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Single
|
Adverse Events
|
NCT00728949
|
There were 6 adverse event categories for cohort 1 of the primary trial which recorded at least one case.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
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13,
14
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[] |
{'Clinical Trial ID': 'NCT00728949', 'Intervention': ['INTERVENTION 1: ', ' IMC-A12 (Cixutumumab) + Antiestrogen Therapy', ' Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.', 'INTERVENTION 2: ', ' IMC-A12 (Cixutumumab)', ' Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' The patient has histologically or cytologically-confirmed invasive breast cancer, which at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is not required if clinical evidence of stage IV disease recurrence is available', ' Tumors are positive for estrogen receptors (ER), progesterone receptors (PgR), or both (ie, 10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR; positive biochemical test results are also acceptable)', ' The patient has received prior antiestrogen therapy:', ' With at least one antiestrogen agent (with or without ovarian suppression) administered for 3 months in the adjuvant or metastatic setting; and', ' Experienced disease progression while on or within 12 months after receiving the last dose of endocrine therapy', ' The patient is postmenopausal and/or meets at least one of the following criteria:', ' Age 18 years with an intact uterus and amenorrhea for 12 months, with estradiol and/or follicle-stimulating hormone (FSH) values in the postmenopausal range', ' History of bilateral oophorectomy', ' History of bilateral salpingo-oophorectomy', ' History of radiation castration and amenorrheic for 3 months', ' The patient has fasting serum glucose < 120 mg/dL or below the ULN', 'Exclusion Criteria:', ' The patient has received more than two regimens of prior chemotherapy in the metastatic (or locally advanced and inoperable breast cancer) and adjuvant setting', ' The patient has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting glucose at study entry < 120 mg/dL or below ULN) and that they are on a stable dietary and/or therapeutic regimen for this condition', ' The patient is known to be positive for infection with the human immunodeficiency virus'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions unequivocal progression of non-target lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS will be estimated following the Kaplan-Meier method.', ' Time frame: From randomization up to 35.1 Months', 'Results 1: ', ' Arm/Group Title: IMC-A12 (Cixutumumab) + Antiestrogen Therapy', ' Arm/Group Description: Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: months 2.0 (1.9 to 3.4)', 'Results 2: ', ' Arm/Group Title: IMC-A12 (Cixutumumab)', ' Arm/Group Description: Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).', ' Overall Number of Participants Analyzed: 31', ' Median (90% Confidence Interval)', ' Unit of Measure: months 3.1 (1.9 to 4.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/56 (28.57%)', ' Pancytopenia 0/56 (0.00%)', ' Pericarditis 0/56 (0.00%)', ' Abdominal pain 1/56 (1.79%)', ' Anal fissure 1/56 (1.79%)', ' Ascites 1/56 (1.79%)', ' Constipation 0/56 (0.00%)', ' Diarrhoea 1/56 (1.79%)', ' Nausea 0/56 (0.00%)', ' Oesophageal pain 0/56 (0.00%)', ' Vomiting 0/56 (0.00%)', ' Disease progression 2/56 (3.57%)', ' Infusion related reaction 1/56 (1.79%)', ' Pain 0/56 (0.00%)', 'Adverse Events 2:', ' Total: 11/37 (29.73%)', ' Pancytopenia 1/37 (2.70%)', ' Pericarditis 1/37 (2.70%)', ' Abdominal pain 2/37 (5.41%)', ' Anal fissure 0/37 (0.00%)', ' Ascites 0/37 (0.00%)', ' Constipation 1/37 (2.70%)', ' Diarrhoea 1/37 (2.70%)', ' Nausea 2/37 (5.41%)', ' Oesophageal pain 1/37 (2.70%)', ' Vomiting 2/37 (5.41%)', ' Disease progression 2/37 (5.41%)', ' Infusion related reaction 0/37 (0.00%)', ' Pain 1/37 (2.70%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
cb9f8a52-b88e-4b04-bb28-a0eabead1439
|
|
Comparison
|
Eligibility
|
NCT02806544
|
NCT00605267
|
A patient with stage 2B , pathologically confirmed estrogen receptor-positive breast cancer is elgible for both the primary trial and the secondary trial.
|
Entailment
|
[
0,
5,
6
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02806544', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen', ' Tamoxifen 20mg by mouth daily', ' Tamoxifen: Tamoxifen 20mg by mouth daily'], 'Eligibility': ['Inclusion Criteria:', ' Patient evaluated and treated at INCAN', ' Patients must provide informed consent', ' Patient must be 18 years of age.', ' Life expectancy 6 months', ' Clinical locally advance breast cancer (Stage IIB or III)', ' Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4', ' Patient must have an ECOG Performance Status of 0-2', ' Patients must be able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years', ' Patient must not be pregnant or nursing', ' Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.', ' Women of childbearing age unable or unwilling to use contraception'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility', ' Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.', ' Time frame: 4-6 months', 'Results 1: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20mg by mouth daily', ' Tamoxifen: Tamoxifen 20mg by mouth daily', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 35'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00605267', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole 1 mg', ' Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection', 'INTERVENTION 2: ', ' Tamoxifen 20 mg', ' Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection'], 'Eligibility': ['Inclusion Criteria:', ' Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent', 'Exclusion Criteria:', ' Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).'], 'Results': ['Outcome Measurement: ', ' Best Overall Response Rate (BORR) (Calliper)', ' The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).', ' CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Anastrozole 1 mg', ' Arm/Group Description: Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection', ' Overall Number of Participants Analyzed: 98', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 70.4', 'Results 2: ', ' Arm/Group Title: Tamoxifen 20 mg', ' Arm/Group Description: Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection', ' Overall Number of Participants Analyzed: 99', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 50.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/98 (1.02%)', ' Benign Neoplasm 1/98 (1.02%)', 'Adverse Events 2:', ' Total: 0/98 (0.00%)', ' Benign Neoplasm 0/98 (0.00%)']}
|
c921d3a1-bd6e-41c9-b0e9-23babf7ead7c
|
Comparison
|
Adverse Events
|
NCT02301988
|
NCT00728949
|
The only type of adverse event recorded by both the secondary trial and the primary trial is Diarrhoea and Abdominal pain.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29
] |
{'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%)']}
|
358a1d3c-9ccc-48fc-badc-1644e326c8cb
|
Comparison
|
Eligibility
|
NCT00045032
|
NCT00416572
|
WOCBP that refuse to use contraception are excluded from the primary trial, but may be eligible for the secondary trial if they are a UK resident.
|
Contradiction
|
[
18
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT00045032', 'Intervention': ['INTERVENTION 1: ', ' Observation Arm', ' Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.', 'INTERVENTION 2: ', ' Herceptin 1-Year Arm', ' Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'], 'Eligibility': ['Inclusion Criteria:', ' Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging', ' Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable', ' Known hormone receptor status', ' Baseline left ventricular ejection fraction (LVEF) greater than or equal to ( ) 55 percent (%)', 'Exclusion Criteria:', ' Prior invasive breast carcinoma', ' Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix', ' Clinical T4 tumors', ' Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the present breast cancer', ' Peripheral stem cell or bone marrow stem cell support', ' Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer', ' Non-irradiated internal mammary nodes or supraclavicular lymph node involvement', ' Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer', ' Concurrent anti-cancer treatment in another investigational trial', ' Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment', ' Poor hematologic, hepatic, or renal function', ' Pregnancy or lactation', ' Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', ' DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.', ' Time frame: From Baseline until time of event (median of 1 year)', 'Results 1: ', ' Arm/Group Title: Observation Arm', ' Arm/Group Description: Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.', ' Overall Number of Participants Analyzed: 1693', ' Measure Type: Number', ' Unit of Measure: percentage of participants 12.9', 'Results 2: ', ' Arm/Group Title: Herceptin 1-Year Arm', ' Arm/Group Description: Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.', ' Overall Number of Participants Analyzed: 1693', ' Measure Type: Number', ' Unit of Measure: percentage of participants 7.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 143/1744 (8.20%)', ' Leukopenia * 1/1744 (0.06%)', ' Lymphadenopathy * 0/1744 (0.00%)', ' Thrombocytopenia * 0/1744 (0.00%)', ' Acute coronary syndrome * 1/1744 (0.06%)', ' Acute myocardial infarction * 0/1744 (0.00%)', ' Angina pectoris * 2/1744 (0.11%)', ' Arrhythmia * 0/1744 (0.00%)', ' Atrial fibrillation * 1/1744 (0.06%)', ' Atrial flutter * 1/1744 (0.06%)', 'Adverse Events 2:', ' Total: 269/1682 (15.99%)', ' Leukopenia * 0/1682 (0.00%)', ' Lymphadenopathy * 1/1682 (0.06%)', ' Thrombocytopenia * 0/1682 (0.00%)', ' Acute coronary syndrome * 1/1682 (0.06%)', ' Acute myocardial infarction * 1/1682 (0.06%)', ' Angina pectoris * 2/1682 (0.12%)', ' Arrhythmia * 1/1682 (0.06%)', ' Atrial fibrillation * 1/1682 (0.06%)', ' Atrial flutter * 0/1682 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00416572', 'Intervention': ['INTERVENTION 1: ', ' Education Intervention', " Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.", 'INTERVENTION 2: ', ' Nutrition Education Intervention', ' Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.'], 'Eligibility': ['INCLUSION CRITERIA (Disease Characteristics):', ' Diagnosis of breast cancer', ' Stage I or II disease', ' No more than 10 positive lymph nodes', ' First-time diagnosis', ' Under the age of 50 at diagnosis', ' Finished active treatment within the past 2 months', ' English-speaking only', " Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania", ' INCLUSION CRITERIA (Patient Characteristics):', ' Female patients only', ' Must be able to communicate', ' EXCLUSION CRITERIA (Patient Characteristics):', ' Other prior malignancies except skin cancer', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).', ' Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.', ' Time frame: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).', 'Results 1: ', ' Arm/Group Title: Education Intervention', " Arm/Group Description: Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.", ' Overall Number of Participants Analyzed: 70', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 5.83 (5.32)', ' Post-intervention: 5.65 (5.53)', ' Final follow-up: 5.07 (4.99)', 'Results 2: ', ' Arm/Group Title: Nutrition Education Intervention', ' Arm/Group Description: Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.', ' Overall Number of Participants Analyzed: 78', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 6.74 (5.94)', ' Post-intervention: 5.70 (5.45)', ' Final follow-up: 4.36 (4.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/83 (0.00%)', 'Adverse Events 2:', ' Total: 0/85 (0.00%)']}
|
60a86c87-7387-4eae-b5dd-6245f8bf541e
|
Single
|
Eligibility
|
NCT00090857
|
Candidates for the primary trial must have a bone density scan 1 month prior to study entry, if the results from this are more than 2 standard deviations below normal, they must be excluded.
|
Contradiction
|
[
7,
8
] |
[] |
{'Clinical Trial ID': 'NCT00090857', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.', 'INTERVENTION 2: ', ' Placebo', ' Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' At increased risk for the development or recurrence of breast cancer, defined as an estradiol level 9 pg/mL', ' No evidence of suspicious or malignant disease, based on the following examinations:', ' Clinical bilateral breast examination within the past 6 months', ' Bilateral* mammogram within 3 months before randomization OR within 30 days after randomization', ' Pelvic exam normal within the past 5 years', ' General physical exam within the past 6 months NOTE: *Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS)', ' Bone density scan within 2 standard deviations from normal within the past 30 days', ' Bone density scan 2 standard deviations below normal allowed if approved by the study physician', ' At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS)', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 35 and over', ' Sex', ' Female', ' Menopausal status', ' Postmenopausal, defined by any of the following criteria:', ' At least 12 months without spontaneous menstrual bleeding', ' Prior hysterectomy and bilateral salpingo-oophorectomy', ' 55 years of age with a prior hysterectomy with or without oophorectomy', ' < 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range', ' Performance status', ' Normal activity must not be restricted for a significant portion of the day', ' Life expectancy', ' At least 10 years', ' Hematopoietic', ' Complete blood count with differential normal', ' Prior benign neutropenia allowed provided the granulocyte count is 1,500/mm^3', ' Hepatic', ' Bilirubin normal', ' Alkaline phosphatase normal', ' SGOT and SGPT normal', ' Renal', ' Creatinine normal', ' Cardiovascular', ' No uncontrolled cardiovascular disease', ' Other', ' Not pregnant', ' No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No osteoporosis', ' No hyperlipidemia', ' No mental health status resulting in cognitive or emotional impairment that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' Not specified', ' Endocrine therapy', ' More than 30 days since prior AND no concurrent use of any of the following hormonal agents:', ' Estrogen or progesterone replacement therapy', ' Oral contraceptives', ' Raloxifene or other plasma estrogen receptor modulators (SERMs)', ' Androgens (e.g., danazol)', ' Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide)', ' Prolactin inhibitors (e.g., bromocriptine)', ' Antiandrogens (e.g., cyproterone)', ' More than 60 days since prior AND no concurrent tamoxifen', ' No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)', ' No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)', ' Dietary soy allowed', ' Radiotherapy', ' See Disease Characteristics', ' Surgery', ' See Disease Characteristics', ' No prior bilateral mastectomy', ' Other', ' More than 60 days since prior treatment for invasive breast cancer or DCIS', ' More than 30 days since prior bisphosphonates or calcitonin', ' No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS', ' No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents', ' No concurrent calcitonin', ' No concurrent bisphosphonate therapy', ' Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed'], 'Results': ['Outcome Measurement: ', ' Change in Lumbar Density From Baseline to 12 Months', ' The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.', ' Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.', ' Overall Number of Participants Analyzed: 29', ' Median (Full Range)', ' Unit of Measure: g/cm^2 -0.036 (-0.092 to 0.272)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.', ' Overall Number of Participants Analyzed: 13', ' Median (Full Range)', ' Unit of Measure: g/cm^2 -0.021 (-0.180 to 0.064)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/33 (3.03%)', ' Pain - Head/Headache 1/33 (3.03%)', ' Urticaria (hives, welts, wheals) 1/33 (3.03%)', ' Pruritus / Itching 1/33 (3.03%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)', ' Pain - Head/Headache 0/16 (0.00%)', ' Urticaria (hives, welts, wheals) 0/16 (0.00%)', ' Pruritus / Itching 0/16 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
bd3055c6-09aa-47f0-89ed-67ad3798a580
|
|
Comparison
|
Eligibility
|
NCT00656019
|
NCT00328783
|
Candidates with hyperparathyroidism are automatically excluded from the primary trial and the secondary trial.
|
Contradiction
|
[
6,
7
] |
[
0,
1,
2,
3,
4,
5,
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': 'NCT00328783', 'Intervention': ['INTERVENTION 1: ', ' Active Breathing Coordinator', ' Patients breathe through the ABC device', ' Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.'], 'Eligibility': ['Inclusion Criteria:', ' Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields', ' Adequate pulmonary function', ' Presence of 5 cc of the heart or liver with the simulation fields', ' Karnofsky Performance Status (KPS) equal to or greater than 70', 'Exclusion Criteria:', ' Pregnant women', ' Patients who have had previous ipsilateral breast or thoracic radiation therapy'], 'Results': ['Outcome Measurement: ', ' Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues', ' To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.', ' The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.', ' Time frame: At time of radiation', 'Results 1: ', ' Arm/Group Title: Active Breathing Coordinator', ' Arm/Group Description: Patients breathe through the ABC device', ' Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.', ' Overall Number of Participants Analyzed: 86', ' Mean (95% Confidence Interval)', ' Unit of Measure: Gy Free breathing (heart): 3.0 (2.6 to 3.3)', ' ABC (heart): 1.1 (0.9 to 1.3)', ' Free breathing (lung): 6.0 (5.3 to 6.8)', ' ABC (lung): 5.4 (4.9 to 5.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}
|
21d7d726-8557-459f-a307-fae3e08f45d8
|
Single
|
Results
|
NCT00054132
|
The majority of patients in the primary trial had an EGFR Expression level of 0, and 0 patients had an EGFR of 3 or above.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT00054132', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Erlotinib Hydrochloride, Bevacizumab)', ' Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed carcinoma of the breast with metastatic (stage IV) disease that is currently stable or progressing after therapy', ' 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 computed tomography (CT) scan', ' Patients must have either stable disease or disease progression on or after therapy with one or two conventional chemotherapy regimens for the treatment of metastatic (stage IV) breast cancer', ' Prior treatment with high-dose chemotherapy and autologous stem cell/bone marrow transplantation is allowed, and is considered one prior regimen when administered for metastatic disease', ' There is no restriction for the number of prior hormonal therapies or immunotherapies', ' If human epidermal growth factor receptor 2 (Her2)/neu-positive (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescence in situ hybridization [FISH]), prior therapy with trastuzumab required', ' Any number of prior regimens of chemotherapy and/or hormonal therapy are allowed in the adjuvant setting, and do not count towards prior therapy when determining eligibility for this trial', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Life expectancy of greater than 3 months', ' Leukocytes >= 3,000/ul', ' Absolute neutrophil count >= 1,000/ul', ' Platelets >= 75,000/ul', ' Total bilirubin within normal institutional limits', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT[) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels outside institutional normal using the Cockcroft-Gault formula', ' Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) 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', ' Patients must have breast cancer tissue available as either paraffin blocks or unstained slides for planned correlative science sub study', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy, radiotherapy immunotherapy or investigational therapy within 3 weeks prior to starting treatment (6 weeks for nitrosoureas or mitomycin C), or hormonal therapy within 2 weeks prior to starting treatment', ' Patients may not be receiving any other investigational agents', ' History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke); all subjects must have a baseline CT or magnetic resonance imaging (MRI) of the head', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or bevacizumab', ' Prior treatment with kinase insert domain receptor (KDR) inhibitors (e.g. vascular endothelial growth factor [VEGF] Trap, Su5416, Su6668, ZD6474, PTK757, IMC-1CII)', ' Prior treatment with EGFR targeting therapies (e.g. ZD1839 or C225)', ' Major surgery, open biopsy or significant traumatic injury occurring within 28 days prior to treatment; this does not apply to indwelling catheters, which require an interval of at least 24 hours between placement of the catheter and treatment with bevacizumab', ' Current or recent (within 10 days prior to treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters; for subjects receiving warfarin, international normalized ratio [INR] should be < 1.5)', ' Chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit the platelet function (e.g. cyclooxygenase [COX]-1 inhibitors)', ' Presence of bleeding diathesis or coagulopathy', ' Cumulative anthracycline and anthracenedione exposure as follows: doxorubicin > 450 mg/m^2; epirubicin > 700 mg/m^2; liposomal doxorubicin > 550 mg/m^2; mitoxantrone > 140 mg/m^2', ' Proteinuria at baseline; subjects unexpectedly discovered to have >= 1+ proteinuria should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate =< 500 mg protein/ 24 hours to allow participation in the study', ' Cardiac ejection fraction (multigated acquisition scan [MUGA] or echocardiogram) less than the local institution lower limit of normal', " Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjögren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)", ' Serious, non-healing wound, ulcer, or bone fracture', ' Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to day 0', ' Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or prior surgical procedures affecting absorption', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with OSI-774', ' Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study', ' Patients with recent (within 6 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, myocardial infarction (MI), or clinically significant peripheral artery disease'], 'Results': ['Outcome Measurement: ', ' Level of EGFR Expression', ' Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)', '1+ - 3+ = positive:', ' faint immunoreactivity (weak staining)', ' intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics.', ' Time frame: Up to 12 years', 'Results 1: ', ' Arm/Group Title: Treatment (Erlotinib Hydrochloride, Bevacizumab)', ' Arm/Group Description: Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants EGFR 0: 24', 'EGFR 1+: 8', 'EGFR 2+: 4', ' EGFR 3+: 0', ' Insufficient tumor tissue: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/38 (15.79%)', ' Diarrhea 1/38 (2.63%)', ' General disorders and administration site conditions-other, specify 2/38 (5.26%)', ' Pain, other 1/38 (2.63%)', ' Dehydration 1/38 (2.63%)', ' Peripheral motor neuropathy 1/38 (2.63%)', ' Dyspnea 1/38 (2.63%)', ' Pleural effusion 1/38 (2.63%)', ' Skin ulceration 1/38 (2.63%)', ' Thrombosis 1/38 (2.63%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9a8157a9-82fc-4d7e-9254-295123459430
|
|
Comparison
|
Adverse Events
|
NCT01856543
|
NCT00365599
|
Across all cohorts of the secondary trial and the primary trial there was only a single recorded case of Myocarditis and Pericarditis.
|
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
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT00365599', 'Intervention': ['INTERVENTION 1: ', ' Vorinostat and Tamoxifen', ' Vorinostat and Tamoxifen as outlined in Intervention Descriptions'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have cytologically/histologically documented locally advanced or metastatic breast cancer with either:', ' Progression on treatment with any aromatase inhibitor for metastatic disease;', ' Recurrence while on adjuvant aromatase inhibitors or within 12 months of completion;', ' Recurrence after having completed adjuvant tamoxifen for at least 12 months;', ' Patient who are not candidates for or are intolerant of aromatase inhibitor treatment;', ' Patients are allowed (but not required) to have one prior chemotherapy regimen for metastatic disease.', ' Tumors must express estrogen or progesterone receptor.', ' Patients are eligible regardless of the menopausal status.', ' Age > 18 years old', ' Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Patients must be able to give informed consent and able to follow guidelines given in the study.', ' Patients must have acceptable organ function, as defined by the following laboratory parameters: white blood count (WBC) >3.0 x 10^9/L; absolute neutrophil count (ANC) >1.5 x 10^9/L; hemoglobin (Hgb) >10.0g/dL; platelets (PLT) >100 x 10^9/L, Bilirubin < 2.0 mg/dl, aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 2.5 X upper limit of normal (ULN), Creatinine <1.8 mg/dl (Creatinine clearance >60 ml/min).', ' Women of childbearing age must have a negative pregnancy test. All patients of reproductive potential must use an effective method of contraception during the study and 6 months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year.', ' Patients must have measurable disease by RECIST criteria by staging studies performed within 30 days of enrollment. For patients with bone only disease: For this protocol isolated bone lesions can be classified as target lesions if they are measurable by MRI at screening and must be followed by MRI.', ' Both men and women of all races and ethnic groups are eligible for this trial.', 'Exclusion Criteria:', ' Patients must not have received tamoxifen for metastatic disease.', ' Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.', ' Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix.', ' Pregnant and breast-feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.', ' Patients with uncontrolled central nervous system (CNS) metastasis or a history of seizures are excluded. Patients with stable CNS metastasis (either surgically resected, treated with gamma knife or stable for 3 months following whole brain radiation therapy [WBRT] are eligible). Patients with stable brain metastases will need an MRI within 4 weeks prior to start of therapy.', ' Patients may not be receiving any other investigational agents and must have stopped all other histone deacetylase inhibitors (including Valproic acid) or other hormonal therapies.', ' Patients must have discontinued their prior therapies for breast cancer and radiation therapy for a minimum of 3 weeks, patient is excluded if radiation therapy was given to a single measurable lesion and the disease is otherwise not measurable.', ' Patients are excluded if they have any known hypersensitivity reaction to tamoxifen.', ' Patient with a history of blood clots are not eligible.', ' Women who have abnormal vaginal bleeding and/or endometrial hyperplasia or cancer are not eligible.', ' Patients with evidence of visceral crisis are not eligible for this study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response (OR)', ' The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained 4 weeks following initial documentation of objective response.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Vorinostat and Tamoxifen', ' Arm/Group Description: Vorinostat and Tamoxifen as outlined in Intervention Descriptions', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/43 (9.30%)', ' Hemoglobin [1]1/43 (2.33%)', ' Hemorrhage/Bleeding [2]1/43 (2.33%)', ' Neutrophils/granulocytes (ANC/AGC) [3]1/43 (2.33%)', ' Platelets [4]1/43 (2.33%)', ' Anorexia [5]1/43 (2.33%)', ' Sodium, serum-low (hyponatremia) [1]1/43 (2.33%)', ' Thrombosis/thrombus/embolism [6]2/43 (4.65%)']}
|
ff37494d-2c61-4c06-86c1-d6bcfbe9e360
|
Comparison
|
Intervention
|
NCT01857882
|
NCT01439945
|
the secondary trial administers 150 mg/Day more of Magnesium Oxide to its patients than the primary trial does.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
7,
14,
15
] |
{'Clinical Trial ID': 'NCT01857882', 'Intervention': ['INTERVENTION 1: ', ' Decision Support Workshop', ' The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.', ' Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.', ' Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities', ' Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system', ' Social worker (30 mins): values clarification exercise', ' Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience', 'INTERVENTION 2: ', ' Standard Care', ' Routine pre-consultation education'], 'Eligibility': ['Inclusion Criteria:', ' Patient age: 18 - 79 years at the time of consultation', ' In situ or invasive biopsy confirmed breast adenocarcinoma', ' Considered for immediate or delayed breast reconstruction', ' First consultation for breast reconstruction', 'Exclusion Criteria:', ' Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast', ' Completion any phase of reconstruction, or for revision reconstruction', ' Patient cannot read or write in English.', ' Cognitive impairment or uncontrolled psychiatric diagnosis'], 'Results': ['Outcome Measurement: ', ' Decision Self-efficacy Scale', ' Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.', ' The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).', ' The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.', ' Time frame: Change from baseline decision self-efficacy at 1 week after surgical consultation', 'Results 1: ', ' Arm/Group Title: Decision Support Workshop', ' Arm/Group Description: The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.', ' Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.', ' Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities', ' Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system', ' Social worker (30 mins): values clarification exercise', ' Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 5.7 (12.8)', 'Results 2: ', ' Arm/Group Title: Standard Care', ' Arm/Group Description: Routine pre-consultation education', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 5.1 (9.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': 'NCT01439945', 'Intervention': ['INTERVENTION 1: ', ' Low Dose Magnesium Oxide (800 mg/Day)', ' Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', 'INTERVENTION 2: ', ' High Dose Magnesium Oxide (1200 mg/Day)', ' Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Women with a history of breast cancer (currently without malignant disease)', ' Bothersome hot flashes (defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)', ' Presence of hot flashes for 30 days prior to study registration', ' Willingness to provide the biologic specimens as required by the protocol', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Women who are postmenopausal as defined by absence of a period in the past 12 months or bilateral oophorectomy', ' Women with at least one ovary but without a uterus should be deemed postmenopausal by either age over 55 or a combination of estrogen within a postmenopausal range (per local lab) and FSH over 40 mIU/mL', ' No women of childbearing potential or who are premenopausal', ' Creatinine clearance > 30 mL/min', ' Ability to complete questionnaire(s) by themselves or with assistance', ' ECOG performance status 0 or 1', ' No history of allergic or other adverse reaction to magnesium', ' No diabetes', ' No patients with conditions that are implicated in decreased absorption of magnesium (e.g., Crohn disease, ETOH abuse)', ' No patients who have diarrhea where magnesium might make it worse (per provider discretion)', ' PRIOR CONCURRENT THERAPY:', ' None of the following current ( 28 days prior to registration) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for 28 days and must not be expected to stop the medication during the study period):', ' Antineoplastic chemotherapy (trastuzumab or lapatinib are allowed)', ' Androgens', ' Estrogens (any delivery route)', ' Progestational agents', ' No prior use of magnesium for hot flashes', ' No current or planned use of gabapentin (for any reasons) or antidepressants (for any reasons) or other agents for treating hot flashes (except stable dose of vitamin E is allowed as long as it was started > 30 days prior to study registration and are to be continued through the study period; soy is allowed, if it is planned to be continued at the same dose during the study period)', ' No current use of magnesium for any indication (except one standard multiple vitamin dose is allowed per day)', ' Not taking diuretics, corticosteroids, bile acid sequestrants, and other prescription and over-the-counter medications that may affect magnesium levels', ' No current ( 7 days prior to registration) or planned use of other non-drug therapies for managing hot flashes, such as acupuncture or yoga (use of these therapies for other reasons is allowed)'], 'Results': ['Outcome Measurement: ', ' The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.', ' The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.', ' The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.', ' The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group.', ' Time frame: Baseline to Week 8', 'Results 1: ', ' Arm/Group Title: Low Dose Magnesium Oxide (800 mg/Day)', ' Arm/Group Description: Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Overall Number of Participants Analyzed: 88', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 81 participants', ' 16.02 (9.62)', ' Week 1: 81 participants', ' 14.28 (9.26)', ' Week 2: 79 participants', ' 12.68 (8.87)', ' Week 3: 78 participants', ' 12.29 (9.79)', ' Week 4: 78 participants', ' 11.73 (10.35)', ' Week 5: 75 participants', ' 11.77 (10.86)', ' Week 6: 71 participants', ' 11.61 (10.46)', ' Week 7: 71 participants', ' 11.92 (11.26)', ' Week 8: 69 participants', ' 12.17 (10.88)', 'Results 2: ', ' Arm/Group Title: High Dose Magnesium Oxide (1200 mg/Day)', ' Arm/Group Description: Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Overall Number of Participants Analyzed: 88', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 81 participants', ' 15.35 (10.53)', ' Week 1: 78 participants', ' 14.47 (11.10)', ' Week 2: 78 participants', ' 12.59 (10.01)', ' Week 3: 76 participants', ' 11.32 (10.72)', ' Week 4: 73 participants', ' 10.14 (8.61)', ' Week 5: 67 participants', ' 9.73 (9.19)', ' Week 6: 67 participants', ' 9.44 (8.99)', ' Week 7: 67 participants', ' 9.37 (9.24)', ' Week 8: 66 participants', ' 9.06 (8.87)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/92 (0.00%)', ' Diarrhea 0/92 (0.00%)', 'Adverse Events 2:', ' Total: 1/93 (1.08%)', ' Diarrhea 1/93 (1.08%)']}
|
eb00b609-f17b-4595-87bd-d0843ec9e39a
|
Comparison
|
Intervention
|
NCT00904033
|
NCT03592121
|
Patients are not required to be sexually active to receive the primary trial intervention, this is however a requirement for the secondary trial where the intervention must be applied during sexual activity.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT03592121', 'Intervention': ['INTERVENTION 1: ', ' AB-101', ' Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' AB-101: Apply approximately 1 hour prior to sexual activity', 'INTERVENTION 2: ', ' Placebo', ' Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' Placebo: Apply approximately 1 hour prior to sexual activity'], 'Eligibility': ['Inclusion Criteria:', ' Female breast cancer survivor', ' Age: 18 to 70', ' First diagnosed with Stage I or II breast cancer', ' Have had breast surgery: nipple sparring mastectomy or lumpectomy', ' At least 3 years post surgery', ' Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)', ' Baseline nipple sensitivity <=5 (likeartLikert scale)', ' QoL-BC (>=7)', ' Delayed orgasm (CTCAE v4.0) Grade 2', ' One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3', ' Able to give informed consent', ' Currently in a monogamous heterosexual relationship for at least 12 months', ' Sexually active within the last 30 days', ' Willing to engage in sexual activity at least once a month during the duration of the study', ' Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet', ' Willing to use an adequate method of birth control', ' Able to comply with the study requirements for 8 consecutive weeks', ' Able to give informed consent', 'Exclusion Criteria:', ' Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class', ' Currently pregnant', ' Nursing within the last 6 months prior to beginning the study', ' History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery', ' Actively being treated for breast cancer', ' Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months', ' Uncontrolled or severe hypertension', ' Decreased oxygen in the tissues or blood', ' Active inflammation of the liver', ' Acute inflammation of the pancreas', ' Overactive thyroid gland', ' Acidosis', ' Diabetes', ' Spinal cord injury', ' Nipple dermatitis', ' Regional complex pain syndrome', ' Use of any hypertensive drugs', ' Use of MAO inhibitors', ' Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I', ' In partners: sexual dysfunction or erectile dysfunction', ' Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days', ' Nipple dermatitis', ' Regional complex pain syndrome', ' Unable to provide consent or make allotted clinical visits'], 'Results': ['Outcome Measurement: ', ' Change in Delayed Orgasm Grade', ' Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0', ' Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax.', ' This is a binary grading system:', ' Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship', ' Time frame: [baseline, week 8]', 'Results 1: ', ' Arm/Group Title: AB-101', ' Arm/Group Description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' AB-101: Apply approximately 1 hour prior to sexual activity', ' Overall Number of Participants Analyzed: 3', ' Mean (Standard Deviation)', ' Unit of Measure: Grade -0.33 (0.58)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' Placebo: Apply approximately 1 hour prior to sexual activity', ' Overall Number of Participants Analyzed: 0', ' Mean (Standard Deviation)', ' Unit of Measure: Grade '], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/0']}
|
8bc9ea31-b731-4799-a1cc-a5ba63da00c1
|
Single
|
Results
|
NCT01684215
|
In the primary trial there was no recorded difference in the Number/percentage of Participants With Dose Limiting Toxicities taking 100 mg vs 125 mg of oral PD-0332991, meaning 0% of patients in the primary trial suffered grade 4 or above thrombocytopenia.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01684215', 'Intervention': ['INTERVENTION 1: ', ' PD-0332991 100 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', 'INTERVENTION 2: ', ' PD-0332991 125 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.'], 'Eligibility': ['Inclusion Criteria:', ' Phase 1', ' In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.', ' In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 or 1.', ' Resolved acute effects of any prior therapy to baseline severity or Grade 1', ' Phase 2', ' Adult women ( 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 to 2.', 'Exclusion Criteria:', ' Phase 1', ' Active uncontrolled or symptomatic CNS metastases.', ' Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse', ' Active or unstable cardiac disease or history of heart attack within 6 months', ' Phase 2', ' HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.', ' Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.', ' Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1', ' DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.', ' Time frame: Lead-in period (Day -7) up to Day 28 (Cycle 1)', 'Results 1: ', ' Arm/Group Title: PD-0332991 100 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: PD-0332991 125 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0864493d-9f64-49d1-a585-21be71704c59
|
|
Single
|
Intervention
|
NCT02780713
|
Both cohorts of the primary trial are administered the same doses of their respective drugs .
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT02780713', 'Intervention': ['INTERVENTION 1: ', ' Treatment Period 1', ' Participants received AZD9496 - Variant A (100 mg).', 'INTERVENTION 2: ', ' Treatment Period 2', ' Participants received AZD9496 - Reference (100 mg).'], 'Eligibility': ['Inclusion Criteria:', ' Provision of signed and dated, written informed consent prior to any study specific procedures.', ' Healthy male and/or female subjects aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.', ' Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria: Post-menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the post-menopausal range (OR) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation', ' Male subjects aged 18 to 39 years must be vasectomized. Male subjects aged 40 to 65 years must either be vasectomized or have no intention of fathering a child for a period of 6 months after receiving the last dose of IMP.', ' Have a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive.', ' Values for AST, ALT, TBL, GGT and ALP must be at or below the upper limit of normal ranges at screening.', 'Exclusion Criteria:', " History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.", ' History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.', ' Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.', ' Previous history of venous or arterial thromboembolism or thrombophilia.', ' History of endometrial polyps, endometrial cancer, atypical endometrial hyperplasia, or other endometrial disorders unless subjects have undergone total hysterectomy and there is no evidence of active disease (females only).', ' Any clinically significant abnormalities in clinical chemistry (other than Inclusion no.6), hematology, or urinalysis results at screening, as judged by the investigator.', ' Any clinically significant abnormal findings in supine vital signs, after 10 minutes of supine rest, at screening and/or admission to the unit, defined as: (a) Systolic blood pressure < 90 mmHg or 150 mmHg (b) Diastolic blood pressure < 50 mmHg or 95 mmHg and (c) Heart rate < 45 or > 90 beats per minute', ' Any clinically important abnormalities in rhythm, conduction or morphology of the resting 12-lead ECG that, as judged by the investigator, that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or pronounced left ventricular hypertrophy.', ' Prolonged QTcF > 460 ms for females and QTcF > 450 ms for males or family history of long QT syndrome.', ' PR (PQ) interval shortening < 110 ms or evidence of ventricular pre-excitation).', ' PR (PQ) interval prolongation > 240 ms, intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block.', ' Persistent or intermittent complete bundle branch block with QRS > 120 ms or evidence of pronounced ventricular hypertrophy or pre-excitation.', ' Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody.', ' Known or suspected history of drug abuse, as judged by the investigator.', ' Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.', ' Known or suspected history of alcohol or drug abuse or excessive intake of alcohol, as judged by the investigator.', ' Positive screen for drugs of abuse, alcohol or cotinine at screening or on each admission to the unit.', ' History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9496.', ' Excessive intake of caffeine/xanthine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.', " Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.", ' Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life Note: Hormonal replacement therapy is not allowed for females.', ' Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening', ' Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion is 3 months after the final dose from previous study or 1 month after the last visit of previous study, whichever is the longest. ote: Subjects consented and screened, but not dosed in this study or a previous phase I study, are not excluded.', ' Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives', ' Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.', ' Subjects who are vegans or have medical dietary restrictions.', ' Subjects who cannot communicate reliably with the investigator.', ' Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.'], 'Results': ['Outcome Measurement: ', ' Pharmacokinetics: Maximum Plasma Concentration (Cmax) for AZD9496 and Its Metabolites at Each Treatment Period.', ' To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.', ' Time frame: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment period', 'Results 1: ', ' Arm/Group Title: Treatment Period 1', ' Arm/Group Description: Participants received AZD9496 - Variant A (100 mg).', ' Overall Number of Participants Analyzed: 14', ' Geometric Mean (Geometric Coefficient of Variation)', ' Unit of Measure: ng/mL AZD9496: 64.85 (73.54%)', ' M3: 10.30 (98.93%)', ' M5: 1.102 (85.27%)', 'Results 2: ', ' Arm/Group Title: Treatment Period 2', ' Arm/Group Description: Participants received AZD9496 - Reference (100 mg).', ' Overall Number of Participants Analyzed: 14', ' Geometric Mean (Geometric Coefficient of Variation)', ' Unit of Measure: ng/mL AZD9496: 381.0 (55.83%)', ' M3: 62.98 (76.91%)', ' M5: 7.409 (75.18%)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c49428a7-cc55-474e-a773-88ff2019de1b
|
|
Comparison
|
Intervention
|
NCT00611624
|
NCT00600340
|
the primary trial and the secondary trial administer their interventions at different frequencies.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00611624', 'Intervention': ['INTERVENTION 1: ', ' Five Days of Mammosite Therapy', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.', ' Patient must be > 50 years old.', ' The patient should have a life expectancy of at least two years.', ' The patient must have stage 0 , I , or II breast cancer. If stage IIA, the tumor size must be 3 cm or less and the patients must be node negative.', ' On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.', ' Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.', ' Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)', ' Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is NOT required for patients with DCIS.)', ' The patient must have the MammoSite catheter placed within 4 weeks or 28 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). Placement of a spacer for the MammoSite catheter is permitted at their final surgery.', ' Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible.', ' Chemotherapy is permitted if planned for >2 weeks after removal of Mammosite catheter.', ' Patient must be ineligible or have refused enrollment on the randomized trial RTOG (Radiation Therapy Oncology Group) 0413.', 'Exclusion Criteria:', ' Men are not eligible for this study.', ' T2 (>3.0 cm), T3, node positive, stage III or IV breast cancer.', ' Any positive axillary nodes.', ' Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.', ' Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.', ' Non-epithelial breast malignancies such as sarcoma or lymphoma.', ' Proven multicentric carcinoma in more than one quadrant or separated by more than 3 centimeters.', " Paget's disease of the nipple.", ' History of invasive breast cancer or DCIS in the same breast.', ' Surgical margins that cannot be microscopically assessed or are less then 2 mm.', ' Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.', ' Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.', ' Patients with coexisting medical conditions in whom life expectancy is < 2 years.', ' Patients with skin involvement, regardless of tumor size.', ' Patients for whom treatment with the MammoSite catheter is not feasible, such as those with too little breast tissue between the skin and the catheter (as determined by distance of dose calculations).'], 'Results': ['Outcome Measurement: ', ' Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.', ' Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.', ' Time frame: one year', 'Results 1: ', ' Arm/Group Title: Five Days of Mammosite Therapy', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 2 Toxicity: 2 7.7%', ' Grade 3 Toxicity: 0 0.0%', ' Grade 4 Toxicity: 0 0.0%', ' Grade 5 Toxicity: 0 0.0%', ' Did not experience >= Grade 2 Toxicity: 24 92.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00600340', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab Plus Paclitaxel', ' Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', 'INTERVENTION 2: ', ' Bevacizumab Plus Capecitabine', ' Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks'], 'Eligibility': ['Inclusion Criteria', ' Written informed consent obtained prior to any study-specific procedure.', ' Age 18 years.', ' Able to comply with the protocol.', ' Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.', ' Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.', ' Life expectancy more than 12 weeks.', ' Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:', ' Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.', ' Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin.', ' Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that:', ' no more than 30% of marrow-bearing bone was irradiated', ' the last fraction of radiotherapy was administered 3 weeks prior to randomization.', ' Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF 50% by either echocardiogram or multigated acquisition scan (MUGA).', ' Adequate hematological function', ' Absolute neutrophil count (ANC) 1.5 x 109/L', ' Platelet count 100 x 109/L', ' Hemoglobin 9 g/dL (may be transfused to maintain or exceed this level).', ' Adequate liver function', ' Total bilirubin 1.25 x upper normal limit (ULN)', ' Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5.0 x ULN in patients with liver metastases.', ' Adequate renal function', ' Serum creatinine 1.25 x ULN or calculated creatinine clearance 50 mL/min.', ' Urine dipstick for proteinuria < +2. Patients discovered to have +2 proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate 1g of protein in 24 hours', ' The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization', ' Patients on heparin treatment should have a baseline activated partial thromboplastin time (aPTT) between 1.5 - 2.5 times ULN or patients value before starting heparin treatment', ' Patients on low molecular weight heparins (LMWH) should receive daily dose of 1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent anticoagulant, according to package insert', ' Patients on coumarin derivatives should have an international normalized ratio (INR) between 2.0 and 3.0 assessed at baseline in two consecutive measurements 1-4 days apart', ' Patients not receiving anticoagulant medication must have an INR 1.5 and aPTT 1.5 times ULN within 7 days prior to randomization', ' Exclusion Criteria', ' Previous chemotherapy for metastatic or locally recurrent breast cancer.', ' Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization.', ' Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above).', ' Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.', ' Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization.', ' Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases.', ' History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).', ' Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.', ' Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization.', ' Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).', ' Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).', ' History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.', ' Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg).', ' Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.', ' Non-healing wound, active peptic ulcer or bone fracture.', ' History of abdominal fistula, or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization.', ' Active infection requiring i.v. antibiotics at randomization.', ' Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.', ' Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug.', ' Men who do not agree to use effective contraception during the study and for a period of 6 months following the last administration of study drug.', ' Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study', ' Clinically significant malabsorption syndrome or inability to take oral medication.', ' Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake.', ' Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.', ' Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications.', ' Known Dihydropyrimidine Dehydrogenase (DPD) deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency)', ' Known hypersensitivity to any of the study drugs (including 5-FU) or excipients. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. History of hypersensitivity reactions with drugs formulated in Cremophor® EL (polyoxyethylated castor oil), or previous therapy with bevacizumab.'], 'Results': ['Outcome Measurement: ', ' Overall Survival (PP Population)', " Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.", ' Time frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab Plus Paclitaxel', ' Arm/Group Description: Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', ' Overall Number of Participants Analyzed: 266', ' Median (95% Confidence Interval)', ' Unit of Measure: months 30.2 (25.6 to 32.6)', 'Results 2: ', ' Arm/Group Title: Bevacizumab Plus Capecitabine', ' Arm/Group Description: Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m twice-daily, days 1-14, every 3 weeks', ' Overall Number of Participants Analyzed: 265', ' Median (95% Confidence Interval)', ' Unit of Measure: months 26.1 (22.3 to 29.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 65/284 (22.89%)', ' Anaemia 0/284 (0.00%)', ' Febrile neutropenia 2/284 (0.70%)', ' Leukopenia 1/284 (0.35%)', ' Neutropenia 1/284 (0.35%)', ' Acute coronary syndrome 0/284 (0.00%)', ' Acute myocardial infarction 1/284 (0.35%)', ' Atrial fibrillation 1/284 (0.35%)', ' Atrioventricular block 1/284 (0.35%)', ' Atrioventricular block complete 0/284 (0.00%)', ' Cardio-respiratory arrest 0/284 (0.00%)', 'Adverse Events 2:', ' Total: 68/277 (24.55%)', ' Anaemia 4/277 (1.44%)', ' Febrile neutropenia 1/277 (0.36%)', ' Leukopenia 1/277 (0.36%)', ' Neutropenia 1/277 (0.36%)', ' Acute coronary syndrome 1/277 (0.36%)', ' Acute myocardial infarction 0/277 (0.00%)', ' Atrial fibrillation 0/277 (0.00%)', ' Atrioventricular block 0/277 (0.00%)', ' Atrioventricular block complete 1/277 (0.36%)', ' Cardio-respiratory arrest 1/277 (0.36%)']}
|
78136809-c8de-4c40-9a7e-1d61d879ba27
|
Single
|
Eligibility
|
NCT00009945
|
Patients with a positive sentinel node biopsy must have surgery to remove lymph nodes from the armpit (underarm or axilla) or they will not be eligible for the primary trial.
|
Entailment
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT00009945', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Clodronate', ' Patient receives 2 tablets once daily for 3 years.', ' clodronate: 1600 mg PO daily', 'INTERVENTION 2: ', ' Arm 2: Placebo', ' Patient receives 2 tablets once daily for 3 years.', ' placebo: 2 pills PO daily'], 'Eligibility': ['Eligibility', ' Patients must have undergone either a total mastectomy or a lumpectomy with either an axillary dissection or sentinel node biopsy. If any sentinel node is histologically positive by H & E, or histologically suspicious on H & E and confirmed positive by immunohistochemistry (IHC), then the patient must have a completion axillary dissection.', ' The tumor must be invasive adenocarcinoma on histologic examination with clinical assessment T1-3, N0-1, M0.', ' Patients must not be participating in any other clinical trials of systemic therapy for early-stage breast cancer. Patients may participate in the following radiation therapy trials:', ' Node-positive patients may participate in the National Cancer Institute of Canada Clinical Trials Group protocol MA.20, provided the requirements of the B-34 protocol continue to be met. (Node-negative B-34 patients may not participate in MA.20.)', ' Node-positive mastectomy patients may participate in Southwest Oncology Group protocol S9927, provided the requirements of the B-34 protocol continue to be met.', ' Patients must have an analysis of both estrogen and progesterone receptors on the primary tumor performed prior to randomization. Tumors will be defined as ER or progesterone receptor (PgR) positive if: 1) the Dextran-coated charcoal or sucrose-density gradient method shows them to have greater than or equal to 10 fmol/mg cytosol protein, or 2) if using individual laboratory criteria they can be shown to be positive by the enzyme immunoassay method (EIA) or immunocytochemical assay. "Marginal or borderline," results (i.e., those not definitively negative) will also be considered positive.', ' At the time of randomization, the patient must have had the following within the past 3 months: history and physical exam, a bone scan, thoracic and lumbar spine x-rays, and a chest x-ray. Within the past 12 months patients must have had a gynecologic exam (for women who have a uterus and who will be taking tamoxifen) and a bilateral mammogram.', ' At the time of randomization:', ' the postoperative absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3 (or less than 1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal);', ' the postoperative platelet count must be greater than or equal to 100,000;', ' there must be postoperative evidence of adequate hepatic function, i.e.,', ' total bilirubin at or below the upper limit of normal (ULN) for the laboratory; and', ' alkaline phosphatase less than 2.5 x the ULN; and', ' the serum glutamate oxaloacetate transaminase (SGOT)/ aspartate transaminase (AST) less than 1.5 x the ULN;', " there must be postoperative evidence of adequate renal function (serum creatinine within or less than the laboratory's normal range).", ' Serum albumin and serum calcium must be within normal limits.', ' A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.', ' Patients with prior nonbreast malignancies are eligible if they have been disease- free for greater than or equal to 5 years before randomization and are deemed at low risk for recurrence by their treating physicians. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast treated by hormone therapy and/or surgery only are eligible, even if these were diagnosed within 5 years before randomization.', ' Patients must have a Zubrod performance status of 0, 1, or 2.', ' Special conditions for eligibility of lumpectomy patients: Irradiation and surgery. Patients treated by lumpectomy and axillary node dissection (or no axillary dissection if sentinel node biopsy is negative) to be followed by breast radiation therapy must meet all the eligibility criteria in addition to the following:', " Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible.", ' The margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS). For patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margins after re-excision(s) must undergo total mastectomy to be eligible.', ' Ineligibility.', ' Significant non-malignant bone disease that is likely to interfere with the interpretation of bone x-rays.', " Ulceration, erythema, infiltration of the skin or the underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these conditions are eligible.)", ' Ipsilateral lymph nodes that on clinical examination are found to be fixed to one another or to other structures (cN2 disease).', ' Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with tumor.', ' Prior therapy for breast cancer, including irradiation, chemotherapy, biotherapy, and/or hormonal therapy, with the exception of tamoxifen. Tamoxifen may be given as adjuvant therapy before study entry, but only if it was started within 28 days before randomization. Patients who started tamoxifen within 28 days before randomization and who are being considered for chemotherapy must have their tamoxifen stopped at the start of chemotherapy.', ' Prior history of breast cancer, except LCIS.', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.) Exceptions: patients may use low-dose estrogen vaginal creams or Estring® for symptomatic vaginal dryness, raloxifene (or other selective estrogen receptor modulators [SERMs]) for the prevention of osteoporosis, and luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists for the purpose of medical ovarian ablation as a component of adjuvant therapy for the breast cancer.', ' Patients currently taking alendronate (Fosamax®) or other bisphosphonates or calcitonin to treat or prevent osteoporosis are not eligible.', ' Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.', ' Psychiatric or addictive disorders that would preclude obtaining informed consent.', ' Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women because the effects of clodronate on such women have not been studied fully.', ' Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.', ' Special conditions for ineligibility of lumpectomy patients: Irradiation and surgery. The following patients will also be ineligible:', ' Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.', ' Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.', ' Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival.', ' Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years', ' Time frame: 8 years', 'Results 1: ', ' Arm/Group Title: Arm 1: Clodronate', ' Arm/Group Description: Patient receives 2 tablets once daily for 3 years.', ' clodronate: 1600 mg PO daily', ' Overall Number of Participants Analyzed: 1655', ' Measure Type: Number', ' Unit of Measure: percentage of patients 81.0', 'Results 2: ', ' Arm/Group Title: Arm 2: Placebo', ' Arm/Group Description: Patient receives 2 tablets once daily for 3 years.', ' placebo: 2 pills PO daily', ' Overall Number of Participants Analyzed: 1656', ' Measure Type: Number', ' Unit of Measure: percentage of patients 79.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 340/1612 (21.09%)', ' Anemia 10/1612 (0.62%)', ' Blood and lymphatic system disorders - Other, specify 3/1612 (0.19%)', ' Febrile neutropenia 7/1612 (0.43%)', ' Cardiac disorders - Other, specify 6/1612 (0.37%)', ' Conduction disorder 2/1612 (0.12%)', ' Myocardial infarction 6/1612 (0.37%)', ' Palpitations 1/1612 (0.06%)', ' Pericardial effusion 0/1612 (0.00%)', ' Sinus bradycardia 2/1612 (0.12%)', 'Adverse Events 2:', ' Total: 350/1623 (21.57%)', ' Anemia 8/1623 (0.49%)', ' Blood and lymphatic system disorders - Other, specify 3/1623 (0.18%)', ' Febrile neutropenia 4/1623 (0.25%)', ' Cardiac disorders - Other, specify 2/1623 (0.12%)', ' Conduction disorder 1/1623 (0.06%)', ' Myocardial infarction 4/1623 (0.25%)', ' Palpitations 0/1623 (0.00%)', ' Pericardial effusion 2/1623 (0.12%)', ' Sinus bradycardia 0/1623 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
b430ea52-fa55-4280-9e23-8a7392afca58
|
|
Single
|
Results
|
NCT00038103
|
There is no difference in the proportions of Subjects With Clinical Benefit in the Exemestane + Celecoxib cohort and in the Exemestane alone cohort of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00038103', 'Intervention': ['INTERVENTION 1: ', ' Exemestane (Exemestane Alone)', ' oral dose exemestane taken with food (25 mg tablet once daily)', 'INTERVENTION 2: ', ' Combination (Exemestane + Celecoxib)', ' oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.', ' Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.', ' at least one measurable lesion', 'Exclusion Criteria:', ' More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.', ' Previous hormonotherapy for advanced disease other than Tamoxifen.', ' Myocardial infarction within previous 6 mo'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Clinical Benefit', ' Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.', ' Time frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)', 'Results 1: ', ' Arm/Group Title: Exemestane (Exemestane Alone)', ' Arm/Group Description: oral dose exemestane taken with food (25 mg tablet once daily)', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants 24', 'Results 2: ', ' Arm/Group Title: Combination (Exemestane + Celecoxib)', ' Arm/Group Description: oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: participants 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9', ' Cardiac Failure Congestive 0/53 (0.00%)', ' Ascites 1/53 (1.89%)', ' Nausea 1/53 (1.89%)', ' Vomiting 2/53 (3.77%)', ' Intestinal Obstruction 1/53 (1.89%)', ' Diarrhoea 0/53 (0.00%)', ' Pain 1/53 (1.89%)', ' Death 1/53 (1.89%)', ' General physical health deterioration 1/53 (1.89%)', ' Gait Disturbance 1/53 (1.89%)', ' Asthenia 2/53 (3.77%)', ' Fatigue 0/53 (0.00%)', 'Adverse Events 2:', ' Total: 14', ' Cardiac Failure Congestive 1/56 (1.79%)', ' Ascites 0/56 (0.00%)', ' Nausea 0/56 (0.00%)', ' Vomiting 0/56 (0.00%)', ' Intestinal Obstruction 0/56 (0.00%)', ' Diarrhoea 1/56 (1.79%)', ' Pain 1/56 (1.79%)', ' Death 1/56 (1.79%)', ' General physical health deterioration 1/56 (1.79%)', ' Gait Disturbance 1/56 (1.79%)', ' Asthenia 0/56 (0.00%)', ' Fatigue 1/56 (1.79%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
adfeff22-7bdd-4868-ab6e-90dd43d9621d
|
|
Comparison
|
Adverse Events
|
NCT00371345
|
NCT00475670
|
There only overlap between adverse events obeserved in the primary trial and the secondary trial is the several case of Sepsis which occurred in both trials.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'Clinical Trial ID': 'NCT00371345', 'Intervention': ['INTERVENTION 1: ', ' Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib', ' Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.', 'INTERVENTION 2: ', ' Her2/Neu-amplified Tumor, 100 mg BID', ' Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.'], 'Eligibility': ['Inclusion Criteria:', ' females, 18 or older', ' recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu', ' paraffin-embedded tissue block must be available', ' measurable disease', ' prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)', ' 0, 1 or 2 chemotherapies in the metastatic setting', ' adequate organ function', 'Exclusion Criteria:', ' Metastatic disease confined to bone only', ' Symptomatic central nervous system (CNS) metastasis', ' Concurrent medical condition which may increase the risk of toxicity', ' Unable to take oral medication'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response', ' Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.', ' Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.', 'Results 1: ', ' Arm/Group Title: Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib', ' Arm/Group Description: Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Her2/Neu-amplified Tumor, 100 mg BID', ' Arm/Group Description: Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/70 (28.57%)', ' NAUSEA 2/70 (2.86%)', ' VOMITING 1/70 (1.43%)', ' DIARRHOEA 2/70 (2.86%)', ' ABDOMINAL PAIN 1/70 (1.43%)', ' ABDOMINAL PAIN LOWER 1/70 (1.43%)', ' FATIGUE 2/70 (2.86%)', ' PYREXIA 1/70 (1.43%)', ' OEDEMA PERIPHERAL 1/70 (1.43%)', ' GENERAL PHYSICAL HEALTH DETERIORATION 3/70 (4.29%)', ' PNEUMONIA 1/70 (1.43%)', ' SINUSITIS 1/70 (1.43%)', ' LOBAR PNEUMONIA 1/70 (1.43%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT00475670', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Monotherapy', ' Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.', 'INTERVENTION 2: ', ' Trastuzumab, Taxane', " Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks."], 'Eligibility': ['Inclusion Criteria:', ' at least 10 months of Herceptin treatment for HER2-positive early breast cancer;', ' metastatic breast cancer >=12 months after discontinuation of Herceptin;', ' measurable disease.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic breast cancer;', ' brain metastases;', ' invasive malignancy other than metastatic breast cancer.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines', ' CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.', ' Time frame: Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited', 'Results 1: ', ' Arm/Group Title: Trastuzumab Monotherapy', ' Arm/Group Description: Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: percentage of participants ', 'Results 2: ', ' Arm/Group Title: Trastuzumab, Taxane', " Arm/Group Description: Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.", ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 61.0 (48.7 to 80.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Febrile Neutropenia * 0/3 (0.00%)', ' Neutropenia * 0/3 (0.00%)', ' Sudden Death * 0/3 (0.00%)', ' Bacterial Infection * 0/3 (0.00%)', ' Bronchitis * 0/3 (0.00%)', ' Sepsis * 0/3 (0.00%)', ' Lymphoedema * 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 6/41 (14.63%)', ' Febrile Neutropenia * 1/41 (2.44%)', ' Neutropenia * 1/41 (2.44%)', ' Sudden Death * 1/41 (2.44%)', ' Bacterial Infection * 1/41 (2.44%)', ' Bronchitis * 1/41 (2.44%)', ' Sepsis * 1/41 (2.44%)', ' Lymphoedema * 1/41 (2.44%)']}
|
51b8964b-86b8-4e93-9fb1-cb4b6f7f3451
|
Single
|
Adverse Events
|
NCT00468585
|
the primary trial recorded several skin infections in their patients.
|
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': 'NCT00468585', 'Intervention': ['INTERVENTION 1: ', ' Group 0', ' Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg', 'INTERVENTION 2: ', ' Group 1', ' Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg'], 'Eligibility': ['Inclusion Criteria:', ' Patient (male or female) with diagnosis of invasive adenocarcinoma of the breast confirmed at MSKCC either by histology or cytology.', ' Clinical evidence of metastatic breast cancer, non-amenable to surgery or radiation therapy with curative intent.', ' Presence of at least one measurable metastatic lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: greater than or equal to 10 mm measured by spiral CT or greater than or equal to 20 mm measured by conventional techniques.', ' Any number of prior endocrine or biologic therapies is permitted on this trial. In addition, patients may be untreated in the metastatic setting or have received any number of prior cytotoxic regimens. All previous chemotherapy must have been discontinued at least 3 weeks prior to study entry. All acute toxic effects (excluding alopecia or neurotoxicity) of any prior therapy must have resolved to NCI CTC (Version 3) Grade less than or equal to 1.', ' Endocrine therapy with an aromatase inhibitor, SERM (ie, tamoxifen) or fulvestrant is permitted within 4 weeks of study entry, however concurrent therapy with these drugs is not acceptable.', ' ECOG performance status of 0, 1 or 2.', ' Patients must be either HER2-negative or HER2-positive and no longer a candidate for trastuzumab therapy. HER2-negative is defined as 0 or 1+ staining on immunohistochemistry or FISH negative for gene amplification. HER2-positive is defined as 3+ staining on immunohistochemistry or FISH positive for gene amplification.', ' Age greater than or equal to 18 years old.', ' Baseline laboratory data within the following limits:', ' Absolute neutrophil count (ANC) >1.5 x 10^9/L', ' Platelets > 100 x 10^9/L', ' Estimated creatinine clearance greater than or equal to 50 ml/min by - Cockcroft-Gault equation', ' Total serum bilirubin <1.5 x upper normal limit', ' ALT, AST < 2.5x upper normal limit (or <5x upper normal limit in the case of liver metastases)', ' Alkaline phosphatase < 2.5x upper normal limit (or >5x upper normal limit in the case of liver metastases or >10x upper normal limit in the case of bone disease)', ' Serum or urine pregnancy test for females of childbearing potential Negative within 14 days of starting treatment', 'Exclusion Criteria:', ' Pregnant or nursing women may not participate. Patients of reproductive potential may not participate unless they have agreed to use an effective method of contraception and to continue contraception for 30 days from the date of the last study drug administration. Postmenopausal woman must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.', ' Life expectancy < 3 months.', ' Serious, uncontrolled, concurrent infection.', ' Any prior fluoropyrimidine therapy with the exception of adjuvant administration. Adjuvant fluoropyrimidine containing therapy must be completed at least 6 months prior to enrollment.', ' Prior severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil. A history of DPD deficiency will exclude patients from the trial.', ' Completion of previous chemotherapy regimen <3 weeks prior to the start of study treatment.', ' Prior adjuvant hormonal therapy is permitted. Use of an aromatase inhibitor, anti-estrogen or fulvestrant must be discontinued prior to treatment start.', ' Biologic therapy (eg, bevacizumab,trastuzumab) for the treatment of metastatic disease must be discontinued >3 weeks from the start of protocol treatment.', ' HER2-positive patients who are candidates for treatment with trastuzumab are excluded from this trial as the concurrent use of trastuzumab may confound study results.', ' History of prior malignancy with the following exceptions: adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission (with no evidence of disease) for more than five years.', ' Non-malignant systemic disease (cardiovascular, renal, hepatic etc) that would preclude any of the study therapy drugs. Specifically excluded are the following cardiac conditions:', ' Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medications)', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) Class II or greater congestive heart failure', ' History of myocardial infarction or unstable angina within 6 months', ' History of stroke or transient ischemic attack within 6 months', ' Significant vascular disease or symptomatic peripheral vascular disease', ' Capecitabine is contraindicated in patients with a creatinine clearance of <30 ml/min.Patients with a creatinine clearance less than 50 ml/minute by Cockroft and Gault Equation will be excluded from the trial.', ' Patients with symptomatic CNS metastases that remain untreated by radiation therapy are excluded from this trial. The presence of asymptomatic brain metastases or brain metastases that have been previously irradiated are not grounds for trial exclusion for the phase I study however, these patients are excluded from the phase II portion of the trial.', ' 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.', ' 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. Any of the above criteria that in the judgment of the investigator would make the subject inappropriate for entry into this study.', ' Presence of uncontrolled gastrointestinal malabsorption syndrome.', ' Concurrent use of oral warfarin anticoagulant therapy is not permitted due to serious drug interactions with capecitabine. Full dose anticoagulation with low molecular weight heparin or other (non-warfarin) anticoagulant is permitted.', ' Unwillingness to give written informed consent or 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 for participation in this clinical trial.', ' Concurrent radiation therapy is not permitted during treatment on protocol.'], 'Results': ['Outcome Measurement: ', ' Overall Objective Response', ' This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Group 0', ' Arm/Group Description: Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants Partial Response (PR): 0', ' Stable Disease (SD): 2', ' Progression of Disease (POD): 1', 'Results 2: ', ' Arm/Group Title: Group 1', ' Arm/Group Description: Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants Partial Response (PR): 0', ' Stable Disease (SD): 1', ' Progression of Disease (POD): 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/4 (50.00%)', ' Atrial fibrillation 0/4 (0.00%)', ' Dehydration 1/4 (25.00%)', ' Fatigue (asthenia, lethargy, malaise) 1/4 (25.00%)', ' Pain - Back 1/4 (25.00%)', ' Urinary tract infection 0/4 (0.00%)', ' Dyspnea (shortness of breath) 0/4 (0.00%)', ' Pericardial effusion 0/4 (0.00%)', ' Thrombosis 0/4 (0.00%)', ' Skin infection 0/4 (0.00%)', ' Rash: hand-foot skin reaction 0/4 (0.00%)', 'Adverse Events 2:', ' Total: 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Fatigue (asthenia, lethargy, malaise) 0/3 (0.00%)', ' Pain - Back 0/3 (0.00%)', ' Urinary tract infection 0/3 (0.00%)', ' Dyspnea (shortness of breath) 0/3 (0.00%)', ' Pericardial effusion 0/3 (0.00%)', ' Thrombosis 0/3 (0.00%)', ' Skin infection 0/3 (0.00%)', ' Rash: hand-foot skin reaction 0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
276f5523-f45b-45b0-ad30-b737f2c1b1d0
|
|
Single
|
Eligibility
|
NCT00295867
|
Patients with an ECOG score between 3-5 are eligible for the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] |
[] |
{'Clinical Trial ID': 'NCT00295867', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid', ' Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.'], 'Eligibility': ['Inclusion Criteria', ' Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.', ' If adjuvant chemotherapy is recommended, it must be completed before study start.', ' Bone marrow aspirate positive by IC/FC assay', ' a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer.', ' ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed.', ' Adequate renal function as defined by:', ' a. Creatinine must be < upper limit of normal', ' Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)', ' Ability to understand and sign informed consent.', ' Concomitant hormonal therapy is allowed', ' Concomitant radiation therapy is allowed', ' Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial', ' Exclusion Criteria', ' History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction.', ' History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause.', ' Karnofsky Performance status < 90%.', ' Any significant medical condition that might interfere with treatment.', ' Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.', ' Patients who are pregnant'], 'Results': ['Outcome Measurement: ', ' Response of Bone Marrow Micrometastases', ' Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months', ' Time frame: up to 2 years', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid', ' Arm/Group Description: Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.', ' Overall Number of Participants Analyzed: 34', ' Median (Full Range)', ' Unit of Measure: DTCs/mL -4.5 (-5.9 to 43.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/45 (2.22%)', ' appendicitis 1/45 (2.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
884ba067-d3fe-4837-ad2a-a802b671b53c
|
|
Single
|
Eligibility
|
NCT02222337
|
Participants for the primary trial must be in pairs, a breast cancer survivor and a caregiver, both must either be fluent in english or spanish.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT02222337', 'Intervention': ['INTERVENTION 1: ', ' Usual Care Survivors', ' Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', 'INTERVENTION 2: ', ' Usual Care Caregivers', ' Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.', ' Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish', 'Exclusion Criteria:', ' Inability to understand spoken English and/or Spanish and/or', ' Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).'], 'Results': ['Outcome Measurement: ', ' PROMIS Physical Functioning', ' Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Usual Care Survivors', ' Arm/Group Description: Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', ' Overall Number of Participants Analyzed: 57', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 44.61 (8.71)', 'Results 2: ', ' Arm/Group Title: Usual Care Caregivers', ' Arm/Group Description: Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 53.82 (7.34)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/140 (0.00%)', 'Adverse Events 2:', ' Total: 0/130 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6619c75a-4073-47e9-8586-5070be1b3d39
|
|
Comparison
|
Eligibility
|
NCT01816594
|
NCT02222337
|
Patients with histologically confirmed, newly diagnosed stage 0 breast cancer cannot take part in the primary trial, or the secondary trial, unless they present LVEF below 50%
|
Contradiction
|
[
11
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01816594', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + BKM120 + Paclitaxel', ' BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.', 'INTERVENTION 2: ', ' Trastuzumab + BKM120 PBO + Paclitaxel', ' BKM120 placebo in combination with trastuzumab and paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Patient had provided a signed study ICF prior to any screening procedure', ' Patient was a female 18 years of age', ' Patient has an ECOG performance status of 0-1', ' Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by MRI', ' Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status', ' Patient has adequate bone marrow, renal and liver function', ' Patient is able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patient has received prior systemic treatment for currently diagnosed disease', ' Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor', ' Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer', ' LVEF below 50% as determined by MUGA scan or ECHO', ' Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol', ' Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120', ' Patient is currently receiving warfarin or other coumarin derived anti-coagulants', ' Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)', ' Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A', ' Patient has certain scores on an anxiety and depression mood questionnaires', ' Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate at the Time of Surgery - All Participants', ' Rate of pCR (as defined by NSABP criteria - absence of invasive disease in the breast [ypT0]) is the number of of participants with pathological complete response (pCR) at the time of surgery. Participants were to be considered in pCR if there was no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. NSABP guidelines do not take into account the histological nodal status to define the pCR.', ' Time frame: After 6 weeks', 'Results 1: ', ' Arm/Group Title: Trastuzumab + BKM120 + Paclitaxel', ' Arm/Group Description: BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 32.0 (14.9 to 53.5)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + BKM120 PBO + Paclitaxel', ' Arm/Group Description: BKM120 placebo in combination with trastuzumab and paclitaxel', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 40.0 (21.1 to 61.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/25 (32.00%)', ' Diarrhoea 1/25 (4.00%)', ' Catheter site pain 1/25 (4.00%)', ' Pyrexia 1/25 (4.00%)', ' Thrombosis in device 0/25 (0.00%)', ' Hepatotoxicity 1/25 (4.00%)', ' Hypersensitivity 1/25 (4.00%)', ' Acute sinusitis 0/25 (0.00%)', ' Pneumonia 1/25 (4.00%)', ' Hepatic enzyme increased 2/25 (8.00%)', ' Headache 0/25 (0.00%)', ' Mental disorder 1/25 (4.00%)', ' Pulmonary oedema 1/25 (4.00%)', 'Adverse Events 2:', ' Total: 2/25 (8.00%)', ' Diarrhoea 0/25 (0.00%)', ' Catheter site pain 0/25 (0.00%)', ' Pyrexia 0/25 (0.00%)', ' Thrombosis in device 1/25 (4.00%)', ' Hepatotoxicity 0/25 (0.00%)', ' Hypersensitivity 0/25 (0.00%)', ' Acute sinusitis 1/25 (4.00%)', ' Pneumonia 0/25 (0.00%)', ' Hepatic enzyme increased 0/25 (0.00%)', ' Headache 1/25 (4.00%)', ' Mental disorder 0/25 (0.00%)', ' Pulmonary oedema 0/25 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02222337', 'Intervention': ['INTERVENTION 1: ', ' Usual Care Survivors', ' Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', 'INTERVENTION 2: ', ' Usual Care Caregivers', ' Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.', ' Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish', 'Exclusion Criteria:', ' Inability to understand spoken English and/or Spanish and/or', ' Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).'], 'Results': ['Outcome Measurement: ', ' PROMIS Physical Functioning', ' Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Usual Care Survivors', ' Arm/Group Description: Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', ' Overall Number of Participants Analyzed: 57', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 44.61 (8.71)', 'Results 2: ', ' Arm/Group Title: Usual Care Caregivers', ' Arm/Group Description: Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 53.82 (7.34)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/140 (0.00%)', 'Adverse Events 2:', ' Total: 0/130 (0.00%)']}
|
d81fafa4-1196-407b-a8c2-27d7b5da2f4f
|
Single
|
Adverse Events
|
NCT00320710
|
There was no adverse event in cohort 2 of the primary trial which occurred in more than 0.5% of patients.
|
Contradiction
|
[
13,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
[] |
{'Clinical Trial ID': 'NCT00320710', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Every (q) 4 Weeks', ' Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.', 'INTERVENTION 2: ', ' Zoledronic Acid q 12 Weeks', ' Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;', 'Exclusion Criteria:', ' Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.', ' Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).', " Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).", ' Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.', ' Other protocol-defined exclusion criteria may have applied.'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)', ' An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.', ' Time frame: 52 weeks', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Every (q) 4 Weeks', ' Arm/Group Description: Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.', ' Overall Number of Participants Analyzed: 200', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 22', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid q 12 Weeks', ' Arm/Group Description: Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.', ' Overall Number of Participants Analyzed: 203', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 23.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 50/198 (25.25%)', ' Anaemia 1/198 (0.51%)', ' Febrile neutropenia 1/198 (0.51%)', ' Leukocytosis 1/198 (0.51%)', ' Leukopenia 2/198 (1.01%)', ' Neutropenia 1/198 (0.51%)', ' Pancytopenia 0/198 (0.00%)', ' Atrial fibrillation 0/198 (0.00%)', ' Cardiac failure congestive 0/198 (0.00%)', ' Palpitations 0/198 (0.00%)', ' Pericardial effusion 1/198 (0.51%)', ' Supraventricular tachycardia 1/198 (0.51%)', 'Adverse Events 2:', ' Total: 51/202 (25.25%)', ' Anaemia 3/202 (1.49%)', ' Febrile neutropenia 2/202 (0.99%)', ' Leukocytosis 0/202 (0.00%)', ' Leukopenia 0/202 (0.00%)', ' Neutropenia 0/202 (0.00%)', ' Pancytopenia 1/202 (0.50%)', ' Atrial fibrillation 1/202 (0.50%)', ' Cardiac failure congestive 1/202 (0.50%)', ' Palpitations 1/202 (0.50%)', ' Pericardial effusion 1/202 (0.50%)', ' Supraventricular tachycardia 1/202 (0.50%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6d8b4720-e600-47d7-b6c5-3b8627f2358f
|
|
Comparison
|
Intervention
|
NCT01646346
|
NCT03283553
|
the secondary trial and the primary trial do not use topical medications in their studies.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01646346', 'Intervention': ['INTERVENTION 1: ', ' 4D Conformal Image-Guided Partial Breast RT', ' This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.', ' 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.', ' Patient must be > 50 years old.', ' The patient should have a life expectancy of at least two years with a karnofsky performance status > 70.', ' The patient must have stage 0 or I breast cancer.', ' On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.', ' Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.', ' Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.)', ' Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS.', ' The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).', ' Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Chemotherapy is permitted if planned for 2 weeks after radiation.', ' Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy.', ' Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed.', ' The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less.', 'Exclusion Criteria:', ' Men are not eligible for this study as men are not breast conservation candidates.', ' T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.', ' Any positive axillary nodes.', ' Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.', ' Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.', ' Non-epithelial breast malignancies such as sarcoma or lymphoma.', ' Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.', " Paget's disease of the nipple.", ' History of invasive breast cancer or DCIS in the same breast.', ' Surgical margins that cannot be microscopically assessed or are less then 2 mm.', ' Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.', ' Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.', ' Patients with coexisting medical conditions in whom life expectancy is < 2 years.', ' Patients with skin involvement, regardless of tumor size.'], 'Results': ['Outcome Measurement: ', ' Patients With Reduction in Incidental Radiation', ' Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.', 'Time frame: 5 day', 'Results 1: ', ' Arm/Group Title: 4D Conformal Image-Guided Partial Breast RT', ' Arm/Group Description: This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.', ' 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 46 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)']}
|
{'Clinical Trial ID': 'NCT03283553', 'Intervention': ['INTERVENTION 1: ', ' Multicomponent Intervention', " 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", 'INTERVENTION 2: ', ' Usual Care', ' Care as usual with the medical oncologist.'], 'Eligibility': ['Inclusion Criteria:', ' Medical oncology patient: Established patient of participating medical oncologist greater than 18 years of age, have a diagnosis of early stage or advanced breast cancer, are receiving active systemic therapy (in the form of IV adjuvant systemic therapy if early stage), are English speaking, able to provide informed consent themselves, and identify a family member who they would like to include in their care.', ' Care partner: Family member (e.g. spouse, adult child, parent, adult sibling or other relative) or unpaid friend who regularly accompanies patient to medical oncology visits.', ' Medical oncology provider: Practicing medical oncology provider at a participating clinic who provides care to patients with breast cancer.', 'Exclusion Criteria:', ' Medical oncology patients: Younger than 18 years, pregnant, not being treated for breast cancer, do not attend medical oncology visits with family member or unpaid friend or unwilling for their family member or unpaid friend to be contacted.', ' Care partner: Paid non-family member who accompanies patient to visits.'], 'Results': ['Outcome Measurement: ', ' Between-group Differences in Patient Complete Illness Understanding at 9-months', ' Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.', ' Time frame: 9 months', 'Results 1: ', ' Arm/Group Title: Multicomponent Intervention', " Arm/Group Description: 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", ' Overall Number of Participants Analyzed: 63', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Illness Understanding at 9-Months: 42 66.7%', ' Not Complete Illness Understanding at 9-Months: 21 33.3%', 'Results 2: ', ' Arm/Group Title: Usual Care', ' Arm/Group Description: Care as usual with the medical oncologist.', ' Overall Number of Participants Analyzed: 55', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Illness Understanding at 9-Months: 38 69.1%', ' Not Complete Illness Understanding at 9-Months: 17 30.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/69 (0.00%)', 'Adverse Events 2:', ' Total: 0/63 (0.00%)']}
|
1b84007d-0002-4ab6-8e05-609e7de58684
|
Comparison
|
Eligibility
|
NCT00213980
|
NCT02536339
|
Adequate hematologic, renal, and hepatic function are required to participate in the secondary trial and the primary trial, however, patients with severe loss in cognitive function are still eligible.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20
] |
{'Clinical Trial ID': 'NCT00213980', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid (ZA)', ' ZA', ' Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles', 'INTERVENTION 2: ', ' Observation', ' Observation only for 12 months'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women, Stage III or axillary node positive', ' Currently disease free of breast cancer and other invasive malignancies at the time of registration', ' No concurrent use of bisphosphonates', 'Exclusion Criteria:', 'Metastatic disease'], 'Results': ['Outcome Measurement: ', ' Change in Bone Mineral Density (BMD) From Baseline to 1 Year', ' To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.', ' Time frame: Up to 1 year', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid (ZA)', ' Arm/Group Description: ZA', ' Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 29', ' Mean (95% Confidence Interval)', ' Unit of Measure: grams per cubic centimeter Lumbar Spine L1-L4 (L1-L4): 0.048 (0.034 to 0.062)', ' Femoral neck (FN): 0.014 (0.002 to 0.027)', ' Total femur (TF): 0.019 (0.011 to 0.026)', ' Trochanter (T): 0.023 (0.013 to 0.34)', ' Calcaneal (OC): 0.010 (0.004 to 0.015)', 'Results 2: ', ' Arm/Group Title: Observation', ' Arm/Group Description: Observation only for 12 months', ' Overall Number of Participants Analyzed: 27', ' Mean (95% Confidence Interval)', ' Unit of Measure: grams per cubic centimeter Lumbar Spine L1-L4 (L1-L4): 0.007 (-0.020 to 0.034)', ' Femoral neck (FN): 0.005 (-0.012 to 0.023)', ' Total femur (TF): 0.004 (-0.006 to 0.015)', ' Trochanter (T): 0.005 (-0.007 to 0.017)', ' Calcaneal (OC): 0.001 (-0.007 to 0.005)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/32 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT02536339', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab', ' Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed HER2-positive MBC', ' Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery', ' Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment', ' Stable systemic disease', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' LVEF at least 50%', ' Adequate hematologic, renal, and hepatic function', ' Life expectancy more than 12 weeks', 'Exclusion Criteria:', ' Progression of systemic disease at Screening', ' Leptomeningeal disease', ' History of intolerance or hypersensitivity to study drug', ' Use of certain investigational therapies within 21 days prior to enrollment', ' Current anthracycline use', ' Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use', ' Active infection', ' Pregnant or lactating women', ' Significant history or risk of cardiac disease', ' Symptomatic intrinsic lung disease or lung involvement', ' History of other malignancy within the last 5 years'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response in the CNS, Assessed Using Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria', ' Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. An objective response in the central nervous system (CNS) was a complete response (CR) or partial response (PR) confirmed by repeat assessment, according to RANO-BM criteria. A CR was defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically; for non-target lesions, a CR was the disappearance of all enhancing CNS non-target lesions and no new CNS lesions. A PR was defined as at least a 30% decrease in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD sustained for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; and stable or improved clinically. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.', ' Time frame: From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab', ' Arm/Group Description: Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants With Objective Response (Confirmed CR or PR): 10.8 (3.03 to 25.42)', ' Confirmed Complete Response (CR): 0.0 (0.00 to 9.49)', ' Confirmed Partial Response (PR): 10.8 (3.03 to 25.42)', ' Without Objective Response: 89.2 [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/39 (17.95%)', ' Gastroenteritis viral 1/39 (2.56%)', ' Parainfluenzae virus infection 1/39 (2.56%)', ' Seizure 4/39 (10.26%)', ' Headache 1/39 (2.56%)', ' Hydrocephalus 1/39 (2.56%)', ' Hypertension 1/39 (2.56%)']}
|
dc4f9c4a-ca42-4f4d-b93a-0e8dd627b009
|
Single
|
Adverse Events
|
NCT01007942
|
Febrile neutropenia was in excess of 5 times more common in cohort 1 of the primary trial, than in cohort 2.
|
Entailment
|
[
0,
4,
12,
16
] |
[] |
{'Clinical Trial ID': 'NCT01007942', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Vinorelbine + Trastuzumab', ' Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', 'INTERVENTION 2: ', ' Placebo + Vinorelbine + Trastuzumab', ' Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' HER2+ status defined as IHC 3+ staining or in situ hybridization positive', ' Patients with resistance to trastuzumab', ' Prior taxane therapy', ' Patients with an ECOG performance status of 0 - 2', ' Patients with measurable disease as per RECIST criteria', ' Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;', ' Patients must meet laboratory criteria defined in the study within 21 days prior to randomization', 'Exclusion Criteria:', ' Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer', ' More than three prior chemotherapy lines for advanced disease.', ' Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus', ' Peripheral neuropathy grade 2 at randomization', ' Active cardiac disease', ' History of cardiac dysfunction', ' Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer', ' Known hypersensitivity to any study medication', ' Breastfeeding or pregnant'], 'Results': ['Outcome Measurement: ', ' Progressive-free Survival (PFS) Per Investigator Assessment', ' PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Vinorelbine + Trastuzumab', ' Arm/Group Description: Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', ' Overall Number of Participants Analyzed: 284', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.00 (6.74 to 8.18)', 'Results 2: ', ' Arm/Group Title: Placebo + Vinorelbine + Trastuzumab', ' Arm/Group Description: Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', ' Overall Number of Participants Analyzed: 285', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.78 (5.49 to 6.90)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 122/280 (43.57%)', ' Agranulocytosis 0/280 (0.00%)', ' Anaemia 10/280 (3.57%)', ' Febrile neutropenia 30/280 (10.71%)', ' Immune thrombocytopenic purpura 1/280 (0.36%)', ' Leukopenia 3/280 (1.07%)', ' Neutropenia 12/280 (4.29%)', ' Thrombocytopenia 4/280 (1.43%)', ' Acute myocardial infarction 1/280 (0.36%)', ' Cardiac failure 1/280 (0.36%)', ' Cataract 2/280 (0.71%)', 'Adverse Events 2:', ' Total: 58/282 (20.57%)', ' Agranulocytosis 1/282 (0.35%)', ' Anaemia 2/282 (0.71%)', ' Febrile neutropenia 4/282 (1.42%)', ' Immune thrombocytopenic purpura 0/282 (0.00%)', ' Leukopenia 0/282 (0.00%)', ' Neutropenia 3/282 (1.06%)', ' Thrombocytopenia 1/282 (0.35%)', ' Acute myocardial infarction 0/282 (0.00%)', ' Cardiac failure 0/282 (0.00%)', ' Cataract 1/282 (0.35%)', ' Cataract subcapsular 1/282 (0.35%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
dc7c4409-32e5-4211-83fe-0a97b6176ca0
|
|
Single
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Results
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NCT00337103
|
Several patients in the Eribulin Mesylate group in the primary trial survived less than a year.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00337103', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate 1.4 mg/m^2', ' Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.', 'INTERVENTION 2: ', ' Capecitabine 2.5 g/m^2/Day', ' Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to ensure that paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen are available for confirmation of diagnosis.', ' Patients with locally advanced or metastatic disease who have received up to three prior chemotherapy regimens, and no more than two prior regimens for advanced and/or metastatic disease.', ' Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and a taxane (e.g., paclitaxel, docetaxel), either in combination or in separate regimens.', ' Patients with known human epidermal growth factor 2 (HER2/neu) over-expressing tumors may additionally have been treated with trastuzumab in centers where this treatment is available.', ' Patients with known estrogen and/or progesterone receptor-expressing tumors may have additionally been treated with hormonal therapy.', ' Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.', ' Life expectancy of >= 3 months.', ' Adequate renal function as evidenced by serum creatinine <1.5 mg/dL or calculated creatinine clearance > 50 mL/minute (min) per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin < 10.0 g/dL acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), or in case of bone metastases, liver specific alkaline phosphatase <= 3 x ULN.', ' Patients willing and able to complete the EORTC (European Organization for Research on the Treatment of Cancer) quality of life questionnaire (QLQ-C30 with breast cancer module QLQ-BR23) and to record their pain level on the Visual Analog Scale (VAS).', ' Patients willing and able to comply with the study protocol for the duration of the study.', ' Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.', 'Exclusion Criteria:', ' Patients who have received more than three prior chemotherapy regimens for their disease, including adjuvant therapies, or patients who have received more than two prior chemotherapy regimens for advanced disease (other therapies are allowed e.g., anti-estrogens, trastuzumab and radiotherapy).', ' Patients who have received capecitabine as a prior therapy for their disease.', ' Patients who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy, within one week before study treatment start, or any investigational drug within four weeks before study treatment start.', ' Radiation therapy encompassing > 30% of marrow.', ' Prior treatment with mitomycin C or nitrosourea.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment with study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing a contrast-enhanced Computed Tomography Scan (CT) or Magnetic Resonance Imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier.', ' Patients with meningeal carcinomatosis.', ' Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT)/international normalized ratio (INR) must be closely monitored.', ' Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (considered to be two methods of contraception, one of which must be a barrier method, e.g. condom, diaphragm or cervical cap). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Severe/uncontrolled intercurrent illness/infection.', ' Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association [NYHA] Grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).', ' Patients with organ allografts requiring immunosuppression.', ' Patients with known positive human immunodeficiency virus (HIV) status.', ' Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence.', ' Patients with pre-existing neuropathy > Grade 2.', ' Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.', ' Patients who participated in a prior E7389 clinical trial.', " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study."], 'Results': ['Outcome Measurement: ', ' Overall Survival (OS)', ' OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 2) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.', ' Time frame: From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate 1.4 mg/m^2', ' Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 554', ' Median (95% Confidence Interval)', ' Unit of Measure: days 484 (462 to 536)', 'Results 2: ', ' Arm/Group Title: Capecitabine 2.5 g/m^2/Day', ' Arm/Group Description: Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.', ' Overall Number of Participants Analyzed: 548', ' Median (95% Confidence Interval)', ' Unit of Measure: days 440 (400 to 487)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 95/544 (17.46%)', ' Neutropenia 10/544 (1.84%)', ' Febrile Neutropenia 7/544 (1.29%)', ' Leukopenia 4/544 (0.74%)', ' Anaemia 3/544 (0.55%)', ' Pancytopenia 1/544 (0.18%)', ' Thrombocytopenia 0/544 (0.00%)', ' Cardiopulmonary Failure 1/544 (0.18%)', ' Myocardial Infarction 1/544 (0.18%)', ' Pericardial Effusion 1/544 (0.18%)', ' Angina Pectoris 1/544 (0.18%)', 'Adverse Events 2:', ' Total: 115/546 (21.06%)', ' Neutropenia 1/546 (0.18%)', ' Febrile Neutropenia 4/546 (0.73%)', ' Leukopenia 0/546 (0.00%)', ' Anaemia 0/546 (0.00%)', ' Pancytopenia 1/546 (0.18%)', ' Thrombocytopenia 1/546 (0.18%)', ' Cardiopulmonary Failure 1/546 (0.18%)', ' Myocardial Infarction 1/546 (0.18%)', ' Pericardial Effusion 1/546 (0.18%)', ' Angina Pectoris 0/546 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
73e7447b-a940-4126-a1d9-fffd7c56c900
|
|
Single
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Eligibility
|
NCT00629499
|
Patients with peripheral neuropathy, but no symptoms of neuropathy, are excluded from the primary trial.
|
Contradiction
|
[
0,
13
] |
[] |
{'Clinical Trial ID': 'NCT00629499', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of <60 days.', ' Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 [including inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.', ' Patients with 1 axillary lymph node containing metastatic adenocarcinoma measuring >0.2 mm, OR lymph node-negative patients with high-risk features', ' Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).', ' Patients who are to receive trastuzumab must have normal cardiac function (MUGA [cardiac ejection fraction >50%, or greater than or equal to the institutional lower limit of normal], or echocardiogram [ECHO] within institutional normal limits).', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.', ' Patients who are either chemotherapy naïve, or who have received prior chemotherapy >5 years ago.', ' Patients with previous invasive cancers (including breast cancer) eligible only if treated >5 years prior to entering this study, and show no evidence of recurrent disease.', ' Adequate bone marrow function', ' Adequate liver function,', ' Adequate renal function,', ' Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.', ' Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.', ' MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.', ' Patients with bilateral, synchronous breast cancer, provided that one primary tumor meets the inclusion criteria.', 'Exclusion Criteria:', ' Patients who are pregnant or breastfeeding.', ' M1 metastatic disease.', ' Patients requiring neoadjuvant chemotherapy.', ' Life expectancy of greater than 6 months.', ' History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF', ' Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.', ' Any investigational agent within 30 days of receiving the first dose of study drug.', ' Treatment with prior trastuzumab or bevacizumab therapy.', ' Concurrent treatment with any other anti-cancer therapy is not permitted.', ' History of significant psychiatric disorders.', ' History of active, uncontrolled infection.', ' A serious, non-healing wound, ulcer, or bone fracture.', ' Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel', ' [Not Specified]', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.', ' Overall Number of Participants Analyzed: 63', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 63 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/63 (6.35%)', ' Hemorrhage - GI 1/63 (1.59%)', ' Vomiting 1/63 (1.59%)', ' Fracture [1]1/63 (1.59%)', ' Mental Status 1/63 (1.59%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c160ae6e-4dfe-47a4-ac9a-7497babbc2a2
|
|
Comparison
|
Eligibility
|
NCT00129389
|
NCT00304096
|
Patients with permanent sensory loss, interfering with daily activities are excluded from the primary trial and the secondary trial.
|
Contradiction
|
[
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%)']}
|
9f1afdf1-1ecf-4c8b-9b40-cc96cac0e063
|
Single
|
Eligibility
|
NCT01908101
|
Prior exposure to taxane is obligatory for patients in the primary trial.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT01908101', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Eribulin Mesylate)', ' Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.', ' Eribulin Mesylate: Given IV', ' Laboratory Biomarker Analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Ability to provide written informed consent', ' Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting', ' At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2', ' Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:', ' Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria', ' At least one non lymph node lesion of >= 1.0 cm or lymph node >= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)', ' Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion', ' Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions < 10 mm or lymph nodes < 15 mm in short axis) with rising serum CA15-3 or CA 27.29 or 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 value must have at least a 20% increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL', ' Absolute neutrophil count >= 1,500/mm^3', ' Hemoglobin >= 10 g/dL', ' Platelets >= 100,000/mm^3', ' Creatinine =< 1.5 x upper limit of normal (ULN)', ' Total bilirubin =< 1.5 x ULN', ' Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)', ' Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation', ' Life expectancy of > 12 weeks', 'Exclusion Criteria:', ' Prior treatment with eribulin', ' Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:', ' Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors', ' Denosumab or bisphosphonates to treat metastatic bone disease', ' Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment', ' Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy', ' Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment', ' Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment', ' Radiotherapy within 14 days of study treatment', ' Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery', ' Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy', ' Patients with peripheral neuropathy > grade 2 regardless of etiology', ' Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)', ' Concomitant severe or uncontrolled medical disease', ' Significant psychiatric or neurologic disorder which would compromise participation in the study', ' Pregnant or breast-feeding females'], 'Results': ['Outcome Measurement: ', ' PFS', ' Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.', ' Time frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year', 'Results 1: ', ' Arm/Group Title: Treatment (Eribulin Mesylate)', ' Arm/Group Description: Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.', ' Eribulin Mesylate: Given IV', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 59', ' Median (95% Confidence Interval)', ' Unit of Measure: months 3.5 (2.6 to 4.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/59 (3.39%)', ' Sepsis 1/59 (1.69%)', ' myocardial infarction 1/59 (1.69%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a7106a35-36da-423a-a6b3-3da62fc0eea8
|
|
Comparison
|
Intervention
|
NCT00952731
|
NCT00956813
|
Cohort 2 in the primary trial and the secondary trial but receive daily placebo doses PO.
|
Contradiction
|
[
5,
6,
7,
8,
9
] |
[
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00952731', 'Intervention': ['INTERVENTION 1: ', ' Treatment Gel + Oral Placebo', ' 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', 'INTERVENTION 2: ', ' Placebo Gel + Oral Treatment', ' Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of hormone receptor positive (more than 5% cells staining for ER + and/ or PR +), any grade (using definition of Page and Lagios) ductal carcinoma in situ (DCIS) with or without evidence of microinvasion on diagnostic core needle biopsy within the previous 60 days.', ' Women of age 18 years. Because no dosing or adverse event data are currently available on the use of 4-hydroxytamoxifen in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.', ' ECOG performance status 1 (Karnofsky 70%)', ' Participants must have normal organ and marrow function as defined below:', ' Leukocytes 3,000/uL', ' Absolute neutrophil count (ANC) 1,500/uL', ' Platelets 100,000/uL', ' Total bilirubin within normal institutional limits', ' AST (SGOT)/ALT (SGPT) 1.5 X institutional ULN', ' Creatinine within normal institutional limits', ' Women of child-bearing potential must agree to practice barrier birth control, abstinence, or use non-hormonal IUDs from the time that the first pregnancy test is performed throughout the duration of the study and for three months after cessation of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', ' Ability and willingness to schedule surgical resection of DCIS lesion for 4-10 weeks (28-70 days) following the start of study agent.', ' Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the 4-10 weeks of study agent dosing.', 'Exclusion Criteria:', ' Prior history of, or at high risk to develop, thromboembolic disease will be excluded.', ' Must not have taken exogenous sex hormones since biopsy diagnosing DCIS and must agree not to use exogenous sex hormones while on study.', ' Must not have taken tamoxifen or other selective estrogen receptor modulators (SERMs) within 2 years prior to entering the study. Women who have discontinued SERM therapy because of thromboembolic or uterine toxicity, will be excluded regardless of duration of use.', ' May not be receiving any other investigational agents.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-hydroxytamoxifen or tamoxifen.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because tamoxifen and 4-hydroxytamoxifen has the potential for teratogenic or abortifacient effects. Women are excluded from enrolling within 3 months of the most recent pregnancy. Women must avoid becoming pregnant in the 3 months following the use of study agent.', ' Women must not have breastfed within three months prior to DCNB. Women who are breast feeding are excluded from entry into this trial because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tamoxifen or 4-hydroxytamoxifen. Women must agree to forego breastfeeding for three months following the use of study agent.', ' Must not have any dermatologic conditions resulting in skin breakdown in the area of gel application.', ' Must not have a history of previous ipsilateral radiation to the affected breast.', ' Must not have had a breast reduction or augmentation within the 6 months prior to first dose of study agents. Patients who have had breast implants more than 6 months prior to first dose of study agents will be eligible.'], 'Results': ['Outcome Measurement: ', ' Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment', ' Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).', ' Time frame: Baseline and after 4-10 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Treatment Gel + Oral Placebo', ' Arm/Group Description: 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -3.4 (5.0)', 'Results 2: ', ' Arm/Group Title: Placebo Gel + Oral Treatment', ' Arm/Group Description: Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -5.1 (5.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00956813', 'Intervention': ['INTERVENTION 1: ', ' Flaxseed', ' Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.', 'INTERVENTION 2: ', ' Placebo', ' Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.'], 'Eligibility': ['Bothersome hot flashes, defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention', ' Presence of hot flashes for 1 month', ' Meets 1 of the following criteria:', ' History of breast cancer or other cancer (currently without malignant disease)', ' No history of breast cancer and wishes to avoid estrogen due to a perceived increased risk of breast cancer', ' Hormone receptor status not specified', ' Postmenopausal as defined by 1 of the following*:', ' NOTE: *Women with 1 ovary but without a uterus should be deemed postmenopausal by either age > 55 OR a combination of estrogen within a postmenopausal range (per local lab) and follicle-stimulating hormone > 40 mIU/mL', ' Absence of a period in the past 12 months', ' Bilateral oophorectomy', ' ECOG performance status 0-1', ' Life expectancy 6 months', ' Able to complete questionnaire(s) alone or with assistance', ' No diabetes requiring oral or injectable antihyperglycemics', ' No hypotension', ' No history of allergic or other adverse reaction to flaxseed', ' No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal condition where the patient should not consume and/or has an intolerance/allergies to seeds or nuts', ' At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents', ' Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for 4 weeks and is not expected to stop the medication during study treatment', ' At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind', ' Trastuzumab allowed', ' No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies', ' No concurrent ( 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal)', ' Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is 800 IU/day, it was started > 30 days before study initiation, and is to be continued through study period', ' Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible', ' No concurrent anticoagulants or anti-platelets (1 mg of Coumadin for central line patency allowed)', ' Aspirin allowed ( 81 mg)', ' No concurrent anti-hypertensives', ' No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk)'], 'Results': ['Outcome Measurement: ', ' To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.', ' The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.', ' The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7.', ' The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.', ' Time frame: Baseline and 7 weeks', 'Results 1: ', ' Arm/Group Title: Flaxseed', ' Arm/Group Description: Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.', ' Overall Number of Participants Analyzed: 69', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -4.9 (6.41)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.', ' Overall Number of Participants Analyzed: 77', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -3.5 (6.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/101 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
f4f50a05-9d63-4006-9680-b7ef68dbb5fe
|
Single
|
Eligibility
|
NCT00741260
|
Patients with HER2 positive tumors are ineligible for the primary trial.
|
Contradiction
|
[
0,
5
] |
[] |
{'Clinical Trial ID': 'NCT00741260', 'Intervention': ['INTERVENTION 1: ', ' N160 + C1500', ' Neratinib 160 mg + Capecitabine 1500 mg/m2', 'INTERVENTION 2: ', ' N160 + C2000', ' Neratinib 160 mg + Capecitabine 2000 mg/m2'], 'Eligibility': ['INCLUSION CRITERIA', ' PART 1:', ' confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.', ' PART 2:', ' confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.', ' erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.', ' disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.', ' Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.', ' PARTS 1 and 2:', ' At least 1 measurable lesion as defined by RECIST criteria.', ' LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).', ' EXCLUSION CRITERIA', ' PART 2:', ' prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.', ' prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.', ' PARTS 1 and 2:', ' Subjects with bone as the only site of disease.', ' Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.', ' Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities', ' Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).', ' Time frame: From first dose date to day 21', 'Results 1: ', ' Arm/Group Title: N160 + C1500', ' Arm/Group Description: Neratinib 160 mg + Capecitabine 1500 mg/m2', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: N160 + C2000', ' Arm/Group Description: Neratinib 160 mg + Capecitabine 2000 mg/m2', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 22.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/6 (83.33%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Thrombocytopenia 0/6 (0.00%)', ' Pericardial effusion 1/6 (16.67%)', ' Tachycardia 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Ascites 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Melaena 0/6 (0.00%)', ' Nausea 1/6 (16.67%)', ' Proctitis 0/6 (0.00%)', ' Small intestinal obstruction 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 4/8 (50.00%)', ' Anaemia 0/8 (0.00%)', ' Febrile neutropenia 0/8 (0.00%)', ' Thrombocytopenia 0/8 (0.00%)', ' Pericardial effusion 0/8 (0.00%)', ' Tachycardia 0/8 (0.00%)', ' Vertigo 0/8 (0.00%)', ' Abdominal pain 1/8 (12.50%)', ' Ascites 1/8 (12.50%)', ' Diarrhoea 0/8 (0.00%)', ' Melaena 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', ' Proctitis 0/8 (0.00%)', ' Small intestinal obstruction 1/8 (12.50%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f34760f4-965e-4bbb-b88f-8b63a7045808
|
|
Single
|
Adverse Events
|
NCT00866905
|
Less than 2% of patients in the primary trial experienced an adverse event.
|
Contradiction
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT00866905', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone/Cyclophosphamide', ' Systemic Therapy followed by surgery and possible radiation therapy'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, age 18 years.', ' Histologically confirmed invasive adenocarcinoma of the breast.', ' 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 without clearly defined palpable breast mass or axillary', ' lymph nodes but radiographically measurable tumor masses are', ' acceptable. Accepted procedures for measuring breast disease', ' are mammography, MRI, and breast ultrasound. This will need to', ' be re-evaluated after 3 cycles and prior to surgery.', ' Eastern Cooperative Oncology Group performance status (ECOG', ' PS) 0-2.', ' No metastatic disease, as documented by complete staging workup', ' 6 weeks prior to initiation of study treatment.', ' No previous treatment for breast cancer.', ' HER2-negative tumor status. HER2-negative is defined as:', ' Immunohistochemical (IHC) 0, IHC 1+ OR', ' IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ', ' hybridization) negative (defined by ratio <2.2).', ' Adequate hematologic function with:', ' Absolute neutrophil count (ANC) >1500/μL.', ' Platelets 100,000/μL.', ' Hemoglobin 10 g/dL.', ' Adequate hepatic function with:', ' Serum bilirubin the institutional upper limit of normal (ULN).', ' Aspartate aminotransferase (AST) 2.5 x institutional ULN.', ' Alanine aminotransferase (ALT) 2.5 x institutional ULN.', ' Adequate renal function with serum creatinine 1.5 x ULN.', ' Estrogen and progesterone receptor status in the primary tumor', ' known or pending at the time of study registration.', ' Knowledge of the investigational nature of the study and ability to', ' provide consent for study participation.', ' 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', ' Bilateral, synchronous breast cancer is allowed if one primary', ' tumor meets the inclusion criteria.', ' Sufficient archived breast tumor specimen available at baseline', ' for the Oncotype DX assay.', ' -', 'Exclusion Criteria:', ' Inflammatory breast cancer.', ' Peripheral neuropathy (motor or sensory) grade 1 by the', ' Common Terminology Criteria for Adverse Events version 3.0', ' (CTCAE v 3.0).', ' Prior radiation that included 30% of major bone marrow containing', ' areas (pelvis, lumbar, spine).', ' Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of', ' the following strong CYP3A4 inhibitors: ketoconazole,', ' itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,', ' telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,', ' delavirdine, and voriconazole. Use of these agents should be', ' discontinued at least 72 hours prior to initiation of study treatment.', ' Chemotherapy within 5 years of starting study treatment except', ' for low doses of agents used for anti-inflammatory indications', ' such as rheumatoid arthritis, psoriasis, and connective tissue', ' disorders. Although such doses and schedules cannot result in', ' myelosuppression, patients must discontinue this therapy while', ' they are receiving study treatment.', ' Known or suspected hypersensitivity to Cremophor®EL', ' (polyoxyethylated castor oil) or a drug formulated in', ' Cremophor®EL such as paclitaxel, or any other agent given in the', ' course of this study.', ' Pregnancy or breast-feeding. A negative serum pregnancy test', ' within 7 days prior to first study treatment (Day 1, Cycle 1) for all', ' women of childbearing potential is required. 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 3 weeks after their 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.', ' Uncontrolled intercurrent illness including (but not limited to)', ' ongoing or active infection.', ' Chronic treatment with corticosteroid unless treatment was begun', ' >6 months prior to study treatment and is at a low dose ( 20 mg', ' methylprednisolone or equivalent).', ' Use of any investigational agent within 30 days of administration', ' of the first dose of study drug.', ' Requirement for radiation therapy concurrent with neoadjuvant', ' study chemotherapy.', ' Concurrent treatment with any anti-cancer therapy other than', ' those agents used in this study.', ' Inability or unwillingness to comply with study procedures', ' including follow-up visits.', ' Mental condition or psychiatric disorder that would prevent patient', ' comprehension of the nature, scope, and possible consequences', ' of the study or that would limit compliance with study', ' requirements.', ' Any other disease(s), 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 affect the', ' interpretation of the results, or that renders the patient at high risk', ' from treatment complications', '-'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (pCR)', ' Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Ixabepilone/Cyclophosphamide', ' Arm/Group Description: Systemic Therapy followed by surgery and possible radiation therapy', ' Overall Number of Participants Analyzed: 161', ' Measure Type: Number', ' Unit of Measure: participants 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/168 (3.57%)', ' FEBRILE NEUTROPENIA 3/168 (1.79%)', ' ENTERITIS 1/168 (0.60%)', ' PERIPHERAL NEUROPATHY 2/168 (1.19%)', ' DEPRESSION 1/168 (0.60%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f4a33395-7e6b-46b9-b222-af3bbfff1591
|
|
Single
|
Adverse Events
|
NCT01421472
|
More than 3 patients in the primary trial suffered from adverse events associated with a low number of white blood cells.
|
Entailment
|
[
0,
2
] |
[] |
{'Clinical Trial ID': 'NCT01421472', 'Intervention': ['INTERVENTION 1: ', ' HR+: MM-121+ Paclitaxel', ' Hormone-receptor positive (HR+) sub-group randomized to receive:', ' 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)', 'INTERVENTION 2: ', ' HR+: Paclitaxel Only', ' Hormone-receptor positive (HR+) sub-group randomized to receive:', ' Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.'], 'Eligibility': ['Inclusion Criteria:', ' Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2)', ' Free of metastatic disease', ' 18 years old', ' Female', ' Had no prior treatment for any cancer', ' Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide', 'Exclusion Criteria:', ' Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL', ' Are pregnant or breastfeeding'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)', ' Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.', ' Time frame: At time of surgery, an expected average of 24-26 weeks', 'Results 1: ', ' Arm/Group Title: HR+: MM-121+ Paclitaxel', ' Arm/Group Description: Hormone-receptor positive (HR+) sub-group randomized to receive:', ' 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: participants Subjects with no pCR: 59', ' Subjects with pCR: 7', 'Results 2: ', ' Arm/Group Title: HR+: Paclitaxel Only', ' Arm/Group Description: Hormone-receptor positive (HR+) sub-group randomized to receive:', ' Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: participants Subjects with no pCR: 29', ' Subjects with pCR: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/67 (20.90%)', ' Febrile Neutropenia * 5/67 (7.46%)', ' Anemia * 3/67 (4.48%)', ' Neutropenia * 0/67 (0.00%)', ' Leukopenia * 0/67 (0.00%)', ' Sinus Tachycardia * 0/67 (0.00%)', ' Diarrhea * 2/67 (2.99%)', ' Nausea * 1/67 (1.49%)', ' Vomiting * 1/67 (1.49%)', ' Pancreatitis * 1/67 (1.49%)', ' Pyrexia * 1/67 (1.49%)', ' Bacteremia * 0/67 (0.00%)', ' Breast Cellulutis * 0/67 (0.00%)', 'Adverse Events 2:', ' Total: 5/33 (15.15%)', ' Febrile Neutropenia * 0/33 (0.00%)', ' Anemia * 0/33 (0.00%)', ' Neutropenia * 0/33 (0.00%)', ' Leukopenia * 0/33 (0.00%)', ' Sinus Tachycardia * 0/33 (0.00%)', ' Diarrhea * 0/33 (0.00%)', ' Nausea * 1/33 (3.03%)', ' Vomiting * 1/33 (3.03%)', ' Pancreatitis * 0/33 (0.00%)', ' Pyrexia * 1/33 (3.03%)', ' Bacteremia * 0/33 (0.00%)', ' Breast Cellulutis * 0/33 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e7d00591-381f-45e2-abdb-2ae1e568b193
|
|
Comparison
|
Adverse Events
|
NCT00885755
|
NCT01075100
|
Patients' appetites were not affected in the primary trial or the secondary trial.
|
Contradiction
|
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{'Clinical Trial ID': 'NCT00885755', 'Intervention': ['INTERVENTION 1: ', ' Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)', ' This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.', 'INTERVENTION 2: ', ' Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks', ' This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' HER2-positive breast cancer;', ' al least one metastatic site amenable for core biopsy;', ' left ventricular ejection fraction >50%.', 'Exclusion Criteria:', ' prior adjuvant/neoadjuvant Herceptin within past 6 months;', ' prior adjuvant taxane therapy within past 12 months;', ' use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;', ' known bleeding diatheses.'], 'Results': ['Outcome Measurement: ', ' Part I: Progression Free Survival (PFS) by Biomarker', ' Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to ( ) median membrane H score, c-MET <median and median membrane H score, phosphatase and tensin homolog gene (PTEN) <median and median cytoplasm H score, HER2 <median and median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subunit wild type (WT) and mutation (M), and FC gamma receptors IIIa homozygous Phenyl alanine (FF), heterozygous Phenyl alanine/Valine (VF) and homozygous Valine (VV), receptor IIa Phenotypes homozygous Histidine (HH), heterozygous Histidine/Arginine (HR) and homozygous Arginine (RR) IIb phenotypes homozygous Isoleucien (II),heterozygous Isoleucine/Threonine (IT) and homozygous Threonine (TT) .', ' Time frame: End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months', 'Results 1: ', ' Arm/Group Title: Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)', ' Arm/Group Description: This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.', ' Overall Number of Participants Analyzed: 27', ' Median (95% Confidence Interval)', ' Unit of Measure: months p95 HER2 +ve (n=9,0): NA [1] (3.384 to NA)', ' p95 HER2 -ve (n=15,1): 13.963 (7.261 to 22.407)', ' IGF1R <median (n=12,0): 12.649 [1] (4.698 to NA)', ' IGF1R median (n=14,1): 22.209 [1] (7.261 to NA)', ' c-MET <median (n=10,1): 18.595 [1] (3.384 to NA)', ' c-MET median (n=15,0): 13.733 [1] (7.031 to NA)', ' PTEN <median (n=12,0): 22.209 [1] (5.914 to NA)', ' PTEN median (n=14,1): 13.963 (6.374 to 31.179)', ' HER2 <median (n=11,1): 13.733 [1] (3.384 to NA)', ' HER2 median (n=14,0): 22.209 [1] (7.031 to NA)', ' PI3K Amino Acids WT (n=17,1): 13.848 [1] (7.261 to NA)', ' PI3K Amino Acids M (n=9,0): 22.407 [1] (4.698 to NA)', ' FC Gamma Receptor IIIa F176V FF (n=9,0): 10.612 [1] (3.384 to NA)', ' FC Gamma Receptor IIIa F176V VF (n=5,1): 11.335 [1] (9.528 to NA)', ' FC Gamma Receptor IIIa F176V VV (n=4,0): 22.407 [1] (22.209 to NA)', ' FC Gamma Receptor IIa R166H HH (n=3,0): NA [1] (9.528 to NA)', ' FC Gamma Receptor IIa R166H HR (n=8,1): 22.209 [1] (3.384 to NA)', ' FC Gamma Receptor IIa R166H RR (n=8,0): 13.963 [1] (5.914 to NA)', ' FC Gamma Receptor IIb I232T II (n=12,1): 11.335 [1] (5.914 to NA)', ' FC Gamma Receptor IIb I232T IT (n=1,0): NA [1] (NA to NA)', ' FC Gamma Receptor IIb I232T TT (n=1,0): NA [1] (NA to NA)', 'Results 2: ', ' Arm/Group Title: Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks', ' Arm/Group Description: This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.', ' Overall Number of Participants Analyzed: 1', ' Median (95% Confidence Interval)', ' Unit of Measure: months p95 HER2 +ve (n=9,0): NA [2] (NA to NA)', ' p95 HER2 -ve (n=15,1): 1.216 [3] (NA to NA)', ' IGF1R <median (n=12,0): NA [2] (NA to NA)', ' IGF1R median (n=14,1): 1.216 [3] (NA to NA)', ' c-MET <median (n=10,1): 1.216 [3] (NA to NA)', ' c-MET median (n=15,0): NA [2] (NA to NA)', ' PTEN <median (n=12,0): NA [2] (NA to NA)', ' PTEN median (n=14,1): 1.216 [3] (NA to NA)', ' HER2 <median (n=11,1): 1.216 [3] (NA to NA)', ' HER2 median (n=14,0): NA [2] (NA to NA)', ' PI3K Amino Acids WT (n=17,1): 1.216 [3] (NA to NA)', ' PI3K Amino Acids M (n=9,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIIa F176V FF (n=9,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIIa F176V VF (n=5,1): 1.216 [3] (NA to NA)', ' FC Gamma Receptor IIIa F176V VV (n=4,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIa R166H HH (n=3,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIa R166H HR (n=8,1): 1.216 [3] (NA to NA)', ' FC Gamma Receptor IIa R166H RR (n=8,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIb I232T II (n=12,1): 1.216 [3] (NA to NA)', ' FC Gamma Receptor IIb I232T IT (n=1,0): NA [2] (NA to NA)', ' FC Gamma Receptor IIb I232T TT (n=1,0): NA [2] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/33 (27.27%)', ' Febrile neutropenia * 1/33 (3.03%)', ' Cardiac failure * 1/33 (3.03%)', ' Pyrexia * 2/33 (6.06%)', ' Chest pain * 1/33 (3.03%)', ' Medical device complication * 1/33 (3.03%)', ' Cellulitis * 1/33 (3.03%)', ' Sepsis * 1/33 (3.03%)', ' Hip fracture * 1/33 (3.03%)', ' Back pain * 1/33 (3.03%)', ' Menorrhagia * 1/33 (3.03%)', ' Thrombosis * 1/33 (3.03%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT01075100', 'Intervention': ['INTERVENTION 1: ', ' Triple Negative', ' ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', 'INTERVENTION 2: ', ' HR Positive', ' ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:', ' Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease', ' Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as 20 mm with conventional techniques (CT, MRI, X-ray) or as 10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.', ' Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:', 'Has had no prior treatment with ixabepilone or platinum agents', ' Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy', ' 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to <Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to <Grade 1 (if applicable).', ' Has an ECOG Performance Status (PS) 0-2', ' Is 18 years of age', ' Has a life expectancy of at least 12 weeks', ' Has laboratory values of:', ' White blood cell (WBC) count 3000 x 106/L Absolute neutrophil count (ANC) 1500 x 106/L Hemoglobin 9 g/dL Total bilirubin 1x upper limit of normal (ULN) AST and ALT 2.5 x ULN Alkaline phosphatase 2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine 1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count 100,000 x 106/L', ' If patient has had radiation therapy, it has been completed >3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.', ' Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause', ' If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter', ' Has signed the most recent Patient Informed Consent Form', ' Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.', 'Exclusion Criteria:', ' A patient will be excluded from this study if he or she meets any of the following criteria:', ' Had prior treatment with ixabepilone or other epothilones', ' Had prior radiation to 30% of major bone marrow containing areas (pelvis, lumbar spine)', ' Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the patient has life-threatening or rapidly progressing visceral disease', ' Has HER2+ disease (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells]), a FISH result of more than 6 HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals of >2.2)', ' Has only lytic bone disease or nonmeasurable disease only', ' Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor®EL (polyoxyethylated castor oil) or has history of severe allergic reactions to cisplatin or other platinum-containing compounds', ' Has been treated previously with a platinum-containing agent', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Washout periods for these prior therapies are specified in Section 5.', ' Is receiving concurrent investigational therapy or has received such therapy within the 30 days prior to dosing Day 1', ' Has neuropathy (motor or sensory) >Grade 1', ' Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible.', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection', ' Has clinically relevant coagulopathy either secondary to hepatic dysfunction or an underlying condition requiring therapeutic anticoagulation (specifically, A-fib, history of DVT). A daily aspirin or Plavix for CAD are permitted.', ' Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs', ' Is a pregnant or breast feeding woman', ' Is unable to comply with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 24 months', 'Results 1: ', ' Arm/Group Title: Triple Negative', ' Arm/Group Description: ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.4 (17.7 to 45.8)', 'Results 2: ', ' Arm/Group Title: HR Positive', ' Arm/Group Description: ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34 (21.5 to 48.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/48 (20.83%)', ' NEUTROPENIA 1/48 (2.08%)', ' THROMBOCYTOPENIA 0/48 (0.00%)', ' VOLUME BLOOD DECREASED 1/48 (2.08%)', ' FIBRILLATION ATRIAL 1/48 (2.08%)', ' HYPOTENSION 1/48 (2.08%)', ' ABDOMINAL PAIN 1/48 (2.08%)', ' APPETITE DECREASED 0/48 (0.00%)', ' DEHYDRATION 4/48 (8.33%)', ' DIARRHEA 4/48 (8.33%)', ' NAUSEA 3/48 (6.25%)', ' VOMITING 2/48 (4.17%)', ' FEVER 1/48 (2.08%)', ' RIGORS 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 5/53 (9.43%)', ' NEUTROPENIA 1/53 (1.89%)', ' THROMBOCYTOPENIA 1/53 (1.89%)', ' VOLUME BLOOD DECREASED 0/53 (0.00%)', ' FIBRILLATION ATRIAL 0/53 (0.00%)', ' HYPOTENSION 0/53 (0.00%)', ' ABDOMINAL PAIN 0/53 (0.00%)', ' APPETITE DECREASED 1/53 (1.89%)', ' DEHYDRATION 0/53 (0.00%)', ' DIARRHEA 0/53 (0.00%)', ' NAUSEA 1/53 (1.89%)', ' VOMITING 1/53 (1.89%)', ' FEVER 1/53 (1.89%)', ' RIGORS 1/53 (1.89%)']}
|
59da1fb5-2636-4ca8-8970-6cb45dedbed3
|
Comparison
|
Intervention
|
NCT04030104
|
NCT02525718
|
Intervention 1 for the secondary trial and the primary trial are for the control groups.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
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[
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{'Clinical Trial ID': 'NCT04030104', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)', ' Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol', ' Patient age, indication for study entry and available medical history', ' Evaluable mammograms and OA and IUS video loops and stills for each mass', 'Exclusion Criteria:', ' Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers', ' Reader-02 Proficiency Test and training cases'], 'Results': ['Outcome Measurement: ', ' Gain in Specificity at Fixed 98% Sensitivity (fSp)', ' Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 38.22 (24.85 to 51.59)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 47.20 (35.91 to 58.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/480 (0.42%)', ' Device breakage [1]1/480 (0.21%)', ' Lung cancer [2]1/480 (0.21%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT02525718', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)', 'INTERVENTION 2: ', ' 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone', ' Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.', ' Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.', '(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.'], 'Eligibility': ['Inclusion Criteria:', ' Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.', 'Exclusion Criteria:', ' Patients under the age of 18, or over the age of 79', ' Allergy to local anesthetics or corticosteroids', ' Patients with history of chronic pain or with chronic use of opioid analgesics', ' Patients with history of lung disease or prior anterior thoracotomy or median sternotomy'], 'Results': ['Outcome Measurement: ', ' Quality of Recovery Score', ' The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:', ' Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.', ' PMID: 10740540', ' Time frame: 24 hours post-operatively', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)', ' Overall Number of Participants Analyzed: 22', ' Median (Inter-Quartile Range)', ' Unit of Measure: score on a scale 165 (143 to 179)', 'Results 2: ', ' Arm/Group Title: 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone', ' Arm/Group Description: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.', ' Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.', '(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.', ' Overall Number of Participants Analyzed: 23', ' Median (Inter-Quartile Range)', ' Unit of Measure: score on a scale 169 (155 to 182)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/22 (0.00%)', 'Adverse Events 2:', ' Total: 0/23 (0.00%)']}
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f144c34b-9428-4836-bf01-5f7030eb579c
|
Comparison
|
Eligibility
|
NCT02073487
|
NCT03371732
|
Heavy smokers (more than 5 cigarettes smoked per day) and patients undergoing methadone or buprenorphine maintenance therapy for opiod addiction are eligible for the secondary trial and the primary trial.
|
Contradiction
|
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32,
33,
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35,
36
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[
0,
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2
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{'Clinical Trial ID': 'NCT02073487', 'Intervention': ['INTERVENTION 1: ', ' T-DM1 + Lapatinib + Abraxane', ' T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.', ' T-DM1: antibody-drug conjugate of trastuzumab and emtansine', ' Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)', ' Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.', 'INTERVENTION 2: ', ' Trastuzumab + Pertuzumab + Paclitaxel', ' Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.', ' Trastuzumab: anti-Her2 monoclonal antibody', ' Paclitaxel: chemotherapy - microtubule inhibitor', ' Pertuzumab: anti-HER2 monoclonal antibody'], 'Eligibility': ['Inclusion Criteria:', ' Female gender;', ' Age 18 years;', ' Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1', ' Histologically confirmed invasive breast cancer:', ' Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.', ' Any N,', ' No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);', ' Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.', ' Known hormone receptor status.', ' Hematopoietic status:', ' CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,', ' Hepatic status:', " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", ' Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,', ' Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.', ' Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)', ' Signed informed consent form (ICF)', ' Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.', 'Exclusion Criteria:', ' Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.', ' Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.', ' Preexisting peripheral neuropathy grade 2', ' Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;', " 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;", ' Unresolved or unstable, serious adverse events from prior administration of another investigational drug;', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;', ' Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);', ' Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;', ' Pregnant or lactating women;', ' Concomitant use of CYP3A4 inhibitors or inducers', ' Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol', ' Patients have an active infection and require IV or oral antibiotics.', ' Pregnant or breast-feeding women', ' Patients unwilling or unable to comply with the protocol'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) RCB-0 or RCB-1', ' To evaluate the pathological complete response (pCR) in the breast after treatment with Trastuzumab Emtansine plus Lapatinib follow by Abraxane in women with HER2 Neu over-expressed breast cancer patients 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.", or similar definition that is accurate and appropriate.', ' Residual cancer burden (RCB)-0 was synonymous with pCR, indicating no residual disease present.', ' Time frame: From date of randomization until the date of surgery, approximately 16 weeks', 'Results 1: ', ' Arm/Group Title: T-DM1 + Lapatinib + Abraxane', ' Arm/Group Description: T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.', ' T-DM1: antibody-drug conjugate of trastuzumab and emtansine', ' Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)', ' Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 14 100.0%', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Pertuzumab + Paclitaxel', ' Arm/Group Description: Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.', ' Trastuzumab: anti-Her2 monoclonal antibody', ' Paclitaxel: chemotherapy - microtubule inhibitor', ' Pertuzumab: anti-HER2 monoclonal antibody', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 10 62.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}
|
{'Clinical Trial ID': 'NCT03371732', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Arm 1: Motivational Intervention group', ' Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.', 'INTERVENTION 2: ', ' Arm 2', ' Arm 2: Educational advises group', ' Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.'], 'Eligibility': ['Inclusion Criteria :', ' women with primary breast cancer, without ongoing support for substance use.', ' An AUDIT-C score >1 or more than one cigarette smoked per day.', ' Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).', ' Exclusion Criteria :', ' Patients who currently use substances for which a second-line care is already committed.', ' Patients with a Karnofsky index <70.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months', ' Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months', ' AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Arm 1: Motivational Intervention group', ' Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Success: 23 47.9%', ' Success not maintained: 18 37.5%', 'Missing: 7 14.6%', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Arm 2: Educational advises group', ' Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Success: 19 35.8%', ' Success not maintained: 29 54.7%', 'Missing: 5 9.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
e7e87023-2227-4594-931a-0a3d89ec686e
|
Single
|
Adverse Events
|
NCT02149524
|
Several adverse events which occurred in the primary trial were not heart related.
|
Entailment
|
[
0,
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2,
3,
4,
5,
6,
7,
8,
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23
] |
[] |
{'Clinical Trial ID': 'NCT02149524', 'Intervention': ['INTERVENTION 1: ', ' Herceptin (Trastuzumab)', ' Intravenous administration', ' Herceptin (trastuzuamb): Intravenous administration', 'INTERVENTION 2: ', ' SB3 (Proposed Trastuzumab Biosimilar)', ' Intravenous administration', ' SB3 (proposed trastuzumab biosimilar): Intravenous administration'], 'Eligibility': ['Inclusion Criteria:', ' Female aged 18-65 years', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer with:', ' tumour size 2 cm', ' histologically confirmed primary invasive carcinoma of the breast', ' HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+', ' Known hormone receptor (oestrogen receptor and progesterone receptor) status', ' Baseline left ventricular ejection fraction (LVEF) 55% measured by echocardiography or multiple gated acquisition (MUGA) scan', ' Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures', 'Exclusion Criteria:', ' Metastatic (stage IV) or bilateral or multifocal/multicentric breast cancer', ' History of any prior invasive breast carcinoma, except for subjects with a past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) treated with surgery only', ' Past or current history of malignant neoplasms within 5 years prior to Randomisation, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin (malignant neoplasms occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)', ' Previous history of radiation therapy, immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy) Major surgery within 4 weeks prior to Randomisation and minor surgery within 2 weeks prior to Randomisation (major surgery is defined as surgery which requires general anaesthesia)', ' Serious cardiac illness that would preclude the use of trastuzumab such as:', ' history of documented congestive heart failure (CHF) (New York Heart Association, NYHA, class II or greater heart disease)', ' LVEF < 55% by echocardiography or MUGA scan', ' angina pectoris requiring anti-anginal medication', ' evidence of transmural infarction on electrocardiogram (ECG)', ' uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg)', ' clinically significant valvular heart disease', ' high risk uncontrolled arrhythmias', ' Serious pulmonary illness enough to cause dyspnoea at rest or requiring supplementary oxygen therapy', ' Known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection', ' Other concurrent serious illnesses that may interfere with planned therapy including severe cardiovascular, pulmonary, metabolic or infectious conditions', ' Known hypersensitivity to the investigational product (IPs), non-IPs or any of the ingredients or excipients of the IPs or non-IPs', ' Known hypersensitivity to murine proteins', ' Known history of dihydropyrimidine dehydrogenase (DPD) deficiency', ' Pre-existing peripheral sensory or motor neuropathy grade 2, defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0', ' Pregnant or lactating women. A pregnancy test result is required for all women of childbearing potential including women who had menopause onset within 2 years prior to Randomisation. Women of childbearing potential must agree to use contraceptive methods (see section 7.4.2) during the study and 6 months after the last dose of IP', ' Concurrent hormonal therapy including birth control pills, ovarian hormone replacement for menopause, selective oestrogen receptor modulator (SERM) either for osteoporosis or breast cancer prevention', ' Subjects unwilling to follow the study requirements'], 'Results': ['Outcome Measurement: ', ' The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour', ' [Not Specified]', ' Time frame: Week 24', 'Results 1: ', ' Arm/Group Title: Herceptin (Trastuzumab)', ' Arm/Group Description: Intravenous administration', ' Herceptin (trastuzuamb): Intravenous administration', ' Overall Number of Participants Analyzed: 398', ' Measure Type: Number', ' Unit of Measure: percentage of responders 42.0', 'Results 2: ', ' Arm/Group Title: SB3 (Proposed Trastuzumab Biosimilar)', ' Arm/Group Description: Intravenous administration', ' SB3 (proposed trastuzumab biosimilar): Intravenous administration', ' Overall Number of Participants Analyzed: 402', ' Measure Type: Number', ' Unit of Measure: percentage of responders 51.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 58/438 (13.24%)', ' Febrile neutropenia 13/438 (2.97%)', ' Neutropenia 5/438 (1.14%)', ' Anaemia 0/438 (0.00%)', ' Thrombocytopenia 0/438 (0.00%)', ' Haemolytic anaemia 1/438 (0.23%)', ' Leukopenia 1/438 (0.23%)', ' Cardiac failure congestive 0/438 (0.00%)', ' Supraventricular tachycardia 0/438 (0.00%)', ' Myocardial infarction 1/438 (0.23%)', ' Vertigo 0/438 (0.00%)', 'Adverse Events 2:', ' Total: 56/437 (12.81%)', ' Febrile neutropenia 10/437 (2.29%)', ' Neutropenia 7/437 (1.60%)', ' Anaemia 2/437 (0.46%)', ' Thrombocytopenia 1/437 (0.23%)', ' Haemolytic anaemia 0/437 (0.00%)', ' Leukopenia 0/437 (0.00%)', ' Cardiac failure congestive 3/437 (0.69%)', ' Supraventricular tachycardia 1/437 (0.23%)', ' Myocardial infarction 0/437 (0.00%)', ' Vertigo 1/437 (0.23%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ca4a190a-9007-4f8f-a199-b8fe4064e55b
|
|
Comparison
|
Intervention
|
NCT00711529
|
NCT02835625
|
the primary trial participants are treated with Cognitive behavioural therapy, this is not used at all in the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT02835625', 'Intervention': ['INTERVENTION 1: ', ' Digital Breast Tomosynthesis', ' Digital Breast Tomosynthesis + Synthetic Mammography (DBT)', ' The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.', 'INTERVENTION 2: ', ' Digital Mammography', ' The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.'], 'Eligibility': ['Inclusion Criteria:', ' Informed consent', 'Exclusion Criteria:', 'Breast implants'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Screen-Detected Breast Cancer', ' Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.', ' Time frame: 36 months from start up of the trial', 'Results 1: ', ' Arm/Group Title: Digital Breast Tomosynthesis', ' Arm/Group Description: Digital Breast Tomosynthesis + Synthetic Mammography (DBT)', ' The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.', ' Overall Number of Participants Analyzed: 14380', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 95 0.7%', 'Results 2: ', ' Arm/Group Title: Digital Mammography', ' Arm/Group Description: The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.', ' Women selected for further assessment (positive screening exam) was recalled.', ' Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.', ' Overall Number of Participants Analyzed: 14369', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 87 0.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14734 (0.00%)', 'Adverse Events 2:', ' Total: 0/14719 (0.00%)']}
|
4f790768-7fa4-4729-bcd6-cf7bcb44fa3c
|
Comparison
|
Intervention
|
NCT02685566
|
NCT03076190
|
the primary trial and the secondary trial have the same number of study groups, but are testing different interventions.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT02685566', 'Intervention': ['INTERVENTION 1: ', ' FFDM Plus DBT', ' Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', 'INTERVENTION 2: ', ' Full-Field Digital Mammography (FFDM)', ' Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects participating in FMSU004A protocol with known clinical status', 'Exclusion Criteria:', ' Subjects with unknown clinical status not participating in FMSU004A protocol.'], 'Results': ['Outcome Measurement: ', ' Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate', ' This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: FFDM Plus DBT', ' Arm/Group Description: Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', ' Overall Number of Participants Analyzed: 100', ' Mean (95% Confidence Interval)', ' Unit of Measure: probability .805 (0.701 to 0.910)', 'Results 2: ', ' Arm/Group Title: Full-Field Digital Mammography (FFDM)', ' Arm/Group Description: Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.', ' This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).', ' Overall Number of Participants Analyzed: 100', ' Mean (95% Confidence Interval)', ' Unit of Measure: probability 0.756 (0.646 to 0.867)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}
|
{'Clinical Trial ID': 'NCT03076190', 'Intervention': ['INTERVENTION 1: ', ' Active Control Group', ' Health Education Active Control Group', 'INTERVENTION 2: ', ' My Surgical Success Treatment Group', ' My Surgical Success Intervention Group'], 'Eligibility': ['Inclusion Criteria:', ' Age 18+', ' Scheduled for breast cancer surgery', ' English speaking', ' Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video', 'Exclusion Criteria:', ' Any conditions causing inability to complete study procedures (e.g. education, cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the investigator.', ' Known pregnancy', ' Ongoing legal action related to pain or disability claim'], 'Results': ['Outcome Measurement: ', ' Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning', ' Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.', ' Time frame: Immediately post-treatment', 'Results 1: ', ' Arm/Group Title: Active Control Group', ' Arm/Group Description: Health Education Active Control Group', ' Overall Number of Participants Analyzed: 32', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.3)', ' Relevant: 4.7 (1.51)', ' Useful: 4.67 (1.52)', ' Satisfaction: 4.67 (1.56)', ' Likely to Use: 5.03 (1.3)', 'Results 2: ', ' Arm/Group Title: My Surgical Success Treatment Group', ' Arm/Group Description: My Surgical Success Intervention Group', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.2)', ' Relevant: 5.0 (1.6)', ' Useful: 5.1 (1.3)', ' Satisfaction: 5.2 (1.2)', ' Likely to Use: 5.3 (1.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
cb133915-dc40-4f93-a6a7-076e4d7f07a1
|
Comparison
|
Eligibility
|
NCT00045032
|
NCT00416572
|
WOCBP that refuse to use contraception are excluded from the primary trial, but may be eligible for the secondary trial.
|
Entailment
|
[
18
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
{'Clinical Trial ID': 'NCT00045032', 'Intervention': ['INTERVENTION 1: ', ' Observation Arm', ' Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.', 'INTERVENTION 2: ', ' Herceptin 1-Year Arm', ' Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'], 'Eligibility': ['Inclusion Criteria:', ' Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging', ' Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable', ' Known hormone receptor status', ' Baseline left ventricular ejection fraction (LVEF) greater than or equal to ( ) 55 percent (%)', 'Exclusion Criteria:', ' Prior invasive breast carcinoma', ' Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix', ' Clinical T4 tumors', ' Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the present breast cancer', ' Peripheral stem cell or bone marrow stem cell support', ' Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer', ' Non-irradiated internal mammary nodes or supraclavicular lymph node involvement', ' Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer', ' Concurrent anti-cancer treatment in another investigational trial', ' Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment', ' Poor hematologic, hepatic, or renal function', ' Pregnancy or lactation', ' Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', ' DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.', ' Time frame: From Baseline until time of event (median of 1 year)', 'Results 1: ', ' Arm/Group Title: Observation Arm', ' Arm/Group Description: Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.', ' Overall Number of Participants Analyzed: 1693', ' Measure Type: Number', ' Unit of Measure: percentage of participants 12.9', 'Results 2: ', ' Arm/Group Title: Herceptin 1-Year Arm', ' Arm/Group Description: Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.', ' Overall Number of Participants Analyzed: 1693', ' Measure Type: Number', ' Unit of Measure: percentage of participants 7.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 143/1744 (8.20%)', ' Leukopenia * 1/1744 (0.06%)', ' Lymphadenopathy * 0/1744 (0.00%)', ' Thrombocytopenia * 0/1744 (0.00%)', ' Acute coronary syndrome * 1/1744 (0.06%)', ' Acute myocardial infarction * 0/1744 (0.00%)', ' Angina pectoris * 2/1744 (0.11%)', ' Arrhythmia * 0/1744 (0.00%)', ' Atrial fibrillation * 1/1744 (0.06%)', ' Atrial flutter * 1/1744 (0.06%)', 'Adverse Events 2:', ' Total: 269/1682 (15.99%)', ' Leukopenia * 0/1682 (0.00%)', ' Lymphadenopathy * 1/1682 (0.06%)', ' Thrombocytopenia * 0/1682 (0.00%)', ' Acute coronary syndrome * 1/1682 (0.06%)', ' Acute myocardial infarction * 1/1682 (0.06%)', ' Angina pectoris * 2/1682 (0.12%)', ' Arrhythmia * 1/1682 (0.06%)', ' Atrial fibrillation * 1/1682 (0.06%)', ' Atrial flutter * 0/1682 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00416572', 'Intervention': ['INTERVENTION 1: ', ' Education Intervention', " Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.", 'INTERVENTION 2: ', ' Nutrition Education Intervention', ' Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.'], 'Eligibility': ['INCLUSION CRITERIA (Disease Characteristics):', ' Diagnosis of breast cancer', ' Stage I or II disease', ' No more than 10 positive lymph nodes', ' First-time diagnosis', ' Under the age of 50 at diagnosis', ' Finished active treatment within the past 2 months', ' English-speaking only', " Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania", ' INCLUSION CRITERIA (Patient Characteristics):', ' Female patients only', ' Must be able to communicate', ' EXCLUSION CRITERIA (Patient Characteristics):', ' Other prior malignancies except skin cancer', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).', ' Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.', ' Time frame: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).', 'Results 1: ', ' Arm/Group Title: Education Intervention', " Arm/Group Description: Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.", ' Overall Number of Participants Analyzed: 70', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 5.83 (5.32)', ' Post-intervention: 5.65 (5.53)', ' Final follow-up: 5.07 (4.99)', 'Results 2: ', ' Arm/Group Title: Nutrition Education Intervention', ' Arm/Group Description: Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.', ' Overall Number of Participants Analyzed: 78', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 6.74 (5.94)', ' Post-intervention: 5.70 (5.45)', ' Final follow-up: 4.36 (4.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/83 (0.00%)', 'Adverse Events 2:', ' Total: 0/85 (0.00%)']}
|
1f0825b6-8e32-44ff-96b7-ab082e24b493
|
Comparison
|
Eligibility
|
NCT00375427
|
NCT00579826
|
Patients diagnosed with osteonecrosis are eligible for the primary trial but excluded from the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18
] |
[
6,
7
] |
{'Clinical Trial ID': 'NCT00375427', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Every 3 Months', ' Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.', 'INTERVENTION 2: ', ' Zoledronic Acid Every 4 Weeks', ' Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.'], 'Eligibility': ['Inclusion criteria:', ' Female patients 18 years of age.', ' Written informed consent given.', ' Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.', ' Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status 2 .', ' Life expectancy 1 year.', 'Exclusion criteria:', ' More than 3 months since last infusion of Zoledronic Acid (Zometa®).', ' Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.', ' Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85', ' Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).', ' Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).', ' Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).', ' History of non-compliance to medical regimens or potential unreliable behavior.', ' Known sensitivity to study drug(s) or class of study drug(s).', ' Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study', ' Use of any other investigational agent in the last 30 days.'], 'Results': ['Outcome Measurement: ', ' Annual Overall Skeletal Morbidity Rate (SMR)', ' The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.', ' SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Every 3 Months', ' Arm/Group Description: Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.', ' Overall Number of Participants Analyzed: 209', ' Mean (Standard Deviation)', ' Unit of Measure: Number of Skeletal Events per Year 0.26 (0.81)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Every 4 Weeks', ' Arm/Group Description: Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.', ' Overall Number of Participants Analyzed: 216', ' Mean (Standard Deviation)', ' Unit of Measure: Number of Skeletal Events per Year 0.22 (0.57)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/209 (10.05%)', ' Anaemia 0/209 (0.00%)', ' Febrile neutropenia 0/209 (0.00%)', ' Thrombocytopenia 0/209 (0.00%)', ' Acute myocardial infarction 0/209 (0.00%)', ' Cardiac failure 0/209 (0.00%)', ' Diplopia 0/209 (0.00%)', ' Gastric haemorrhage 0/209 (0.00%)', ' Nausea 0/209 (0.00%)', ' Oral pain 0/209 (0.00%)', ' Vomiting 1/209 (0.48%)', ' Mucosal inflammation 0/209 (0.00%)', ' Pain 1/209 (0.48%)', 'Adverse Events 2:', ' Total: 29/216 (13.43%)', ' Anaemia 2/216 (0.93%)', ' Febrile neutropenia 2/216 (0.93%)', ' Thrombocytopenia 2/216 (0.93%)', ' Acute myocardial infarction 1/216 (0.46%)', ' Cardiac failure 1/216 (0.46%)', ' Diplopia 1/216 (0.46%)', ' Gastric haemorrhage 1/216 (0.46%)', ' Nausea 1/216 (0.46%)', ' Oral pain 2/216 (0.93%)', ' Vomiting 2/216 (0.93%)', ' Mucosal inflammation 1/216 (0.46%)', ' Pain 0/216 (0.00%)']}
|
{'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: ']}
|
db96c4d6-ffcd-401a-8af3-807f665f16f7
|
Single
|
Eligibility
|
NCT00976989
|
Patients with LVEF equal to 53.5% are eligible for the primary trial.
|
Contradiction
|
[
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': ''}
|
b74dc1bc-76c3-4ce6-9735-634e7a507ff5
|
|
Comparison
|
Eligibility
|
NCT01740323
|
NCT00127205
|
the secondary trial and the primary trial only accept 18 year olds.
|
Contradiction
|
[
0,
1
] |
[
15,
16,
17
] |
{'Clinical Trial ID': 'NCT01740323', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Placebo', ' Placebo: daily placebo for 6 weeks', 'INTERVENTION 2: ', ' Curcumin', ' 500 mg BID', ' Curcumin: 500 mg BID'], 'Eligibility': ['Inclusion Criteria:', ' Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT.', 'Exclusion Criteria:', ' Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study.'], 'Results': ['Outcome Measurement: ', ' PBMC NF-kB DNA Binding Measured in ng/Well', ' The primary outcome to be measured will be the change in NF-kB DNA binding (measured in peripheral blood mononuclear cells as ng/well) after six weeks of treatment with daily placebo or Meriva. NF-kB DNA binding and has been associated with fatigue in breast cancer patients.', ' Time frame: Baseline, 6 weeks following completion of XRT', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo', ' Placebo: daily placebo for 6 weeks', ' Overall Number of Participants Analyzed: 13', ' Mean (Standard Deviation)', ' Unit of Measure: ng/well Baseline: 9.01 (14.70)', ' 6 weeks post-treatment: 17.54 (9.24)', 'Results 2: ', ' Arm/Group Title: Curcumin', ' Arm/Group Description: 500 mg BID', ' Curcumin: 500 mg BID', ' Overall Number of Participants Analyzed: 15', ' Mean (Standard Deviation)', ' Unit of Measure: ng/well Baseline: 9.56 (5.63)', ' 6 weeks post-treatment: 16.04 (16.13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', ' Chest Pain *0/15 (0.00%)', ' Motor vehicle accident *0/15 (0.00%)', 'Adverse Events 2:', ' Total: 2/15 (13.33%)', ' Chest Pain *1/15 (6.67%)', ' Motor vehicle accident *1/15 (6.67%)']}
|
{'Clinical Trial ID': 'NCT00127205', 'Intervention': ['INTERVENTION 1: ', ' Arm I Zoledronate', ' Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', ' zoledronic acid: Given IV', 'INTERVENTION 2: ', ' Arm II Clodronate', ' Patients receive oral clodronate once daily for 35 months.', ' clodronate disodium: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed primary adenocarcinoma of the breast', ' Stage I-III disease', ' No evidence of metastatic disease', ' Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks', ' Axillary evaluation per institutional standards', ' Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer', ' Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible', ' Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible', ' Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab [Herceptin^®], bevacizumab, or hematopoietic growth factors)', ' Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs 12 weeks after completion of surgery', ' Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease', ' Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Creatinine 2 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No renal failure', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of esophageal stricture or motility disorders', ' Gastroesophageal reflux disorder allowed', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior or concurrent hematopoietic growth factors allowed', ' HER-2-targeted therapies allowed', ' Antiangiogenics allowed', ' Chemotherapy', ' See Disease Characteristics', ' Endocrine therapy', ' See Disease Characteristics', ' Radiotherapy', ' Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician', ' Surgery', ' See Disease Characteristics', ' Other', ' Prior neoadjuvant therapy allowed', ' Prior bisphosphonates for bone density allowed', ' No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis', ' No concurrent enrollment in clinical trials with bone density as an endpoint', ' Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.', ' Time frame: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'Results 1: ', ' Arm/Group Title: Arm I Zoledronate', ' Arm/Group Description: Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', ' zoledronic acid: Given IV', ' Overall Number of Participants Analyzed: 2231', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 88 (87 to 90)', 'Results 2: ', ' Arm/Group Title: Arm II Clodronate', ' Arm/Group Description: Patients receive oral clodronate once daily for 35 months.', ' clodronate disodium: Given orally', ' Overall Number of Participants Analyzed: 2235', ' Measure Type: Number', ' Unit of Measure: percentage of analyzed participants 88 (86 to 89)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/2125 (0.99%)', ' Febrile neutropenia 0/2125 (0.00%)', ' Hemoglobin 0/2125 (0.00%)', ' Cardiac General-Other 0/2125 (0.00%)', ' Cardiac-ischemia/infarction 1/2125 (0.05%)', ' Conduction abnorm/AV block - Sick sinus syndrome 0/2125 (0.00%)', ' Left ventricular diastolic dysfunction 0/2125 (0.00%)', ' Left ventricular systolic dysfunction 0/2125 (0.00%)', ' Pain - Cardiac/heart 0/2125 (0.00%)', 'Adverse Events 2:', ' Total: 190/2186 (8.69%)', ' Febrile neutropenia 3/2186 (0.14%)', ' Hemoglobin 3/2186 (0.14%)', ' Cardiac General-Other 2/2186 (0.09%)', ' Cardiac-ischemia/infarction 1/2186 (0.05%)', ' Conduction abnorm/AV block - Sick sinus syndrome 1/2186 (0.05%)', ' Left ventricular diastolic dysfunction 3/2186 (0.14%)', ' Left ventricular systolic dysfunction 1/2186 (0.05%)', ' Pain - Cardiac/heart 3/2186 (0.14%)']}
|
f078c722-b879-40f2-ac72-c733001b93dd
|
Comparison
|
Results
|
NCT02041429
|
NCT00068588
|
the primary trial and the secondary trial use the same outcome measurements, same drugs and the same cohort sizes.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02041429', 'Intervention': ['INTERVENTION 1: ', ' All Phase I Participants', ' Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles', ' 1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Phase I', ' Participants must meet the following criteria on screening examination to be eligible to participate in the study:', ' Participants must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.', ' Patients may not have received > 2 prior chemotherapies for advanced disease.', ' Either measurable or evaluable disease is allowed.', ' Age 18 years. Because no dosing or adverse event data are currently available on the use of ruxolitinib in participants <18 years of age, children are excluded from this study.', ' Life expectancy of greater than 3 months.', ' ECOG performance status 2 (see Appendix A).', ' Participants must have normal organ and marrow function as defined below:', ' Leukocytes 3,000/mcL', ' Absolute neutrophil count 1,500/mcL', ' Platelets 100,000/mcL', ' Total bilirubin within normal institutional limits', ' AST (SGOT)/ALT (SGPT) 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits or creatinine clearance 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal', ' Both men and women are allowed.', ' The effects of ruxolitinib on the developing human fetus are unknown. For this reason 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.', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Phase I', ' Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.', ' Participants may not be receiving any other study agents within 2 weeks of initiating treatment.', ' Participants with untreated or uncontrolled brain metastases are excluded from this clinical trial. Patients with treated and stable (> 4 weeks) brain metastasis are allowed.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib.', ' Participants receiving any medications or substances that are strong inhibitors of CYP3A4 are ineligible. (Please refer to Appendix B for list and washout periods).', ' Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily.', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because ruxolitinib is a JAK inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib. These potential risks may also apply to other agents used in this study.', ' Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.', ' Clinically significant malabsorption syndrome.', ' Prior chemotherapy or radiation administered within 2 weeks from initiating study treatment.'], 'Results': ['Outcome Measurement: ', ' Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I]', ' Ruxolitinib MTD in combination with paclitaxel 80 mg/m2 intravenously (IV) weekly is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition', ' If a DLT was observed in 0 of 3 patients in a cohort, then 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.', ' If a DLT was observed in 1 of 3 patients in a cohort, then 3 additional patients were added, and then if no further DLTs were observed, 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.', ' The MTD is identified as the level BELOW the cohort where DLT occurred in less than one third of patients within the cohort.', " If no DLT's are observed, the MTD is not reached.", ' Time frame: Participants were assessed prior to each dose of paclitaxel with ruxolitinib; The observation period for MTD evaluation was the first 2 cycles of treatment. (Up to 8 weeks).', 'Results 1: ', ' Arm/Group Title: All Phase I Participants', ' Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles', ' 1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: mg 15'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Anemia 0/3 (0.00%)', ' Anemia 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Neutrophil count decreased 0/3 (0.00%)', ' Lymphedema 0/3 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00068588', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', 'INTERVENTION 2: ', ' Arm 2', ' Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the breast', ' Patients must have measurable disease, defined as lesions 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 progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease; patients must not have received prior capecitabine or 5-fluorouracil; patients with hormone-sensitive tumors should have received hormone treatment and any prior number of hormonal agents will be allowed; patients with tumors that overexpress HER-2/neu (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received herceptin, either in the adjuvant or metastatic setting, unless there is a contraindication to herceptin therapy; all prior therapies must have been completed 4 weeks before treatment', ' Life expectancy of greater than 3 months', ' ECOG performance status =< 2 (Karnofsky >= 50%)', ' Leukocytes >= 3,000/μL', ' Absolute neutrophil count >= 1,500/μL', ' Platelets >= 100,000/μL', ' Total bilirubin within normal institutional limits', ' AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min', ' Patients must have completed radiation treatment > 4 weeks prior to study entry; previously radiated area(s) must not be the only site of disease', ' All major surgical procedures must be completed > 4 weeks prior to study entry; placement of vascular access device or tissue biopsy will not be considered major surgery', ' 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', ' Ability to understand and the willingness to sign a written informed consent document', ' Patients must agree to the placement of a central venous catheter in order to receive the continuous infusion treatment', 'Exclusion Criteria:', ' Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following:', ' 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', ' Patients who have had chemotherapy, hormone therapy, 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 investigational agents; patients may not have received prior GTI-2040', ' 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', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GTI-2040 or to capecitabine or 5-fluorouracil', ' Patients requiring anticoagulant therapy; low-dose anticoagulant (warfarin 1 mg per day) for the primary prophylaxis of venous catheter-associated thrombosis is permitted', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study because GTI-2040 and capecitabine have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GTI-2040 and capecitabine, breastfeeding should be discontinued if the mother is treated', ' Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GTI-2040 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose Determined by Dose-limiting Toxicities', ' 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0', ' Time frame: 21 days', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT ', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Diarrhea * 0/3 (0.00%)', ' Nausea * 0/3 (0.00%)', ' Vomiting * 0/3 (0.00%)', ' Fatigue * 0/3 (0.00%)', ' Catheter related infection * 1/3 (33.33%)', ' Infection NOS * 1/3 (33.33%)', ' Aspartate aminotransferase increased * 1/3 (33.33%)', ' Dehydration * 0/3 (0.00%)', ' Hypercalcemia * 0/3 (0.00%)', ' Hypokalemia * 0/3 (0.00%)', ' Hypophosphatemia * 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 6/21 (28.57%)', ' Diarrhea * 2/21 (9.52%)', ' Nausea * 1/21 (4.76%)', ' Vomiting * 1/21 (4.76%)', ' Fatigue * 1/21 (4.76%)', ' Catheter related infection * 0/21 (0.00%)', ' Infection NOS * 1/21 (4.76%)', ' Aspartate aminotransferase increased * 1/21 (4.76%)', ' Dehydration * 1/21 (4.76%)', ' Hypercalcemia * 1/21 (4.76%)', ' Hypokalemia * 2/21 (9.52%)', ' Hypophosphatemia * 2/21 (9.52%)']}
|
c33d78e5-13be-4cde-b36e-7cc097f180a2
|
Comparison
|
Intervention
|
NCT00075270
|
NCT01781299
|
the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing an implant.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT00075270', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib With Paclitaxel', ' Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', 'INTERVENTION 2: ', ' Placebo With Paclitaxel', ' Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.'], 'Eligibility': ['Inclusion criteria:', ' Signed Informed Consent', ' Able to swallow an oral medication', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram', ' Adequate kidney and liver function', ' Adequate bone marrow function', ' Tumor tissue available for testing', ' Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone', ' No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested', 'Exclusion criteria:', ' Prior treatment regimens for advanced or metastatic breast cancer.', ' Pregnant or lactating', ' Conditions that would effect the absorption of an oral drug', ' Active infection', ' Brain metastases', ' Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.', ' Known hypersensitivity to Taxol or excipients of Taxol', ' Peripheral neuropathy of Grade 2 or greater is not permitted', ' Severe Cardiovascular disease or cardiac disease requiring a device.', " Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent."], 'Results': ['Outcome Measurement: ', ' Time to Progression as Evaluated by the Investigator', ' Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.', ' Time frame: Randomization until the date of disease progression or death (average of 26 weeks)', 'Results 1: ', ' Arm/Group Title: Lapatinib With Paclitaxel', ' Arm/Group Description: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 291', ' Median (Inter-Quartile Range)', ' Unit of Measure: weeks 29.0 (13.9 to 46.9)', 'Results 2: ', ' Arm/Group Title: Placebo With Paclitaxel', ' Arm/Group Description: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 288', ' Median (Inter-Quartile Range)', ' Unit of Measure: weeks 22.9 (12.0 to 38.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/293 (35.15%)', ' Neutropenia 22/293 (7.51%)', ' Febrile neutropenia 10/293 (3.41%)', ' Disseminated intravascular coagulation 0/293 (0.00%)', ' Leukopenia 0/293 (0.00%)', ' Thrombocythemia 1/293 (0.34%)', ' Left ventricular dysfunction 2/293 (0.68%)', ' Atrial fibrillation 1/293 (0.34%)', ' Cardiac arrest 1/293 (0.34%)', ' Cardiac failure 1/293 (0.34%)', ' Myocardial infarction 0/293 (0.00%)', 'Adverse Events 2:', ' Total: 63/286 (22.03%)', ' Neutropenia 14/286 (4.90%)', ' Febrile neutropenia 3/286 (1.05%)', ' Disseminated intravascular coagulation 1/286 (0.35%)', ' Leukopenia 1/286 (0.35%)', ' Thrombocythemia 0/286 (0.00%)', ' Left ventricular dysfunction 1/286 (0.35%)', ' Atrial fibrillation 0/286 (0.00%)', ' Cardiac arrest 0/286 (0.00%)', ' Cardiac failure 0/286 (0.00%)', ' Myocardial infarction 1/286 (0.35%)']}
|
{'Clinical Trial ID': 'NCT01781299', 'Intervention': ['INTERVENTION 1: ', ' AlloDerm RTU', ' Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.', 'AlloDerm RTU', 'INTERVENTION 2: ', ' SurgiMend PRS', ' Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.', 'SurgiMend PRS'], 'Eligibility': ['Inclusion Criteria:', " Subject's with ability to provide informed consent.", ' Subjects greater than 18 years old', ' Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and', ' Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits.', 'Exclusion Criteria:', ' Subjects less than 18 years of age', " Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product", ' Pregnancy', 'Bovine allergy'], 'Results': ['Outcome Measurement: ', ' Complication Rates', ' To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: AlloDerm RTU', ' Arm/Group Description: Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.', ' AlloDerm RTU', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 100.0%', 'Results 2: ', ' Arm/Group Title: SurgiMend PRS', ' Arm/Group Description: Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.', ' SurgiMend PRS', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 75.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/4 (0.00%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)']}
|
58dbc33b-d32c-4e91-a940-ca1148bbdae4
|
Comparison
|
Intervention
|
NCT00602043
|
NCT01720602
|
Several treatments in the secondary trial are administered by mouth, none of the treatments in the primary trial are given via this route.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'Clinical Trial ID': 'NCT00602043', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites', ' Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.', ' laboratory biomarker analysis: Correlative studies', 'INTERVENTION 2: ', ' Diagnostic FES: Patients With FES Negative Sites of Disease', ' Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.'], 'Eligibility': ['Inclusion Criteria:', ' Patients will have pathologically confirmed invasive breast cancer with clinical, radiographic and/or pathologic evidence of stage IV disease; patients must have tissue blocks available from biopsy of at least one site of metastatic disease and/or from diagnosis of their primary breast cancer', ' Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or non-measurable but must be present in at least one non-liver site and imageable on FDG PET scan; in patients with non-measurable disease by RECIST criteria, one of the following may be used to assess and follow disease: MUC-1 antigen level (either cancer antigen [CA] 27.29 or carcinoembryonic antigen [CEA]) > 2 x upper limit of normal (ULN), Circulating tumor cell assay > 5, or FDG-PET SUV > 2.5 in purely lytic lesions; elevated tumor markers alone are insufficient', ' No prior endocrine therapy for breast cancer or', ' Off adjuvant endocrine therapy for > 6 months or', ' Greater than 2 years of a single adjuvant endocrine therapy at the time of first recurrence and plan to change to alternate endocrine therapy; use of tamoxifen must be discontinued 6-8 weeks prior to entrance into the study', ' Prior chemotherapy regimens in the adjuvant or neoadjuvant setting are allowed', ' Women treated with adjuvant LHRH (luteinizing hormone-releasing hormone) analog are eligible', ' Be assessed for menopausal status; for study purposes, postmenopausal is defined as:', ' A prior documented bilateral oophorectomy, or', ' A history of at least 12 months without spontaneous menstrual bleeding, or', ' Age 60 or older with a prior hysterectomy without oophorectomy, or', ' Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented follicle stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab', ' Premenopausal patients must have a baseline FSH, and estradiol levels to determine menopausal status; measures will be repeated at 3-6 months to confirm menopausal status', ' Patients must be positive for estrogen receptor (ER) and may or may not be positive for progesterone receptor (PgR) by IHC in the primary tumor and/or metastatic site; the pathology report for assay of ER will be reviewed by one of the investigators prior to enrollment, the study pathologist will review the pathology report if necessary for determination of study eligibility', ' Tumor HER2/neu expression must be determined prior to study enrollment; assessment may be by fluorescence in situ hybridization (FISH) assay or by immunohistochemistry (ICC); if determination is intermediate by ICC, FISH must be performed', ' Life expectancy > 16 weeks', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Absolute neutrophil count (ANC) >= 1,000', ' Platelet count >= 50,000', ' Hemoglobin within normal limits (WNL) for the institution', ' Serum creatinine =< 1.5 x institutional ULN (IULN) and estimated creatinine clearance > 50 mL/min using the Cockroft-Gault formula', ' Bilirubin =< 1.5 x ULN', ' Serum glutamic oxaloacetic transaminase (SGOT)/ serum glutamic pyruvate transaminase (SGPT) =< 1.5 x ULN', ' Alkaline phosphatase =< 2.5 x ULN', ' Patients must be planning a course of endocrine therapy with one of the following: tamoxifen +/- ovarian suppression, aromatase inhibitor +/- fulvestrant (with ovarian suppression in pre-menopausal patients) or fulvestrant alone', ' After entry into the study, patients are expected to be followed for at least 6 months after the injection of [^18F] FES', ' Have a negative pregnancy test within 7 days prior to registration if of childbearing potential', ' No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures', ' Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', 'Exclusion Criteria:', ' Patients with a history of prior endocrine therapy for metastatic disease are NOT eligible; adjuvant endocrine therapy for < 2 years total or discontinued less than 6 months before first disease recurrence also excludes the patient', ' Patients with disease in the liver only are NOT eligible for the study', ' Patients who are HER2/neu positive disease and planning to undergo HER2-directed therapy (trastuzumab or lapatinib) are NOT eligible for the study', ' Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded', ' Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases', ' History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent', ' Any other life-threatening illness (e.g., serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)', ' Unwillingness to give informed consent', " Medically unstable as judged by the patient's physician", ' Psychological, familial, sociological, or geographical conditions which do not permit compliance with the study protocol', " Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion", ' Patient weight greater than 400 lbs (exceeds weight limit for tomograph table)', ' Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)', ' Adult patients who require monitored anesthesia for PET scanning'], 'Results': ['Outcome Measurement: ', ' Best Overall Response', ' Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease [per response evaluation criteria in solid tumors (RECIST, version 1.1)], size-based response criteria were used to assess response.', ' For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).', ' The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).', ' Time frame: Up to 6 months', 'Results 1: ', ' Arm/Group Title: Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites', ' Arm/Group Description: Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: patients with progressive disease 5', 'Results 2: ', ' Arm/Group Title: Diagnostic FES: Patients With FES Negative Sites of Disease', ' Arm/Group Description: Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.', ' Patients begin clinically indicated endocrine therapy.', ' Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.', ' This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: patients with progressive disease 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT01720602', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Vorinostat, AI Therapy)', ' Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.', ' vorinostat: Given PO', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' positron emission tomography: Correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' fludeoxyglucose F 18: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven diagnosis of breast cancer', ' Stage IV disease', ' Patient has previously derived clinical benefit from endocrine therapy, but is no longer deriving benefit to endocrine therapy in the opinion of the treating investigator', ' At least one site of measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Female patient is post menopausal as defined by one of the following; free from menses for >= 2 years, surgically sterilized, FSH and estradiol in post-menopausal range AND surgical absence of uterus OR chemotherapy induced amenorrhea lasting > 1 year OR currently on ovarian suppression', ' Female patient of childbearing potential has a negative urine or serum (beta human chorionic gonadotropin [B-hCG]) pregnancy test within 14 days prior to receiving the first dose of vorinostat', ' Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study', ' Absolute neutrophil count (ANC) >= 1,500/mcL', ' Platelets >= 50,000/mcL', ' Hemoglobin >= 9 g/dL', ' Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation', ' Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation', ' Potassium (K) levels normal limits', ' Magnesium (Mg) levels normal limits', ' Calculated creatinine clearance >= 30 mL/min', ' Creatinine clearance should be calculated per institutional standard', ' Serum total bilirubin =< 1.5 x ULN', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x ULN', ' Alkaline phosphatase =< 2.5 x ULN', " Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent", ' Patient has a life expectancy of at least 12 weeks in the opinion of the treating investigator', ' Patient is willing to continue on same AI therapy', ' Patient agrees to participate in imaging protocol 7184 and is separately consented', 'Exclusion Criteria:', ' Patient has not derived clinical benefit from prior endocrine therapy', ' Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184', ' Patient has received an ER blocking therapy (selective estrogen receptor modulating or downregulating selective estrogen receptor modulator [SERM] or selective estrogen receptor degrader [SERD] i.e. tamoxifen or fulvestrant) within the past 6 weeks', ' Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidepsin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period', ' Patient is on any systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone during the 30 days prior to the start of the study drugs', ' Patient has known hypersensitivity to the components of study drug or its analogs', ' Patients with uncontrolled brain metastases', ' New York Heart Association (NYHA) class III or IV congestive heart failure, myocardial infarction within the previous 6 months, QTc > 0.47 seconds, or uncontrolled arrhythmia', ' Type I diabetes mellitus; patients with type II diabetes mellitus will be included as long as their glucose can be controlled to under 200 mg/dL', ' Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study', ' Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse', ' Patients with known active viral hepatitis', " Patient has a history or current evidence of any condition, therapy, or laboratory (lab) abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate"], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST', ' A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.', ' Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).', ' Time frame: 8 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Vorinostat, AI Therapy)', ' Arm/Group Description: Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.', ' vorinostat: Given PO', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' positron emission tomography: Correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' fludeoxyglucose F 18: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of patients 60 (35 to 81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Liver failure [1]1/15 (6.67%)', ' Fever [1]1/15 (6.67%)']}
|
fbbad9dc-58a9-4527-86c5-49cb0a3e7d0e
|
Single
|
Adverse Events
|
NCT01216176
|
Urosepsis was the only recorded adverse event in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT01216176', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 - Cohort A', ' Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', 'AZD0530'], 'Eligibility': ['Inclusion Criteria - Phase 1 (Cohort A):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses > 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor', ' Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease', ' Measurable or evaluable disease according to RECIST criteria (see appendix VII)', ' Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab and/or lapatinib.', ' ECOG performance status 0-2 (see appendix VI)', ' Patients are suitable candidates for treatment with anastrozole (patients may have had any prior endocrine therapy or prior chemotherapy for treatment of their disease, either as adjuvant therapy, or as treatment for advanced disease). There is no restriction on the number of prior regimens in the phase I cohort A.', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count to 1.5 x 10^9/L', ' Hemoglobin to 9.0 g/dL', ' Platelet count to 100 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.0 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT within protocol parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.', ' Inclusion Criteria - Phase 2 (Cohort B):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor. Patients may have bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS in either breast but the DCIS will not be measured as part of the study endpoints.', ' Tumor size 2 cm', ' Tumor measurable either by clinical examination, mammography, MRI, or ultrasound', ' HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by IHC)', ' ECOG performance status 0-1 (see Appendix VI)', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count 1.5 x 10^9/L', ' Hemoglobin 9.0 g/dL', ' Platelet count 70 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.5 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT 1.5 x upper limit of normal (ULN)', ' Exclusion Criteria - Phase 1 (Cohort A):', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration.', ' Ongoing, chronic administration of bisphosphonate therapy is allowed so long as such treatment was ongoing at the time of study entry.', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their excipients', ' Evidence of bleeding diathesis or coagulopathy.', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication with drugs listed in Appendix XI should be excluded from study.', ' Any evidence of severe or uncontrolled systemic medical or psychiatric conditions (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.', ' Exclusion Criteria - Phase 2 (Cohort B):', ' Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast cancer is not an exclusion criterion.', ' Inflammatory breast cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast, or pathologically defined as dermal lymphatic invasion', ' Prior excisional biopsy or complete resection of the primary invasive tumor (prior sentinel node biopsy allowed)', ' Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer', ' Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular node involvement and/or direct invasion of the primary tumor into skin is allowed', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped for one week prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC AE version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g. history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 (saracatinib) or their excipients', ' Evidence of bleeding diathesis or coagulopathy', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' AZD0530 (saracatinib) is a substrate and inhibitor of CYP3A4. Since concurrent administration of AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted at MD discretion. Drugs listed in Appendix X that are known to strongly induce or inhibit CYP3A4 activity should be discontinued prior to study entry and should not be initiated during protocol treatment.', ' Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) disease.', ' Subjects unwilling or unable to undergo breast MRI as required by protocol will be excluded from study'], 'Results': ['Outcome Measurement: ', ' Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole', ' To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.', ' Time frame: Cycle 1: Days 1 - 28', 'Results 1: ', ' Arm/Group Title: Phase 1 - Cohort A', ' Arm/Group Description: Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', ' AZD0530', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: mg/day oral dose anastrozole: 1', 'saracatinib: 175'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/12 (25.00%)', ' Atrial fibrillation 0/12 (0.00%)', ' Cardiac ischemia/infarction [1]0/12 (0.00%)', ' Congestive Heart Failure [2]0/12 (0.00%)', ' Diverticulitis 0/12 (0.00%)', ' Cholecystitis 0/12 (0.00%)', ' Hyperbilirubinemia 0/12 (0.00%)', ' Urosepsis 2/12 (16.67%)', ' Brain hemorrhage complicating CNS metastasis 1/12 (8.33%)', ' Rash [3]0/12 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2c462296-35f5-482a-9ece-3b4ed4c2f53a
|
|
Single
|
Eligibility
|
NCT01196052
|
Participants in the primary trial must be willing to undergo cyclophosphamide-based chemotherapy.
|
Contradiction
|
[
0,
4
] |
[] |
{'Clinical Trial ID': 'NCT01196052', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Adult patients 18 years of age.', ' Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).', ' Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.', ' Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.', ' Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.', ' Patients may enroll before or after AC/FEC chemotherapy has completed.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate hematologic, biochemistry, and cardiac assessments.', 'Exclusion Criteria:', ' Stage IV breast cancer or bilateral breast cancer.', ' Pregnant or breastfeeding women.', ' History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.', ' Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.', ' Active cardiac history.', ' Current chronic daily treatment with oral corticosteroids or equivalent.', ' Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.', ' Active, unresolved infections at screening.', ' Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.', ' Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.', ' Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.', ' Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.', ' Grade 2 peripheral neuropathy at Baseline.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment', ' A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10% from Baseline to an LVEF of < 50%.', ' Time frame: Baseline to 12 weeks after the start of trastuzumab emtansine treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 0 (0.00 to 2.45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/148 (10.14%)', ' Febrile neutropenia 1/148 (0.68%)', ' Atrial fibrillation 2/148 (1.35%)', ' Abdominal pain 1/148 (0.68%)', ' Diarrhoea 1/148 (0.68%)', ' Pyrexia 2/148 (1.35%)', ' Cellulitis 1/148 (0.68%)', ' Device related infection 2/148 (1.35%)', ' Gastroenteritis viral 1/148 (0.68%)', ' Gastrointestinal infection 1/148 (0.68%)', ' Upper respiratory tract infection 1/148 (0.68%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
16358be6-3895-48f7-8006-4effeb3f74b3
|
|
Comparison
|
Eligibility
|
NCT00703326
|
NCT00274768
|
Participants with HER2- primary liver tumors, confirmed by fluorescence in-situ hybridization are eligible for the secondary trial and the primary trial.
|
Contradiction
|
[
0,
3,
5
] |
[
0,
1,
7,
8
] |
{'Clinical Trial ID': 'NCT00703326', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab (IMC-1121B) + Docetaxel', ' Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', 'INTERVENTION 2: ', ' Placebo + Docetaxel', ' Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Participant is able to provide signed informed consent', ' Participant is female and 18 years of age or older if required by local laws or regulations', ' Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis', ' Participant has measurable and/or non-measurable disease', " Participants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)", ' Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer', ' Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization', ' Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization', ' Participant completed all prior radiotherapy with curative intent 3 weeks prior to randomization', ' Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting 2 weeks prior to randomization', " Participant's left ventricular ejection fraction is within normal institutional ranges", ' Participant has resolution to grade 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade 2', ' Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Participant is amenable to compliance with protocol schedules and testing', ' Participant has adequate hematological functions [absolute neutrophil count (ANC) 1500 cells/microliter (mcL), hemoglobin 9 grams/deciliter (g/dL), and platelets 100,000 cells/mcL and 850,000 cells/mcL]', ' Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times the upper limit of normal (ULN), or 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase 5.0 times the ULN]', ' Participant has serum creatinine 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min)', " Participant's urinary protein is 1+ on dipstick or routine urinalysis (UA); if urine protein 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study", ' Participant must have adequate coagulation function as defined by international normalized ratio (INR) 1.5 and a partial thromboplastin time (PTT) 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices)', ' Women of childbearing potential must implement adequate contraception in the opinion of the investigator', ' Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer', 'Exclusion Criteria:', ' 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. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years', ' Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80', ' Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF)', ' Participant has a history of chronic diarrheal disease within 6 months prior to randomization', ' Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization', ' Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization', ' Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization', ' Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy', ' Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator', ' Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease', ' Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness', ' Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Participant is pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after 2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.', ' Time frame: Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)', 'Results 1: ', ' Arm/Group Title: Ramucirumab (IMC-1121B) + Docetaxel', ' Arm/Group Description: Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m ) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 759', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.5 (8.3 to 9.8)', 'Results 2: ', ' Arm/Group Title: Placebo + Docetaxel', ' Arm/Group Description: Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m ) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 385', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.2 (7.1 to 8.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 285/752 (37.90%)', ' Anaemia 2/752 (0.27%)', ' Disseminated intravascular coagulation 2/752 (0.27%)', ' Febrile neutropenia 51/752 (6.78%)', ' Neutropenia 47/752 (6.25%)', ' Thrombocytopenia 2/752 (0.27%)', ' Atrial fibrillation 1/752 (0.13%)', ' Atrial flutter 0/752 (0.00%)', ' Cardiac failure congestive 1/752 (0.13%)', ' Left ventricular dysfunction 0/752 (0.00%)', 'Adverse Events 2:', ' Total: 117/382 (30.63%)', ' Anaemia 3/382 (0.79%)', ' Disseminated intravascular coagulation 0/382 (0.00%)', ' Febrile neutropenia 11/382 (2.88%)', ' Neutropenia 20/382 (5.24%)', ' Thrombocytopenia 0/382 (0.00%)', ' Atrial fibrillation 1/382 (0.26%)', ' Atrial flutter 1/382 (0.26%)', ' Cardiac failure congestive 0/382 (0.00%)', ' Left ventricular dysfunction 1/382 (0.26%)']}
|
{'Clinical Trial ID': 'NCT00274768', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine', ' The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast', ' Evidence of metastatic involvement (stage IV disease)', ' Patients must have measurable disease', ' At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)', ' Treated brain metastases (surgery or radiation therapy) allowed if clinically stable', ' Patients with leptomeningeal disease are ineligible', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Male or female', ' Menopausal status not specified', ' Absolute neutrophil count (ANC) 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Creatinine clearance > 50 mL/min', ' Fertile patients must use effective contraception', ' No history of another severe and/or life-threatening medical disease', ' No other active primary malignancy', ' Not pregnant or nursing', ' Negative pregnancy test', ' Patients with asymptomatic HIV infection are eligible', ' Liver dysfunction score 9', ' No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)', ' No active gastrointestinal malabsorption illness', ' No clinically significant cardiac disease, including the following:', ' Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months', ' No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency', ' No history of uncontrolled seizures or central nervous system disorders', ' No significant history of noncompliance to medical regimens', ' No clinically significant psychiatric disability that would preclude study compliance', ' PRIOR CONCURRENT THERAPY:', ' No previous capecitabine', ' Up to 3 prior cytotoxic regimens allowed for metastatic disease', ' Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)', ' No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy', ' No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy', ' No other concurrent investigational drugs', ' No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)', ' Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed', ' At least 4 weeks since prior sorivudine or brivudine', ' Concurrent use of bisphosphonates allowed if initiated before beginning study therapy', ' Concurrent use of megestrol acetate suspension as an appetite stimulant allowed'], 'Results': ['Outcome Measurement: ', ' Response Rate', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/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: Participants were followed to progression, evaluated every 12 weeks', 'Results 1: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants 21'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/26 (7.69%)', ' Death [1]2/26 (7.69%)']}
|
6d4ecb16-6586-4ea8-a1dc-f825e951e060
|
Comparison
|
Adverse Events
|
NCT01252290
|
NCT00479674
|
Unlike the secondary trial, the primary trial does not record any instances of Anemia, Dyspepsia, Nausea or vomiting.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT01252290', 'Intervention': ['INTERVENTION 1: ', ' Lovaza™', ' Lovaza™: 4 capsules daily for 6 months'], 'Eligibility': ['Inclusion Criteria', ' Subjects must be postmenopausal and between the ages of 25 and 69 years. Menopause is defined by no menstrual period for more than one year and intact uterus and ovaries, or women with intact ovaries but without a uterus and age 50 and over, or a woman with both estradiol and follicle stimulating hormone (FSH) in the postmenopausal range or any woman who has had her ovaries removed.', ' Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:', ' A five-year Gail risk of 1.67% or 2X the average risk for a woman of the same age using either the Surveillance Epidemiology and End Results (SEER, http://seer.cancer.gov) database, the NCI Breast Cancer Risk Assessment Tool (www.cancer.gov/bcrisktool), or the International Breast Cancer Intervention Study (IBIS) Risk Evaluator (http://www.emstrials.', ' org/riskevaluator/), or a ten-year Tyrer-Cuzick model risk of 2x that of the population risk.', ' A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer.', ' Multiple prior biopsies or at least one prior biopsy exhibiting atypical hyperplasia (AH), lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS).', ' Random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia within the last three years;', ' Chest or neck radiation before age 30;', ' Mammographic breast density by visual estimate equals or exceeds 50%.', ' Subjects must be willing to continue the same hormonal milieu present at baseline throughout trial (Cannot start or stop any type of hormone replacement therapy with the exception of vagifem or estring).', ' Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial), ingestion of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker assessment. .', ' Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen or raloxifene and are either not eligible or are not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by RPFNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied', ' Subjects must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Women must be willing to have an off-study mammogram performed 6 months after study entry.', ' Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at ~6.5 months after starting Lovaza™.', 'Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score > 13). There must be 500 epithelial cells on the slide for cytomorphology. There must be sufficient reserved methanol-formalin- fixed material for quantitative reverse transcription polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.', ' Subjects must be willing to undergo phlebotomy at baseline and 6 months and 6.5 months. Approximately 3 tablespoons of blood will be obtained at baseline and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .', ' Subjects must produce a spot urine sample at baseline, 6 months, and at study conclusion', ' Subjects must be willing to undergo measurement of height, weight, and BMI and undergo body composite analysis (DEXA) at initiation and conclusion of intervention.', ' Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life as well as relevant family history personal health and reproductive history and medications at initiation and conclusion of the intervention. Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA.', ' Exclusion Criteria', ' Women that have had a metastatic malignancy of any kind.', ' Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.', ' Women who are currently taking anticoagulants.', ' Women who have breast implants.', ' Women who have undergone change in their hormonal milieu in the past 6 months.', ' Women who have taken omega 3 fatty acid or flaxseed supplements within 3 weeks prior to their baseline RPFNA or women who have taken high dose omega 3 within the past three months.', ' Women who regularly take NSAIDS (>7 tablets weekly).', ' Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline RPFNA.', ' Women who have abnormal renal or hepatic function at baseline, defined as blood chemistry values clinically significantly outside of normal institutional ranges.', ' Women who have a history of an allergy, including hives, to fish products.', ' Women who have a BMI of 40 kg/m^2 or greater.', ' Inclusion of Women and Minorities This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast.'], 'Results': ['Outcome Measurement: ', ' The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day', ' To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.', ' Time frame: 6 month visit', 'Results 1: ', ' Arm/Group Title: Lovaza™', ' Arm/Group Description: Lovaza™: 4 capsules daily for 6 months', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: proportion of enrolled participants 0.97'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/35 (5.71%)', ' Gastroesophageal reflux disease * 1/35 (2.86%)', ' Ductal carcinoma in situ * 1/35 (2.86%)']}
|
{'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%)']}
|
5bb009f0-bc19-4a85-85b8-bd7bf0675f3f
|
Comparison
|
Results
|
NCT01323530
|
NCT01106040
|
the secondary trial and the primary trial do not have comparable Outcome Measurements.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT01323530', 'Intervention': ['INTERVENTION 1: ', ' Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)', ' Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).', 'INTERVENTION 2: ', ' Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)', ' Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).'], 'Eligibility': ['Inclusion Criteria', ' Subjects who meet all of the following criteria will be included in the study:', ' Dose-escalation cohorts (Phase 1b):', ' Histologically or cytologically confirmed cancer that is advanced and/or metastatic', ' Resistant/refractory to approved therapies (defined as progressive disease during or within 6 months after the last anti-cancer therapy) or for whom single agent capecitabine at this dose level and schedule would be a reasonable treatment option in the opinion of the investigator', ' For subjects that previously received capecitabine, all capecitabine related toxicities must have completely resolved', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement.', ' Females of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin (hCG) at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.', ' Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly affective method of contraception (e.g. condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously)', ' Life expectancy of greater than 3 months', ' Willing and able to comply with all aspects of the protocol', ' Provide written informed consent', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2', ' Males and females, age greater than or equal to18 years', ' Dose-confirmation cohorts (Phase 2):', ' Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic', ' Received up to three prior chemotherapy regimens in any setting (sequential neoadjuvant/ adjuvant treatment counting as one regimen)', ' Chemotherapy regimens must have included an anthracycline (unless anthracycline containing chemotherapy is inappropriate) and a taxane, either in combination or in separate regimens', ' No prior treatment with capecitabine in any setting', ' At least one lesion of greater than or equal to 1.5cm in longest diameter for non-lymph nodes and greater than or equal to 1.5cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 7', ' Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement.', ' Females of childbearing potential must have a negative urine or serum beta hCG at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD, or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential', ' Life expectancy of greater than 3 months', ' Willing and able to comply with all aspects of the protocol', ' ECOG-PS 0 or 1', ' Females, age greater than or equal to 18 years', ' Exclusion Criteria', ' Subjects who meet any of the following criteria will be excluded from participation in the study:', ' Radiotherapy, chemotherapy, biological therapy or investigational agents within 4 weeks prior to the start of study treatment; subjects must have recovered from any previous therapy related toxicity to less than Grade 1 at study entry (except for stable sensory neuropathy less than or equal to Grade 2 and alopecia)', ' Treatment with mitomycin C or nitrosourea within 6 weeks prior to commencing on study treatment', ' Hormonal treatment within 2 weeks prior to start of study treatment (continued use of antiandrogens and/or gonadorelin analogues for treatment of prostate cancer permitted)', ' Prior participation in an eribulin clinical study, even if not assigned to eribulin treatment', ' Subject with hypersensitivity to halochondrin B and /or halochondrin B chemical derivates or capecitabine or any of the excipients', ' Suspected dihydropyrimidine dehydrogenase (DPD) deficiency', ' Previous radiotherapy encompassing greater than 30% of marrow', ' Previous organ allograft requiring immunosuppression', ' Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier', ' Meningeal carcinomatosis', ' Significant cardiovascular impairment (history of congestive heart failure greater than New York Heart Association [NYHA] grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia)', " Electrocardiogram (ECG) with QT interval corrected for heart rate (QTc) interval greater than 470 msec (as measured either by Bazett's or Fredericia's formula)", ' Pre-existing neuropathy greater than Grade 2', ' Anti-coagulant therapy with warfarin or related compounds, other than for line patency, that cannot be changed to heparin-based therapy for the duration of the study', ' Subjects with known positive serology for Human Immunodeficiency Virus (HIV), or Hepatitis B or C', " Subjects with other significant disease or disorder that, in the Investigator's opinion, would exclude the subject from the study", ' Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study', ' Unable to swallow tablets'], 'Results': ['Outcome Measurement: ', ' Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)', ' DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count [ANC] less than 1.0*10^9/liter [L], fever of at least 38.5 degree celsius [°C]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline.', ' Time frame: Cycle 1 (21 days)', 'Results 1: ', ' Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)', ' Arm/Group Description: Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 12.5%', 'Results 2: ', ' Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)', ' Arm/Group Description: Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/8 (25.00%)', ' Febrile neutropenia 1/8 (12.50%)', ' Heparin-induced Thrombocytopenia 0/8 (0.00%)', ' Neutropenia 0/8 (0.00%)', ' Constipation 0/8 (0.00%)', ' Dysphagia 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', ' Vomiting 0/8 (0.00%)', ' Abdominal Pain 0/8 (0.00%)', ' Diarrhoea 0/8 (0.00%)', ' Intestinal Ischaemia 0/8 (0.00%)', ' Small intestine obstruction 0/8 (0.00%)', ' Fatigue 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 4/6 (66.67%)', ' Febrile neutropenia 0/6 (0.00%)', ' Heparin-induced Thrombocytopenia 0/6 (0.00%)', ' Neutropenia 2/6 (33.33%)', ' Constipation 0/6 (0.00%)', ' Dysphagia 1/6 (16.67%)', ' Nausea 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Abdominal Pain 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Intestinal Ischaemia 0/6 (0.00%)', ' Small intestine obstruction 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01106040', 'Intervention': ['INTERVENTION 1: ', ' Intent-To-Treat', ' Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.'], 'Eligibility': ['Inclusion Criteria:', ' The patient has provided written informed consent with HIPAA authorization.', ' The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.', ' The patient is at least 18 years of age at the time of consent.', ' The patient has an ECOG performance status of Grade 0 - 2 (see Appendix A).', ' The patient has a clinical negative node status at the time of study entry (i.e. T0-4, N0, M0, see Appendix D and E).', ' If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.', ' Melanoma Patients', ' The patient has a diagnosis of primary melanoma. Breast Cancer Patients', ' The patient has a diagnosis of primary breast cancer.', ' Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.', 'Exclusion Criteria:', ' The patient is pregnant or lactating.', ' The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0, see Appendix D and E).', ' The patient has a known hypersensitivity to Lymphazurin.', ' The patient has participated in another investigational drug study within 30 days of scheduled surgery.', ' Melanoma Patients', ' The patient has a tumor with a Breslow depth less than 0.75mm.', ' Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.', ' Patient has been diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin.', ' Patient has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma.', ' Patient has undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap, or skin graft of any type).', ' Breast Cancer Patients', ' The patient has bilateral primary breast cancers or multiple tumors within their breast.', ' Patient has had prior surgical procedures such as breast implants, reduction mammoplasty, or axillary surgery.', ' Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the contraindicated breast will not undergo lymph node mapping.', ' Patient has had preoperative radiation therapy to the affected breast or axilla.'], 'Results': ['Outcome Measurement: ', ' Concordance of Blue Dye and Lymphoseek', ' The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.', ' Time frame: Surgery after injections of Lymphoseek and blue dye', 'Results 1: ', ' Arm/Group Title: Intent-To-Treat', ' Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.', ' Overall Number of Participants Analyzed: 133', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Lymph Nodes Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000 (0.9840 to 1.0000)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/153 (5.23%)', ' Bradycardia [1]1/153 (0.65%)', ' Tachycardia [1]1/153 (0.65%)', ' Cellulitis [1]2/153 (1.31%)', ' Herpes Zoster Ophthalmic [1]1/153 (0.65%)', ' Seroma [1]1/153 (0.65%)', ' Syncope [1]1/153 (0.65%)', ' Asthma [1]1/153 (0.65%)']}
|
2731552d-195a-4f43-b6b5-02a3fbda81d9
|
Single
|
Results
|
NCT01231659
|
Less than 40% of the primary trial participants achieved either complete response (CR) or partial response (PR).
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01231659', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Letrozole', ' All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.', ' Refractory disease to hormonal therapy is defined as:', ' Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.', ' Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.', ' Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.', 'Exclusion Criteria:', ' Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.', ' Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Response Rate (ORR)', ' Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.', ' Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Letrozole', ' Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 37.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/72 (36.11%)', ' Anaemia 5/72 (6.94%)', ' Cardiac arrest 1/72 (1.39%)', ' Cardiac failure congestive 1/72 (1.39%)', ' Hypercalcaemia 1/72 (1.39%)', ' Nausea 1/72 (1.39%)', ' Vomiting 3/72 (4.17%)', ' Death 1/72 (1.39%)', ' Disease progression 2/72 (2.78%)', ' Infusion related reaction 1/72 (1.39%)', ' Pyrexia 3/72 (4.17%)', ' Cholecystitis 1/72 (1.39%)', ' Cellulitis 2/72 (2.78%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8fee5ce4-3e46-4731-842e-a5b1df451c7d
|
|
Single
|
Intervention
|
NCT02518191
|
Cohort 2 of the primary trial is the control group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6
] |
[] |
{'Clinical Trial ID': 'NCT02518191', 'Intervention': ['INTERVENTION 1: ', ' GnRHa (Gonadotrophin-releasing Hormone Analogues) Group', ' Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.', ' Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.', 'INTERVENTION 2: ', ' None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group', ' Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' Premenopausal women 18 to 49 years of age are eligible for enrollment', ' Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.', ' Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.', ' Human chorionic gonadotropin negative by urine test before entering the group.', ' Informed consent, understanding and compliance with the requirements of the study.', ' No significant chronic disease and any organ dysfunction.', 'Exclusion Criteria:', ' Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.', ' Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.', ' Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.', ' Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.', ' Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.', ' Allergic to active or inactive excipients of GnRHa is an exclusion criterion.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Premature Ovarian Insufficiency', ' The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH<0.5ng/mL in this study.', ' Time frame: 1 years', 'Results 1: ', ' Arm/Group Title: GnRHa (Gonadotrophin-releasing Hormone Analogues) Group', ' Arm/Group Description: Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.', ' Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.', ' Overall Number of Participants Analyzed: 165', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 10 6.1%', 'Results 2: ', ' Arm/Group Title: None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group', ' Arm/Group Description: Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.', ' Overall Number of Participants Analyzed: 165', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 38 23.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/165 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
def4199f-a22d-4939-b15d-66fd073fb280
|
|
Single
|
Adverse Events
|
NCT00871858
|
1 patient in the primary trial was diagnosed with a Clear cell renal cell carcinoma.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00871858', 'Intervention': ['INTERVENTION 1: ', ' Arm A (ANA)', ' Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.', ' anastrozole: Given orally', 'INTERVENTION 2: ', ' Arm B (FULV)', ' Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.', ' fulvestrant: Given intramuscularly'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:', ' SBR grade I-II disease (patients < 65 years of age)', ' SBR grade I-III disease (patients > 65 years of age)', ' T2 (2-5 cm), T3, or T4B, and N0-1 disease', ' No metastatic disease', ' Breast lesion not amenable to breast-conserving resection', ' No inflammatory breast cancer', ' No prior breast cancer', ' Hormone receptor status:', ' Estrogen receptor- and/or progesterone receptor-positive', ' PATIENT CHARACTERISTICS:', ' Postmenopausal', ' No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix', ' No contraindication to anti-hormonal treatment', ' No psychological, familial, social, or geographical reasons that would preclude follow up', ' PRIOR CONCURRENT THERAPY:', ' At least 8 days since prior hormone replacement therapy', ' No concurrent anti-vitamin K treatment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Determined by Clinical Palpation', ' Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.', ' Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Arm A (ANA)', ' Arm/Group Description: Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.', ' anastrozole: Given orally', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.9 (45.0 to 71.9)', 'Results 2: ', ' Arm/Group Title: Arm B (FULV)', ' Arm/Group Description: Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.', ' fulvestrant: Given intramuscularly', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 53.8 (39.5 to 67.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/60 (3.33%)', ' Bronchial infection 0/60 (0.00%)', ' Ankle fracture 1/60 (1.67%)', ' Clear cell kidney cancer 0/60 (0.00%)', ' Programmed peritoneal dialysis 1/60 (1.67%)', ' Endometrial atrophy 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 3/58 (5.17%)', ' Bronchial infection 1/58 (1.72%)', ' Ankle fracture 0/58 (0.00%)', ' Clear cell kidney cancer 1/58 (1.72%)', ' Programmed peritoneal dialysis 0/58 (0.00%)', ' Endometrial atrophy 1/58 (1.72%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c16dcd52-f2f0-40b7-9b2b-af3fd7f438b2
|
|
Comparison
|
Eligibility
|
NCT03624972
|
NCT01216176
|
A 56 year old patient presenting occasional memory loss would be excluded from both the secondary trial and the primary trial.
|
Contradiction
|
[
4,
7
] |
[
56,
73
] |
{'Clinical Trial ID': 'NCT03624972', 'Intervention': ['INTERVENTION 1: ', ' Resources Only', ' Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.', 'INTERVENTION 2: ', ' Resources + Video', ' Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.', ' Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.'], 'Eligibility': ['Inclusion Criteria:', ' Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago', ' Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)', ' Willing to have clinic visit audio recorded', 'Exclusion Criteria:', ' Unable to speak English', ' Eastern Cooperative Oncology Group (ECOG) Performance score > 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member', ' Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.'], 'Results': ['Outcome Measurement: ', ' Self-Reported Self-Efficacy for Communicating About Sexual Health Issues', " Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.", ' Time frame: 2 weeks', 'Results 1: ', ' Arm/Group Title: Resources Only', ' Arm/Group Description: Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.', ' Overall Number of Participants Analyzed: 71', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale 8.5 (1.8)', 'Results 2: ', ' Arm/Group Title: Resources + Video', ' Arm/Group Description: Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.', ' Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.', ' Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.', ' Overall Number of Participants Analyzed: 71', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale 8.8 (2.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/71 (0.00%)', 'Adverse Events 2:', ' Total: 0/73 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01216176', 'Intervention': ['INTERVENTION 1: ', ' Phase 1 - Cohort A', ' Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', 'AZD0530'], 'Eligibility': ['Inclusion Criteria - Phase 1 (Cohort A):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses > 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor', ' Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease', ' Measurable or evaluable disease according to RECIST criteria (see appendix VII)', ' Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab and/or lapatinib.', ' ECOG performance status 0-2 (see appendix VI)', ' Patients are suitable candidates for treatment with anastrozole (patients may have had any prior endocrine therapy or prior chemotherapy for treatment of their disease, either as adjuvant therapy, or as treatment for advanced disease). There is no restriction on the number of prior regimens in the phase I cohort A.', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count to 1.5 x 10^9/L', ' Hemoglobin to 9.0 g/dL', ' Platelet count to 100 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.0 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT within protocol parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.', ' Inclusion Criteria - Phase 2 (Cohort B):', ' Female patient 18 years', ' Patient must be postmenopausal, verified by 1 of the following:', ' Bilateral surgical oophorectomy', ' No spontaneous menses 1 year', ' No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry', ' Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor. Patients may have bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS in either breast but the DCIS will not be measured as part of the study endpoints.', ' Tumor size 2 cm', ' Tumor measurable either by clinical examination, mammography, MRI, or ultrasound', ' HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by IHC)', ' ECOG performance status 0-1 (see Appendix VI)', ' Patient is accessible and willing to comply with treatment and follow-up', ' Patient is willing to provide written informed consent prior to the performance of any study-related procedures', ' Required laboratory values', ' Absolute neutrophil count 1.5 x 10^9/L', ' Hemoglobin 9.0 g/dL', ' Platelet count 70 x 10^9/L', ' Creatinine 1.5 mg/dL', ' Total bilirubin 1.5 x upper limit of normal (ULN)', ' Alkaline phosphatase and AST/ALT 1.5 x upper limit of normal (ULN)', ' Exclusion Criteria - Phase 1 (Cohort A):', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration.', ' Ongoing, chronic administration of bisphosphonate therapy is allowed so long as such treatment was ongoing at the time of study entry.', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their excipients', ' Evidence of bleeding diathesis or coagulopathy.', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication with drugs listed in Appendix XI should be excluded from study.', ' Any evidence of severe or uncontrolled systemic medical or psychiatric conditions (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.', ' Exclusion Criteria - Phase 2 (Cohort B):', ' Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast cancer is not an exclusion criterion.', ' Inflammatory breast cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast, or pathologically defined as dermal lymphatic invasion', ' Prior excisional biopsy or complete resection of the primary invasive tumor (prior sentinel node biopsy allowed)', ' Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer', ' Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular node involvement and/or direct invasion of the primary tumor into skin is allowed', ' Concurrent therapy with any other non-protocol anti-cancer therapy', ' Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration', ' Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped for one week prior to randomization)', ' Presence of neuropathy grade 2 (NCI-CTC AE version 3.0) at baseline', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix', ' Clinically significant cardiovascular disease (e.g. history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication', ' Active, uncontrolled infection requiring parenteral antimicrobials', ' A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 (saracatinib) or their excipients', ' Evidence of bleeding diathesis or coagulopathy', ' Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.', ' AZD0530 (saracatinib) is a substrate and inhibitor of CYP3A4. Since concurrent administration of AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted at MD discretion. Drugs listed in Appendix X that are known to strongly induce or inhibit CYP3A4 activity should be discontinued prior to study entry and should not be initiated during protocol treatment.', ' Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol', ' Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) disease.', ' Subjects unwilling or unable to undergo breast MRI as required by protocol will be excluded from study'], 'Results': ['Outcome Measurement: ', ' Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole', ' To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.', ' Time frame: Cycle 1: Days 1 - 28', 'Results 1: ', ' Arm/Group Title: Phase 1 - Cohort A', ' Arm/Group Description: Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer', ' Anastrozole', ' AZD0530', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: mg/day oral dose anastrozole: 1', 'saracatinib: 175'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/12 (25.00%)', ' Atrial fibrillation 0/12 (0.00%)', ' Cardiac ischemia/infarction [1]0/12 (0.00%)', ' Congestive Heart Failure [2]0/12 (0.00%)', ' Diverticulitis 0/12 (0.00%)', ' Cholecystitis 0/12 (0.00%)', ' Hyperbilirubinemia 0/12 (0.00%)', ' Urosepsis 2/12 (16.67%)', ' Brain hemorrhage complicating CNS metastasis 1/12 (8.33%)', ' Rash [3]0/12 (0.00%)']}
|
d97c3981-50f9-4221-aec6-60661b831c8e
|
Single
|
Eligibility
|
NCT01028352
|
Patients with aromatase inhibitor associated musculoskeletal symptoms, such as Grade 1 or above musculoskeletal pain or grade 0 sensory neuropathy, are eligible for the primary trial.
|
Contradiction
|
[
0,
4,
5,
6
] |
[] |
{'Clinical Trial ID': 'NCT01028352', 'Intervention': ['INTERVENTION 1: ', ' Duloxetine', ' Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.'], 'Eligibility': ['Inclusion Criteria:', ' Female;', ' Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). Women with oligometastatic disease may be included at the discretion of the principal investigator. Surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab;', ' AI therapy has been ongoing for 2 weeks and treatment is expected to continue;', ' AI-associated musculoskeletal symptoms, defined as:', ' Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on CGICS) during AI therapy or', ' Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on CGICS) during AI therapy;', ' Average pain of 4 on the 11-point Likert scale of question #5 of the Brief Pain Inventory;', ' ECOG performance status 0-2;', ' Willing and able to sign an informed consent document.', 'Exclusion Criteria:', ' Known hypersensitivity to duloxetine or any of the inactive ingredients;', ' New musculoskeletal pain that is due specifically to fracture or traumatic injury;', ' Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment;', ' Concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants;', ' Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder;', ' Chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by the Cockroft-Gault equation;', ' Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder;', ' Pregnant or breast feeding;', ' History of alcohol or other substance abuse or dependence within the year prior to enrollment;', ' Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.', ' Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.', ' Time frame: 8 weeks', 'Results 1: ', ' Arm/Group Title: Duloxetine', ' Arm/Group Description: Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 72.4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
86c1430c-553b-4388-a034-b82f78afdc0d
|
|
Single
|
Intervention
|
NCT01905592
|
both the primary trial cohorts receive Physician selection from 4 standard of care metastatic breast cancer chemotherapies.
|
Contradiction
|
[
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': ''}
|
b7cef0e1-7bd8-4c0e-a044-b11708cf927c
|
|
Single
|
Adverse Events
|
NCT00444587
|
A total of 2/93 patients in the primary trial were observed with either Leukopenia, Cardiopulmonary failure or Diarrhoea.
|
Contradiction
|
[
3,
6,
8
] |
[] |
{'Clinical Trial ID': 'NCT00444587', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + 2nd Line Chemotherapy', ' Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >= 18 years of age;', ' metastatic breast cancer;', ' HER2 overexpression (IHC 3+ and/or FISH positive);', ' disease progression during or after previous 1st line chemotherapy + Herceptin;', ' scheduled to receive 2nd line chemotherapy.', 'Exclusion Criteria:', ' concurrent immunotherapy or hormonal therapy;', ' anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;', ' cardiac toxicity during previous 1st line chemotherapy + Herceptin;', ' history of other malignancy within last 5 years.'], 'Results': ['Outcome Measurement: ', ' Median Time to Disease Progression', " Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.", ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab + 2nd Line Chemotherapy', ' Arm/Group Description: Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.', ' Overall Number of Participants Analyzed: 73', ' Median (95% Confidence Interval)', ' Unit of Measure: Days By Computer (n = 65): 171 (136 to 322)', ' By Investigator (n = 73): 171 (136 to 265)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/93 (21.51%)', ' Granulocytosis 1/93 (1.08%)', ' Leukopenia 2/93 (2.15%)', ' Angina pectoris 0/93 (0.00%)', ' Atrial fibrillation 1/93 (1.08%)', ' Cardiopulmonary failure 2/93 (2.15%)', ' Retinal detachment 1/93 (1.08%)', ' Diarrhoea 3/93 (3.23%)', ' Nausea 1/93 (1.08%)', ' Vomiting 1/93 (1.08%)', ' Chest pain 1/93 (1.08%)', ' Death 0/93 (0.00%)', ' Pyrexia 1/93 (1.08%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0b55d5b7-5e71-497f-96ad-9dc2f872c4aa
|
|
Comparison
|
Eligibility
|
NCT01217385
|
NCT01202591
|
Prior exposure to exemestane is not explicitly banned for patients in the secondary trial or 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
] |
[
6,
7
] |
{'Clinical Trial ID': 'NCT01217385', 'Intervention': ['INTERVENTION 1: ', ' Diffuse Optical Spectroscopy Imaging (DOSI', ' Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.', ' DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.'], 'Eligibility': ['Inclusion Criteria', ' Pathologically confirmed diagnosis of invasive breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy;', ' Tumor size >2cm, measured on imaging or estimated by physical exam;', ' No contraindications for primary chemotherapy;', ' Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;', ' Age 18 years or older;', ' ECOG Performance Status 2 (Karnofsky 60%; see Appendix II);', ' Normal organ and marrow function as follows:', ' leukocytes 3,000/μl;', ' absolute neutrophil count 1,500/μl;', ' platelets 100,000/μl;', ' total bilirubin within normal institutional limits;', ' AST(SGOT)/ALT(SGPT) 2.5 times the institutional upper limit of normal;', ' creatinine within normal institutional limits; OR', ' creatinine clearance 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;', ' If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional Standard of Care (SOC), and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;', ' Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines;', ' Exclusion Criteria', ' Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy;', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;', ' Medically unstable;', ' Under age 18;', ' Pregnant or nursing;', ' Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years.'], 'Results': ['Outcome Measurement: ', ' Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)', ' This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).', ' Time frame: From baseline to mid-therapy', 'Results 1: ', ' Arm/Group Title: Diffuse Optical Spectroscopy Imaging (DOSI', ' Arm/Group Description: Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.', ' DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: probability 0.60 (0.39 to 0.81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01202591', 'Intervention': ['INTERVENTION 1: ', ' AZD4547 80mg bd Cont + Ex 25mg', ' 80 mg AZD4547 BD continuous + 25 mg exemestane', 'INTERVENTION 2: ', ' AZD4547 40mg Cont + Ex 25mg', ' 40 mg AZD4547 BD continuous + 25 mg exemestane'], 'Eligibility': ['Inclusion Criteria:', ' Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)', ' Histological confirmation of Breast Cancer with documented ER+ receptor status', ' Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL', ' Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.', ' Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits', 'Exclusion Criteria:', ' Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.', ' More than 1 prior regimen of chemotherapy for breast cancer', ' ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction', ' History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.', ' Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks'], 'Results': ['Outcome Measurement: ', ' Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)', ' [Not Specified]', ' Time frame: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).', 'Results 1: ', ' Arm/Group Title: AZD4547 80mg bd Cont + Ex 25mg', ' Arm/Group Description: 80 mg AZD4547 BD continuous + 25 mg exemestane', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: Participants 5', 'Results 2: ', ' Arm/Group Title: AZD4547 40mg Cont + Ex 25mg', ' Arm/Group Description: 40 mg AZD4547 BD continuous + 25 mg exemestane', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: Participants 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/5 (40.00%)', ' ANAEMIA 0/5 (0.00%)', ' DIARRHOEA 0/5 (0.00%)', ' OESOPHAGEAL ACHALASIA 0/5 (0.00%)', ' STOMATITIS 0/5 (0.00%)', ' DEVICE DEPOSIT ISSUE 0/5 (0.00%)', ' INFLAMMATION 0/5 (0.00%)', ' GAIT DISTURBANCE 0/5 (0.00%)', ' LOWER RESPIRATORY TRACT INFECTION VIRAL 0/5 (0.00%)', ' NEUTROPENIC SEPSIS 1/5 (20.00%)', ' PLEURAL INFECTION 1/5 (20.00%)', ' PYELONEPHRITIS 0/5 (0.00%)', 'Adverse Events 2:', ' Total: 2/5 (40.00%)', ' ANAEMIA 1/5 (20.00%)', ' DIARRHOEA 0/5 (0.00%)', ' OESOPHAGEAL ACHALASIA 0/5 (0.00%)', ' STOMATITIS 0/5 (0.00%)', ' DEVICE DEPOSIT ISSUE 0/5 (0.00%)', ' INFLAMMATION 0/5 (0.00%)', ' GAIT DISTURBANCE 0/5 (0.00%)', ' LOWER RESPIRATORY TRACT INFECTION VIRAL 0/5 (0.00%)', ' NEUTROPENIC SEPSIS 0/5 (0.00%)', ' PLEURAL INFECTION 0/5 (0.00%)', ' PYELONEPHRITIS 0/5 (0.00%)']}
|
225f95a5-7c22-4cb7-a463-1c57d5b69d7a
|
Comparison
|
Intervention
|
NCT03061175
|
NCT03098550
|
Cohort 1 of the secondary trial does not receive the same doses of Daratumumab for the entire duration of the study, whereas Cohort 1 of the primary trial has the same intervention for the full study.
|
Entailment
|
[
0,
1,
2,
3,
4
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT03061175', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Web-Based CPM-DA)', ' Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.', ' Internet-Based Intervention: Receive web-based CPM-DA', ' Survey Administration: Ancillary studies', 'INTERVENTION 2: ', ' Arm II (Usual Care)', ' Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.', ' Survey Administration: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)', ' PHASE I: Speaks and reads English', ' PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome [BReast CAncer gene (BRCA) carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation', ' PHASE I: Able to provide meaningful informed consent', ' PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)', ' PHASE II: Has home internet access', ' PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer', ' PHASE II: Speaks and reads English', ' PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome [BRCA carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation', ' PHASE II: Able to provide meaningful informed consent'], 'Results': ['Outcome Measurement: ', ' Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants', " CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.", ' Time frame: 2-4 week follow up', 'Results 1: ', ' Arm/Group Title: Arm I (Web-Based CPM-DA)', ' Arm/Group Description: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.', ' Internet-Based Intervention: Receive web-based CPM-DA', ' Survey Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 39', ' Mean (Standard Error)', ' Unit of Measure: score on a scale 62.47 (3.40)', 'Results 2: ', ' Arm/Group Title: Arm II (Usual Care)', ' Arm/Group Description: Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.', ' Survey Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 44', ' Mean (Standard Error)', ' Unit of Measure: score on a scale 51.33 (3.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT03098550', 'Intervention': ['INTERVENTION 1: ', ' Nivolumab + Daratumumab (TNBC)', ' Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', 'INTERVENTION 2: ', ' Nivolumab + Daratumumab (NSCLC)', ' Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)'], 'Eligibility': ['Inclusion Criteria:', ' For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com', ' Patients with metastatic or advanced solid tumors', ' Women with histologically or cytologically confirmed triple negative breast carcinoma', ' Participants with histologically or cytologically confirmed pancreatic adenocarcinoma', ' Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)', 'Exclusion Criteria:', ' Active brain metastases or leptomeningeal metastases.', ' Any serious or uncontrolled medical disorder', ' Prior malignancy active within the previous 3 years', ' Other protocol defined inclusion/exclusion criteria could apply'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events (AEs)', ' Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab', ' Time frame: From first dose to 30 days post last dose (up to 34 months)', 'Results 1: ', ' Arm/Group Title: Nivolumab + Daratumumab (TNBC)', ' Arm/Group Description: Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 41 100.0%', 'Results 2: ', ' Arm/Group Title: Nivolumab + Daratumumab (NSCLC)', ' Arm/Group Description: Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 21 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 36/41 (87.80%)', ' Anaemia 0/41 (0.00%)', ' Febrile bone marrow aplasia 1/41 (2.44%)', ' Acute coronary syndrome 0/41 (0.00%)', ' Atrial fibrillation 0/41 (0.00%)', ' Cardiac tamponade 1/41 (2.44%)', ' Cardio-respiratory arrest 0/41 (0.00%)', ' Pericardial effusion 0/41 (0.00%)', ' Abdominal pain 0/41 (0.00%)', ' Colitis 0/41 (0.00%)', ' Diarrhoea 0/41 (0.00%)', 'Adverse Events 2:', ' Total: 17/21 (80.95%)', ' Anaemia 0/21 (0.00%)', ' Febrile bone marrow aplasia 0/21 (0.00%)', ' Acute coronary syndrome 1/21 (4.76%)', ' Atrial fibrillation 0/21 (0.00%)', ' Cardiac tamponade 0/21 (0.00%)', ' Cardio-respiratory arrest 0/21 (0.00%)', ' Pericardial effusion 1/21 (4.76%)', ' Abdominal pain 0/21 (0.00%)', ' Colitis 1/21 (4.76%)', ' Diarrhoea 1/21 (4.76%)']}
|
5464e8a7-159c-4e00-8710-45a44ceaeda3
|
Comparison
|
Adverse Events
|
NCT00382018
|
NCT03012477
|
Between the patients in the primary trial and the secondary trial, only 1.56% suffered from sepsis.
|
Contradiction
|
[
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%)']}
|
98965d07-e2db-41bf-ac3e-a5c130513275
|
Comparison
|
Eligibility
|
NCT00429104
|
NCT00878709
|
Patients with end-stage liver disease are excluded from the primary trial and the secondary trial.
|
Contradiction
|
[
7,
12
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'Clinical Trial ID': 'NCT00429104', 'Intervention': ['INTERVENTION 1: ', ' HER2+ Metastatic Breast Cancer', ' Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously'], 'Eligibility': ['Inclusion Criteria:', ' Histological confirmation of invasive carcinoma of the breast.', ' HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).', ' Stage IV breast cancer with measurable disease.', ' Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.', ' Zubrod performance status 0 or 1.', ' Adequate hematological parameters (White Blood cells-WBC > 3,000/mm3, platelet count > 100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) < 3 x normal).', 'Exclusion Criteria:', ' Active Brain metastasis.', ' No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).', ' More than 2 Herceptin containing regimens in metastatic breast cancer.', ' Known history of HIV positive.', ' Chronic active hepatitis or cirrhosis.', ' Symptomatic pulmonary disease.', ' Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Tumor Response (Stable Disease)', ' Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.', ' Time frame: 2 months', 'Results 1: ', ' Arm/Group Title: HER2+ Metastatic Breast Cancer', ' Arm/Group Description: Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00878709', 'Intervention': ['INTERVENTION 1: ', ' Neratinib', ' Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.', 'INTERVENTION 2: ', ' Placebo', ' Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.'], 'Eligibility': ['Inclusion Criteria:', ' Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.', ' Been treated for early breast cancer with standard of care duration of trastuzumab.', ' Could have been treated neoadjuvantly but have not reached pathologic complete response.', 'Exclusion Criteria:', ' Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.', ' History of heart disease.', ' Corrected QT (QTc) interval >0.45 seconds', ' History of gastrointestinal disease with diarrhea as the major symptom.'], 'Results': ['Outcome Measurement: ', ' Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2', ' Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.', ' Time frame: From randomization until time of event up to 2 years', 'Results 1: ', ' Arm/Group Title: Neratinib', ' Arm/Group Description: Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.', ' Overall Number of Participants Analyzed: 1420', ' Measure Type: Number', ' Unit of Measure: percentage of participants with events 4.7', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.', ' Overall Number of Participants Analyzed: 1420', ' Measure Type: Number', ' Unit of Measure: percentage of participants with events 7.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/1408 (7.32%)', ' Anaemia 1/1408 (0.07%)', ' Angina pectoris 1/1408 (0.07%)', ' Myocardial infarction 1/1408 (0.07%)', ' Atrial fibrillation 0/1408 (0.00%)', ' Sinus tachycardia 0/1408 (0.00%)', ' Tachycardia 0/1408 (0.00%)', ' Vertigo 0/1408 (0.00%)', ' Diarrhoea 22/1408 (1.56%)', ' Vomiting 12/1408 (0.85%)', ' Nausea 4/1408 (0.28%)', ' Abdominal pain 2/1408 (0.14%)', ' Pancreatitis 2/1408 (0.14%)', 'Adverse Events 2:', ' Total: 85/1408 (6.04%)', ' Anaemia 1/1408 (0.07%)', ' Angina pectoris 0/1408 (0.00%)', ' Myocardial infarction 1/1408 (0.07%)', ' Atrial fibrillation 1/1408 (0.07%)', ' Sinus tachycardia 1/1408 (0.07%)', ' Tachycardia 1/1408 (0.07%)', ' Vertigo 1/1408 (0.07%)', ' Diarrhoea 1/1408 (0.07%)', ' Vomiting 1/1408 (0.07%)', ' Nausea 1/1408 (0.07%)', ' Abdominal pain 0/1408 (0.00%)', ' Pancreatitis 1/1408 (0.07%)']}
|
784cc905-937f-43fd-96a6-34ea8dce9e8d
|
Comparison
|
Results
|
NCT00706030
|
NCT00171704
|
the primary trial studies the interventions impact on target lesions and the secondary trial measures changes in Bone Mineral Density, the results from these two studies are therefore not directly comparable.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT00706030', 'Intervention': ['INTERVENTION 1: ', ' Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib', ' Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure', 'INTERVENTION 2: ', ' Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib', ' Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).', ' At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).', ' At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).', 'Exclusion Criteria:', " More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).", ' Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.', ' Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate', ' Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.', ' Time frame: From first dose date to progression or last tumor assessment, up to four years and six months.', 'Results 1: ', ' Arm/Group Title: Neratinb 240 mg + Vinorelbine 25 mg/m - No Prior Lapatinib', ' Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: percentage of participants 35.9 (24.3 to 48.9)', 'Results 2: ', ' Arm/Group Title: Neratinib 240 mg + Vinorelbine 25 mg/m - Prior Lapatinib', ' Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.3 (1.7 to 40.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/6 (50.00%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Neutropenia 0/6 (0.00%)', ' Bradycardia 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Pancreatitis 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Disease progression 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)', ' Pyrexia 0/6 (0.00%)', ' Cholelithiasis 0/6 (0.00%)', ' Hepatic pain 0/6 (0.00%)', ' Bacteraemia 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 3/6 (50.00%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Neutropenia 1/6 (16.67%)', ' Bradycardia 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Pancreatitis 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Disease progression 0/6 (0.00%)', ' Fatigue 1/6 (16.67%)', ' Pyrexia 1/6 (16.67%)', ' Cholelithiasis 0/6 (0.00%)', ' Hepatic pain 1/6 (16.67%)', ' Bacteraemia 0/6 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00171704', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' 2.5 mg once daily (q.d.)orally for 5 years', 'INTERVENTION 2: ', ' Tam-Let', ' 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.'], 'Eligibility': ['Inclusion Criteria', ' Female', ' Post-menopausal hormone status defined as:', ' Patients with menostasis (amenorrhea) > 12 months or history of oophorectomy.', ' Patients 55 years with history of hysterectomy or having continued/renewed menstruation on cyclic hormone treatment.', ' Patients of 50-54 years: Menopausal status was determined on the basis of follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values.', ' Histologically confirmed resected breast cancer and eligible for adjuvant endocrine therapy. As a minimum, patients had to have receptor-positive tumors, which were defined either as estrogen receptor (ER) and/or progesterone receptor (PgR) 10 fmol/mg cytosol protein; or 10% of the tumor cells positive by immunocytochemical evaluation.', ' Adequate bone marrow function (white blood cell count [WBC] > 3.0 x 109 /L, platelets 100.0 x 109 /L, and hemoglobin > 10 g/dL).', ' Documented evidence of adequate renal function (creatinine < 180 µmol/L) and hepatic function (bilirubin < 30 µmol/L, alanine aminotransferase (ALT) < 1.5 x upper normal limit of the laboratory).', ' Life expectancy of at least 24 months at the time of enrollment.', ' Written voluntary informed consent prior to initiation of any study procedure.', ' Willingness to undergo all scheduled tests and examinations for evaluation of bone density and bone metabolism, and lipid profiles in addition to the standard assessments for monitoring their breast cancer status.', ' Exclusion Criteria', ' Patients with distant metastases as defined by the criteria of the Danish Breast Cancer Co-operative Group (DBCCOG).', " Pre-existing bone disease (e.g. osteomalacia, osteogenesis imperfecta, Paget's disease).", ' Patients receiving bisphosphonates for more than 3 months before randomization.', ' Chronic treatment with drugs known to interfere with bone metabolism, e.g.', ' Anti-convulsants within the past year.', ' Corticosteroids at doses greater than the equivalent of 5 mg/day prednisone for more than two weeks in the past 6 months (prior to randomization).', ' Any previous treatment with sodium fluoride at daily doses 5 mg/day for a period exceeding 1 month.', ' Anabolic steroids in the past 12 months.', ' Long term use of coumarin derivatives and heparin at the time of randomization.', " Metabolic diseases known to interfere with bone metabolism (e.g., Hyperparathyroidism, hypoparathyroidism, uncontrolled thyroid disease, Cushing's disease, vitamin D deficiency, malabsorption syndrome, etc.).", ' Treatment with lipid-lowering agents within the 3 months prior to randomization (this exclusion criterion did not apply to patients randomized in the United Kingdom).', ' Patients receiving other anti-cancer treatment.', ' Previous neoadjuvant / adjuvant chemotherapy and /or previous adjuvant endocrine therapy (e.g., anti-estrogens, AIs).', ' History of previous or concomitant malignancy within the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who had a previous other malignancy must have been disease free for five years. Patients with endometrial cancer and/or invasive breast cancer at any time in their medical history were excluded. Patients with invasive bilateral breast cancer were excluded. Patients with vaginal discharge/ vaginal bleeding with evidence of malignancy were excluded.', ' Any other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)', ' Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.', ' Time frame: Baseline, 24 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years', ' Overall Number of Participants Analyzed: 63', ' Median (Full Range)', ' Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)', 'Results 2: ', ' Arm/Group Title: Tam-Let', ' Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.', ' Overall Number of Participants Analyzed: 68', ' Median (Full Range)', ' Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 50/133 (37.59%)', ' Acute myocardial infarction 0/133 (0.00%)', ' Angina pectoris 1/133 (0.75%)', ' Angina unstable 0/133 (0.00%)', ' Arrhythmia 1/133 (0.75%)', ' Atrial fibrillation 2/133 (1.50%)', ' Atrial flutter 0/133 (0.00%)', ' Bundle branch block left 1/133 (0.75%)', ' Myocardial infarction 0/133 (0.00%)', ' Pericarditis 0/133 (0.00%)', ' Sinus bradycardia 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 41/130 (31.54%)', ' Acute myocardial infarction 2/130 (1.54%)', ' Angina pectoris 1/130 (0.77%)', ' Angina unstable 1/130 (0.77%)', ' Arrhythmia 0/130 (0.00%)', ' Atrial fibrillation 2/130 (1.54%)', ' Atrial flutter 1/130 (0.77%)', ' Bundle branch block left 0/130 (0.00%)', ' Myocardial infarction 1/130 (0.77%)', ' Pericarditis 1/130 (0.77%)', ' Sinus bradycardia 1/130 (0.77%)']}
|
2e3f2fde-569e-46ef-958d-710599fec9a1
|
Single
|
Intervention
|
NCT00106002
|
the primary trial participants are treated with 600 mg/m2 of Pemetrexed intravenously every 2 weeks until complete response or disease progression.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00106002', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed', ' 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression'], 'Eligibility': ['Inclusion Criteria:', ' Must have been diagnosed with either advanced or metastatic breast cancer.', ' Chemotherapy has not been given for advanced or metastatic breast cancer.', ' The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.', ' Able to carry out work of a light nature (for example, light housework, office work).', ' Must be at least 18 years old.', 'Exclusion Criteria:', ' Have received prior bone marrow or peripheral stem cell transplantation.', ' Have received prior chemotherapy for metastatic breast cancer.', ' Are currently pregnant or breast-feeding.', ' Have an active infection that your doctor decides will affect your safety.', ' Are unable to take folic acid or vitamin B12.'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression', 'Results 1: ', ' Arm/Group Title: Pemetrexed', ' Arm/Group Description: 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 8', ' Stable Disease: 14', ' Progressive Disease: 9', ' Best Response Not Evaluable: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14', ' Anaemia 2/36 (5.56%)', ' Febrile neutropenia 1/36 (2.78%)', ' Angina pectoris 1/36 (2.78%)', ' Abdominal pain upper 1/36 (2.78%)', ' Diarrhoea 1/36 (2.78%)', ' Nausea 3/36 (8.33%)', ' Vomiting 2/36 (5.56%)', ' Asthenia 1/36 (2.78%)', ' Fatigue 1/36 (2.78%)', ' Cellulitis 2/36 (5.56%)', ' Peritonitis bacterial 1/36 (2.78%)', ' Upper respiratory tract infection 1/36 (2.78%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d1080199-2591-44bd-bdad-0dea3830e657
|
|
Comparison
|
Intervention
|
NCT02352779
|
NCT00263588
|
The differences between cohorts in the primary trial is once cohort recieves a 750mg Low-dose Omega-3 Fatty Acid and the other 500mg, in contrast the difference in the secondary trial is patient characteristics.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT02352779', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Low-dose Omega-3 Fatty Acid)', ' Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Placebo: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies', 'INTERVENTION 2: ', ' Arm II (High-dose Omega-3 Fatty Acid)', ' Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past', ' Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer', ' Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)', ' Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine', ' Be able to read English', ' Able to swallow medication', ' Give written informed consent', 'Exclusion Criteria:', ' Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)', ' Be taking anticoagulant medication (does not include aspirin)', ' Have sensitivity or allergy to fish and/or shellfish', ' Have sensitivity or allergy to soy and/or soybeans', ' Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue'], 'Results': ['Outcome Measurement: ', ' Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value', ' BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).', ' MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).', ' Time frame: Baseline to 6 weeks', 'Results 1: ', ' Arm/Group Title: Arm I (Low-dose Omega-3 Fatty Acid)', ' Arm/Group Description: Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Placebo: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 24', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: units on a scale BFI-SF Mean Post - Pre: -3.66 (-4.37 to -2.96)', ' MFSI-SF Mean Post - Pre: -11.03 (-16.55 to -5.50)', 'Results 2: ', ' Arm/Group Title: Arm II (High-dose Omega-3 Fatty Acid)', ' Arm/Group Description: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.', 'Omega-3 Fatty Acid: Given PO', ' Questionnaire Administration: Ancillary studies', ' Laboratory Biomarker Analysis: Correlative studies', ' Overall Number of Participants Analyzed: 30', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: units on a scale BFI-SF Mean Post - Pre: -3.68 (-4.31 to -3.05)', ' MFSI-SF Mean Post - Pre: -13.93 (-18.82 to -9.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00263588', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings', 'INTERVENTION 2: ', ' Cohort B', ' 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.'], 'Eligibility': ['Inclusion criteria:', ' Signed Informed Consent', ' ErbB2(HER2)overexpressing breast cancer.', ' Brain lesion(s) which are progressing.', ' Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).', ' Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.', ' Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.', ' Able to swallow an oral medication.', ' Adequate kidney and liver function.', ' Adequate bone marrow function.', 'Exclusion criteria:', ' Pregnant or lactating females.', ' Conditions that would effect the absorption of an oral drug.', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.', ' Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.', " Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent."], 'Results': ['Outcome Measurement: ', ' The Number of Participants With Central Nervous System (CNS) Best Overall Response', ' Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)', ' Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.', ' The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)', ' A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms', ' Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings', ' Overall Number of Participants Analyzed: 94', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response (CR): 0 0.0%', ' Partial response (PR): 6 6.4%', ' Stable disease (SD): 40 42.6%', ' Progressive disease (PD): 40 42.6%', 'Unknown: 8 8.5%', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response (CR): 0 0.0%', ' Partial response (PR): 9 6.3%', ' Stable disease (SD): 46 32.2%', ' Progressive disease (PD): 70 49.0%', ' Unknown: 18 12.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 36/95 (37.89%)', ' Atrial fibrillation 0/95 (0.00%)', ' Cardio-respiratory arrest 1/95 (1.05%)', ' Left ventricular dysfunction 0/95 (0.00%)', ' Pericardial effusion 0/95 (0.00%)', ' Vertigo 0/95 (0.00%)', ' Constipation 1/95 (1.05%)', ' Diarrhoea 6/95 (6.32%)', ' Duodenal ulcer 0/95 (0.00%)', ' Duodenal ulcer haemorrhage 0/95 (0.00%)', ' Gastrointestinal haemorrhage 0/95 (0.00%)', 'Adverse Events 2:', ' Total: 52/147 (35.37%)', ' Atrial fibrillation 1/147 (0.68%)', ' Cardio-respiratory arrest 0/147 (0.00%)', ' Left ventricular dysfunction 1/147 (0.68%)', ' Pericardial effusion 1/147 (0.68%)', ' Vertigo 1/147 (0.68%)', ' Constipation 0/147 (0.00%)', ' Diarrhoea 4/147 (2.72%)', ' Duodenal ulcer 1/147 (0.68%)', ' Duodenal ulcer haemorrhage 1/147 (0.68%)', ' Gastrointestinal haemorrhage 2/147 (1.36%)']}
|
c37c21f5-19a0-4fcc-af92-89690fb64091
|
Comparison
|
Adverse Events
|
NCT01276041
|
NCT00688909
|
0 patients in the primary trial or the secondary trial died.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT01276041', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab in Combination With Trastuzumab and Paclitaxel', ' This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.'], 'Eligibility': ['Inclusion Criteria:', ' Age 18', ' Stage IV HER2 (+) breast cancer.', ' Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of 2.0 of primary or metastatic site; results from the local lab are acceptable. (Optional tumor sample collection from primary or metastatic site may be obtained for HER2 testing at MSKCC).', ' ECOG performance 0 -1 (Appendix A)', " 0-1 prior treatment in the metastatic setting (ie: hormone, chemotherapy, biologic, targeted agents). Prior anthracycline, paclitaxel, and trastuzumab in the adjuvant setting are allowed. If the patient has one trastuzumab-based treatment in the metastatic setting and is given a break (even intermittently) from the partner drug given with trastuzumab and is continued on trastuzumab alone, this would still be considered as one treatment. For example, if the patient was given paclitaxel + trastuzumab and was later continued on trastuzumab alone or then restarted on paclitaxel + trastuzumab (at the physician's discretion for any reason), the regimen paclitaxel + trastuzumab followed by trastuzumab alone (or followed by paclitaxel + trastuzumab again) may be considered as one treatment.", ' Measurable or non-measurable disease. Measurable lesions are defined as those that can be measured accurately in at least one diameter, that is 20 mm using conventional imaging techniques (including incremental CT) or 10 mm using spiral CT equipment and a lymph node 15 mm along the short axis. Non-measurable lesions are all other lesions, including small lesions (longest diameter <10mm pathological a lymph nodes with 10 to less than 15mm along the short axis, bony metastases, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast cancer, lymphangitis carcinomatosis, and heavily calcified and cystic/necrotic lesions.', ' LVEF 50%', ' Hematologic parameters: white blood cell (WBC) count of 3000/ul, absolute neutrophil count (ANC) 1500/ul, platelets 100,000/ul, hemoglobin 10.0 g/dl', ' Non-hematologic parameters: bilirubin 1.5 mg/dl, AST/ALT 2.5 x upper limit of normal (ULN), alkaline phosphatase 5 x ULN.', ' Creatinine 1.5 mg/dl', ' Patients with stable and treated brain lesions of a duration of 2 months may be enrolled.', 'Exclusion Criteria:', ' History of prior cardiac morbidities within 12 months (unstable angina, myocardial infarction, CHF, uncontrolled ventricular arrhythmias)', ' Prior pertuzumab', ' History of prior G 3 hypersensitivity (HSR) or any toxicity to trastuzumab that warranted permanent cessation of this antibody', ' History of prior G 3 HSR or any toxicity to paclitaxel warranted permanent cessation of this chemotherapy', ' > G 2 peripheral neuropathy', ' Patients with a history of chronic hepatitis B or C should be excluded from the study as paclitaxel is potentially hepatotoxic', 'Pregnant patients'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients Who Are Progression Free at 6 Months or Later.', ' Patients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark. 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: 6 months', 'Results 1: ', ' Arm/Group Title: Pertuzumab in Combination With Trastuzumab and Paclitaxel', ' Arm/Group Description: This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: percentage of partcipants 86 (75 to 93)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/70 (25.71%)', ' Cardiac arrest 1/70 (1.43%)', ' Pericardial effusion 1/70 (1.43%)', ' Ear pain 1/70 (1.43%)', ' Blurred vision 1/70 (1.43%)', ' Eye disorders - Other, specify 2/70 (2.86%)', ' Abdominal Pain 5/70 (7.14%)', ' Colitis 1/70 (1.43%)', ' Diarrhea 2/70 (2.86%)', ' Nausea 2/70 (2.86%)', ' Death NOS 1/70 (1.43%)', ' Edema limbs 1/70 (1.43%)', ' Fatigue 3/70 (4.29%)']}
|
{'Clinical Trial ID': 'NCT00688909', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:', ' Age 50 y and amenorrheic for 12 or more months.', ' Age 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.', ' Age < 50 y and amenorrheic for 12 or more months.', ' Prior bilateral oophorectomy.', ' Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards.', ' Age > 55 y and prior hysterectomy.', ' Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.', ' Hormone receptor-positive tumors as defined by institutional standards.', ' ECOG performance status of 0, 1, or 2', ' Consent to participate in the trial. -', 'Exclusion Criteria:', ' Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.', ' Recent history of pain associated with non-traumatic bone fracture.', ' Pain requiring chronic use of analgesics (due to any reason).', ' History of rheumatological disease except osteoarthritis.', ' Prior hormonal therapy with AIs other than anastrozole.', ' Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.', ' Concomitant disease which significantly affects quality of life.', ' Patient unable to complete self administered questionnaire.', ' Patients unable to sign consent form.', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.', ' The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.', ' Time frame: End of Study (24 weeks)', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.', ' Overall Number of Participants Analyzed: 261', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 25 9.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/261 (1.92%)', ' Cholecystitis chronic 1/261 (0.38%)', ' Post procedural bile leak 1/261 (0.38%)', ' Spinal column stenosis 1/261 (0.38%)', ' Depression 1/261 (0.38%)', ' Mania 1/261 (0.38%)', ' Pulmonary embolism 1/261 (0.38%)']}
|
bea7f10e-09d6-42c3-9e89-dfd1112a33d5
|
Single
|
Intervention
|
NCT00545077
|
Only cohort 2 of the primary trial receive letrozole, but both cohorts undergo Endocrine Therapy .
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00545077', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Endocrine Therapy (ET)', ' Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', 'Fulvestrant', 'INTERVENTION 2: ', ' Arm B: ET With Bevacizumab (ET-B)', ' Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', ' Bevacizumab', 'Fulvestrant'], 'Eligibility': ['Inclusion Criteria:', ' Before starting the specific protocol procedures, the written informed consent must be obtained and documented.', ' Women 18 years.', ' Capacity to comply with all the protocol requirements.', ' Functional Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.', ' Life expectancy 24 weeks.', ' Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or Nuclear magnetic resonance (NMR) if there is any doubt after a single bone scan.', ' Patients with HER2-negative disease evaluated by Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH)/Chromogenic in situ hybridisation (CISH) (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.', ' Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.', ' Patients who are candidates for receiving first-line treatment with letrozole.', ' Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization. Patients must be recovered from toxicity.', ' The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:', ' Not more than 30% of bone marrow has been irradiated.', ' The patient has recovered from the reversible acute effects of the radiation.', ' The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.', ' The patients may have received any kind of previous (neo)adjuvant hormone therapy provided that they are considered to be candidates for first-line hormonotherapy with either letrozole or fulvestrant.', ' The treatment with bisphosphonates is allowed and recommended for patients with bone metastases. Whenever it is possible, the treatment should be started before or within the 4 weeks of starting the study therapy. The patients starting treatment with bisphosphonates must be carefully evaluated so that they do not mask the progression of the disease.', ' In the patients with heart failure risk (e.g. previously treated with > 360mg/m2 of doxorubicin or equivalent doses of other anthracyclines), the Left Ventricular Ejection Fraction (LVEF) must be determined by means of an echocardiogram or radionuclide ventriculography (MUGA), and it must t be > the lower limit of normal.', 'Exclusion Criteria:', " Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.", ' Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.', ' Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.', ' Previous therapy with anti-vascular endothelial growth factor (VEGF) or VEGF Receptor (VEGFR) tyrosine-kinase inhibitors.', ' History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.', ' Evidence of central nervous system (CNS) metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.', ' History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).', ' History of peripheral neuropathy National Cancer Institute (NCI) CTCAE grade >2 at the time of randomization.', ' Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.', ' Minor surgical procedures in the 7 days prior to randomization.', ' Unsuitable bone marrow supply: absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L or Hb < 10 g/dL.', ' Impaired liver function: total bilirubin total > 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 2.5 x ULN (> 5 x ULN in patients with liver metastases).', ' Impaired kidney function:', ' Serum creatinine > 2.0 mg/dL or 177 µmol/L.', ' Proteinuria determined by reactive strip > 2+. A 24h determination of proteins in urine will be requested for the patients with > 2+ in the baseline analysis and must have a protein figure < 1 g/24 h.', ' Chronic treatment with oral corticoids (dose > 10 mg/day of methylprednisolone or equivalent): the use of inhaled corticoids is allowed.', ' Chronic treatment with acetylsalicylic acid (> 325 mg/day) or clopidogrel (> 75 mg/day).', ' Uncontrolled arterial hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant cardiovascular disease: for example cerebrovascular accident (CVA) (in the 6 months prior to randomization), coronaropathy or history of acute mycardial infarction (AMI) in the last 6 months, unstable angina, congestive heart failure of grade > II of the New York Heart Association (NYHA) or severe heart arrhythmias which are not controlled with medication or which can potentially interfere with the study treatment.', ' History or evidence of hemorrhagic diathesis or coagulopathy with bleeding risk.', ' History of abdominal fistula, gastrointestinal perforation or intra-abdominal abcess in the 6 months prior to randomization.', ' Active infection requiring i.v. antibiotics at the time of randomization.', ' Unhealed wounds, active peptic ulcer, esophageal varices.', " Any other disease, psychological or metabolic alteration, found in the physical or laboratory examination, providing reasonable indications for suspecting a disease or complaint for which the use of any of the study drugs are contraindicated, or which may affect the patient's compliance with the routine procedures of the study or which places the patient at a high risk of experiencing complications related to the treatment.", ' Current or recent (within 30 days prior to that start of the study treatment) treatment with another drug under investigation or participation in another investigation study.', ' Known hypersensitivity to any of the study drugs or their components.', ' Hypersensitivity to the products of Chinese hamster ovary cells or to other human or humanized recombinant antibodies.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS was defined as the time elapsed from randomization until the date in which the progression of the disease or the death for any reason (whichever occurs first) is documented.', ' Time frame: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Arm A: Endocrine Therapy (ET)', ' Arm/Group Description: Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', ' Fulvestrant', ' Overall Number of Participants Analyzed: 184', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 14.4 (11.4 to 17.5)', 'Results 2: ', ' Arm/Group Title: Arm B: ET With Bevacizumab (ET-B)', ' Arm/Group Description: Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', ' Bevacizumab', ' Fulvestrant', ' Overall Number of Participants Analyzed: 190', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 19.3 (16.5 to 22.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/184 (11.41%)', ' Lymphangitis 0/184 (0.00%)', ' Angina pectoris 0/184 (0.00%)', ' Cardiac infarction 0/184 (0.00%)', ' Heart failure 0/184 (0.00%)', ' Infarction 0/184 (0.00%)', ' Acute pancreatitis 0/184 (0.00%)', ' Anal fistula 0/184 (0.00%)', ' Colitis 1/184 (0.54%)', ' Diarrhoea 0/184 (0.00%)', ' Diverticulitis 0/184 (0.00%)', ' Hemorrhoids 0/184 (0.00%)', 'Adverse Events 2:', ' Total: 64/190 (33.68%)', ' Lymphangitis 1/190 (0.53%)', ' Angina pectoris 1/190 (0.53%)', ' Cardiac infarction 1/190 (0.53%)', ' Heart failure 1/190 (0.53%)', ' Infarction 1/190 (0.53%)', ' Acute pancreatitis 1/190 (0.53%)', ' Anal fistula 1/190 (0.53%)', ' Colitis 0/190 (0.00%)', ' Diarrhoea 2/190 (1.05%)', ' Diverticulitis 1/190 (0.53%)', ' Hemorrhoids 1/190 (0.53%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3d41d86b-f53f-4bf9-a4dd-eae2412c485e
|
|
Comparison
|
Adverse Events
|
NCT01015131
|
NCT00312208
|
Both the primary trial and the secondary trial record instances of Rectal Hemorrhage within their patient cohorts.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8
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[
0,
1,
2,
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7,
8,
9,
10,
11,
12
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{'Clinical Trial ID': 'NCT01015131', 'Intervention': ['INTERVENTION 1: ', ' All Participants', ' Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy'], 'Eligibility': ['Inclusion Criteria:', ' Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer', ' Is eligible for pre-operative (neo-adjuvant) chemotherapy', 'Exclusion Criteria:', ' Has a contraindication to magnetic resonance imaging (MRI)', ' Any condition that would limit ability to undergo MRI or PET scans', ' Is a nursing mother', ' Has moderate to end-stage renal disease and is not on dialysis or has renal failure on chronic dialysis'], 'Results': ['Outcome Measurement: ', ' Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.', ' Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest.', ' Time frame: Baseline and up to 3 weeks', 'Results 1: ', ' Arm/Group Title: All Participants', ' Arm/Group Description: Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: SUV Baseline: 2.79 (1.36)', ' End of Cycle 1: 1.78 (1.03)', ' Change from Baseline: 1.00 (0.95)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/44 (18.18%)', ' Febrile neutropenia4/44 (9.09%)', ' Rectal bleeding1/44 (2.27%)', ' Chest pain2/44 (4.55%)', ' Fever1/44 (2.27%)', ' Catheter site infection1/44 (2.27%)', ' Neutrophil count decreased1/44 (2.27%)', ' Dizziness1/44 (2.27%)']}
|
{'Clinical Trial ID': 'NCT00312208', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)', ' AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.', 'INTERVENTION 2: ', ' Docetaxel + Doxorubicin and Cyclophosphamide (TAC)', ' TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.'], 'Eligibility': ['Inclusion Criteria :', ' Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration is less than or equal to 60 days. A central pathology review may be performed post randomization for confirmation of diagnosis and molecular studies.', ' Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and Ductal Carcinoma In Situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.', ' Histologic examination of the tumor: Invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes.', ' Tumor must show negative HER2 neu proto-oncogene overexpression by FISH (Fluorescence In Situ Hybridization). Confirmation of non overexpression will be centrally assessed by authorized BCIRG (Breast Cancer International Research Group) laboratories prior to randomization.', ' Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.(Note: Patients whose tumor is estrogen receptor negative with progesterone receptor status unknown or undetermined, must have the progesterone receptor assayed in order to determine hormonal receptor status. Patients whose tumor is progesterone receptor negative with estrogen receptor status unknown or undetermined, must have the estrogen receptor assayed in order to determine hormonal receptor status).', ' Karnofsky Performance status index > 80%.', ' Normal cardiac function must be confirmed by LVEF (Lef Ventricular Ejection Fraction) i.e. MUGA (Multi Gated Acquisition) scan or echocardiography and ECG within 3 months prior to registration. LVEF result must be above or equal to the lower limit of normal for the institution. The ECG results must be within normal limits or show no significant abnormalities.', ' Laboratory requirements: (within 14 days prior to registration)', ' Hematology:', ' Neutrophils > or = 2.0 x 10^9/L', ' Platelets > or = 100 x 10^9/L', ' Hemoglobin > or = 10 g/dL', ' Hepatic function:', ' Total bilirubin < or = 1 UNL (Upper Normal Limit)', ' ASAT (Aspartate Amino Transferase) and ALAT (Alanine Amino Transferase) < or = 2.5 UNL', ' Alkaline phosphatase < or = 5 UNL', ' Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.', ' Renal function:', ' Creatinine < or = 175 µmol/L (2 mg/dL);', ' If limit reached, the calculated creatinine clearance should be > or = 60mL/min.', ' Complete staging work-up within 3 months prior to registration. All patients will have contralateral mammography, chest X-ray (Posteroanterior and lateral) and/or CT scan and/or MRI (Magnetic Resonance Imaging), abdominal ultrasound and/or CT scan (computerized tomography) and/or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory to rule out the possibility of non-metastatic hot spots. Other tests may be performed as clinically indicated.', ' Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.', ' Exclusion Criteria :', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, genetherapy , chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must have negative urine or serum pregnancy test within 7 days prior to registration.', ' Any T4 or N2 or known N3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC (National Cancer Institute - Common Toxicity Criteria), version 2.0.', ' Other serious illness or medical condition:', ' congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias', ' history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent', ' active uncontrolled infection', ' active peptic ulcer, unstable diabetes mellitus', ' Past or current history of neoplasm other than breast carcinoma, except for:', ' curatively treated non-melanoma skin cancer', ' carcinoma in situ of the cervix', ' other cancer curatively treated and with no evidence of disease for at least 10 years', ' ipsilateral ductal carcinoma in-situ (DCIS) of the breast', ' lobular carcinoma in-situ (LCIS) of the breast', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone or equivalent).', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents prior to randomization.', " The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."], 'Results': ['Outcome Measurement: ', ' Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)', ' The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.', ' Time frame: Median follow-up 65 months', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)', ' Arm/Group Description: AC x 4: Doxorubicin 60 mg/m as an IV bolus in combination with cyclophosphamide 600 mg/m as IV followed by docetaxel 100 mg/m as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.', ' Overall Number of Participants Analyzed: 1649', ' Measure Type: Number', ' Unit of Measure: Participants 356', 'Results 2: ', ' Arm/Group Title: Docetaxel + Doxorubicin and Cyclophosphamide (TAC)', ' Arm/Group Description: TAC x 6 : Docetaxel 75 mg/m as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.', ' Overall Number of Participants Analyzed: 1649', ' Measure Type: Number', ' Unit of Measure: Participants 352'], 'Adverse Events': ['Adverse Events 1:', ' Total: 331/1634 (20.26%)', ' Anemia 3/1634 (0.18%)', ' Coagulation disorders 1/1634 (0.06%)', ' Hemorrhage Vaginal 1/1634 (0.06%)', ' Leukopenia 18/1634 (1.10%)', ' Lymphadenopathy 0/1634 (0.00%)', ' Lymphedema 0/1634 (0.00%)', ' Pancytopenia 0/1634 (0.00%)', ' Thrombocytopenia 0/1634 (0.00%)', ' Arrhythmia 3/1634 (0.18%)', ' Arrhythmia Ventricular 0/1634 (0.00%)', ' Cardiomyopathy 1/1634 (0.06%)', 'Adverse Events 2:', ' Total: 520/1635 (31.80%)', ' Anemia 5/1635 (0.31%)', ' Coagulation disorders 0/1635 (0.00%)', ' Hemorrhage Vaginal 0/1635 (0.00%)', ' Leukopenia 56/1635 (3.43%)', ' Lymphadenopathy 1/1635 (0.06%)', ' Lymphedema 2/1635 (0.12%)', ' Pancytopenia 1/1635 (0.06%)', ' Thrombocytopenia 1/1635 (0.06%)', ' Arrhythmia 3/1635 (0.18%)', ' Arrhythmia Ventricular 1/1635 (0.06%)', ' Cardiomyopathy 0/1635 (0.00%)']}
|
0159bfb3-231e-4711-b3ee-2798c66f5f6a
|
Comparison
|
Adverse Events
|
NCT00392392
|
NCT00503906
|
the primary trial records two different types of pain in its adverse events, in the cranial and foot area, the secondary trial does not record any types of pain in its participants.
|
Contradiction
|
[
0,
6,
7
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
{'Clinical Trial ID': 'NCT00392392', 'Intervention': ['INTERVENTION 1: ', ' Nab-Paclitaxel/Bevacizumab/Trastuzumab', ' Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer', ' Clinical stage T 1-4, N 0-3, M0', ' FISH+ HER2 gene amplified breast cancer', ' 18 years or older', ' Normal cardiac function', ' Performance status 0-2', ' Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.', ' Previous diagnosis of noninvasive breast cancer is OK.', ' Must have adequate bone marrow, renal and liver function.', ' Pregnant or lactating females not allowed.', ' Preexisting peripheral neuropathy must be equal to or less than grade 1', ' Must have archived tumor tissue for tissue testing.', 'Exclusion Criteria:', ' You cannot be in this study if you any of the following:', ' History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure', ' Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.', ' No prior investigational drug within the last 30 days', ' No prior trastuzumab or bevacizumab therapy', ' 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.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery', ' Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Nab-Paclitaxel/Bevacizumab/Trastuzumab', ' Arm/Group Description: Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: percentage of participants 56'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/29 (27.59%)', ' Hemorrhage - Nose 1/29 (3.45%)', ' Left Ventricular Systolic Dysfunction 1/29 (3.45%)', ' Vomiting 1/29 (3.45%)', ' Esophagitis 1/29 (3.45%)', ' Pain - Abdomen 1/29 (3.45%)', ' Pain - Chest 1/29 (3.45%)', ' Infection - Skin 1/29 (3.45%)', ' Infection - Sepsis 2/29 (6.90%)', ' Creatinine 1/29 (3.45%)', ' Wound Complication, Non-Infectious 1/29 (3.45%)']}
|
{'Clinical Trial ID': 'NCT00503906', 'Intervention': ['INTERVENTION 1: ', ' Abraxane, Avastin and Gemcitabine', ' Each treatment cycle is 28 days. Participants will be treated until disease progression:', ' Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.'], 'Eligibility': ['Inclusion Criteria', ' Patients must either be:', ' treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or', ' HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).', ' No previous chemotherapy regimen for metastatic breast cancer.', ' 18 years of age or older.', ' Measurable disease as defined by RECIST criteria or evaluable disease.', ' Eastern Cooperative Oncology Group (ECOG) 0-1.', ' Life expectancy greater than 3 months.', ' For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study', ' Provide written informed consent before any study-related procedure not part of normal medical care is conducted', ' Willing and able to comply with the protocol requirement', ' Laboratory parameters as follows:', ' Neutrophils: 1.5 x109/L or greater', ' Platelets: 100 x109/L or greater', ' Hemoglobin: 9.0 g/dL', ' Serum Creatinine: 1.5mg/dL', ' Bilirubin: ULN, except when caused by metastatic disease', ' Alanine transaminase (ALT)/Aspartate transaminase (AST): 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease', ' Urine protein creatinine (UPC) ratio < 1.0 at screening.', ' Exclusion Criteria', ' Previous treatment with gemcitabine.', ' History of Gastrointestinal Bleeding in the previous 3 months.', ' Chemotherapy within 4 weeks prior to enrollment.', ' Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.', ' Any major surgery within 4 weeks prior to enrollment.', ' Presence of central nervous system or brain metastases.', ' Urine protein: creatinine ratio 1.0 at screening.', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).', ' A prior history of hypertensive crisis or hypertensive encephalopathy.', ' Peripheral neuropathy > grade I.', ' Clinical AIDS or known positive HIV serology', ' No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.', ' Unstable angina.', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infarction within 6 months.', ' History of stroke within 6 months.', ' Clinically significant peripheral vascular disease.', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.', ' Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.', ' Pregnant (positive pregnancy test) or lactating.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Inability to comply with study and/or follow-up procedures', ' Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.', ' Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.'], 'Results': ['Outcome Measurement: ', ' Median Progression-Free Survival', ' Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.', ' Time frame: Up to 24 months', 'Results 1: ', ' Arm/Group Title: Abraxane, Avastin and Gemcitabine', ' Arm/Group Description: Each treatment cycle is 28 days. Participants will be treated until disease progression:', ' Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.', ' Overall Number of Participants Analyzed: 29', ' Median (95% Confidence Interval)', ' Unit of Measure: months 10.4 (5.6 to 15.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/29 (27.59%)', ' Leukopenia [1]1/29 (3.45%)', ' Thrombocytopenia [1]1/29 (3.45%)', ' Abscess [1]1/29 (3.45%)', ' Breast Abscess 1/29 (3.45%)', ' Fever/Sepsis [1]1/29 (3.45%)', ' Neutropenic Fever [2]1/29 (3.45%)', ' Peripheral Neuropathy [1]1/29 (3.45%)', ' Seizure/Syncope [1]1/29 (3.45%)', ' Hematuria [1]1/29 (3.45%)', ' UTI [1]1/29 (3.45%)', ' Shortness of breath [1]1/29 (3.45%)']}
|
9e7628cd-931e-4b1f-b4c1-f03f0449ac27
|
Single
|
Adverse Events
|
NCT00312208
|
Cases of Cardiomyopathy and Leukopenia were only observed in cohort 1 of the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
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10,
11,
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14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
[] |
{'Clinical Trial ID': 'NCT00312208', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)', ' AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.', 'INTERVENTION 2: ', ' Docetaxel + Doxorubicin and Cyclophosphamide (TAC)', ' TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.'], 'Eligibility': ['Inclusion Criteria :', ' Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration is less than or equal to 60 days. A central pathology review may be performed post randomization for confirmation of diagnosis and molecular studies.', ' Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and Ductal Carcinoma In Situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.', ' Histologic examination of the tumor: Invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes.', ' Tumor must show negative HER2 neu proto-oncogene overexpression by FISH (Fluorescence In Situ Hybridization). Confirmation of non overexpression will be centrally assessed by authorized BCIRG (Breast Cancer International Research Group) laboratories prior to randomization.', ' Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.(Note: Patients whose tumor is estrogen receptor negative with progesterone receptor status unknown or undetermined, must have the progesterone receptor assayed in order to determine hormonal receptor status. Patients whose tumor is progesterone receptor negative with estrogen receptor status unknown or undetermined, must have the estrogen receptor assayed in order to determine hormonal receptor status).', ' Karnofsky Performance status index > 80%.', ' Normal cardiac function must be confirmed by LVEF (Lef Ventricular Ejection Fraction) i.e. MUGA (Multi Gated Acquisition) scan or echocardiography and ECG within 3 months prior to registration. LVEF result must be above or equal to the lower limit of normal for the institution. The ECG results must be within normal limits or show no significant abnormalities.', ' Laboratory requirements: (within 14 days prior to registration)', ' Hematology:', ' Neutrophils > or = 2.0 x 10^9/L', ' Platelets > or = 100 x 10^9/L', ' Hemoglobin > or = 10 g/dL', ' Hepatic function:', ' Total bilirubin < or = 1 UNL (Upper Normal Limit)', ' ASAT (Aspartate Amino Transferase) and ALAT (Alanine Amino Transferase) < or = 2.5 UNL', ' Alkaline phosphatase < or = 5 UNL', ' Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.', ' Renal function:', ' Creatinine < or = 175 µmol/L (2 mg/dL);', ' If limit reached, the calculated creatinine clearance should be > or = 60mL/min.', ' Complete staging work-up within 3 months prior to registration. All patients will have contralateral mammography, chest X-ray (Posteroanterior and lateral) and/or CT scan and/or MRI (Magnetic Resonance Imaging), abdominal ultrasound and/or CT scan (computerized tomography) and/or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory to rule out the possibility of non-metastatic hot spots. Other tests may be performed as clinically indicated.', ' Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.', ' Exclusion Criteria :', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, genetherapy , chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must have negative urine or serum pregnancy test within 7 days prior to registration.', ' Any T4 or N2 or known N3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC (National Cancer Institute - Common Toxicity Criteria), version 2.0.', ' Other serious illness or medical condition:', ' congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias', ' history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent', ' active uncontrolled infection', ' active peptic ulcer, unstable diabetes mellitus', ' Past or current history of neoplasm other than breast carcinoma, except for:', ' curatively treated non-melanoma skin cancer', ' carcinoma in situ of the cervix', ' other cancer curatively treated and with no evidence of disease for at least 10 years', ' ipsilateral ductal carcinoma in-situ (DCIS) of the breast', ' lobular carcinoma in-situ (LCIS) of the breast', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone or equivalent).', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents prior to randomization.', " The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."], 'Results': ['Outcome Measurement: ', ' Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)', ' The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.', ' Time frame: Median follow-up 65 months', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)', ' Arm/Group Description: AC x 4: Doxorubicin 60 mg/m as an IV bolus in combination with cyclophosphamide 600 mg/m as IV followed by docetaxel 100 mg/m as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.', ' Overall Number of Participants Analyzed: 1649', ' Measure Type: Number', ' Unit of Measure: Participants 356', 'Results 2: ', ' Arm/Group Title: Docetaxel + Doxorubicin and Cyclophosphamide (TAC)', ' Arm/Group Description: TAC x 6 : Docetaxel 75 mg/m as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.', ' Overall Number of Participants Analyzed: 1649', ' Measure Type: Number', ' Unit of Measure: Participants 352'], 'Adverse Events': ['Adverse Events 1:', ' Total: 331/1634 (20.26%)', ' Anemia 3/1634 (0.18%)', ' Coagulation disorders 1/1634 (0.06%)', ' Hemorrhage Vaginal 1/1634 (0.06%)', ' Leukopenia 18/1634 (1.10%)', ' Lymphadenopathy 0/1634 (0.00%)', ' Lymphedema 0/1634 (0.00%)', ' Pancytopenia 0/1634 (0.00%)', ' Thrombocytopenia 0/1634 (0.00%)', ' Arrhythmia 3/1634 (0.18%)', ' Arrhythmia Ventricular 0/1634 (0.00%)', ' Cardiomyopathy 1/1634 (0.06%)', 'Adverse Events 2:', ' Total: 520/1635 (31.80%)', ' Anemia 5/1635 (0.31%)', ' Coagulation disorders 0/1635 (0.00%)', ' Hemorrhage Vaginal 0/1635 (0.00%)', ' Leukopenia 56/1635 (3.43%)', ' Lymphadenopathy 1/1635 (0.06%)', ' Lymphedema 2/1635 (0.12%)', ' Pancytopenia 1/1635 (0.06%)', ' Thrombocytopenia 1/1635 (0.06%)', ' Arrhythmia 3/1635 (0.18%)', ' Arrhythmia Ventricular 1/1635 (0.06%)', ' Cardiomyopathy 0/1635 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f1108cbc-db27-431d-9154-1a267278bda4
|
|
Single
|
Eligibility
|
NCT04396665
|
Any patient can enter into the primary trial as long as they are willing to provide Informed consent and are capable of using the internet.
|
Entailment
|
[
0,
1,
2,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT04396665', 'Intervention': ['INTERVENTION 1: ', ' Intervention Group', ' Women in the intervention group', 'INTERVENTION 2: ', ' Control Group', ' Women in the control group'], 'Eligibility': ['Inclusion Criteria:', ' Informed consent signed', ' Capability to use internet', 'Exclusion Criteria:', ' Breast cancer diagnosis duting the intervention'], 'Results': ['Outcome Measurement: ', ' Feasibility of an Educational Intervention: Adherence to the Intervention', ' Participants that finish the intervention', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Intervention Group', ' Arm/Group Description: Women in the intervention group', ' Overall Number of Participants Analyzed: 134', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 99 73.9%', 'Results 2: ', ' Arm/Group Title: Control Group', ' Arm/Group Description: Women in the control group', ' Overall Number of Participants Analyzed: 90', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 83 92.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8eb69e3e-ac08-4e85-98be-211aecd4525d
|
|
Single
|
Results
|
NCT01432886
|
None of the patients in either cohort of the primary trial experienced DLT.
|
Entailment
|
[
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01432886', 'Intervention': ['INTERVENTION 1: ', ' E7389 With Weekly Trastuzumab', ' Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.', 'INTERVENTION 2: ', ' E7389 With Tri-weekly Trastuzumab', ' Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.'], 'Eligibility': ['Inclusion Criteria', ' Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.', ' Histologically or cytologically confirmed with breast cancer', ' Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method', ' Subjects who meet any of the following criteria:', ' Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane', ' Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane', ' Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer', ' Adequate organ function', ' Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1', ' Subjects who have submitted written informed consent for study entry', ' Exclusion Criteria', ' Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment', ' Subjects with severe active infection requiring active treatment', ' Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.', ' Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives', ' Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.', ' Subjects who are pregnant (positive B-hCG test) or breastfeeding', ' Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT)', ' For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.', ' Time frame: Up to 3 weeks', 'Results 1: ', ' Arm/Group Title: E7389 With Weekly Trastuzumab', ' Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: E7389 With Tri-weekly Trastuzumab', ' Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
baf7e338-91fd-47d0-b766-a4e039efc5d7
|
|
Single
|
Eligibility
|
NCT00458237
|
Patient who have undergone External beam radiation therapy and major surgery in the last two weeks are eligible for the primary trial.
|
Contradiction
|
[
0,
6,
12,
21
] |
[] |
{'Clinical Trial ID': 'NCT00458237', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Everolimus (Dose Level 1) and Trastuzumab', ' Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Phase I: Everolimus (Dose Level 2) and Trastuzumab', ' Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, with stage IV disease', ' Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.', ' Primary tumor or metastasis must overexpress HER2', ' Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.', ' Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.', ' Patients may have received prior radiation therapy', ' Patients may have received hormonal therapy in the adjuvant or metastatic setting', ' 18 years of age or older', ' Life expectancy of greater than 6 months', ' Normal organ and marrow function as defined in the protocol', ' Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal', 'Exclusion Criteria:', ' Treatment with any investigational drug within 4 weeks', ' Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent', ' Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001', ' An active, bleeding diathesis or an oral anti-vitamin K medication', ' Prior treatment with an mTOR inhibitor', ' History of non-compliance with medical regimens', ' Unwillingness or inability to comply with the protocol', ' Major surgery within 2 weeks before study entry', ' Patients with active brain metastases or leptomeningeal carcinomatosis', ' Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration', ' Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.', ' Pregnant or breast-feeding women', ' HIV positive patients', ' Known hypersensitivity to RAD001 (everolimus) or other rapamycins'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD)', ' The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):', ' Any grade 4 hematologic toxicity, excluding anemia.', ' Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.', ' Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity.', ' Time frame: Cycle One (first 21 days of treatment)', 'Results 1: ', ' Arm/Group Title: Phase I: Everolimus (Dose Level 1) and Trastuzumab', ' Arm/Group Description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants with DLT 0', 'Results 2: ', ' Arm/Group Title: Phase I: Everolimus (Dose Level 2) and Trastuzumab', ' Arm/Group Description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants with DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Muco/stomatitis (symptom) oral cavity 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Vascular access-Thrombosis/embolism [1]0/3 (0.00%)', ' Leukocytes 0/3 (0.00%)', ' Lymphopenia 0/3 (0.00%)', ' Neutrophils 0/3 (0.00%)', ' Platelets 0/3 (0.00%)', ' Hypokalemia 0/3 (0.00%)', ' Thrombosis/thrombus/embolism [2]0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' Muco/stomatitis (symptom) oral cavity 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Vascular access-Thrombosis/embolism [1]0/3 (0.00%)', ' Leukocytes 0/3 (0.00%)', ' Lymphopenia 1/3 (33.33%)', ' Neutrophils 0/3 (0.00%)', ' Platelets 0/3 (0.00%)', ' Hypokalemia 0/3 (0.00%)', ' Thrombosis/thrombus/embolism [2]0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9401b12d-3888-4a41-93a1-b2075930098b
|
|
Comparison
|
Eligibility
|
NCT00908791
|
NCT00297596
|
Female patients over the age of 60, with Histologically confirmed breast cancer and advanced Alzheimer's disease are ineligible for both the secondary trial and the primary trial.
|
Entailment
|
[
0,
10
] |
[
0,
21
] |
{'Clinical Trial ID': 'NCT00908791', 'Intervention': ['INTERVENTION 1: ', ' Pre CLA', ' Women with histologically proven invasive non-metastatic breast cancer.', 'INTERVENTION 2: ', ' Post CLA', ' Women with histologically proven invasive non-metastatic breast cancer.'], 'Eligibility': ['Inclusion Criteria:', ' All study patients must have histologically confirmed invasive adenocarcinoma of the breast. Their breast cancer must be resectable clinical stage I or II breast cancer as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).', ' All patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.', ' All subjects must be Age >18 years.', ' All subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (AST or ALT) 1.5 times the upper limits of normal, total bilirubin 1.5 times the upper limits of normal, serum creatinine 1.5 times the upper limit of normal or eCRCl 60 mL/min.', 'Exclusion criteria:', ' Patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.', ' Patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.', ' Women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. Women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. Women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.', ' Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.', ' A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Spot 14 Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2', ' To determine whether 10 days of CLA consumption suppresses Spot 14 expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).', ' Time frame: Up to 28 days', 'Results 1: ', ' Arm/Group Title: Pre CLA', ' Arm/Group Description: Women with histologically proven invasive non-metastatic breast cancer.', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: participants Spot 14 Expression Grade 0: 0', ' Spot 14 Expression Grade 1: 10', ' Spot 14 Expression Grade 2: 14', 'Results 2: ', ' Arm/Group Title: Post CLA', ' Arm/Group Description: Women with histologically proven invasive non-metastatic breast cancer.', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: participants Spot 14 Expression Grade 0: 0', ' Spot 14 Expression Grade 1: 22', ' Spot 14 Expression Grade 2: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/24 (0.00%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT00297596', 'Intervention': ['INTERVENTION 1: ', ' Oxaliplatin/Trastuzumab', ' Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Females 18 years of age', ' Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type', ' Measurable disease by RECIST and an ECOG 2', ' Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)', ' Baseline LVEF value within the institutional normal range', ' Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.', ' Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.', ' Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.', ' Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.', ' All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.', ' Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.', ' Patients must have recovered from toxicities due to prior therapy.', ' Lab values in accordance with the protocol', ' Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).', 'Exclusion Criteria:', ' Bone only disease are ineligible', ' Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.', ' Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.', ' Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.', ' Uncontrolled nervous system metastases', ' Dementia or significantly altered mental status that would interfere with proper consenting.', ' Receiving other investigational therapy.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Oxaliplatin/Trastuzumab', ' Arm/Group Description: Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 20 (4.3 to 35.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/25 (28.00%)', ' Perforated appendix 1/25 (4.00%)', ' Allergic reaction 1/25 (4.00%)', ' Pathologic fracture of let proximal humeral diaphysis 1/25 (4.00%)', ' Pathologic fracture of right proximal humeral diaphysis 1/25 (4.00%)', ' Respiratory failure secondary to metastatic disease 1/25 (4.00%)', ' Breast cancer 1/25 (4.00%)', ' Progressive disease 1/25 (4.00%)']}
|
c7aa030a-6b76-4bd7-a934-f02a4638a1ac
|
Single
|
Results
|
NCT01823107
|
several Patients implanted with a Meso BioMatrix Acellular Peritoneum Matrix suffered Breast Related Adverse Events in both reconstructed breasts.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01823107', 'Intervention': ['INTERVENTION 1: ', ' Meso BioMatrix Acellular Peritoneum Matrix', ' All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.'], 'Eligibility': ['Inclusion Criteria:', ' Non-smoker', ' Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction', ' Life expectancy greater than 18 months', ' Agreement to return for the trial required follow-up visits', 'Exclusion Criteria:', ' Body mass index 35', ' Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty', ' History of chronic corticosteroid use', ' Type I Diabetes', ' History of radiation therapy to the chest', ' Pre-operative treatment with induction chemotherapy for breast cancer', ' Pregnancy', ' Participating in another investigational drug or device trial that has not completed the follow-up period'], 'Results': ['Outcome Measurement: ', ' Rate of Breast Related Adverse Events', ' Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Meso BioMatrix Acellular Peritoneum Matrix', ' Arm/Group Description: All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.', ' Overall Number of Participants Analyzed: 25', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Reconstructed breasts Measure Type: NumberUnit of Measure: Reconstructed breasts affected: 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/25 (28.00%)', ' Hematoma 1/25 (4.00%)', ' Fever 1/25 (4.00%)', ' Seroma 1/25 (4.00%)', ' Wound dehiscence 4/25 (16.00%)', ' Skin flap necrosis 1/25 (4.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
94f9a957-33bb-4409-8878-ba734d6b0d5c
|
|
Comparison
|
Adverse Events
|
NCT00087152
|
NCT00203502
|
the primary trial recorded less patients with nausea than the secondary trial.
|
Entailment
|
[
0,
3
] |
[
0,
5
] |
{'Clinical Trial ID': 'NCT00087152', 'Intervention': ['INTERVENTION 1: ', ' Imatinib Mesylate & Capecitabine', ' Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.'], 'Eligibility': ['Histologically or cytologically confirmed adenocarcinoma of the breast', ' Stage IV measurable disease', ' Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease', ' Patients with hormone-sensitive tumors must have received prior hormonal therapy', ' Patients with human epidermal growth factor receptor 2 (HER2)/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) in the adjuvant or metastatic setting (unless contraindicated)', ' No clinical evidence of or known brain or central nervous system (CNS) disease', ' Hormone Receptor status known', ' Female age 18 and over', ' Performance status Zubrod 0-2', ' Absolute neutrophil count > 1,500/mm^3', ' Leukocyte count > 3,000/mm^3', ' Platelet count > 100,000/mm^3', ' Bilirubin normal', ' aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 times upper limit of normal', ' Creatinine normal OR Creatinine clearance > 60 mL/min', ' Not pregnant or nursing', ' Fertile patients must use effective contraception during and for 3 months after study participation', ' No history of severe hypersensitivity reaction to compounds of similar chemical or biological composition to imatinib mesylate, capecitabine, or fluorouracil', ' 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 prior biologic therapy (e.g., vaccines)', ' No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia', ' No prior capecitabine or fluorouracil for metastatic breast cancer', ' Prior hormonal therapy allowed', ' More than 4 weeks since prior radiotherapy - Previously irradiated area(s) must not be the only site of disease', ' More than 4 weeks since prior major surgery', ' More than 4 weeks since prior therapy for breast cancer', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent investigational or commercial agents or therapies for metastatic breast cancer'], 'Results': ['Outcome Measurement: ', ' Confirmed Response Rate (Complete and Partial)', ' Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Imatinib Mesylate & Capecitabine', ' Arm/Group Description: Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/20 (20.00%)', ' Diarrhea 1/20 (5.00%)', ' Nausea 1/20 (5.00%)', ' Sodium, serum-low (hyponatremia) 1/20 (5.00%)', ' Death - Disease progression NOS 1/20 (5.00%)', ' Dyspnea (shortness of breath) 1/20 (5.00%)', ' Hypoxia 1/20 (5.00%)']}
|
{'Clinical Trial ID': 'NCT00203502', 'Intervention': ['INTERVENTION 1: ', ' Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin', ' Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2', ' + Avastin 15 mg/kg', ' Q 3 weeks X 4 cycles', ' Bevacizumab/Avastin: IV 15mg/kg 21 days', ' Cyclophosphamide: 500mg per meter squared, IV every 21 days', ' Doxorubicin: 60 mg per meter squared, IV every 21 days'], 'Eligibility': ['Inclusion Criteria:', ' The diagnosis of breast cancer established by biopsy.', ' Normal kidney function', ' Normal LVEF evaluated by MUGA Scan', ' >18 years of age', ' Good performance status defined by ECOG scale of 0 or 1', ' Consent', ' Women of childbearing potential must have a negative pregnancy test.', ' Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.', ' Peripheral Neuropathy: must be < grade 1', ' Hematologic (minimal values)', ' Absolute neutrophil count >1,500/mm3', ' Hemoglobin >8.0 g/dl', ' Platelet count >100,000/mm3', ' Hepatic', ' Total bilirubin <ULN', ' AST, ALT, Alkaline Phosphatase must be within range', 'Exclusion Criteria:', ' Patients with locally advanced breast cancer with skin ulcerations', ' Stage IV breast cancer', ' Inflammatory breast cancer', ' Allergy to any component of the treatment regimen', ' Women who are breast feeding', ' Pregnancy or refusal to use effective contraception', ' Inability to comply with study and/or follow-up procedures.', ' Current, recent, or planned participation in a experimental drug study', ' Blood pressure of >150/100 mmHg. Essential hypertension well controlled with anti hypertensives is not an exclusion criterion.', ' unstable angina', ' New York Heart Association Grade II or greater congestive heart failure', ' history of myocardial infarction within 6 months', ' history of stroke within 6 months', ' Clinical significant peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Presence of central nervous system or brain metastasis', ' major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0', ' Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days prior to day 0', ' Pregnant or lactating', ' Urine protein: creatinine ratio >1.0 at screening', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0', ' Serious, non-healing wound, ulcer, or bone fracture'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response.', ' Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.', ' Time frame: Participants were assessed during surgery, an average of one hour', 'Results 1: ', ' Arm/Group Title: Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin', ' Arm/Group Description: Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2', ' + Avastin 15 mg/kg', ' Q 3 weeks X 4 cycles', ' Bevacizumab/Avastin: IV 15mg/kg 21 days', ' Cyclophosphamide: 500mg per meter squared, IV every 21 days', ' Doxorubicin: 60 mg per meter squared, IV every 21 days', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of evaluable patients 41 (27.7 to 55.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/39 (100.00%)', ' Febrile Neutropenia 1/39 (2.56%)', ' Heart failure 1/39 (2.56%)', ' Diarrhea 3/39 (7.69%)', ' Nausea/vomiting 4/39 (10.26%)', ' Mucositis 3/39 (7.69%)', ' Fatigue 4/39 (10.26%)', ' infection 3/39 (7.69%)', ' Urinary tract infection 2/39 (5.13%)', ' Musculoskeletal pain 6/39 (15.38%)', ' Syncope 1/39 (2.56%)', ' Insomnia 3/39 (7.69%)', ' Anxiety 2/39 (5.13%)']}
|
04fd88c2-cf92-468d-bbc4-567cae19948d
|
Comparison
|
Adverse Events
|
NCT00499122
|
NCT00454805
|
There were no cases of Multi-Organ Failure in both cohort 1 of the secondary trial and cohort 1 of the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
{'Clinical Trial ID': 'NCT00499122', 'Intervention': ['INTERVENTION 1: ', ' NOV-002 and Chemotherapy', ' NOV-002:', ' Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart', ' Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration', ' Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections', ' Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1', ' Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1', ' Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1'], 'Eligibility': ['Inclusion Criteria:', ' Females age 18 years or older.', ' The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time.', ' Histologically confirmed infiltrating (invasive) breast cancer by core needle biopsy, with no evidence of metastatic disease except to the ipsilateral axillary lymph nodes.', ' Clinical stage IIB - IIIC (T2-4, N0 or N1, M0 or - any T, N1-3, M0) breast cancer. The primary tumor must be greater than or equal to 2 cm (T2-4) or with pathologically proven axillary nodal involvement (N1-3).', ' Patients with inflammatory breast cancer (T4) are permitted into the study.', ' Clinically palpable tumor that meets the criteria of RECIST for palpable measurable disease. The primary tumor must be greater than or equal to 2 cm (T2-4) or with pathologically proven axillary nodal involvement (N1-3). Bilateral synchronic breast cancers are allowed but one of the primary tumors should be selected as the target tumor.', ' Primary tumor may be estrogen or progesterone receptor negative or positive, and human epidermal growth factor receptor 2 (HER-2/neu) negative as determined by either Fluorescent In Situ Hybridization (FISH) or 0-2+ staining by immunohistochemistry (IHC) (Hercept™).', ' Normal cardiac ejection fraction (EF 50%) as determined by screening multigated acquisition scan (MUGA) or echocardiogram.', ' No prior history of myocardial infarction, congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias.', ' Patients must be ambulatory with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.', ' The patient or her caregiver must be able to self administer daily subcutaneous injections.', ' Life expectancy greater than 6 months.', 'Exclusion Criteria:', ' Prior therapy of any modality for the treatment of breast cancer', ' Any prior therapy with an anthracycline or a taxane for any other indication', ' HER-2 positive breast cancer defined as either gene amplification by Fluorescent In Situ Hybridization (FISH) or 3+ staining by IHC (Hercept™).', ' Women who have a positive pregnancy test, no pregnancy test available, who are pregnant or who are lactating.', ' Women of childbearing potential must agree to use a reliable and appropriate contraceptive method, which could include a double barrier method (condom plus diaphragm), an intrauterine device or oral contraceptives. Women with ER or PR positive breast cancer, should not, however, use oral contraceptives as a method of contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Women with breast cancer that do not have palpable breast tumors at screening.', ' History of another malignancy within the last 5 years except curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia.', ' Clinically significant (i.e. active) cardiac disease (NYHA Grade II or greater congestive heart failure, symptomatic coronary artery disease, unstable angina, and cardiac arrhythmia not well-controlled with medication), myocardial infarction within the last 6 months prior to study start, or screening ejection fraction of < 50%.', ' Any of the following abnormal laboratory values:', ' Absolute neutrophil count < 1.5 x 109/L', ' Platelet count < 100 x 109/L', ' Serum bilirubin > 1.5 x upper limit of normal (ULN)', ' Serum alanine transaminase (ALT), aspartate transaminase (AST) > 2.5 x ULN', ' Serum creatinine > 2.0 mg/dL or 177mmol/L or calculated creatinine clearance by the method of Cockcroft and Gault < 50mL/min).', ' Any severe or poorly controlled systemic disease (e.g., hypertension; clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound-healing, ulcer or bone fracture).', ' Patients who have received any investigational treatment within 4 weeks of study start.', ' Known infection with HIV, Hepatitis B virus (HBV), or Hepatitis C virus (HCV).', ' Known hypersensitivity to any of the components of NOV-002 or to any of the study drugs.', ' Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.'], 'Results': ['Outcome Measurement: ', ' Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy', ' The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.', ' Time frame: About 7 months', 'Results 1: ', ' Arm/Group Title: NOV-002 and Chemotherapy', ' Arm/Group Description: NOV-002:', ' Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart', ' Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration', ' Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections', ' Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1', ' Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1', ' Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1', ' Overall Number of Participants Analyzed: 39', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Tumors Median (95% Confidence Interval)Unit of Measure: percentage of tumors: 39 (25 to 45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/41 (65.85%)', ' Febrile Neutropenia 4/41 (9.76%)', ' Neutropenia 1/41 (2.44%)', ' Deep Vein Thrombosis 1/41 (2.44%)', ' Pulmonary embolism 1/41 (2.44%)', ' Femoral Artery occlusion 1/41 (2.44%)', ' Abdominal Pain 2/41 (4.88%)', ' Constipation 1/41 (2.44%)', ' Fatigue 2/41 (4.88%)', ' Headache 1/41 (2.44%)', ' Nausea 1/41 (2.44%)', ' Cellulitis 1/41 (2.44%)', ' Muscular Weakness 1/41 (2.44%)']}
|
{'Clinical Trial ID': 'NCT00454805', 'Intervention': ['INTERVENTION 1: ', ' Cediranib 45 mg', ' Cediranib 45 mg+Fulvestrant 250 mg', ' Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: cediranib 45 mg (administered orally)', 'INTERVENTION 2: ', ' Placebo', ' Placebo+Fulvestrant 250 mg', ' Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: placebo to match cediranib (administered orally)'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease', ' One or more evaluable lesions', 'Exclusion Criteria:', ' Prior hormonal therapy with fulvestrant', ' More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer', ' Prior biologic therapy for ABC including Anti-VEGF agents', ' Radiation therapy within 4 weeks prior to provision of consent'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.', ' Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.', 'Results 1: ', ' Arm/Group Title: Cediranib 45 mg', ' Arm/Group Description: Cediranib 45 mg+Fulvestrant 250 mg', ' Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: cediranib 45 mg (administered orally)', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 223 (129 to 340)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo+Fulvestrant 250 mg', ' Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: placebo to match cediranib (administered orally)', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 112 (59 to 329)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/31 (48.39%)', ' Intracardiac Thrombus 1/31 (3.23%)', ' Diarrhoea 2/31 (6.45%)', ' Nausea 2/31 (6.45%)', ' Vomiting 2/31 (6.45%)', ' Ascites 0/31 (0.00%)', ' Ileus 1/31 (3.23%)', ' Small Intestinal Obstruction 1/31 (3.23%)', ' Multi-Organ Failure 0/31 (0.00%)', ' Sepsis 1/31 (3.23%)', ' Weight Decreased 1/31 (3.23%)', ' Dehydration 2/31 (6.45%)', ' Hypokalaemia 0/31 (0.00%)', 'Adverse Events 2:', ' Total: 4/31 (12.90%)', ' Intracardiac Thrombus 0/31 (0.00%)', ' Diarrhoea 0/31 (0.00%)', ' Nausea 0/31 (0.00%)', ' Vomiting 0/31 (0.00%)', ' Ascites 1/31 (3.23%)', ' Ileus 0/31 (0.00%)', ' Small Intestinal Obstruction 0/31 (0.00%)', ' Multi-Organ Failure 1/31 (3.23%)', ' Sepsis 0/31 (0.00%)', ' Weight Decreased 0/31 (0.00%)', ' Dehydration 0/31 (0.00%)', ' Hypokalaemia 1/31 (3.23%)']}
|
8a0d98d1-3a04-4fe4-8dc9-a41fdad5acdd
|
Comparison
|
Eligibility
|
NCT00375427
|
NCT00579826
|
Patients diagnosed with osteoporosis are eligible for the primary trial but excluded from the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18
] |
[
6,
7
] |
{'Clinical Trial ID': 'NCT00375427', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Every 3 Months', ' Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.', 'INTERVENTION 2: ', ' Zoledronic Acid Every 4 Weeks', ' Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.'], 'Eligibility': ['Inclusion criteria:', ' Female patients 18 years of age.', ' Written informed consent given.', ' Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.', ' Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status 2 .', ' Life expectancy 1 year.', 'Exclusion criteria:', ' More than 3 months since last infusion of Zoledronic Acid (Zometa®).', ' Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.', ' Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85', ' Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).', ' Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).', ' Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).', ' History of non-compliance to medical regimens or potential unreliable behavior.', ' Known sensitivity to study drug(s) or class of study drug(s).', ' Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study', ' Use of any other investigational agent in the last 30 days.'], 'Results': ['Outcome Measurement: ', ' Annual Overall Skeletal Morbidity Rate (SMR)', ' The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.', ' SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Every 3 Months', ' Arm/Group Description: Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.', ' Overall Number of Participants Analyzed: 209', ' Mean (Standard Deviation)', ' Unit of Measure: Number of Skeletal Events per Year 0.26 (0.81)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Every 4 Weeks', ' Arm/Group Description: Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.', ' Overall Number of Participants Analyzed: 216', ' Mean (Standard Deviation)', ' Unit of Measure: Number of Skeletal Events per Year 0.22 (0.57)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/209 (10.05%)', ' Anaemia 0/209 (0.00%)', ' Febrile neutropenia 0/209 (0.00%)', ' Thrombocytopenia 0/209 (0.00%)', ' Acute myocardial infarction 0/209 (0.00%)', ' Cardiac failure 0/209 (0.00%)', ' Diplopia 0/209 (0.00%)', ' Gastric haemorrhage 0/209 (0.00%)', ' Nausea 0/209 (0.00%)', ' Oral pain 0/209 (0.00%)', ' Vomiting 1/209 (0.48%)', ' Mucosal inflammation 0/209 (0.00%)', ' Pain 1/209 (0.48%)', 'Adverse Events 2:', ' Total: 29/216 (13.43%)', ' Anaemia 2/216 (0.93%)', ' Febrile neutropenia 2/216 (0.93%)', ' Thrombocytopenia 2/216 (0.93%)', ' Acute myocardial infarction 1/216 (0.46%)', ' Cardiac failure 1/216 (0.46%)', ' Diplopia 1/216 (0.46%)', ' Gastric haemorrhage 1/216 (0.46%)', ' Nausea 1/216 (0.46%)', ' Oral pain 2/216 (0.93%)', ' Vomiting 2/216 (0.93%)', ' Mucosal inflammation 1/216 (0.46%)', ' Pain 0/216 (0.00%)']}
|
{'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: ']}
|
8074c35f-b74c-4250-94f1-9ad22fa315d7
|
Comparison
|
Eligibility
|
NCT00580333
|
NCT00934856
|
Candidates must have a life expectancy less than 12 weeks to particpate in the primary trial and the secondary trial.
|
Contradiction
|
[
8,
11
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
{'Clinical Trial ID': 'NCT00580333', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin/Avastin', ' Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)', ' cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles', ' bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel', ' doxorubicin: Postoperative: Given intravenously for four 2-week cycles', ' cyclophosphamide: Postoperative: Given intravenously for four two-week cycles', ' paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week'], 'Eligibility': ['Inclusion Criteria:', ' All tumors must be ER-, PR- and HER2-negative', ' Clinical stage T2 or T3, N0-3, M0. Subjects with inflammatory breast cancer are not eligible', " For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes.", ' 18 years of age or older', ' Performance status (PS) of 0 or 1', ' Use of an effective means of contraception in subjects of child-bearing potential', ' Normal organ function as described in the protocol', 'Exclusion Criteria:', ' Any prior cytotoxic chemotherapy or radiation for the current breast cancer', ' HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer', ' Life expectancy of less than 12 weeks', ' Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study', ' Renal dysfunction for which exposure to cisplatin would require dose modifications', ' Steroid dependent asthma', ' Peripheral neuropathy of any etiology that exceeds grade 1', ' Uncontrolled diabetes', ' History of malignancy treated without curative intent', ' Any other pre-existing medical condition that would represent toxicity in excess of grade 1', ' Inadequately controlled hypertension', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) Grade II or greater congestive hear failure', ' History of myocardial infarction or unstable angina within 12 months prior to study enrollment', ' Any history of stroke or transient ischemic attack at any time', ' Known central nervous system (CNS) disease', ' Significant vascular disease', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious, non-healing wound, ulcer or bone fracture', ' Proteinuria at screening', ' Known hypersensitivity to any component of bevacizumab', ' Pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.', ' The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cisplatin/Avastin', ' Arm/Group Description: Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)', ' cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles', ' bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel', ' doxorubicin: Postoperative: Given intravenously for four 2-week cycles', ' cyclophosphamide: Postoperative: Given intravenously for four two-week cycles', ' paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (7 to 29)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/51 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00934856', 'Intervention': ['INTERVENTION 1: ', ' MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', 'INTERVENTION 2: ', ' MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)', ' HER2-positive metastatic or locally advanced breast cancer', ' For MBC participants:', ' Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel', ' History of disease progression within 3 months prior to study entry', ' For LABC participants:', ' Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)', 'Exclusion Criteria:', ' Significant cardiac disease', ' Inadequate bone marrow, liver or renal function', ' For MBC participants:', ' Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases', ' Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.', ' For LABC participants:', ' Clinically or radiologically detectable metastasis (M1 disease)', ' Participants for whom surgery as primary intent procedure is the best option to treat their disease', ' Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population', ' DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.', ' Time frame: Cycle 1 (up to 21 days)', 'Results 1: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 2', 'Results 2: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 0/6 (0.00%)', ' Thrombocytopenia * 1/6 (16.67%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 1/6 (16.67%)', ' Cholecystitis * 1/6 (16.67%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 1/6 (16.67%)', ' Thrombocytopenia * 0/6 (0.00%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 0/6 (0.00%)', ' Cholecystitis * 0/6 (0.00%)']}
|
afc4a45b-6592-4ca8-b174-033fb6a0624a
|
Single
|
Eligibility
|
NCT00033514
|
Elizabeth has HER2 positive breast cancer, she is eligible for the primary trial.
|
Entailment
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00033514', 'Intervention': ['INTERVENTION 1: ', ' Treatment Phase 1 Plus Phase 2', ' trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.', ' erlotinib hydrochloride: 150 mg daily.'], 'Eligibility': ['Inclusion Criteria:', ' Women aged > 18 years', ' Histologically documents metastatic breast cancer', ' HER2 positive using Fluorescence In Situ Hybridization (FISH)', ' For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.', ' For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2', ' A life expectancy of > 3 months', ' Use of effective means of contraception', 'Exclusion Criteria:', ' For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.'], 'Results': ['Outcome Measurement: ', ' The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.', ' Complete Response:', ' The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.', ' Partial Response:', ' A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Treatment Phase 1 Plus Phase 2', ' Arm/Group Description: trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.', ' erlotinib hydrochloride: 150 mg daily.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: participants Partial Response: 4', 'Stable Disease: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/27 (59.26%)', ' Dyspnea * 6/27 (22.22%)', ' hypertension with headache * 1/27 (3.70%)', ' pain/chest pressure/SOB * [1]1/27 (3.70%)', ' LVEF less than the lower limit of normal * 2/27 (7.41%)', ' subendocardial myocardial infarction * 1/27 (3.70%)', ' dehydration/pain management * 1/27 (3.70%)', ' gastroenteritis * [2]1/27 (3.70%)', ' progressive brain mets * 2/27 (7.41%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2e1d4811-ae58-4b81-b53a-dbcb8c980a08
|
|
Comparison
|
Eligibility
|
NCT00568022
|
NCT01120184
|
Completely disabled patients, totally confined to bed or chair and unable to carry on any selfcare are eligible for the primary trial but excluded from the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4
] |
[
0,
5
] |
{'Clinical Trial ID': 'NCT00568022', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.', 'INTERVENTION 2: ', ' Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Women 20 years', ' Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast', 'Exclusion Criteria:', ' Number of prior chemotherapy lines of treatment in the metastatic setting 3'], 'Results': ['Outcome Measurement: ', ' Participants Experiencing Dose Limiting Toxicity (DLT)', ' DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.', ' Time frame: From initiation of drug through last day of Cycle 2 (Day 42)', 'Results 1: ', ' Arm/Group Title: Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Arm/Group Description: Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Arm/Group Description: Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' NEUTROPENIA 0/3 (0.00%)', ' SKIN INFECTION 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' NEUTROPENIA 0/3 (0.00%)', ' SKIN INFECTION 1/3 (33.33%)']}
|
{'Clinical Trial ID': 'NCT01120184', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Taxane', " Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.", 'INTERVENTION 2: ', ' Trastuzumab Emtansine + Placebo', ' Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.'], 'Eligibility': ['Inclusion Criteria:', ' Adult participants >/=18 years of age', ' HER2-positive breast cancer', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.', ' Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1', ' Adequate organ function as determined by laboratory results', 'Exclusion Criteria:', ' History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease', ' An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis', ' Hormone therapy <7 days prior to randomization', ' Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization', ' Prior trastuzumab emtansine or pertuzumab therapy'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment', ' Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to ( ) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.', ' Time frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Taxane', " Arm/Group Description: Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.", ' Overall Number of Participants Analyzed: 365', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.3', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine + Placebo', ' Arm/Group Description: Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 367', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 81/353 (22.95%)', ' Febrile neutropenia * 13/353 (3.68%)', ' Anaemia * 21/353 (0.28%)', ' Neutropenia * 25/353 (1.42%)', ' Thrombocytopenia * 20/353 (0.00%)', ' Hypercoagulation * 21/353 (0.28%)', ' Leukopenia * 21/353 (0.28%)', ' Atrial fibrillation * 1/353 (0.28%)', ' Cardiac failure * 0/353 (0.00%)', ' Cardiac failure congestive * 0/353 (0.00%)', ' Myocardial infarction * 1/353 (0.28%)', 'Adverse Events 2:', ' Total: 86/361 (23.82%)', ' Febrile neutropenia * 0/361 (0.00%)', ' Anaemia * 25/361 (1.39%)', ' Neutropenia * 20/361 (0.00%)', ' Thrombocytopenia * 22/361 (0.55%)', ' Hypercoagulation * 20/361 (0.00%)', ' Leukopenia * 20/361 (0.00%)', ' Atrial fibrillation * 0/361 (0.00%)', ' Cardiac failure * 0/361 (0.00%)', ' Cardiac failure congestive * 0/361 (0.00%)', ' Myocardial infarction * 0/361 (0.00%)']}
|
d4f738c5-c99a-4d8d-b335-5821ce97fbd5
|
Single
|
Adverse Events
|
NCT01262027
|
More than 1 patient in the primary trial suffered an adverse event.
|
Contradiction
|
[
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': ''}
|
f27b25bd-c28e-4aac-8ad6-951fd7381ce4
|
|
Comparison
|
Adverse Events
|
NCT00127933
|
NCT00191789
|
the primary trial recorded at least one patient with an infection, whereas in the secondary trial none where observed.
|
Contradiction
|
[
12,
25
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT00191789', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine+Doxorubicin+Cisplatin+Surgery', ' Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).', ' Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of breast carcinoma', ' No previous chemotherapy, with bidimensionally measurable locally advanced disease', ' Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.', 'Exclusion Criteria:', ' Inflammatory breast cancer', ' Pregnancy and Breast-feeding', ' Serious concomitant disorder or infection', ' Previous cancer within the last 5 years or a second primary malignancy.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)', ' Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.', ' Time frame: tumor assessment at baseline and during surgery after eight 21-day treatment cycles', 'Results 1: ', ' Arm/Group Title: Gemcitabine+Doxorubicin+Cisplatin+Surgery', ' Arm/Group Description: Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).', ' Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.', ' Overall Number of Participants Analyzed: 65', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/65 (26.15%)', ' Febrile neutropenia 3/65 (4.62%)', ' Neutropenia 2/65 (3.08%)', ' Pancytopenia 1/65 (1.54%)', ' Thrombocytopenia 1/65 (1.54%)', ' Cardiac arrest 2/65 (3.08%)', ' Myocardial infarction 1/65 (1.54%)', ' Diarrhoea 5/65 (7.69%)', ' Stomatitis 1/65 (1.54%)', ' Vomiting 2/65 (3.08%)', ' Fatigue 1/65 (1.54%)', ' Jaundice 1/65 (1.54%)', ' Neutropenic infection 2/65 (3.08%)']}
|
5311216c-94e0-4d04-acd2-b95b932ddc02
|
Single
|
Adverse Events
|
NCT00191451
|
Patients in the primary trial experienced a variety of Oesophageal and cardiac adverse events.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
[] |
{'Clinical Trial ID': 'NCT00191451', 'Intervention': ['INTERVENTION 1: ', ' HER2+', ' Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).', 'INTERVENTION 2: ', ' HER2- (Taxane-)', ' Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of metastatic breast cancer', " Able to visit the doctor's office at least every 14 days during the actual treatment", ' Able to care for yourself, even if you cannot work or participate in other normal activities', ' Your blood results must be adequate for therapy.', ' If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.', 'Exclusion Criteria:', ' Have received gemcitabine, paraplatin, or trastuzumab for your cancer.', ' Be pregnant or breastfeeding', ' Have cancer to the brain and has not been treated', ' Have another active cancer besides breast cancer', ' Have received stem cell or bone marrow transplant for hematologic (blood type) cancer'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.', ' Time frame: baseline to disease progression/recurrence (up to 3.5 years)', 'Results 1: ', ' Arm/Group Title: HER2+', ' Arm/Group Description: Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 6', ' Partial Response (PR): 26', ' Stable Disease (SD): 12', ' Progressive Disease (PD): 4', 'Not Evaluable (NE): 2', 'Results 2: ', ' Arm/Group Title: HER2- (Taxane-)', ' Arm/Group Description: Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 13', ' Stable Disease (SD): 20', ' Progressive Disease (PD): 12', 'Not Evaluable (NE): 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/50 (20.00%)', ' Anaemia 0/50 (0.00%)', ' Febrile neutropenia 0/50 (0.00%)', ' Neutropenia 0/50 (0.00%)', ' Thrombocytopenia 0/50 (0.00%)', ' Diastolic dysfunction 0/50 (0.00%)', ' Tachycardia 0/50 (0.00%)', ' Intestinal obstruction 0/50 (0.00%)', ' Nausea 1/50 (2.00%)', ' Oesophageal spasm 0/50 (0.00%)', ' Oesophagitis 0/50 (0.00%)', ' Retching 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 11/48 (22.92%)', ' Anaemia 4/48 (8.33%)', ' Febrile neutropenia 0/48 (0.00%)', ' Neutropenia 2/48 (4.17%)', ' Thrombocytopenia 2/48 (4.17%)', ' Diastolic dysfunction 1/48 (2.08%)', ' Tachycardia 1/48 (2.08%)', ' Intestinal obstruction 0/48 (0.00%)', ' Nausea 0/48 (0.00%)', ' Oesophageal spasm 1/48 (2.08%)', ' Oesophagitis 0/48 (0.00%)', ' Retching 1/48 (2.08%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
01dfa37b-ce65-4e90-addc-395241c92f5f
|
|
Single
|
Eligibility
|
NCT03197389
|
Both men and women of child bearing potential must use adequate methods of contraception to be eligible for the primary trial.
|
Entailment
|
[
0,
16,
17,
18
] |
[] |
{'Clinical Trial ID': 'NCT03197389', 'Intervention': ['INTERVENTION 1: ', ' Cohort A1', ' Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.', ' Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.', 'INTERVENTION 2: ', ' Cohort A2', ' Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.', ' Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.'], 'Eligibility': ['Inclusion Criteria:', ' Be willing and able to provide written informed consent/assent for the trial.', ' Be 18 years of age on day of signing informed consent.', ' Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion if needed. Newly obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 0. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.', ' Have a performance status of 0 or 1 on the ECOG Performance Scale.', ' Have non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:', ' Histologically confirmed', ' ER/PR negative or ER positive. ER/PR status will be evaluated with Allred score (semi-quantitative measurement) following ASCO CAP guidelines 2009.', ' HER2 negative of positive. HER2 status will be evaluated using IHC followed by FISH with dual probe (ASCO CAP guidelines 2013).', ' Primary tumor size greater than 1 cm, measured by any of clinical examination, mammography, ultrasound or magnetic resonance imaging', ' Any clinical nodal status', ' Have evaluable core biopsy for IHC', ' Be willing to provide plasma/blood samples', ' After neo-adjuvant chemotherapy (cohort B1 and B2) patients must have residual tumor >1cm and must be willing to provide evaluable new tumor biopsy for IHC', ' Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation.', ' Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.', ' Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after receiving the study medication.', ' Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.', ' Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, until 120 after receiving the study therapy.', ' Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.', 'Exclusion Criteria:', ' Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of receiving the treatment dose.', ' Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to receiving the trial treatment.', ' Has a known history of active TB (Bacillus Tuberculosis)', ' Hypersensitivity to pembrolizumab or any of its excipients.', ' Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.', ' Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 0 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to a previously administered agent.', ' Note: Subjects with Grade 2 neuropathy are an exception to this criterion and may qualify for the study.', ' Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.', ' Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.', ' Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. 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.', ' Has known history of (non-infectious) pneumonitis that required steroids or current pneumonitis.', ' Has an active infection requiring systemic therapy.', " Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.", ' Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.', ' Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.', ' Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or co-inhibitory T-cell receptor therapy (e.g. OX40-CD137, CTLA-4)', ' Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).', ' Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).', ' Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.'], 'Results': ['Outcome Measurement: ', ' PD-1 Expression', ' PD-1 expression after a single dose of pembrolizumab.', " Immunohistochemical stains were performed on 5-μm thick sections using an automatic immunostainer (Bond Max Autostainer, Leica) according to the manufacturer's instructions.", ' A monoclonal antibodie was used for PD1 (clone NAT105, Abcam). PD1 expression on sTIL was assessed semi quantitatively.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A1', ' Arm/Group Description: Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda ) administered intravenously at 200 mg 10 +/- 4 days before surgery.', ' Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.', ' Overall Number of Participants Analyzed: 15', ' Median (Full Range)', ' Unit of Measure: percentage 0 (0 to 10)', 'Results 2: ', ' Arm/Group Title: Cohort A2', ' Arm/Group Description: Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda ) administered intravenously at 200 mg 10 +/- 4 days before surgery.', ' Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.', ' Overall Number of Participants Analyzed: 4', ' Median (Full Range)', ' Unit of Measure: percentage 0 (0 to 1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
43588c50-7dc4-4d46-a53d-e94576e8ab55
|
|
Single
|
Eligibility
|
NCT02683083
|
sufferers of hyperthyroidism are excluded from the primary trial.
|
Entailment
|
[
11,
12,
13,
14,
15,
16
] |
[] |
{'Clinical Trial ID': 'NCT02683083', 'Intervention': ['INTERVENTION 1: ', ' [131I]-SGMIB Anti-HER2 VHH1', ' All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).'], 'Eligibility': ['Inclusion Criteria:', ' Subjects will only be included in the study if they meet all of the following criteria:', ' Subjects who have given informed consent', ' Subjects that agree not to drink alcoholic beverages or use any drugs during the study', ' Subject with blood parameters within normal ranges', ' Age: at least 18 years old', ' Patients will only be included in the study if they meet all of the following criteria:', ' Patients who have given informed consent', ' Patients that agree not to drink alcoholic beverages or use any drugs during the study', ' Age: at least 18 years old', ' Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).', 'Exclusion Criteria:', ' Patients will not be included in the study if one of the following criteria applies:', ' Pregnant patients', ' Breast feeding patients', ' Patients with occupational exposure to ionizing irradiation', ' Patients with previous thyroid disorders', ' Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.', ' Patients with absolute contra-indications for thyroid blockage with potassium iodide.', ' Patients with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.', ' Patients with abnormal kidney function: < 50 ml/min/1,73 m2', ' Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom', ' Patients with any serious active infection', ' Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical', ' Patients who cannot communicate reliably with the investigator', ' Patients who are unlikely to cooperate with the requirements of the study', ' Patients at increased risk of death from a pre-existing concurrent illness', ' Patients who participated already in this study', ' Patients who participated in a previous trial with Anti-HER2 VHH1', ' Subjects will not be included in the study if one of the following criteria applies:', ' Pregnant subjects', ' Breast feeding subjects', ' Subjects with occupational exposure to ionizing irradiation', ' Subjects with clinical significant disease or on concomitant therapy (except contraception)', ' Subjects with previous thyroid disorders', ' Subjects that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.', ' Subjects with absolute contra-indications for thyroid blockage with potassium iodide.', ' Subjects with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.', ' Subjects with abnormal kidney function: < 50 ml/min/1,73 m2', ' Subjects with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom', ' Subjects with any serious active infection', ' Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical', ' Subjects who cannot communicate reliably with the investigator', ' Subjects who are unlikely to cooperate with the requirements of the study', ' Subjects at increased risk of death from a pre-existing concurrent illness', ' Subjects who participated already in this study', ' Subjects who participated in a previous trial with Anti-HER2 VHH1'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', ' [Not Specified]', 'Time frame: 1 day', 'Results 1: ', ' Arm/Group Title: [131I]-SGMIB Anti-HER2 VHH1', ' Arm/Group Description: All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f419f810-ca53-4168-86fd-d1d9a9154d3a
|
|
Single
|
Results
|
NCT00206518
|
The least common Chevalier grades for patients in the primary trial treated with Taxotere/Docetaxel were 1, 3D and 3C.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22
] |
[] |
{'Clinical Trial ID': 'NCT00206518', 'Intervention': ['INTERVENTION 1: ', ' A: Taxotere/Docetaxel', ' Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.', 'Taxotere/Docetaxel: Taxotere', ' doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.', 'INTERVENTION 2: ', ' B: AC Adriamycin/Cytoxan', ' In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.', 'Adriamycin/Cytoxan: Adriamycin/Cytoxan'], 'Eligibility': ['Inclusion Criteria:', ' All patients must be female.', ' Signed informed consent.', ' Primary breast cancers must be of clinical and/or radiologic size >3 cm, and deemed surgically operable.', ' Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.', ' Adequate bone marrow function:', ' Hematocrit of greater than 30%,', ' total neutrophil count must be >1.5 x 10^9/L and', ' platelets of > 100 x 10^9/L prior to the start of any cycle.', ' Renal function tests:', " creatinine within 1.5 times of the institution's upper limit of normal (ULN).", ' Liver function tests:', ' Total serum bilirubin within ULN, and', ' liver transaminases within 2.5 times ULN, and', ' alkaline phosphatase within 5 times ULN.', ' Electrocardiogram showing no acute ischemic changes.', ' Performance status (World Health Organization [WHO] scale) <2.', ' Age > 18 years.', ' Patients older than 70 years of age should have left ventricular ejection fraction within ULN by multigated acquisition scan (MUGA) or 2D echocardiogram.', 'Exclusion Criteria:', ' Patients with metastatic breast cancer.', ' Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.', ' Women who are lactating or breastfeeding.', ' Severe underlying chronic illness or disease.', ' Peripheral neuropathy - grade 2 or greater.', ' Patients on other investigational drugs while on study will be excluded.', ' Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.', ' Prior taxane or anthracycline chemotherapy for malignancy.', ' Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.', ' No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.'], 'Results': ['Outcome Measurement: ', ' Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)', " The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:", ' Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)', ' Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)', ' Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4', ' No or few modification of tumoral appearance (pNR).', ' Time frame: 10 years', 'Results 1: ', ' Arm/Group Title: A: Taxotere/Docetaxel', ' Arm/Group Description: Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.', 'Taxotere/Docetaxel: Taxotere', ' doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.', ' Overall Number of Participants Analyzed: 83', ' Measure Type: Number', ' Unit of Measure: participants 1: 3', ' 2: 2', ' 3A: 18', ' 3B: 15', ' 3C: 18', ' 3D: 10', '4: 3', 'N/A: 14', 'Results 2: ', ' Arm/Group Title: B: AC Adriamycin/Cytoxan', ' Arm/Group Description: In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.', 'Adriamycin/Cytoxan: Adriamycin/Cytoxan', ' Overall Number of Participants Analyzed: 84', ' Measure Type: Number', ' Unit of Measure: participants 1: 9', ' 2: 1', ' 3A: 15', ' 3B: 18', ' 3C: 15', ' 3D: 8', '4: 0', 'N/A: 18'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/83 (14.46%)', ' NEUTROPENIA *8/83 (9.64%)', ' ABDOMINAL PAIN *0/83 (0.00%)', ' GASTRITIS *0/83 (0.00%)', ' FEVER *2/83 (2.41%)', ' ALLERGIC/REACTION *1/83 (1.20%)', ' INFECTION *4/83 (4.82%)', ' RENAL FAILURE *0/83 (0.00%)', 'Adverse Events 2:', ' Total: 5/84 (5.95%)', ' NEUTROPENIA *3/84 (3.57%)', ' ABDOMINAL PAIN *1/84 (1.19%)', ' GASTRITIS *1/84 (1.19%)', ' FEVER *1/84 (1.19%)', ' ALLERGIC/REACTION *0/84 (0.00%)', ' INFECTION *1/84 (1.19%)', ' RENAL FAILURE *1/84 (1.19%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
630a8241-b776-4799-a7ca-b1fddf17686c
|
|
Comparison
|
Eligibility
|
NCT00675259
|
NCT01875367
|
Patients with an ImmunoHistoChemistry test result of 3+ are excluded from the primary trial but included in the secondary trial.
|
Entailment
|
[
15,
18
] |
[
0,
3
] |
{'Clinical Trial ID': 'NCT00675259', 'Intervention': ['INTERVENTION 1: ', ' Neoadjuvant, Surgery, Adjuvant', " Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered 3 weeks after completing the regimen."], 'Eligibility': ['Inclusion:', ' Histologically confirmed breast cancer', ' Clinically or radiographically measurable residual tumor after core biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Age 18 yrs', ' Absolute neutrophil count 1,500/mm³', ' Hemoglobin 9 g/dL', ' Platelet count 100,000/ mm³', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Urine protein:creatinine ratio < 1.0', ' AST (aspartate aminotransferase) and ALT 2.5 times ULN', ' Alkaline phosphatase 2.5 times ULN', ' Bilirubin normal', ' Women of childbearing potential must use effective contraception', ' Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA', ' Exclusion:', ' No residual tumor after initial biopsy', ' Peripheral neuropathy of grade 2 or higher', ' HER-2 neu overexpression either by IHC 3+ or FISH+', ' No history of any prior treatment of breast cancer.', ' No history of unstable angina or myocardial infarction within the past 12 months', ' Pregnant or nursing women', ' Anticoagulation therapy within the last 6 months', ' History of gastrointestinal bleeding', ' Recent hemoptysis', ' No known hepatitis B or HIV seropositivity', ' No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications', ' History of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association class II-IV congestive heart failure', ' History of stroke or transient ischemic attack at any time', ' Significant vascular disease (e.g., aortic aneurysm or aortic dissection)', ' No symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Significant traumatic injury within the past 28 days', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months', ' Serious, non-healing wound, ulcer, or bone fracture', ' Known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathologic Complete Response (pCR)', ' pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.', ' Time frame: every 4 weeks', 'Results 1: ', ' Arm/Group Title: Neoadjuvant, Surgery, Adjuvant', " Arm/Group Description: Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered 3 weeks after completing the regimen.", ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: patients 6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/33 (0.00%)']}
|
{'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%)']}
|
8f3fddf2-97ab-4456-bff7-8f83b27e3849
|
Comparison
|
Intervention
|
NCT00485953
|
NCT00068601
|
the cyclophosphamide dose in the secondary trial is 150mg once every 4 weeks and the Placebo dose in the primary trial is 12mg QD.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8
] |
{'Clinical Trial ID': 'NCT00485953', 'Intervention': ['INTERVENTION 1: ', ' Active Medicine Group', ' risedronate 35 mg weekly', 'INTERVENTION 2: ', ' Placebo Group', ' Received placebo medication once weekly'], 'Eligibility': ['Inclusion Criteria:', ' elderly postmenopausal women (ages 55 and older)', ' osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.', ' with breast cancer on aromatase inhibitor therapy', ' with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)', ' type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients', ' Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits', 'Exclusion Criteria:', ' Women with stage 4 breast cancer (presence of distant metastases)', ' Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.', ' Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.', ' Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).', ' Those with untreated active peptic ulcer disease', ' Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.', ' Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)', ' Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor', ' Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study', ' Use of fluoride for more than 1 month ever (except for dental treatment)', ' Less than 2 evaluable vertebrae', ' Distant metastatic disease'], 'Results': ['Outcome Measurement: ', ' BMD of Spine by DXA', ' BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.', ' Time frame: at 24 months', 'Results 1: ', ' Arm/Group Title: Active Medicine Group', ' Arm/Group Description: risedronate 35 mg weekly', ' Overall Number of Participants Analyzed: 55', ' Mean (Standard Error)', ' Unit of Measure: percentage change 2.269 (0.583)', 'Results 2: ', ' Arm/Group Title: Placebo Group', ' Arm/Group Description: Received placebo medication once weekly', ' Overall Number of Participants Analyzed: 54', ' Mean (Standard Error)', ' Unit of Measure: percentage change -1.735 (0.611)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/55 (18.18%)', ' Cardiovascular related events5/55 (9.09%)', ' Gastrointestinal Events0/55 (0.00%)', ' Other events0/55 (0.00%)', ' Infection related events2/55 (3.64%)', ' Musculoskeletal related events2/55 (3.64%)', ' Other cancers0/55 (0.00%)', ' Urogenital related events0/55 (0.00%)', ' Breast related events1/55 (1.82%)', 'Adverse Events 2:', ' Total: 16/54 (29.63%)', ' Cardiovascular related events2/54 (3.70%)', ' Gastrointestinal Events1/54 (1.85%)', ' Other events4/54 (7.41%)', ' Infection related events3/54 (5.56%)', ' Musculoskeletal related events5/54 (9.26%)', ' Other cancers2/54 (3.70%)', ' Urogenital related events1/54 (1.85%)', ' Breast related events2/54 (3.70%)']}
|
{'Clinical Trial ID': 'NCT00068601', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy', ' Patients receive cyclophosphamide-containing chemotherapy alone.', ' cyclophosphamide: Part of planned chemotherapy regimen', 'INTERVENTION 2: ', ' Chemotherapy Plus Goserelin', ' Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' goserelin acetate: Given subcutaneously'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer', ' Stage I-IIIA', ' Operable disease', ' Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative', ' Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:', ' 3-month/4-course anthracycline-based regimen', ' 6- to 8-month/course anthracycline-based regimen', ' 6- to 8-month/course non-anthracycline-based regimen', ' Hormone receptor status:', ' Estrogen receptor negative', ' Progesterone receptor negative', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 to 49', ' Sex', ' Female', ' Menopausal status', ' Premenopausal', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Not specified', ' Other', ' Not pregnant or nursing', ' Fertile patients must use effective barrier contraception', ' No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' See Disease Characteristics', ' No prior cytotoxic chemotherapy', ' Endocrine therapy', ' No other concurrent hormonal therapy', ' Radiotherapy', ' Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed', ' Surgery', ' See Disease Characteristics', ' Other', ' Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed'], 'Results': ['Outcome Measurement: ', ' Rate of Premature Ovarian Failure at 2 Years', ' Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy', ' Arm/Group Description: Patients receive cyclophosphamide-containing chemotherapy alone.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 21.7%', 'Results 2: ', ' Arm/Group Title: Chemotherapy Plus Goserelin', ' Arm/Group Description: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' goserelin acetate: Given subcutaneously', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 5 7.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/111 (0.00%)', ' Thrombosis/thrombus/embolism 0/111 (0.00%)', 'Adverse Events 2:', ' Total: 1/103 (0.97%)', ' Thrombosis/thrombus/embolism 1/103 (0.97%)']}
|
11617367-193f-4f6b-bc3e-e58ea76d1052
|
Comparison
|
Eligibility
|
NCT01840163
|
NCT02005549
|
the primary trial and the secondary trial do not exclude patients with non-melanoma skin cancer.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT01840163', 'Intervention': ['INTERVENTION 1: ', ' CanSORT Online Tool (Intervention)', ' Comprehensive (interactive) version of decision tool', ' CanSORT Online Tool', 'INTERVENTION 2: ', ' Static Version of CanSORT Tool (Control)', ' Static version (non-interactive) version of CanSORT decision tool', ' Static version of CanSORT tool'], 'Eligibility': ['Inclusion Criteria:', ' Stage 1-2 invasive breast cancer diagnosis,', ' DCIS', ' Ability to read English', 'Exclusion Criteria:', 'Male'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.', ' Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.', ' Time frame: 4-5 weeks from date of enrollment', 'Results 1: ', ' Arm/Group Title: CanSORT Online Tool (Intervention)', ' Arm/Group Description: Comprehensive (interactive) version of decision tool', ' CanSORT Online Tool', ' Overall Number of Participants Analyzed: 251', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 148 59.0%', 'Results 2: ', ' Arm/Group Title: Static Version of CanSORT Tool (Control)', ' Arm/Group Description: Static version (non-interactive) version of CanSORT decision tool', ' Static version of CanSORT tool', ' Overall Number of Participants Analyzed: 245', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 105 42.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/267 (0.00%)', 'Adverse Events 2:', ' Total: 0/270 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02005549', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab+Docetaxel+Capecitabine', ' Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, 18-70years of age;', ' histologically-proven invasive breast cancer;', ' no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;', ' no distant disease/secondary cancer.', 'Exclusion Criteria:', ' pregnant or lactating women;', ' pre-operative local treatment for breast cancer;', ' prior or concurrent systemic antitumor therapy;', ' clinically significant cardiac disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR)', ' pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.', ' Time frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])', 'Results 1: ', ' Arm/Group Title: Bevacizumab+Docetaxel+Capecitabine', ' Arm/Group Description: Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 22.22 (6.41 to 47.64)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/18 (27.78%)', ' Intestinal perforation * 1/18 (5.56%)', ' General physical health deterioration * 1/18 (5.56%)', ' Impaired healing * 1/18 (5.56%)', ' Neutropenic infection * 1/18 (5.56%)', ' Contralateral breast cancer * 1/18 (5.56%)', ' Menorrhagia * 1/18 (5.56%)', ' Deep vein thrombosis * 2/18 (11.11%)']}
|
882f22f6-36d9-4c2f-8f49-52469d570977
|
Single
|
Adverse Events
|
NCT01250379
|
None of the patients in the primary trial had Thrombocytopenia, heart failure, Pancytopenia, Acute coronary syndrome or Atrial fibrillation.
|
Contradiction
|
[
0,
8,
5,
7,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT01250379', 'Intervention': ['INTERVENTION 1: ', ' CT Arm', " Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.", 'INTERVENTION 2: ', ' CT+BV Arm', " Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study."], 'Eligibility': ['Inclusion Criteria:', ' Female patients, >/= 18 years of age', ' Histologically confirmed HER2-negative breast cancer', ' Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer', ' Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy', ' ECOG performance status 0-2', ' At least 28 days since prior radiation therapy or surgery and recovery from treatment', 'Exclusion Criteria:', ' Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment', ' Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years', ' Inadequate renal function', ' Clinically relevant cardio-vascular disease', ' Known CNS disease except for treated brain metastases', ' Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)', ' Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.', ' Time frame: Baseline (less than or equal to [ ] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years', 'Results 1: ', ' Arm/Group Title: CT Arm', " Arm/Group Description: Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.", ' Overall Number of Participants Analyzed: 247', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.7', 'Results 2: ', ' Arm/Group Title: CT+BV Arm', " Arm/Group Description: Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.", ' Overall Number of Participants Analyzed: 247', ' Measure Type: Number', ' Unit of Measure: percentage of participants 93.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 55/238 (23.11%)', ' Febrile neutropenia * 5/238 (2.10%)', ' Neutropenia * 6/238 (2.52%)', ' Leukopenia * 1/238 (0.42%)', ' Thrombocytopenia * 0/238 (0.00%)', ' Anaemia * 1/238 (0.42%)', ' Pancytopenia * 0/238 (0.00%)', ' Cardiac failure * 1/238 (0.42%)', ' Acute coronary syndrome * 0/238 (0.00%)', ' Atrial fibrillation * 0/238 (0.00%)', ' Cardiac failure congestive * 0/238 (0.00%)', 'Adverse Events 2:', ' Total: 89/245 (36.33%)', ' Febrile neutropenia * 12/245 (4.90%)', ' Neutropenia * 10/245 (4.08%)', ' Leukopenia * 2/245 (0.82%)', ' Thrombocytopenia * 5/245 (2.04%)', ' Anaemia * 1/245 (0.41%)', ' Pancytopenia * 1/245 (0.41%)', ' Cardiac failure * 2/245 (0.82%)', ' Acute coronary syndrome * 1/245 (0.41%)', ' Atrial fibrillation * 1/245 (0.41%)', ' Cardiac failure congestive * 2/245 (0.82%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8f5423c9-17b5-4f66-aa9f-1fc9763958b2
|
|
Single
|
Adverse Events
|
NCT00846027
|
None of the adverse events recorded for the primary trial occurred less than twice.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00846027', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab + Paclitaxel + Gemcitabine', ' Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients, 18 years of age.', ' Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.', ' HER-2 negative disease.', ' Candidates for chemotherapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 2.', 'Exclusion Criteria:', ' Previous chemotherapy for metastatic or locally advanced breast cancer.', ' Previous radiotherapy for treatment of metastatic breast cancer.', ' Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.', ' Chronic daily treatment with corticosteroids ( 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.', ' Time frame: Baseline to the end of the study (up to 2 years 10 months)', 'Results 1: ', ' Arm/Group Title: Bevacizumab + Paclitaxel + Gemcitabine', ' Arm/Group Description: Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.', ' Overall Number of Participants Analyzed: 90', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 11.51 (9.01 to 17.59)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/82 (25.61%)', ' Neutrophils count decreased 1/82 (1.22%)', ' Cardiac ischemia/infarction 1/82 (1.22%)', ' Left ventricular systolic dysfunction 1/82 (1.22%)', ' Hypertension 1/82 (1.22%)', ' Supraventricular and nodal arrhythmia 1/82 (1.22%)', ' Anorexia 1/82 (1.22%)', ' Gastrointestinal perforation 1/82 (1.22%)', ' Vomiting 1/82 (1.22%)', ' Dehydration 1/82 (1.22%)', ' Diarrhoea 1/82 (1.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
0c45a782-1a3d-4e9b-a258-136ab080dbb6
|
|
Single
|
Eligibility
|
NCT00654836
|
Patients with metastatic HER-2 positive adenocarcinoma of the breast can never be eligible for the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
5
] |
[] |
{'Clinical Trial ID': 'NCT00654836', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin, ABI-007 and Bevacizumab', " Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15."], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed primary adenocarcinoma of the breast', ' Locally recurrent or metastatic disease', ' Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past', ' 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 by conventional techniques or as > 10 mm by spiral CT scan.', ' No known CNS disease', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Postmenopausal status not specified', ' ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%', ' Life expectancy > 12 weeks', ' WBC 3,000/mcL', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Total bilirubin normal', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', 'Exclusion criteria:', ' Pre-existing neuropathy grade 1', ' Uncontrolled intercurrent illness including, but not limited to, any of the following:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' Serious, non-healing wound, ulcer, or bone fracture', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)', ' History of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association class II-IV congestive heart failure', ' History of myocardial infarction or unstable angina within the past 6 months', ' History of stroke or transient ischemic attack within the past 6 months', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Significant traumatic injury within the past 28 days', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months', ' Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+', ' Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g', ' History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from all prior therapy', ' No prior chemotherapy for locally recurrent or metastatic disease', ' Prior neoadjuvant or adjuvant chemotherapy allowed', ' More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device', ' More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy', ' More than 4 weeks since prior radiotherapy', ' More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)', ' At least 1 year since prior taxane regimen', ' No other concurrent investigational agents', ' Concurrent anticoagulation allowed, provided the following criteria are met:', ' Stable dose of warfarin or low molecular weight heparin', ' INR within desired range (2-3)', ' No evidence of active bleeding or coagulopathy', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was measured from treatment initiation to 30 months. 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: 30 Months', 'Results 1: ', ' Arm/Group Title: Carboplatin, ABI-007 and Bevacizumab', " Arm/Group Description: Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.", ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 16 (9.80 to 22.20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/32 (75.00%)', ' Disease Progression * [1]24/32 (75.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4e42302d-2cd9-4a91-9338-8e3b0ffb9292
|
|
Single
|
Results
|
NCT00270894
|
60% of Subjects in the primary trial were able to Complete at least 85% of the Planned Dose on Schedule.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT00270894', 'Intervention': ['INTERVENTION 1: ', ' Neoadjuvant Therapy', ' Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.'], 'Eligibility': ['Inclusion Criteria:', ' Non-pregnant females =/> 18 years of age', ' Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative', ' Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status', ' Normal cardiac function and adequate hematologic function', ' Human epidermal growth factor receptor 2 protein (HER2) positive', ' No evidence of metastatic disease', ' ECOG Performance Status 0 - 1', ' Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment', 'Exclusion Criteria:', ' Treated with other investigational drugs within 30 days', ' Uncontrolled intercurrent disease or active infection', ' Known sensitivity to e. coli-derived proteins or polysorbate 80', ' Psychiatric illness or social situation that would limit study compliance', ' Pre-existing peripheral neuropathy > Grade 1', ' Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast', ' Bilateral synchronous breast cancer', ' Inflammatory breast cancer', ' Women who are pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule', ' Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.', ' Time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)', 'Results 1: ', ' Arm/Group Title: Neoadjuvant Therapy', ' Arm/Group Description: Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/30 (13.33%)', ' Congestive heart failure * 1/30 (3.33%)', ' Pneumonia * 1/30 (3.33%)', ' Medical Error * 1/30 (3.33%)', ' Interstitial lung disease * 1/30 (3.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a5d5e6da-f3cd-49c7-92a7-f789468c4c4c
|
|
Single
|
Eligibility
|
NCT00981812
|
Women who have undergone a breast enlargement procedure in the last 2 years are excluded from the primary trial.
|
Entailment
|
[
5,
8
] |
[] |
{'Clinical Trial ID': 'NCT00981812', 'Intervention': ['INTERVENTION 1: ', ' Lesions Visualized Using Positron Emission Mammography (PEM)', ' Total lesions visualized using positron emission mammography.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' subject is 25-100 years of age', ' subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy', ' subject is able to provide informed consent', 'Exclusion Criteria:', ' subject is pregnant', ' subject is actively lactating or discontinued breastfeeding less than 2 months ago', ' subject has breast implants', ' subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study', ' subject has contraindications for core biopsy and other invasive procedures', ' subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus', ' subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months', ' subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging'], 'Results': ['Outcome Measurement: ', ' Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.', ' [Not Specified]', ' Time frame: At time of biopsy', 'Results 1: ', ' Arm/Group Title: Lesions Visualized Using Positron Emission Mammography (PEM)', ' Arm/Group Description: Total lesions visualized using positron emission mammography.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: Breast Lesions Index Lesioins: 22', ' Index Lesions Visualized at PEM: 21', ' Additional Lesions seen only at PEM: 6', ' Lesions technically adequate for targeting: 26', ' Number of Lesions Biopsied: 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
da2ea2e9-3109-433e-9033-9ae322c30c4b
|
|
Single
|
Adverse Events
|
NCT00863655
|
There were 5 more cases of Anaemia and 1 more case of Disseminated intravascular coagulation in cohort 1 of the primary trial compared to cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00863655', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Exemestane', ' Everolimus 10 mg daily in combination with exemestane 25 mg daily', 'INTERVENTION 2: ', ' Placebo + Exemestane', ' Placebo of everolimus in combination with exemestane 25 mg daily'], 'Eligibility': ['Inclusion Criteria:', ' Adult women ( 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.', ' Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer', ' Postmenopausal women.', ' Disease refractory to non steroidal aromatase inhibitors (NSAI),', ' Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.', ' Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.', 'Exclusion Criteria:', ' HER2-overexpressing patients', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).', ' Patients who received more than one chemotherapy line for Advanced Breast Cancer.', ' Previous treatment with exemestane or mTOR inhibitors.', ' Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).', ' Radiotherapy within four weeks prior to randomization', ' Currently receiving hormone replacement therapy,', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.', ' Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of 1 new lytic lesions in bone; the appearance of new lesions outside of bone and unequivocal progression of existing bone lesions.', ' 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 19 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Exemestane', ' Arm/Group Description: Everolimus 10 mg daily in combination with exemestane 25 mg daily', ' Overall Number of Participants Analyzed: 485', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.93 (6.44 to 8.05)', 'Results 2: ', ' Arm/Group Title: Placebo + Exemestane', ' Arm/Group Description: Placebo of everolimus in combination with exemestane 25 mg daily', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.83 (2.76 to 4.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 158/482 (32.78%)', ' Anaemia 7/482 (1.45%)', ' Disseminated intravascular coagulation 1/482 (0.21%)', ' Lymphadenopathy 0/482 (0.00%)', ' Neutropenia 0/482 (0.00%)', ' Thrombocytopenia 2/482 (0.41%)', ' Anaemia 28/482 (1.66%)', ' Disseminated intravascular coagulation 21/482 (0.21%)', ' Febrile neutropenia 21/482 (0.21%)', ' Lymphadenopathy 20/482 (0.00%)', ' Neutropenia 20/482 (0.00%)', 'Adverse Events 2:', ' Total: 37/238 (15.55%)', ' Anaemia 2/238 (0.84%)', ' Disseminated intravascular coagulation 0/238 (0.00%)', ' Lymphadenopathy 1/238 (0.42%)', ' Neutropenia 1/238 (0.42%)', ' Thrombocytopenia 0/238 (0.00%)', ' Anaemia 22/238 (0.84%)', ' Disseminated intravascular coagulation 20/238 (0.00%)', ' Febrile neutropenia 21/238 (0.42%)', ' Lymphadenopathy 21/238 (0.42%)', ' Neutropenia 21/238 (0.42%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c77c8e02-7abb-4b63-8917-01babe5cd372
|
|
Single
|
Intervention
|
NCT00911898
|
the primary trial does not explain its intervention in the intervention section.
|
Entailment
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00911898', 'Intervention': ['INTERVENTION 1: ', ' MM-111', 'All participants'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed advanced cancer that is:', ' HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation', ' Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory', ' Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining', " Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.", ' Patients must be >= 18 years of age', ' Patients or their legal representatives must be able to understand and sign an informed consent', ' Patients may have measurable or non-measurable tumor(s)', ' Patients should have ECOG Performance Score (PS) 0 or 1', ' Patients must have adequate bone marrow reserves as evidenced by:', ' Absolute neutrophil count (ANC) >= 1,500/uL and', ' Platelet count >= 100,000/uL', ' Hemoglobin >= 9 g/dL', ' Patients must have tumor tissue amenable to biopsy', ' Patients must be willing to undergo biopsy prior to treatment to MM-111', 'Exclusion Criteria:', ' Patients for whom potentially curative antineoplastic therapy is available', ' Patients who are pregnant or lactating', ' Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)', ' Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial', ' Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)', ' Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD) or Maximum Feasible Dose', ' The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.', ' Time frame: 28 days', 'Results 1: ', ' Arm/Group Title: MM-111', ' Arm/Group Description: All participants', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: mg/kg NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/20 (15.00%)', ' Disease Progression1/20 (5.00%)', ' Acute viral myocarditis1/20 (5.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f2b14720-6ff2-4ff7-a5bc-3841b93f647e
|
|
Comparison
|
Eligibility
|
NCT00568022
|
NCT01120184
|
Completely disabled patients below the age of 20, totally confined to bed or chair and unable to carry on any selfcare are eligible for the primary trial but excluded from the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4
] |
[
0,
5
] |
{'Clinical Trial ID': 'NCT00568022', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.', 'INTERVENTION 2: ', ' Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Women 20 years', ' Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast', 'Exclusion Criteria:', ' Number of prior chemotherapy lines of treatment in the metastatic setting 3'], 'Results': ['Outcome Measurement: ', ' Participants Experiencing Dose Limiting Toxicity (DLT)', ' DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.', ' Time frame: From initiation of drug through last day of Cycle 2 (Day 42)', 'Results 1: ', ' Arm/Group Title: Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Arm/Group Description: Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day', ' Arm/Group Description: Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' NEUTROPENIA 0/3 (0.00%)', ' SKIN INFECTION 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' NEUTROPENIA 0/3 (0.00%)', ' SKIN INFECTION 1/3 (33.33%)']}
|
{'Clinical Trial ID': 'NCT01120184', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Taxane', " Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.", 'INTERVENTION 2: ', ' Trastuzumab Emtansine + Placebo', ' Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.'], 'Eligibility': ['Inclusion Criteria:', ' Adult participants >/=18 years of age', ' HER2-positive breast cancer', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.', ' Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1', ' Adequate organ function as determined by laboratory results', 'Exclusion Criteria:', ' History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease', ' An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis', ' Hormone therapy <7 days prior to randomization', ' Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization', ' Prior trastuzumab emtansine or pertuzumab therapy'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment', ' Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to ( ) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.', ' Time frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Taxane', " Arm/Group Description: Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.", ' Overall Number of Participants Analyzed: 365', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.3', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine + Placebo', ' Arm/Group Description: Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 367', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 81/353 (22.95%)', ' Febrile neutropenia * 13/353 (3.68%)', ' Anaemia * 21/353 (0.28%)', ' Neutropenia * 25/353 (1.42%)', ' Thrombocytopenia * 20/353 (0.00%)', ' Hypercoagulation * 21/353 (0.28%)', ' Leukopenia * 21/353 (0.28%)', ' Atrial fibrillation * 1/353 (0.28%)', ' Cardiac failure * 0/353 (0.00%)', ' Cardiac failure congestive * 0/353 (0.00%)', ' Myocardial infarction * 1/353 (0.28%)', 'Adverse Events 2:', ' Total: 86/361 (23.82%)', ' Febrile neutropenia * 0/361 (0.00%)', ' Anaemia * 25/361 (1.39%)', ' Neutropenia * 20/361 (0.00%)', ' Thrombocytopenia * 22/361 (0.55%)', ' Hypercoagulation * 20/361 (0.00%)', ' Leukopenia * 20/361 (0.00%)', ' Atrial fibrillation * 0/361 (0.00%)', ' Cardiac failure * 0/361 (0.00%)', ' Cardiac failure congestive * 0/361 (0.00%)', ' Myocardial infarction * 0/361 (0.00%)']}
|
03e9368b-18a7-4643-a38b-a7b002403bf1
|
Single
|
Results
|
NCT00422903
|
Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee was highest in cohort 2.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT00422903', 'Intervention': ['INTERVENTION 1: ', ' Letrozole + Placebo', ' Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.', 'INTERVENTION 2: ', ' Letrozole + Lapatinib', ' Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed infiltrating primary breast cancer of 2.0 cm or more in largest clinical diameter', ' ER and/or PgR positive cancer (> 10% of positive cancer cell assessed by IHC)', ' Postmenopausal status, defined by at least one of the following:', ' 60 years of age < 60 years of age and amenorrheic for 12 months prior to day 1 < 60 years of age and amenorrheic for < 12 months prior to day, or without a uterus: luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months', ' HER2 negative tumors (IHC 0-2+, or FISH negative)', ' Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment', ' Age over 18 years', ' ECOG PS 0-1', ' Normal organ and marrow function as defined below:', ' leukocytes > 3000/mL absolute neutrophil count > 1,500/mL platelets > 100,000/mL total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT)< 2.5 X institutional upper limit of normal Creatinine within normal institutional limits', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan.', ' 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.', ' A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided', ' Ability to understand and the willingness to sign a written informed consent document.', ' Ability to swallow and retain oral medication.', 'Exclusion criteria:', ' Stage IIIB, IIIC, and inflammatory breast cancer', ' Stage IV breast cancer', ' Contraindication to the treatment with letrozole', ' Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies', ' Treatment with any other investigational agents, or with all herbal (alternative) medicines', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib', ' Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' HIV-positive patients receiving combination anti-retroviral therapy', " 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 (See section 3.7.4.2 Other concomitant treatments)'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee', ' cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.', ' Time frame: From Baseline (Day 1) up to 6 months, evaluated every 12 weeks', 'Results 1: ', ' Arm/Group Title: Letrozole + Placebo', ' Arm/Group Description: Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: percentage of participants CR: 2', 'PR: 58', 'Results 2: ', ' Arm/Group Title: Letrozole + Lapatinib', ' Arm/Group Description: Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants CR: 12', 'PR: 54'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/49 (2.04%)', ' Myocardial infarction 1/49 (2.04%)', ' Cardiac failure 0/49 (0.00%)', ' Sphincter of Oddi dysfunction 0/49 (0.00%)', ' Overdose 0/49 (0.00%)', ' Spinal cord compression 0/49 (0.00%)', 'Adverse Events 2:', ' Total: 3/43 (6.98%)', ' Myocardial infarction 0/43 (0.00%)', ' Cardiac failure 1/43 (2.33%)', ' Sphincter of Oddi dysfunction 1/43 (2.33%)', ' Overdose 1/43 (2.33%)', ' Spinal cord compression 1/43 (2.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c5dbd52d-01d4-4919-bfe9-2b7885490d6a
|
|
Comparison
|
Eligibility
|
NCT00630032
|
NCT00428922
|
Patients with radiologically confirmed bone metatases are excluded from both the secondary trial and the primary trial.
|
Contradiction
|
[
13,
14
] |
[
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00630032', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel', ' 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)', ' Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks', 'INTERVENTION 2: ', ' Ixabepilone', ' 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);', ' Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', 'Inclusion criteria:', ' Histologically proven invasive unilateral breast cancer (regardless of the type)', ' Initial clinical condition compatible with complete initial resection', ' No residual macro or microscopic tumor after surgical excision', ' Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :', ' Stage II or III disease', ' pT >20 mm (T1-4)', ' Patients must meet 1 of the following hormone-receptor criteria:', ' Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)', ' Node-negative patients: triple-negative* tumor only', ' NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative', ' Must be able to begin chemotherapy no later than day 49 after the initial surgery', 'Exclusion criteria:', ' Clinically or radiologically detectable metastases (M0)', ' Bilateral breast cancer or contralateral ductal carcinoma in situ', ' Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type', ' Any tumor T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)', ' HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive', ' Any clinically or radiologically suspect and non-explored damage to the contralateral breast', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Female', ' Pre- or postmenopausal', ' ECOG performance status 0-1', ' Peripheral neuropathy grade 1', ' Neutrophil count 2,000/mm³', ' Platelet count 100,000/mm³', ' Hemoglobin >9 g/dL', ' AST and ALT 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN', ' Total bilirubin 1.0 times ULN', ' Serum creatinine 1.5 times ULN', ' LVEF 50% by MUGA scan or echocardiography', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment', 'Exclusion criteria:', ' Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer', ' Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study', ' Clinically significant cardiovascular disease within the past 6 months including any of the following:', ' Unstable angina', ' Congestive heart failure', ' Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)', ' Myocardial infarction', ' Cerebral vascular accidents', ' Known prior severe hypersensitivity reactions to agents containing Cremophor EL', ' Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule', ' Patients deprived of liberty or placed under the authority of a tutor', ' PRIOR CONCURRENT THERAPY:', ' At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered', ' At least 3 weeks since prior major surgery and adequately recovered', ' No prior chemotherapy, hormonal therapy, or radiotherapy', ' More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:', ' Amiodarone', ' Clarithromycin', ' Amprenavir', ' Delavirdine', ' Voriconazole', ' Erythromycin', ' Fluconazole', ' Itraconazole', ' Ketoconazole', ' Indinavir', ' Nelfinavir', ' Ritonavir', ' Saquinavir', ' No concurrent participation in another therapeutic trial involving an experimental drug'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease-free Survival (DFS)', ' DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first', ' Time frame: At 5 years', 'Results 1: ', ' Arm/Group Title: Docetaxel', ' Arm/Group Description: 3 cycles of FEC100 (F and C, each at 500 mg/m , E 100 mg/m , every 3 weeks) followed by 3 cycles of D (100 mg/m every 3 weeks)', ' Cyclophosphamide: 500 mg/m every 3 weeks Docetaxel: 100 mg/m every 3 weeks Epirubicin hydrochloride: 100 mg/m every 3 weeks Fluorouracil: 500 mg/m every 3 weeks', ' Overall Number of Participants Analyzed: 398', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 78.97 (74.53 to 82.73)', 'Results 2: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: 3 cycles of FEC100 (F and C, each at 500 mg/m , E 100 mg/m , every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m every 3 weeks);', ' Cyclophosphamide: 500 mg/m every 3 weeks Epirubicin hydrochloride: 100 mg/m every 3 weeks Fluorouracil: 500 mg/m every 3 weeks Ixabepilone: 40 mg/m every 3 weeks', ' Overall Number of Participants Analyzed: 364', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 83.37 (79.06 to 86.87)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 207/398 (52.01%)', ' Anemia 1/398 (0.25%)', ' Aplasia bone marrow 1/398 (0.25%)', ' Febrile aplasia 1/398 (0.25%)', ' Febrile neutropenia 56/398 (14.07%)', ' Lymphocele 0/398 (0.00%)', ' Neutropenia 141/398 (35.43%)', ' Auricular fibrillation 1/398 (0.25%)', ' Non ST segment elevation acute coronary syndrome 0/398 (0.00%)', ' Tachycardia 1/398 (0.25%)', ' Ear disorder 0/398 (0.00%)', 'Adverse Events 2:', ' Total: 158/364 (43.41%)', ' Anemia 2/364 (0.55%)', ' Aplasia bone marrow 1/364 (0.27%)', ' Febrile aplasia 4/364 (1.10%)', ' Febrile neutropenia 27/364 (7.42%)', ' Lymphocele 1/364 (0.27%)', ' Neutropenia 95/364 (26.10%)', ' Auricular fibrillation 0/364 (0.00%)', ' Non ST segment elevation acute coronary syndrome 1/364 (0.27%)', ' Tachycardia 1/364 (0.27%)', ' Ear disorder 1/364 (0.27%)']}
|
{'Clinical Trial ID': 'NCT00428922', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Bevacizumab, and Docetaxel', ' Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed breast cancer with evidence of metastatic disease', ' HER2 3+ or FISH (fluorescent in situ hybridization)+', ' Age 18 years', ' No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.', ' No prior chemotherapy in the metastatic setting.', 'Exclusion Criteria:', ' CNS (central nervous system) metastases', ' Prior radiation therapy within the last 4 weeks', ' Pregnant (positive pregnancy test) or lactating women', ' Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study', ' Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.', ' The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.', ' Time frame: up to 3 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Bevacizumab, and Docetaxel', ' Arm/Group Description: Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M ]', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.3 (9.3 to 35)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)']}
|
83115abd-1c07-4ee7-8ba5-b4575be2d50f
|
Comparison
|
Intervention
|
NCT01857882
|
NCT01439945
|
the secondary trial administers Magnesium Oxide to its patients whereas the primary trial tests an education intervention.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
7,
14,
15
] |
{'Clinical Trial ID': 'NCT01857882', 'Intervention': ['INTERVENTION 1: ', ' Decision Support Workshop', ' The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.', ' Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.', ' Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities', ' Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system', ' Social worker (30 mins): values clarification exercise', ' Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience', 'INTERVENTION 2: ', ' Standard Care', ' Routine pre-consultation education'], 'Eligibility': ['Inclusion Criteria:', ' Patient age: 18 - 79 years at the time of consultation', ' In situ or invasive biopsy confirmed breast adenocarcinoma', ' Considered for immediate or delayed breast reconstruction', ' First consultation for breast reconstruction', 'Exclusion Criteria:', ' Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast', ' Completion any phase of reconstruction, or for revision reconstruction', ' Patient cannot read or write in English.', ' Cognitive impairment or uncontrolled psychiatric diagnosis'], 'Results': ['Outcome Measurement: ', ' Decision Self-efficacy Scale', ' Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.', ' The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).', ' The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.', ' Time frame: Change from baseline decision self-efficacy at 1 week after surgical consultation', 'Results 1: ', ' Arm/Group Title: Decision Support Workshop', ' Arm/Group Description: The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.', ' Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.', ' Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities', ' Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system', ' Social worker (30 mins): values clarification exercise', ' Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 5.7 (12.8)', 'Results 2: ', ' Arm/Group Title: Standard Care', ' Arm/Group Description: Routine pre-consultation education', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 5.1 (9.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
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{'Clinical Trial ID': 'NCT01439945', 'Intervention': ['INTERVENTION 1: ', ' Low Dose Magnesium Oxide (800 mg/Day)', ' Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', 'INTERVENTION 2: ', ' High Dose Magnesium Oxide (1200 mg/Day)', ' Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Women with a history of breast cancer (currently without malignant disease)', ' Bothersome hot flashes (defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)', ' Presence of hot flashes for 30 days prior to study registration', ' Willingness to provide the biologic specimens as required by the protocol', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Women who are postmenopausal as defined by absence of a period in the past 12 months or bilateral oophorectomy', ' Women with at least one ovary but without a uterus should be deemed postmenopausal by either age over 55 or a combination of estrogen within a postmenopausal range (per local lab) and FSH over 40 mIU/mL', ' No women of childbearing potential or who are premenopausal', ' Creatinine clearance > 30 mL/min', ' Ability to complete questionnaire(s) by themselves or with assistance', ' ECOG performance status 0 or 1', ' No history of allergic or other adverse reaction to magnesium', ' No diabetes', ' No patients with conditions that are implicated in decreased absorption of magnesium (e.g., Crohn disease, ETOH abuse)', ' No patients who have diarrhea where magnesium might make it worse (per provider discretion)', ' PRIOR CONCURRENT THERAPY:', ' None of the following current ( 28 days prior to registration) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for 28 days and must not be expected to stop the medication during the study period):', ' Antineoplastic chemotherapy (trastuzumab or lapatinib are allowed)', ' Androgens', ' Estrogens (any delivery route)', ' Progestational agents', ' No prior use of magnesium for hot flashes', ' No current or planned use of gabapentin (for any reasons) or antidepressants (for any reasons) or other agents for treating hot flashes (except stable dose of vitamin E is allowed as long as it was started > 30 days prior to study registration and are to be continued through the study period; soy is allowed, if it is planned to be continued at the same dose during the study period)', ' No current use of magnesium for any indication (except one standard multiple vitamin dose is allowed per day)', ' Not taking diuretics, corticosteroids, bile acid sequestrants, and other prescription and over-the-counter medications that may affect magnesium levels', ' No current ( 7 days prior to registration) or planned use of other non-drug therapies for managing hot flashes, such as acupuncture or yoga (use of these therapies for other reasons is allowed)'], 'Results': ['Outcome Measurement: ', ' The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.', ' The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.', ' The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.', ' The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group.', ' Time frame: Baseline to Week 8', 'Results 1: ', ' Arm/Group Title: Low Dose Magnesium Oxide (800 mg/Day)', ' Arm/Group Description: Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Overall Number of Participants Analyzed: 88', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 81 participants', ' 16.02 (9.62)', ' Week 1: 81 participants', ' 14.28 (9.26)', ' Week 2: 79 participants', ' 12.68 (8.87)', ' Week 3: 78 participants', ' 12.29 (9.79)', ' Week 4: 78 participants', ' 11.73 (10.35)', ' Week 5: 75 participants', ' 11.77 (10.86)', ' Week 6: 71 participants', ' 11.61 (10.46)', ' Week 7: 71 participants', ' 11.92 (11.26)', ' Week 8: 69 participants', ' 12.17 (10.88)', 'Results 2: ', ' Arm/Group Title: High Dose Magnesium Oxide (1200 mg/Day)', ' Arm/Group Description: Week 2:', ' Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Week 3:', ' Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Weeks 4-9:', ' Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).', ' Overall Number of Participants Analyzed: 88', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 81 participants', ' 15.35 (10.53)', ' Week 1: 78 participants', ' 14.47 (11.10)', ' Week 2: 78 participants', ' 12.59 (10.01)', ' Week 3: 76 participants', ' 11.32 (10.72)', ' Week 4: 73 participants', ' 10.14 (8.61)', ' Week 5: 67 participants', ' 9.73 (9.19)', ' Week 6: 67 participants', ' 9.44 (8.99)', ' Week 7: 67 participants', ' 9.37 (9.24)', ' Week 8: 66 participants', ' 9.06 (8.87)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/92 (0.00%)', ' Diarrhea 0/92 (0.00%)', 'Adverse Events 2:', ' Total: 1/93 (1.08%)', ' Diarrhea 1/93 (1.08%)']}
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784872db-8ccf-4ddc-a432-6ee00fd0b0cc
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