.33%)', ' Breast Infection *0/12 (0.00%)', ' Skin Infection *1/12 (8.33%)', ' Neosplasms Benign *0/12 (0.00%)', ' Dysarthria *1/12 (8.33%)', ' Pleural Effusion *1/12 (8.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
568beebd-b350-4ba1-b8fc-c43f4d6ed517
|
|
Single
|
Results
|
NCT00076024
|
The minimum number of days from start of study treatment to first documentation of objective tumor progression or death due to cancer for any patient in the primary trial, was 191.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00076024', 'Intervention': ['INTERVENTION 1: ', ' Axitinib + Docetaxel (Phase 2, Double-blind)', ' Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.', 'INTERVENTION 2: ', ' Docetaxel + Placebo (Phase 2, Double-blind)', ' Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)', ' Adequate bone marrow, liver, and renal function', 'Exclusion Criteria:', ' Adjuvant chemotherapy given in the past 12 months', ' Uncontrolled brain metastases'], 'Results': ['Outcome Measurement: ', ' Time to Tumor Progression (TTP)', ' Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).', ' Time frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks', 'Results 1: ', ' Arm/Group Title: Axitinib + Docetaxel (Phase 2, Double-blind)', ' Arm/Group Description: Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.', ' Overall Number of Participants Analyzed: 112', ' Median (95% Confidence Interval)', ' Unit of Measure: days 247 (208 to 265)', 'Results 2: ', ' Arm/Group Title: Docetaxel + Placebo (Phase 2, Double-blind)', ' Arm/Group Description: Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.', ' Overall Number of Participants Analyzed: 55', ' Median (95% Confidence Interval)', ' Unit of Measure: days 215 (191 to 247)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Agranulocytosis * 0/6 (0.00%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 0/6 (0.00%)', ' Arrhythmia supraventricular * 0/6 (0.00%)', ' Left ventricular dysfunction * 0/6 (0.00%)', ' Palpitations * 0/6 (0.00%)', ' Pericardial effusion * 0/6 (0.00%)', ' Restrictive cardiomyopathy * 0/6 (0.00%)', ' Hypothyroidism * 0/6 (0.00%)', ' Angle closure glaucoma * 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 54/111 (48.65%)', ' Agranulocytosis * 0/111 (0.00%)', ' Febrile neutropenia * 9/111 (8.11%)', ' Neutropenia * 10/111 (9.01%)', ' Arrhythmia supraventricular * 1/111 (0.90%)', ' Left ventricular dysfunction * 1/111 (0.90%)', ' Palpitations * 1/111 (0.90%)', ' Pericardial effusion * 1/111 (0.90%)', ' Restrictive cardiomyopathy * 1/111 (0.90%)', ' Hypothyroidism * 0/111 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6bcc18b7-b063-49a1-8ab7-773636c02f1d
|
|
Single
|
Results
|
NCT01519700
|
There was less than 24hrs difference in Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy for the two arms of the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01519700', 'Intervention': ['INTERVENTION 1: ', ' EP2006 + EP2006 & Neupogen', ' All subjects randomized to receive either EP2006 in Cycle 1', 'INTERVENTION 2: ', ' Neupogen + Neupogen & EP2006', ' All subjects randomized to receive Neupogen in Cycle 1'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy', ' Women 18 years of age', ' Estimated life expectancy of more than six months', 'Exclusion Criteria:', ' Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry', ' Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy', ' Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)', ' Time frame: 21 days (Cycle 1 of chemotherapy treatment)', 'Results 1: ', ' Arm/Group Title: EP2006 + EP2006 & Neupogen', ' Arm/Group Description: All subjects randomized to receive either EP2006 in Cycle 1', ' Overall Number of Participants Analyzed: 101', ' Mean (Standard Deviation)', ' Unit of Measure: Days 1.17 (1.11)', 'Results 2: ', ' Arm/Group Title: Neupogen + Neupogen & EP2006', ' Arm/Group Description: All subjects randomized to receive Neupogen in Cycle 1', ' Overall Number of Participants Analyzed: 103', ' Mean (Standard Deviation)', ' Unit of Measure: Days 1.2 (1.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/53 (11.32%)', ' Febrile Neutropenia3/53 (5.66%)', ' Anaemia0/53 (0.00%)', ' Leukopenia1/53 (1.89%)', ' Diarrhoea0/53 (0.00%)', ' Embolism1/53 (1.89%)', 'Adverse Events 2:', ' Total: 4/54 (7.41%)', ' Febrile Neutropenia4/54 (7.41%)', ' Anaemia0/54 (0.00%)', ' Leukopenia0/54 (0.00%)', ' Diarrhoea0/54 (0.00%)', ' Embolism0/54 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
dfa2ecee-96cf-4551-875e-aedd8aac5df9
|
|
Comparison
|
Adverse Events
|
NCT00190671
|
NCT00455533
|
In the primary trial cohort 2 had more patients with Leukopenia than cohort 1, whereas in the secondary trial cohort 1 had more than cohort 2. Cohort 2 of the primary trial had the highest proportion of patients with leukopenia.
|
Entailment
|
[
0,
5,
14,
19
] |
[
0,
3,
12,
15
] |
{'Clinical Trial ID': 'NCT00190671', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed 600mg/m2', ' Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', 'INTERVENTION 2: ', ' Pemetrexed 1800mg/m2', ' Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles'], 'Eligibility': ['Inclusion Criteria: - You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12. Exclusion Criteria: - You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.'], 'Results': ['Outcome Measurement: ', ' Best Tumor Response', ' Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.', ' Time frame: baseline to measured progressive disease', 'Results 1: ', ' Arm/Group Title: Pemetrexed 600mg/m2', ' Arm/Group Description: Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 8', ' Stable Disease: 18', ' Progressive Disease: 13', ' Unknown: 3', 'Not Assessed: 0', 'Results 2: ', ' Arm/Group Title: Pemetrexed 1800mg/m2', ' Arm/Group Description: Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 20', ' Stable Disease: 26', ' Progressive Disease: 8', ' Unknown: 5', 'Not Assessed: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Agranulocytosis 0/42 (0.00%)', ' Anaemia 2/42 (4.76%)', ' Febrile neutropenia 1/42 (2.38%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 1/42 (2.38%)', ' Thrombocytopenia 1/42 (2.38%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)', ' Gastric ulcer haemorrhage 0/42 (0.00%)', ' Melaena 0/42 (0.00%)', ' Fatigue 1/42 (2.38%)', ' Multi-organ failure 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 13', ' Agranulocytosis 1/61 (1.64%)', ' Anaemia 1/61 (1.64%)', ' Febrile neutropenia 0/61 (0.00%)', ' Leukopenia 2/61 (3.28%)', ' Neutropenia 2/61 (3.28%)', ' Thrombocytopenia 1/61 (1.64%)', ' Cardio-respiratory arrest 1/61 (1.64%)', ' Pericardial effusion 0/61 (0.00%)', ' Gastric ulcer haemorrhage 1/61 (1.64%)', ' Melaena 1/61 (1.64%)', ' Fatigue 1/61 (1.64%)', ' Multi-organ failure 1/61 (1.64%)']}
|
{'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%)']}
|
81c85a29-d449-4f79-a3b3-682ba5f288ca
|
Single
|
Intervention
|
NCT00338728
|
Participants of the primary trial more Imatinib mesylate than Letrozole on a daily basis.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00338728', 'Intervention': ['INTERVENTION 1: ', ' Letrozole and Imatinib Mesylate', ' Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women able to comply with the protocol requirements with metastatic breast cancer, whose tumors are estrogen (ER) and/or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with greater than 10% positive malignant epithelial cells', ' Patients must have documented expression of either PDGFR or CD117 (c-kit) by immunohistochemistry', ' Patients may have received tamoxifen in the adjuvant/neoadjuvant or setting. Patients may have previously received chemotherapy in the adjuvant/ neoadjuvant setting, though this is not required. Prior chemotherapy for metastatic breast cancer is allowed. Concomitant bisphosphonates are allowed for patients with bone metastases and who have another site of measurable disease', ' Post menopausal status defined by one of the following: no spontaneous menses for at least 1 year, in women greater than or equal to 55 years spontaneous menses within the past 1 year in women greater than or equal to 55 years with postmenopausal gonadotrophin levels (luteinizing hormone [LH] and follicle stimulating hormone [FSH] levels greater than 40 IU/L ) or postmenopausal estradiol levels (less than 5 mg/dl) or according to the definition of "postmenopausal range" for the laboratory involved bilateral oophorectomy', ' Performance status, Eastern Cooperative Oncology Group (ECOG) greater than or equal to 2', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 10 mm with conventional techniques. Bone disease only will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease', ' Absolute neutrophil count (ANC) = 1.5 x 10 to the 9th power/L', ' Platelets greater than or equal to 100.0 x 10 to the 9th power/L', ' Hemoglobin greater than 10.0 g/dL', ' Creatinine less than 1.5 mg/dl', ' Total (T.) bilirubin less than 1.5 x normal', ' Aspartate aminotransferase (AST) less than 2.5 x normal', ' A life expectancy of at least 6 months', ' Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of imatinib mesylate. Patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 2-4 weeks)', ' Ability to understand and the willingness to sign a written informed consent', 'Exclusion Criteria:', ' Prior treatment with Femara or Gleevec', " Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's syndrome, Addison's disease (treated or untreated)", " Patients with unstable angina, or uncontrolled cardiac disease (e.g. class III or IV New York Heart Association's functional classification)", " Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence", ' Concomitant treatment with steroids, e.g. glucocorticoids for indications other than cancer, except aerosol for obstructive airways diseases and steroid injection to the joints for treatment of inflammation', ' Other investigational drugs within the past 3 weeks and the concomitant use of investigational drugs', ' History of non-compliance to medical regimens and patients who are considered potentially unreliable', ' Patients with known brain metastasis', ' Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis)', ' Patients with known diagnosis of human immunodeficiency virus (HIV) infection', ' Patients who received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing', ' Patients who previously received radiotherapy to greater than or equal to 25% of the bone marrow', ' Patients who had a major surgery within 2 weeks prior to study entry'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Among participants with CR or PR as the best overall response, duration of response (DOR) was defined as the time from which measurement criteria were met for CR or PR until the date of progression. Progression-free survival (PFS) was defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. PFS data were censored at the time of removal from study. Overall survival (OS) was defined as the time from study registration to death from any cause. Information on vital status was collected following study completion through July 23, 2018 and was used in the determination of OS. Among patients with SD as the best overall response, duration of SD was defined as the time from study enrollment to disease progression or removal from study.', ' Time frame: From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months', 'Results 1: ', ' Arm/Group Title: Letrozole and Imatinib Mesylate', ' Arm/Group Description: Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response (CR): 0 0.0%', ' Partial Response (PR): 5 11.1%', ' SD (including non-CR/Non-PD)>/=24 weeks: 16 35.6%', ' SD (including non-CR/Non-PD)</=24 weeks: 8 17.8%', ' Progressive Disease: 11 24.4%', ' Non-Evaluable: 5 11.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/45 (31.11%)', ' Neutropenia 22/45 (4.44%)', ' Diarrhea 7/45 (15.56%)', ' Fatigue 23/45 (6.67%)', ' Elevated bilirubin 21/45 (2.22%)', ' Myalgia 21/45 (2.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9c48c5d6-83fd-42cc-aacc-2e888099bcdb
|
|
Single
|
Eligibility
|
NCT00293540
|
Males are not eligible for the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
79a3bb0d-315f-4c39-8786-2aa98e2e3f6f
|
|
Single
|
Eligibility
|
NCT00503750
|
All participants of the primary trial must have recently undergone either an echocardiography or a MUGA scan.
|
Entailment
|
[
0,
6
] |
[] |
{'Clinical Trial ID': 'NCT00503750', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine', ' Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast carcinoma.', ' Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.', ' 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.', " Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and 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 the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.", ' ECOG performance status 0 to 2 within 14 days of study entry.', ' Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography.', ' Must be 18 years of age or older.', ' Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.', 'Exclusion Criteria:', ' Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.', ' Medical, psychological, or surgical condition which the investigator feels might compromise study participation.', ' Pregnant or lactating women are not eligible.', ' Patients with history 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 sensory and/or peripheral neuropathy.', ' Serious, uncontrolled, concurrent infections.', ' Major surgery within 4 weeks of the start of study treatment without complete recovery.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Pathologic Response.', ' 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.', ' Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.', ' Time frame: assess at 8 weeks', 'Results 1: ', ' Arm/Group Title: Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine', ' Arm/Group Description: Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta ) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/27 (44.44%)', ' Anemia1/27 (3.70%)', ' Fatigue1/27 (3.70%)', ' Neuropathy3/27 (11.11%)', ' Neutropenia6/27 (22.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
cea17554-6736-4b52-b76c-b3c5dc9ecb77
|
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