Datasets:

tasksource

/

nli4ct

like 1

Comparison

Results

NCT01855828

NCT00696072

the secondary trial uses Overall Survival (OS) as outcome measurement, which is different from Proportion of Participants With a Pathologic Complete Response Rate which is used for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01855828', 'Intervention': ['INTERVENTION 1: ', ' Chemo Plus Pertuzumab,Trastuzumab', ' During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).', ' Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)', ' Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).', ' For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).', ' Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).', ' 5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).', ' Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).', ' Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).'], 'Eligibility': ['Inclusion Criteria:', ' - Patients with histologically confirmed stage I-III, HER2-positive invasive breast cancer for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment following NCCN practice guidelines.', ' HER2 overexpression or amplification will be based on local test results and is defined as either:', ' (i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to chromosome 17 signals) of greater than or equal to 2.0.', ' Patients with synchronous bilateral breast cancers are eligible if at least one of the tumors is HER2-positive.', " Left Ventricular Ejection Fraction (LVEF) greater or equal to 50% at baseline as determined by either ECHO or MUGA, or within the institution's normal limits.", ' Women of childbearing potential must have a negative pregnancy test (serum or urine beta HCG) prior to initiation of chemotherapy. Both female and male breast cancer patients who are sexually active have to agree to practice contraception while participating in the trial and for 3 month after completion of therapy.', ' Adequate bone marrow function as indicated by the following:', ' ANC greater than or equal to 1500/uL', ' Platelets greater than or equal to 100,000/uL', ' Hemoglobin greater than or equal to 10 g/dL', ' Adequate renal function, as indicated by creatinine less than or equal to 1.5 times upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin less than or equal to 1.5 X ULN and AST or ALT less than or equal to 2x ULN.', ' Signed informed consent.', 'Exclusion Criteria:', ' Patients will be excluded from the study based on any of the following criteria:', ' Patients who underwent partial excisional biopsy, lumpectomy, segmental mastectomy, modified radical mastectomy or sentinel node biopsy and, therefore cannot be assessed for pathologic response accurately.', ' Patients who are high risk for developing the following anthracycline, paclitaxel, trastuzumab or pertuzumab related toxicities including:', ' History of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled hypertension despite adequate medications Pre-existing peripheral neuropathy > grade 3 Prior anthracycline therapy Known hypersensitivity to any of the study medications Patients older than age 65 due to increased risk of cardiotoxicity', ' Active infection requiring systemic antibiotic therapy.', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Proportion of Participants With a Pathologic Complete Response Rate', ' To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.', ' Time frame: 20 weeks', 'Results 1: ', ' Arm/Group Title: Chemo Plus Pertuzumab,Trastuzumab', ' Arm/Group Description: During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).', ' Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)', ' Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).', ' For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).', ' Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).', ' 5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).', ' Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).', ' Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: proportion of participants HR Positive: 23 participants', ' .26 (.13 to .46)', ' HR Negative: 25 participants', ' .80 (.60 to .91)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/50 (12.00%)', ' Ventricular tachycardia 1/50 (2.00%)', ' Fever [1]1/50 (2.00%)', ' Flu like symptoms 1/50 (2.00%)', ' Catheter related infection 2/50 (4.00%)', ' Suicidal ideation * [2]1/50 (2.00%)', ' Thromboembolic event 1/50 (2.00%)']}

{'Clinical Trial ID': 'NCT00696072', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib Plus Letrozole', ' Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years', ' Dasatinib 100 mg + Letrozole 2.5 mg', ' Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days', 'INTERVENTION 2: ', ' Letrozole', ' Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years', ' Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days'], 'Eligibility': ['For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.', 'Inclusion Criteria:', ' Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease', ' Has measurable or evaluable-only disease', ' Is female, 18 yrs of age, post menopausal or surgically sterile', ' HER2 negative, HR+, ER+ and/or PgR+ breast cancer', ' 0-1 prior chemotherapy regimen for metastatic disease.', ' Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior', ' Prior tamoxifen therapy is allowed', ' No AI therapy for >1 year without recurrence', 'Exclusion Criteria:', ' Pregnant or breast feeding', ' Prior hormonal therapy for metastatic or locally recurrent disease', ' >1 chemotherapy regimen for metastatic disease', ' Pleural or pericardial effusion', ' Serious cardiac condition'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population', ' CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.', ' Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)', 'Results 1: ', ' Arm/Group Title: Dasatinib Plus Letrozole', ' Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years', ' Dasatinib 100 mg + Letrozole 2.5 mg', ' Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: participants CBR (CR+PR+SD): 40', ' CBR, DFI <= 2 Years: 20', 'CBR, DFI > 2 Years: 20', 'Results 2: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years', ' Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants CBR (CR+PR+SD): 40', ' CBR, DFI <= 2 Years: 20', 'CBR, DFI > 2 Years: 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/57 (24.56%)', ' Anemia * 0/57 (0.00%)', ' CVA * 2/57 (3.51%)', ' Cardiac Insufficiency * 0/57 (0.00%)', ' Congestive Heart Failure * 0/57 (0.00%)', ' Coronary Insufficiency * 1/57 (1.75%)', ' Effusion Pericardial * 0/57 (0.00%)', ' Cholelithiasis * 1/57 (1.75%)', ' Colitis * 0/57 (0.00%)', ' Dehydration * 1/57 (1.75%)', ' Diverticulitis * 0/57 (0.00%)', ' Nausea * 2/57 (3.51%)', 'Adverse Events 2:', ' Total: 2/63 (3.17%)', ' Anemia * 1/63 (1.59%)', ' CVA * 0/63 (0.00%)', ' Cardiac Insufficiency * 1/63 (1.59%)', ' Congestive Heart Failure * 1/63 (1.59%)', ' Coronary Insufficiency * 0/63 (0.00%)', ' Effusion Pericardial * 1/63 (1.59%)', ' Cholelithiasis * 0/63 (0.00%)', ' Colitis * 1/63 (1.59%)', ' Dehydration * 1/63 (1.59%)', ' Diverticulitis * 1/63 (1.59%)', ' Nausea * 0/63 (0.00%)']}

6214280f-f665-48d3-b33f-9d798deff71f

Single

Results

NCT00089999

In total more participants in the primary trial had no tumor Response, than partial response, and 0 participants had a complete response.

Entailment

{'Clinical Trial ID': 'NCT00089999', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib 1500 mg QD', ' Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.', 'INTERVENTION 2: ', ' Lapatinib 500 mg BID', ' Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.', ' Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)', ' Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)', ' Adequate renal, hepatic and cardiac function', 'Exclusion criteria:', ' Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.', ' Patients with active brain metastases', ' Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)', ' OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.', ' Time frame: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)', 'Results 1: ', ' Arm/Group Title: Lapatinib 1500 mg QD', ' Arm/Group Description: Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: Participants CR: 0', 'PR: 15', 'Results 2: ', ' Arm/Group Title: Lapatinib 500 mg BID', ' Arm/Group Description: Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: Participants CR: 0', 'PR: 18'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/69 (21.74%)', ' Anaemia 0/69 (0.00%)', ' Febrile neutropenia 1/69 (1.45%)', ' Thrombocytopenia 0/69 (0.00%)', ' Left ventricular dysfunction 0/69 (0.00%)', ' Pericardial effusion 1/69 (1.45%)', ' Diarrhoea 1/69 (1.45%)', ' Constipation 0/69 (0.00%)', ' Gastritis 1/69 (1.45%)', ' Oesophagitis 1/69 (1.45%)', ' Vomiting 1/69 (1.45%)', ' Asthenia 0/69 (0.00%)', ' Pyrexia 0/69 (0.00%)', 'Adverse Events 2:', ' Total: 18/69 (26.09%)', ' Anaemia 1/69 (1.45%)', ' Febrile neutropenia 0/69 (0.00%)', ' Thrombocytopenia 1/69 (1.45%)', ' Left ventricular dysfunction 1/69 (1.45%)', ' Pericardial effusion 0/69 (0.00%)', ' Diarrhoea 1/69 (1.45%)', ' Constipation 1/69 (1.45%)', ' Gastritis 0/69 (0.00%)', ' Oesophagitis 0/69 (0.00%)', ' Vomiting 0/69 (0.00%)', ' Asthenia 2/69 (2.90%)', ' Pyrexia 1/69 (1.45%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

108b54a9-b5cc-4f31-956f-e4e2e653d756

Comparison

Results

NCT00723125

NCT00617942

57% of patients in cohort 1 of the primary trial had Pathological Complete Response Rates at Surgery, compared to 60% in cohort 1 of the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00723125', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1', ' Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)', 'INTERVENTION 2: ', ' Cohort 2', ' Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)'], 'Eligibility': ['Eligibility criteria', 'Inclusion criteria:', ' Histologically documented adenocarcinoma of the breast', ' ANC > 1000 cells', ' Female; age > 18', ' Zubrod PS 0-1', ' Platelets > 100,000', ' Stage IIA-IIIB disease', ' Total bilirubin < 1.5 ULN', ' No evidence of any metastatic disease', ' Serum Creatinine < 1.5 gm/dl', ' No prior systemic therapy for breast cancer or Creat Cl > 30 ml/min', ' Not pregnant or lactating', ' Serum ALT < 2.0 ULN', ' ER, PR and HER2 status required', ' LVEF (MUGA/echo WNL)', ' No baseline > 2 neuropathy', ' Urine protein: creat ratio < 1.0', ' HER2-negative - either IHC 0-1+ or FISH ratio < 2.0', ' Hemoglobin > 9 gm/dl', ' (FISH testing is required for all HER2 2-3+ tumors by IHC)', 'Exclusion criteria:', ' No Histologically documented adenocarcinoma of the breast', ' No-ANC > 1000 cells', ' Female; age < 18', ' Zubrod PS > 0-1', ' Platelets < 100,000', ' Stage IV disease', ' Total bilirubin > 1.5 ULN', ' metastatic disease', ' Serum Creatinine > 1.5 gm/dl', ' prior systemic therapy for breast cancer or Creat Cl > 30 ml/min', ' pregnant or lactating', ' Serum ALT > 2.0 ULN baseline > 2 neuropathy', ' Urine protein: creat ratio >1.0', ' HER2-positive', ' Hemoglobin < 9 gm/dl'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response Rates at Surgery', ' [Not Specified]', ' Time frame: at surgery approximately 5 months after initial treatment', 'Results 1: ', ' Arm/Group Title: Cohort 1', ' Arm/Group Description: Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants 16', 'Results 2: ', ' Arm/Group Title: Cohort 2', ' Arm/Group Description: Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/28 (17.86%)', ' gr 3 Nausea, gr 3 vomiting 1/28 (3.57%)', ' gr 3 nausea, gr 2 infection with noraml ANC, gr 2 HGB, gr 1 glucose 1/28 (3.57%)', ' gr 2 non-cardiac chest pain, gr 2 anemia 1/28 (3.57%)', ' gr 3 infection (normal ANC) (cellulitis & pain in buttock - RT infection), gr 1 epistaxis 1/28 (3.57%)', 'Adverse Events 2:', ' Total: 8/27 (29.63%)', ' gr 3 Nausea, gr 3 vomiting 0/27 (0.00%)', ' gr 3 nausea, gr 2 infection with noraml ANC, gr 2 HGB, gr 1 glucose 0/27 (0.00%)', ' gr 2 non-cardiac chest pain, gr 2 anemia 0/27 (0.00%)', ' gr 3 infection (normal ANC) (cellulitis & pain in buttock - RT infection), gr 1 epistaxis 0/27 (0.00%)']}

{'Clinical Trial ID': 'NCT00617942', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1', '[Not Specified]', 'INTERVENTION 2: ', ' Cohort 2', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented adenocarcinoma of the breast', ' ANC > 1000 cells', ' Female; age > 18; Zubrod PS 0-1', ' Platelets > 100,000', ' Stage IIA-IIIB disease', ' Total bilirubin < or = ULN', ' No evidence of metastatic disease Not pregnant or lactating', ' No prior systemic therapy for this breast cancer', ' Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min', ' Serum ALT < 2.5 x ULN', ' ER, PR and HER2 status required', ' LVEF (MUGA/echo)WNL', ' No baseline > 2 neuropathy', ' Hemoglobin > 9.0 gm/dl', ' HER2+, defined by IHC 3+ or FISH ratio > 2.0'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;', ' These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Cohort 1', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: participants 12', 'Results 2: ', ' Arm/Group Title: Cohort 2', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/37 (18.92%)', ' gr 3port infection, 1/37 (2.70%)', ' flu 1/37 (2.70%)', ' Febrile Neutropenia 1/37 (2.70%)', ' gr 4 sepsis, intubated [1]1/37 (2.70%)', ' Diarrhea gr 2, Nausea gr 3, infection gr 3 1/37 (2.70%)', ' infection normal ANC/viral grade 1 1/37 (2.70%)', ' Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 1/37 (2.70%)', ' gr 3cellulitis - breast 1/37 (2.70%)', 'Adverse Events 2:', ' Total: 8/23 (34.78%)', ' gr 3port infection, 0/23 (0.00%)', ' flu 0/23 (0.00%)', ' Febrile Neutropenia 0/23 (0.00%)', ' gr 4 sepsis, intubated [1]0/23 (0.00%)', ' Diarrhea gr 2, Nausea gr 3, infection gr 3 0/23 (0.00%)', ' infection normal ANC/viral grade 1 0/23 (0.00%)', ' Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 0/23 (0.00%)', ' gr 3cellulitis - breast 0/23 (0.00%)']}

662f4992-0155-4a82-926f-b1821539aab7

Comparison

Adverse Events

NCT01091454

NCT00054275

There were more cases of Anemia and Leukopenia in the primary trial than the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01091454', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Cisplatin and Brostallicin)', ' Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria', ' Histologically or cytologically confirmed adenocarcinoma of the breast with clinical evidence of metastatic disease', ' Triple negative breast cancer defined as HER2-(according to current American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER- (defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)', ' 0 to 4 prior chemotherapy regimens in the metastatic setting', ' Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only', ' Hemoglobin >= 10.0 g/dL', ' Absolute neutrophil count (ANC) >= 1500/mm^3', ' Platelet count >= 100,000/mL', ' Total bilirubin =< 1.5 x upper limit of normal (ULN)', ' Serum creatinine =< 1.5 mg/dL', ' Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases', ' Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are due to liver metastases', ' Electrocardiogram (EKG) completed =< 15 days prior to registration', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2', ' Life expectancy > 3 months', ' Has written informed consent', ' Willingness to return to NCCTG enrolling institution for treatment and follow-up', ' Patient willing to provide blood samples for research purposes', ' Exclusion Criteria', ' HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified) breast cancer by ASCO/CAP guidelines', ' Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as > 1% of either receptor by IHC)', ' Any of the following', ' Pregnant women', ' Nursing women', ' Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs', ' Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration', ' Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the CTCAE)', ' Major surgery =< 4 weeks prior to registration', ' Chemotherapy or immunologic therapy =< 3 weeks prior to registration', ' Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only', ' * NOTES:', ' Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed', ' If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 2 weeks', ' Acute adverse events from radiation must have resolved to =< grade 1 (according to the CTEP active version of the CTCAE)', ' Evidence of active brain metastasis including leptomeningeal involvement', ' * NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed; to be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued', ' History of allergy or hypersensitivity to the drugs used in this study (or their excipients) including platinum compounds (cisplatin, carboplatin)', ' Active, unresolved infection', ' Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations or co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or would interfere significantly with the proper assessment of safety of the prescribed regimens or would limit compliance with study requirements or would make it undesirable for patient to participate in the trial', ' Clinically significant cardiovascular or cerebrovascular disease, including any history of the following =< 6 months prior to registration:', ' Myocardial infarction', ' Unstable angina', ' New York Heart Association (NYHA) class II or greater congestive heart failure', ' Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' * NOTE: Patient may not enroll in such clinical trials while participating in this study; exception may be granted for trials related to symptom management (cancer control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial', ' Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD)4 count within institutional normal range and no history of an AIDS-defining illness are eligible'], 'Results': ['Outcome Measurement: ', ' 3-month Progression-free Survival (3-mo PFS) Rate', ' A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Treatment (Cisplatin and Brostallicin)', ' Arm/Group Description: Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.511 (0.386 to 0.676)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/48 (60.42%)', ' Anemia 4/48 (8.33%)', ' Febrile neutropenia 7/48 (14.58%)', ' Atrial fibrillation 1/48 (2.08%)', ' Pericardial effusion 1/48 (2.08%)', ' Sinus bradycardia 1/48 (2.08%)', ' Nausea 2/48 (4.17%)', ' Vomiting 2/48 (4.17%)', ' Death NOS 1/48 (2.08%)', ' Fatigue 3/48 (6.25%)', ' Allergic reaction 1/48 (2.08%)', ' Lung infection 1/48 (2.08%)', ' Mucosal infection 1/48 (2.08%)']}

{'Clinical Trial ID': 'NCT00054275', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and OSI-774', ' docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed stage IV or recurrent adenocarcinoma of the breast', ' Measurable disease', ' Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel', ' Stable brain metastases allowed', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Male or female', ' Menopausal status', ' Not specified', ' Performance status', ' ECOG (Eastern Cooperative Oncology Group) 0-2 OR', ' Karnofsky 60-100%', ' Life expectancy', ' More than 6 months', ' Hematopoietic', ' WBC(White Blood Count) at least 3,000/mm^3', ' Platelet count at least 100,000/mm^3', ' Absolute neutrophil count at least 1,500/mm^3', ' Hemoglobin at least 8 g/dL', ' Hepatic', ' Bilirubin normal', ' AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal', ' Renal', ' Creatinine normal OR', ' Creatinine clearance at least 60 mL/min', ' No clinically significant proteinuria', ' No significant impairment of renal function', ' Cardiovascular', ' No New York Heart Association class III or IV heart disease', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' No inadequately controlled hypertension', ' Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception', ' No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80', ' No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer', ' No ongoing or active infection', ' No peripheral neuropathy greater than grade 1', ' No other concurrent uncontrolled medical condition that would preclude study participation', ' No psychiatric illness or social situation that would preclude study compliance', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Prior trastuzumab (Herceptin) allowed', ' Chemotherapy', ' See Disease Characteristics', ' No prior chemotherapy for recurrent or metastatic disease', ' Prior adjuvant chemotherapy allowed', ' Endocrine therapy', ' Prior hormonal therapy allowed', ' Radiotherapy', ' Not specified', ' Surgery', ' Not specified', ' Other', ' No other concurrent investigational agents'], 'Results': ['Outcome Measurement: ', ' Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000', ' Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.', ' Time frame: after 6 course (6 months) of combination therapy', 'Results 1: ', ' Arm/Group Title: Docetaxel and OSI-774', ' Arm/Group Description: docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants Partial response: 11', ' Disease progression: 14', 'Stable disease: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/39 (71.79%)', ' Anemia 1/39 (2.56%)', ' Leukopenia 4/39 (10.26%)', ' Neutropenia 4/39 (10.26%)', ' Chest Pain 1/39 (2.56%)', ' Pericarditis 1/39 (2.56%)', ' Sinus Tach. 1/39 (2.56%)', ' Sinus Tachycardia 1/39 (2.56%)', ' Eye tearing 1/39 (2.56%)', ' Diarrhea 7/39 (17.95%)', ' Mucositis 3/39 (7.69%)', ' Nausea 2/39 (5.13%)', ' Vomiting [1]1/39 (2.56%)', ' Fatigue 6/39 (15.38%)']}

398f744b-97cf-4f95-b162-99ec6652d327

Single

Intervention

NCT00632489

the primary trial uses a set dosage of 1000 mg PO daily of Lapatinib, whereas the dose of Capecitabine changes with Body surface area.

Entailment

{'Clinical Trial ID': 'NCT00632489', 'Intervention': ['INTERVENTION 1: ', ' LBH589 With Capecitabine', ' MTD, LBH589 with Capecitabine', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.', 'INTERVENTION 2: ', ' LBH589 and Lapatinib', ' LBH589 and Lapatinib', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented metastatic or locally unresectable, incurable malignancy for which capecitabine is clinically appropriate.', ' Male or female patients aged 18 years old.', ' Maximum of 3 prior regimens in a metastatic setting allowed and may include other targeted agents, immunotherapy and chemotherapy.', ' Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.', ' Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.', ' Baseline MUGA or ECHO must demonstrate LVEF > than the lower limits of the institutional normal.', ' Laboratory values as follows:', ' ANC > 1500/μL', ' Hgb > 9 g/dL', ' Platelets > 100,000/uL', ' Bilirubin < 1.5 mg/dL', ' AST/SGOT < 2.5 x ULN or < 5.0 x ULN and ALT/SGPT in patients with liver metastases', ' Creatinine < 1.5 mg/dL or calculated creatinine clearance > 50 ml/min', ' Albumin > 3 g/dL', ' Potassium > lower limit of normal (LLN)', ' Phosphorous > LLN', ' Calcium > LLN', ' Magnesium > LLN', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment and must commit to begin two acceptable methods of birth control, one highly effective method of birth control and one additional effective method at the same time before starting treatment.', ' Life expectancy > 12 weeks.', ' Accessible for treatment and follow-up.', ' All patients must be able to understand the nature of the study and give written informed consent prior to study entry.', ' Additional Breast Cancer Patient Subset (Part 2 and Part 3) Inclusion Criteria:', ' Incurable carcinoma of the breast, with measurable locally recurrent or metastatic disease.', ' ICH 3+ overexpression or FISH amplification documented by a local laboratory in primary or metastatic tumor tissue.', ' Prior treatment with an anthracycline, taxane, and trastuzumab or not a candidate for such treatment. Patient may have received these drugs in combination or in sequence for the treatment of locally advanced or metastatic disease and/or adjuvant therapy.', 'Exclusion Criteria:', ' Prior treatment with an HDAC inhibitor or current treatment with valproic acid.', ' Previous treatment with capecitabine.', ' Impaired cardiac function including any of the following:', ' Screening ECG with a QTc > 450 msec.', ' Congenital long QT syndrome.', ' History of sustained ventricular tachycardia.', ' Any history of ventricular fibrillation or torsades de pointes.', ' Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate > 50 beats per minute are eligible.', ' Myocardial infarction or unstable angina within 6 months of study entry.', ' Congestive heart failure (NY Heart Association class III or IV).', ' Right bundle branch block and left anterior hemiblock (bifascicular block).', ' Atrial fibrillation or flutter.', ' Ongoing therapy with antiarrhythmics or other medications associated with QTc prolongation.', ' Uncorrected hypokalemia or hypomagnesaemia.', ' Uncontrolled hypertension (systolic blood pressure [BP] 180 or diastolic BP > 100 mm Hg) or uncontrolled cardiac arrhythmias.', ' Active CNS disease, including meningeal metastases.', ' Known diagnosis of human immunodeficiency virus (HIV) infection.', ' Unresolved diarrhea > CTCAE grade 1.', ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.', ' Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.', ' Patients with known hypersensitivity to 5-fluorouracil chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting study drug or patients that have not recovered from side effects of previous therapy.', ' Patient is < 5 years free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.', ' Concomitant use of any anti-cancer therapy or radiation therapy.', ' Pregnant or breast feeding or female of reproductive potential not using two effective methods of birth control.', ' Male patients whose sexual partners are women of childbearing potential not using effective birth control.', " Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).", ' Other concurrent severe, uncontrolled infection or intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Patients taking any medications listed in "Prohibited Medications" for both capecitabine and lapatinib .', ' Patients with uncontrolled coagulopathy (PT and/or PTT > 1.2 x ULN; patient must also be on stable dose of anticoagulant for a defined medical indication).', ' Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible.', ' Additional Breast Cancer Patient Subset (Part 2 and Part 3) Exclusion Criteria:', ' 1. Prior treatment with lapatinib'], 'Results': ['Outcome Measurement: ', ' To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil', ' MTD for Capecitabine, BID', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: LBH589 With Capecitabine', ' Arm/Group Description: MTD, LBH589 with Capecitabine', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: mg/m2 100', 'Results 2: ', ' Arm/Group Title: LBH589 and Lapatinib', ' Arm/Group Description: LBH589 and Lapatinib', ' LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.', ' Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: mg/m2 '], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/15 (40.00%)', ' Constipation 1/15 (6.67%)', ' General disorders and administration site conditions - Other, disease progression 2/15 (13.33%)', ' General disorders and administration site conditions - Other, failure to thrive 0/15 (0.00%)', ' Infections and infestations - Other, unspecified 1/15 (6.67%)', ' Platelet count decreased 1/15 (6.67%)', ' Dehydration 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 3/5 (60.00%)', ' Constipation 0/5 (0.00%)', ' General disorders and administration site conditions - Other, disease progression 1/5 (20.00%)', ' General disorders and administration site conditions - Other, failure to thrive 1/5 (20.00%)', ' Infections and infestations - Other, unspecified 0/5 (0.00%)', ' Platelet count decreased 0/5 (0.00%)', ' Dehydration 1/5 (20.00%)', ' Dysarthria 0/5 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

43421f19-878e-46f7-b456-8031835af649

Single

Results

NCT02260531

the percentage of participants achieving complete response (CR) or partial response (PR) was much lower in the HER2-positive group in the primary trial,than in the ER+ and/or PR+ group.

Entailment

{'Clinical Trial ID': 'NCT02260531', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1 - Cabozantinib, Trastuzumab for HER2+', ' HER2-positive', ' Cabozantinib- orally administered daily per treatment cycle', ' Trastuzumab- IV administered once per cycle', ' MRI- Baseline, Cycle 2 Day 1, and every 2 cycles', ' Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,', ' Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.', ' Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.', 'INTERVENTION 2: ', ' Cohort 2 - Cabozantinib for ER+ and/or PR+', ' Hormone receptor-positive (ER+ and/or PR+)', ' Cabozantinib- orally administered daily per treatment cycle', ' MRI- Baseline, Cycle 2 Day 1, and every 2 cycles', ' Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,', ' Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease.', " New or progressive CNS lesions, as assessed by the patient's treating physician.", ' For patients who have received prior cranial radiation, no increase in corticosteroid dose in the week prior to the baseline brain MRI', ' Discontinued prior therapy (with the exception of trastuzumab for patients with HER2+ breast cancer)', ' Recovery to baseline or Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy;', ' The subject has an ECOG performance status of 0 or 1', ' Patients must have normal organ and marrow function and laboratory values as follows within 14 days before the first dose of cabozantinib', ' Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s)', ' Subjects of childbearing potential must not be pregnant at screening.', ' Patients on bisphosphonates may continue receiving bisphosphonate therapy during study. Patients wanting to initiate bisphosphonate therapy may do so.', ' The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib', 'Exclusion Criteria:', ' The subject has received cabozantinib or another c-Met inhibitor (please note ARQ 197 is not considered a MET inhibitor for purposes of this study given data to suggest it inhibits tubulin)', ' The subject has uncontrolled, significant intercurrent or recent illness', ' Leptomeningeal disease as the only site of CNS involvement', ' Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body', ' More than 2 seizures over the last 4 weeks prior to study entry', ' Grade 1 or higher CNS hemorrhage on baseline brain MRI, or history of grade 2 or higher CNS hemorrhage within 12 months', ' Has experienced clinically-significant GI bleeding within 6 months before first dose of cabozantinib; hemoptysis of 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of cabozantinib; any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of cabozantinib', ' The subject has tumor in contact with, invading or encasing any major blood vessels', ' The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib', ' The subject requires concomitant treatment, in therapeutic doses, with anticoagulants. Low dose aspirin ( 81 mg/day), low-dose warfarin ( 1 mg/day), and prophylactic LMWH are permitted.', ' The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test 1.3 × the laboratory ULN within 7 days before the first dose of cabozantinib.', ' Inability to swallow intact tablets', ' Pregnant or lactating females', ' Diagnosis of another malignancy within 2 years before the first dose of cabozantinib, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy', ' Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible', ' The subject is known to be positive for the human immunodeficiency virus (HIV)', ' Subjects with clinically relevant ongoing complications from prior surgery are not eligible', ' QTcF > 500 msec on average of screening EKGs performed within 28 days of first dose of cabozantinib. Three EKGs must be performed at screening. If the average of these three consecutive results for QTcF is > 500 msec, the subject is ineligible.', ' Active infection requiring IV antibiotics at Day 1 of cycle 1', ' No prior lapatinib within 7 days prior to initiation of protocol treatment', ' Receive concurrent investigational agents while on study', ' Receive any concurrent chemotherapy, radiotherapy, or hormonal therapy while on study', ' Previously identified allergy or hypersensitivity to components of the cabozantinib formulations', ' The subject requires chronic concomitant treatment with strong CYP3A4 inducers'], 'Results': ['Outcome Measurement: ', ' CNS Objective Response Rate (ORR)', ' The central nervous system (CNS) ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria in the evaluation CNS lesions on treatment: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.', ' Time frame: Disease assessments occurred every 6 cycles. Patients with stable or responsive disease after completion of 6 cycles could reduce frequency of assessments to every 3 cycles. Response was evaluated up to 25 months.', 'Results 1: ', ' Arm/Group Title: Cohort 1 - Cabozantinib, Trastuzumab for HER2+', ' Arm/Group Description: HER2-positive', ' Cabozantinib- orally administered daily per treatment cycle', ' Trastuzumab- IV administered once per cycle', ' MRI- Baseline, Cycle 2 Day 1, and every 2 cycles', ' Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,', ' Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.', ' Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants 5 (.2 to 24)', 'Results 2: ', ' Arm/Group Title: Cohort 2 - Cabozantinib for ER+ and/or PR+', ' Arm/Group Description: Hormone receptor-positive (ER+ and/or PR+)', ' Cabozantinib- orally administered daily per treatment cycle', ' MRI- Baseline, Cycle 2 Day 1, and every 2 cycles', ' Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,', ' Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: percentage of participants 14 (.4 to 58)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/21 (28.57%)', ' Diarrhea 1/21 (4.76%)', ' Dyspepsia 0/21 (0.00%)', ' Mucositis oral 0/21 (0.00%)', ' Nausea 0/21 (0.00%)', ' Vomiting 1/21 (4.76%)', ' Fatigue 1/21 (4.76%)', ' Portal vein thrombosis 0/21 (0.00%)', ' Ejection fraction decreased 1/21 (4.76%)', ' Alanine aminotransferase increased 0/21 (0.00%)', ' Aspartate aminotransferase increased 0/21 (0.00%)', ' Lipase increased 3/21 (14.29%)', 'Adverse Events 2:', ' Total: 4/7 (57.14%)', ' Diarrhea 0/7 (0.00%)', ' Dyspepsia 1/7 (14.29%)', ' Mucositis oral 1/7 (14.29%)', ' Nausea 0/7 (0.00%)', ' Vomiting 0/7 (0.00%)', ' Fatigue 1/7 (14.29%)', ' Portal vein thrombosis 1/7 (14.29%)', ' Ejection fraction decreased 0/7 (0.00%)', ' Alanine aminotransferase increased 1/7 (14.29%)', ' Aspartate aminotransferase increased 2/7 (28.57%)', ' Lipase increased 0/7 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

13fa44e7-38be-48fb-a0eb-6b212549f526

Single

Results

NCT02308020

There were no participants in cohort 1 of the primary trial with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria.

Entailment

{'Clinical Trial ID': 'NCT02308020', 'Intervention': ['INTERVENTION 1: ', ' Part A Abemaciclib: HR+, HER2+ Breast Cancer', ' Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.', 'INTERVENTION 2: ', ' Part B Abemaciclib: HR+, HER2- Breast Cancer', ' Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).', ' Participants may continue to receive treatment until discontinuation criteria are met.'], 'Eligibility': ['Inclusion Criteria:', ' Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.', ' Have either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or negative HER2- (Study Part B) breast cancer.', ' Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.', ' Participants in Part D must have NSCLC of any subtype.', ' Participants in Part E must have melanoma of any subtype.', ' Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.', ' For Parts A, B, D, and E: Must have at least 1 measurable brain lesion 10 millimeters (mm) in the longest diameter (LD).', ' For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.', ' Have completed local therapy (surgical resection, whole-breast radiotherapy (WBRT), or SRS) 14 days prior to initiating abemaciclib and recovered from all acute effects.', ' If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.', ' Have a Karnofsky performance status of 70.', ' Have a life expectancy 12 weeks.', ' For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.', ' For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.', ' For NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.', ' Have adequate organ function.', 'Exclusion Criteria:', ' Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.', ' Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).', ' Have evidence of significant (ie, symptomatic) intracranial hemorrhage.', ' For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.', ' Have experienced >2 seizures within 4 weeks prior to study entry.', ' For Parts A, B, D, E, and F: Have previously received treatment with any cyclin dependent kinase 6 (CDK6) inhibitor. For Part C participants may have received prior palbociclib or ribociclib, but not abemaciclib treatment.', ' Have known contraindication to Gd-MRI.', ' Have a preexisting chronic condition resulting in persistent diarrhea.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)', ' OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to ( ) 20% increase in sum LD relative to nadir and a relative increase of 20%, 1 lesion must increase by absolute value of 5 millimeter (mm).', ' Time frame: Baseline to Objective Disease Progression (Up to 36 Months)', 'Results 1: ', ' Arm/Group Title: Part A Abemaciclib: HR+, HER2+ Breast Cancer', ' Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Part B Abemaciclib: HR+, HER2- Breast Cancer', ' Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).', ' Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 5.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/27 (22.22%)', ' Anaemia 0/27 (0.00%)', ' Thrombocytopenia 1/27 (3.70%)', ' Acute coronary syndrome 0/27 (0.00%)', ' Cardiac failure 0/27 (0.00%)', ' Myocardial infarction 0/27 (0.00%)', ' Glaucoma 0/27 (0.00%)', ' Diarrhoea 2/27 (7.41%)', ' Enterocolitis 1/27 (3.70%)', ' Haemorrhoidal haemorrhage 0/27 (0.00%)', ' Lower gastrointestinal haemorrhage 0/27 (0.00%)', ' Nausea 0/27 (0.00%)', 'Adverse Events 2:', ' Total: 16/58 (27.59%)', ' Anaemia 0/58 (0.00%)', ' Thrombocytopenia 0/58 (0.00%)', ' Acute coronary syndrome 0/58 (0.00%)', ' Cardiac failure 0/58 (0.00%)', ' Myocardial infarction 0/58 (0.00%)', ' Glaucoma 1/58 (1.72%)', ' Diarrhoea 2/58 (3.45%)', ' Enterocolitis 0/58 (0.00%)', ' Haemorrhoidal haemorrhage 0/58 (0.00%)', ' Lower gastrointestinal haemorrhage 0/58 (0.00%)', ' Nausea 0/58 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

12ae2315-cc50-43ac-a595-762c85c1ec58

Comparison

Adverse Events

NCT02536339

NCT00371345

Respiratory illnesses were observed in most of the patients in the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT02536339', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab', ' Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed HER2-positive MBC', ' Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery', ' Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment', ' Stable systemic disease', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' LVEF at least 50%', ' Adequate hematologic, renal, and hepatic function', ' Life expectancy more than 12 weeks', 'Exclusion Criteria:', ' Progression of systemic disease at Screening', ' Leptomeningeal disease', ' History of intolerance or hypersensitivity to study drug', ' Use of certain investigational therapies within 21 days prior to enrollment', ' Current anthracycline use', ' Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use', ' Active infection', ' Pregnant or lactating women', ' Significant history or risk of cardiac disease', ' Symptomatic intrinsic lung disease or lung involvement', ' History of other malignancy within the last 5 years'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response in the CNS, Assessed Using Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria', ' Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. An objective response in the central nervous system (CNS) was a complete response (CR) or partial response (PR) confirmed by repeat assessment, according to RANO-BM criteria. A CR was defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically; for non-target lesions, a CR was the disappearance of all enhancing CNS non-target lesions and no new CNS lesions. A PR was defined as at least a 30% decrease in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD sustained for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; and stable or improved clinically. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.', ' Time frame: From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab', ' Arm/Group Description: Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants With Objective Response (Confirmed CR or PR): 10.8 (3.03 to 25.42)', ' Confirmed Complete Response (CR): 0.0 (0.00 to 9.49)', ' Confirmed Partial Response (PR): 10.8 (3.03 to 25.42)', ' Without Objective Response: 89.2 [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/39 (17.95%)', ' Gastroenteritis viral 1/39 (2.56%)', ' Parainfluenzae virus infection 1/39 (2.56%)', ' Seizure 4/39 (10.26%)', ' Headache 1/39 (2.56%)', ' Hydrocephalus 1/39 (2.56%)', ' Hypertension 1/39 (2.56%)']}

{'Clinical Trial ID': 'NCT00371345', 'Intervention': ['INTERVENTION 1: ', ' Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib', ' Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.', 'INTERVENTION 2: ', ' Her2/Neu-amplified Tumor, 100 mg BID', ' Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.'], 'Eligibility': ['Inclusion Criteria:', ' females, 18 or older', ' recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu', ' paraffin-embedded tissue block must be available', ' measurable disease', ' prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)', ' 0, 1 or 2 chemotherapies in the metastatic setting', ' adequate organ function', 'Exclusion Criteria:', ' Metastatic disease confined to bone only', ' Symptomatic central nervous system (CNS) metastasis', ' Concurrent medical condition which may increase the risk of toxicity', ' Unable to take oral medication'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response', ' Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.', ' Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.', 'Results 1: ', ' Arm/Group Title: Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib', ' Arm/Group Description: Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Her2/Neu-amplified Tumor, 100 mg BID', ' Arm/Group Description: Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/70 (28.57%)', ' NAUSEA 2/70 (2.86%)', ' VOMITING 1/70 (1.43%)', ' DIARRHOEA 2/70 (2.86%)', ' ABDOMINAL PAIN 1/70 (1.43%)', ' ABDOMINAL PAIN LOWER 1/70 (1.43%)', ' FATIGUE 2/70 (2.86%)', ' PYREXIA 1/70 (1.43%)', ' OEDEMA PERIPHERAL 1/70 (1.43%)', ' GENERAL PHYSICAL HEALTH DETERIORATION 3/70 (4.29%)', ' PNEUMONIA 1/70 (1.43%)', ' SINUSITIS 1/70 (1.43%)', ' LOBAR PNEUMONIA 1/70 (1.43%)', 'Adverse Events 2:', ' ']}

11403f92-661b-4334-8dfb-098586610ec6

Single

Intervention

NCT01422408

the primary trial is a phase II trial in which all participants will recieve topical fluocinonide 0.05% face cream twice daily for two weeks.

Contradiction

{'Clinical Trial ID': 'NCT01422408', 'Intervention': ['INTERVENTION 1: ', ' Supportive Care (Fluocinonide Cream)', ' This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.', ' All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention', ' Vaginal dryness or dyspareunia must be present for at least two months prior to study entry', ' Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study', ' Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream', ' Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2', ' Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance', ' Subjects must sign informed consent', ' Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent', 'Exclusion Criteria:', ' Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)', ' Use of any estrogen containing medications, products, or preparations', ' Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted', ' Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia', ' Subject reported symptoms of vaginal infection with significant vaginal discharge or odor', ' Known current vaginal infection', ' Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms', ' Known intolerance of topical steroid preparations', ' Pregnant or lactating women (to be obtained via subject report only)', " Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or Cushing's syndrome", ' No prior chemotherapeutic treatment for any malignancy other than breast cancer'], 'Results': ['Outcome Measurement: ', ' Change in Symptom Scores of Vaginal Dryness', ' Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.', ' Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.', ' Time frame: Baseline and 4 weeks', 'Results 1: ', ' Arm/Group Title: Supportive Care (Fluocinonide Cream)', ' Arm/Group Description: This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.', ' All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.', ' Overall Number of Participants Analyzed: 34', ' Median (Inter-Quartile Range)', ' Unit of Measure: units on a scale -2 (-3 to -1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2823adfc-b3a4-4626-9690-0c292aa8da04

Comparison

Intervention

NCT02504424

NCT03708393

the primary trial and the secondary trial do not have the same number of study groups.

Entailment

{'Clinical Trial ID': 'NCT02504424', 'Intervention': ['INTERVENTION 1: ', ' AeroForm Tissue Expander', ' AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.'], 'Eligibility': ['Inclusion Criteria:', ' Subject is female between the ages of 18-70', ' Subject requires tissue expansion as part of breast reconstruction', ' Subject is able to provide written informed consent', ' Subject is able and willing to comply with all of the study requirements', ' Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen', 'Exclusion Criteria:', " Subject's tissue integrity is unsuitable for tissue expansion", ' Subject has residual gross malignancy at the intended expansion site', ' Subject has current or prior infection at the intended expansion site', ' Subject has a history of failed tissue expansion or breast reconstruction', ' Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)', ' Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).'], 'Results': ['Outcome Measurement: ', ' Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event', ' The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: AeroForm Tissue Expander', ' Arm/Group Description: AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', ' Overall Number of Participants Analyzed: 48', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: breasts: 80 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/50 (22.00%)', ' neutropenic fever, weakness 1/50 (2.00%)', ' urinary tract infection 1/50 (2.00%)', ' cellulitis 4/50 (8.00%)', ' wound dehiscence 1/50 (2.00%)', ' hematoma 1/50 (2.00%)', ' seroma 1/50 (2.00%)', ' inflammation (red breast syndrome) 2/50 (4.00%)']}

{'Clinical Trial ID': 'NCT03708393', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' - Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status', 'Exclusion Criteria:', ' - Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status'], 'Results': ['Outcome Measurement: ', ' The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1', ' Primary effectiveness endpoint was the specificity of Imagio [IUS+OA] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for 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).', ' Time frame: Baseline to 12 month follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 80.9 (69.1 to 92.7)', ' fSp (96.0%): 78.7 (65.7 to 91.7)', ' fSp (97.0%): 75.8 (61.4 to 90.3)', ' fSp (97.5%): 74 (58.7 to 89.4)', ' fSp (98.0%): 71.8 (55.4 to 88.3)', ' fSp (99.0%): 65.2 (45.8 to 84.6)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 75.4 (61.5 to 89.3)', ' fSp (96.0%): 71.4 (55.8 to 87.0)', ' fSp (97.0%): 66.1 (48.6 to 83.7)', ' fSp (97.5%): 62.8 (44.1 to 81.6)', ' fSp (98.0%): 58.9 (38.8 to 79)', ' fSp (99.0%): 47.7 (24.5 to 71.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/155 (0.00%)', 'Adverse Events 2:', ' ']}

1cda051f-27d0-4027-94cf-7b5340173ca2

Comparison

Results

NCT00435409

NCT00319254

The patient with the shortest PFS was in the secondary trial, at only 5 days, and the longest recorded PFS was in the primary trial at 78 months.

Contradiction

{'Clinical Trial ID': 'NCT00435409', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib + Capecitabine', ' Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.'], 'Eligibility': ['Inclusion Criteria:', ' Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.', ' Previous treatment with an anthracycline and a taxane in any setting', ' Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months', 'Exclusion Criteria:', ' History of inflammatory carcinoma if there is no other measurable disease', ' More than 2 chemotherapy agents in the advanced disease setting', 'Brain metastases'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.', ' Time frame: Baseline until disease progression (up to 3 years from first dose)', 'Results 1: ', ' Arm/Group Title: Sunitinib + Capecitabine', ' Arm/Group Description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.', ' Overall Number of Participants Analyzed: 221', ' Median (95% Confidence Interval)', ' Unit of Measure: months Independent radiology assessment: 5.5 (4.5 to 6.0)', " Investigator's assessment: 5.4 (4.4 to 5.8)", 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.', ' Overall Number of Participants Analyzed: 221', ' Median (95% Confidence Interval)', ' Unit of Measure: months Independent radiology assessment: 5.9 (5.4 to 7.6)', " Investigator's assessment: 5.5 (4.3 to 6.8)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 85/217 (39.17%)', ' Anaemia * 7/217 (3.23%)', ' Bone marrow failure * 1/217 (0.46%)', ' Leukopenia * 2/217 (0.92%)', ' Neutropenia * 3/217 (1.38%)', ' Thrombocytopenia * 7/217 (3.23%)', ' Pancytopenia * 21/217 (0.46%)', ' Cardiac failure acute * 1/217 (0.46%)', ' Congestive cardiomyopathy * 0/217 (0.00%)', ' Pericardial effusion * 1/217 (0.46%)', ' Supraventricular tachycardia * 0/217 (0.00%)', 'Adverse Events 2:', ' Total: 59/215 (27.44%)', ' Anaemia * 1/215 (0.47%)', ' Bone marrow failure * 0/215 (0.00%)', ' Leukopenia * 0/215 (0.00%)', ' Neutropenia * 0/215 (0.00%)', ' Thrombocytopenia * 0/215 (0.00%)', ' Pancytopenia * 20/215 (0.00%)', ' Cardiac failure acute * 0/215 (0.00%)', ' Congestive cardiomyopathy * 1/215 (0.47%)', ' Pericardial effusion * 0/215 (0.00%)', ' Supraventricular tachycardia * 1/215 (0.47%)']}

{'Clinical Trial ID': 'NCT00319254', 'Intervention': ['INTERVENTION 1: ', ' Bosutinib', ' Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IIIB, IIIC or IV breast cancer not curable with available therapy.', ' Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.', ' Life expectancy of at least 16 weeks.', ' Ability to swallow whole capsules.', 'Exclusion Criteria:', ' Use of or requirement for bisphosphonates within 8 weeks prior to screening.', ' Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ', ' Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.', ' Recent or ongoing significant gastrointestinal disorder'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) Rate', ' PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.', ' Time frame: Baseline up to Week 16', 'Results 1: ', ' Arm/Group Title: Bosutinib', ' Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: percentage of participants 39.6 (28.1 to 50.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/73 (32.88%)', ' Diarrhoea * 2/73 (2.74%)', ' Ileus * 1/73 (1.37%)', ' Vomiting * 1/73 (1.37%)', ' Disease progression * 2/73 (2.74%)', ' Oedema peripheral * 2/73 (2.74%)', ' Chest discomfort * 1/73 (1.37%)', ' General physical health deterioration * 1/73 (1.37%)', ' Performance status decreased * 1/73 (1.37%)', ' Cytolytic hepatitis * 1/73 (1.37%)', ' Hepatic failure * 1/73 (1.37%)']}

2ca24749-7c1d-4697-a1aa-8bf5d13fb8c3

Single

Results

NCT00513292

In the primary trial the FEC-75 Then Paclitaxel/Trastuzumab group produced better Pathological complete response (pCR) rates than the Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 group.

Entailment

{'Clinical Trial ID': 'NCT00513292', 'Intervention': ['INTERVENTION 1: ', ' FEC-75 Then Paclitaxel/Trastuzumab', ' Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', 'INTERVENTION 2: ', ' Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', ' Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of invasive adenocarcinoma by core needle biopsy', ' Fine needle aspiration allowed provided primary tumor size < 2 cm and lymph node metastases are present', ' Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present', ' Primary tumor 2 cm and/or 1 biopsy-positive lymph node', ' HER2-positive disease', ' Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification', ' Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score', ' Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed', ' Synchronous invasive breast cancer not allowed', ' Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed', ' Those treated with radiation therapy are not allowed', ' No definitive clinical or radiologic evidence of metastatic disease', ' No history of invasive breast cancer', ' Hormone receptor status known', ' Menopausal status not specified', ' ECOG performance status of 0 -1', ' Absolute neutrophil count 1,200/mm³', ' Platelet count 100,000/mm³', ' Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal [ULN]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin', ' Alkaline phosphatase 2.5 times ULN', ' AST 1.5 times ULN', ' Creatinine normal', ' Left ventricular ejection fraction (LVEF) 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months', ' Patients with either skeletal pain or alkaline phosphatase that is > ULN but 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease', ' Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy', ' Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence', ' Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:', ' Carcinoma in situ of the cervix', ' Colon carcinoma in situ', ' Melanoma in situ', ' Basal cell and squamous cell carcinoma of the skin', ' No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:', ' Active cardiac disease', ' Angina pectoris that requires the use of antianginal medication', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Clinically significant valvular disease', ' Cardiomegaly on chest x-ray', ' Ventricular hypertrophy on EKG', " Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)", ' Patients with hypertension that is well controlled on medication are eligible', ' History of cardiac disease', ' Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests', ' Documented congestive heart failure', ' Documented cardiomyopathy', " No sensory or motor neuropathy grade 2, as defined by the NCI's CTCAE v3.0", ' Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy', ' Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration', ' Not pregnant or nursing', ' No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements', ' No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens', ' No prior surgical axillary staging procedure', ' Prior non-excisional biopsy of an axillary node allowed', ' No prior treatment for this breast cancer', ' Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry', ' Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery', ' No prior therapy with anthracyclines or taxanes for any malignancy', ' No other investigational agents within the past 30 days', ' No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)', ' No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention'], 'Results': ['Outcome Measurement: ', ' pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy', ' Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: FEC-75 Then Paclitaxel/Trastuzumab', ' Arm/Group Description: Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 138', ' Measure Type: Number', ' Unit of Measure: percentage of participants 56.5 (47.8 to 64.9)', 'Results 2: ', ' Arm/Group Title: Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', ' Arm/Group Description: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 142', ' Measure Type: Number', ' Unit of Measure: percentage of participants 54.2 (45.7 to 62.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/138 (13.77%)', ' Blood disorder 1/138 (0.72%)', ' Febrile neutropenia 1/138 (0.72%)', ' Hemoglobin decreased 8/138 (5.80%)', ' Hemolysis 0/138 (0.00%)', ' Atrial fibrillation 0/138 (0.00%)', ' Left ventricular failure 3/138 (2.17%)', ' Myocardial ischemia 0/138 (0.00%)', ' Sinus tachycardia 1/138 (0.72%)', ' Supraventricular tachycardia 0/138 (0.00%)', ' Extraocular muscle paresis 0/138 (0.00%)', 'Adverse Events 2:', ' Total: 26/142 (18.31%)', ' Blood disorder 1/142 (0.70%)', ' Febrile neutropenia 3/142 (2.11%)', ' Hemoglobin decreased 11/142 (7.75%)', ' Hemolysis 1/142 (0.70%)', ' Atrial fibrillation 1/142 (0.70%)', ' Left ventricular failure 5/142 (3.52%)', ' Myocardial ischemia 1/142 (0.70%)', ' Sinus tachycardia 1/142 (0.70%)', ' Supraventricular tachycardia 1/142 (0.70%)', ' Extraocular muscle paresis 1/142 (0.70%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

1e91c023-96e8-459b-9070-02df13339617

Single

Adverse Events

NCT03012477

One patient in the primary trial experienced a thromboembolic event, a condition associated with a high degree of morbidity and mortality. However, the most common adverse event was Anemia.

Contradiction

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a15b4c0c-232b-4209-bf60-35d160e41d2c

Single

Intervention

NCT02667626

the primary trial is testing a web-based educational tool and the secondary trial is testing a medical device on Post-menopausal Women.

Contradiction

{'Clinical Trial ID': 'NCT02667626', 'Intervention': ['INTERVENTION 1: ', ' SCPR Intervention', ' Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.', ' Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence', 'INTERVENTION 2: ', ' Control', ' Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.', ' Control: Web-based resource lists and text-based study adherence reminders'], 'Eligibility': ['Inclusion:', ' Breast cancer (Stages 0-III) diagnosis', ' Breast cancer diagnosis age 45 years', ' 5 years since breast cancer diagnosis', ' Current age 18 to 50 years', ' Completed treatment with surgery, radiation and chemotherapy (if applicable)', ' Able to read English', ' Able to consent to the study', ' Access to an Internet connection', ' Exclusion:', ' Women who are pregnant at recruitment'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a 50% Decrease in Hot Flash Score', ' 50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.', ' Time frame: Baseline and 24 weeks', 'Results 1: ', ' Arm/Group Title: SCPR Intervention', ' Arm/Group Description: Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.', ' Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence', ' Overall Number of Participants Analyzed: 86', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 50 58.1%', 'Results 2: ', ' Arm/Group Title: Control', ' Arm/Group Description: Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.', ' Control: Web-based resource lists and text-based study adherence reminders', ' Overall Number of Participants Analyzed: 96', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 53 55.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/86 (0.00%)', 'Adverse Events 2:', ' Total: 0/96 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

795d634a-9f9c-49a2-a4e7-ec99bd3600f2

Comparison

Adverse Events

NCT01463007

NCT00965523

A significantly higher proportion of patients in the secondary trial suffured from infection compared to the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01463007', 'Intervention': ['INTERVENTION 1: ', ' Radiation', ' AccuBoost APBI- 34.0 Gy in 10fx', ' Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions', 'INTERVENTION 2: ', ' Extended to 5 Years of Follow Up-Rhode Island Hospital Only', ' Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.'], 'Eligibility': ['Inclusion Criteria:', ' A confirmed histological diagnosis of invasive breast carcinoma or DCIS', ' Age greater or equal to 50 years old', ' Life expectancy > 6 months', ' Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy', ' Pathologic tumor size less than or equal to 2 cm', ' Invasive ductal, mucinous, tubular or colloid histology', ' Estrogen receptor positive for invasive carcinoma.', ' Unifocal/unicentric disease', ' Negative surgical margins greater than or equal to 2 mm', ' Pathologic lymph node negative', ' No evidence of lymphovascular invasion', ' ECOG performance status of 0 or 1 (Appendix 1)', ' Informed consent signed.', 'Exclusion Criteria:', ' Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)', ' Autoimmune disorder', ' Pregnancy', ' Breast implants', ' Psychiatric or addictive disorder that would preclude attending follow-up', ' Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)', ' Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)', ' Lobular features on histology (pure or mixed) or sarcoma histology', ' Node positive on axillary dissection or in the sentinel lymph node biopsy;', ' Extensive in situ carcinoma (EIC)', ' Multicentric or multifocal disease', " Paget's disease of the nipple", ' Distant metastases', ' Lumpectomy cavity not well visualized on AccuBoost imaging', ' Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)', ' Breast separation with compression > 7cm.', ' Overlap of skin between orthogonal treatment axes.'], 'Results': ['Outcome Measurement: ', ' Early and Intermediate Toxicity', ' Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Radiation', ' Arm/Group Description: AccuBoost APBI- 34.0 Gy in 10fx', ' Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: participants 40', 'Results 2: ', ' Arm/Group Title: Extended to 5 Years of Follow Up-Rhode Island Hospital Only', ' Arm/Group Description: Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants 28'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/41 (2.44%)', ' Infection 1/41 (2.44%)', ' Creatinine 1/41 (2.44%)', ' Hypokalemia 1/41 (2.44%)', ' Bicarbonate 1/41 (2.44%)', ' SGOT 1/41 (2.44%)', ' Alkaline Phosphatase value 1/41 (2.44%)', ' Hyperbilirubineamia 1/41 (2.44%)', ' Hypoalbuminemia 1/41 (2.44%)', ' Leukocytes 1/41 (2.44%)', ' Hemoglobin 1/41 (2.44%)', ' Neutrophils 1/41 (2.44%)', ' INR 1/41 (2.44%)', ' PTT 1/41 (2.44%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00965523', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion criteria:', ' Female patients with histologically or cytologically confirmed breast cancer.', ' Patients who have received prior chemotherapy including anthracycline and taxane.', ' Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.', ' Patients with a measurable lesion.', ' Patients with an expected survival of 3 months from the start of study drug therapy.', ' Female patients in whom continued administration of E7389 following Study 221 will be useful.', ' Patients who have met the criteria for starting the next cycle in Study 221.', ' Namely, patients who meet all of the following criteria:', ' Neutrophil count >= 1,500 /µL', ' Platelet count >= 100,000 /µL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)', ' Total bilirubin <= 1.5 times ULN', ' Serum creatinine <= 1.5 times ULN', ' Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)', 'Exclusion criteria:', ' Patients with systemic infection with a fever ( 38.0°C).', ' Patients with pleural effusion, ascites or pericardial fluid requiring drainage.', ' Patients with brain metastasis presenting clinical symptoms.', ' Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.', ' Patients with serious complications:', ' Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)', ' Patients with myocardial infarction within 6 months prior to study entry', ' Patients with a complication of hepatic cirrhosis', ' Patients with interstitial pneumonia and pulmonary fibrosis', ' Patients with a bleeding tendency', ' Patients with an active double cancer.', ' Pregnant women or nursing mothers.', ' Patients who have received extensive radiotherapy ( 30% of bone marrow).', ' Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.', ' Patients who are participating in other clinical studies.', ' Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Adverse Events.', ' [Not Specified]', ' Time frame: Every week during treatment and up to 30 days after last dose of study treatment', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Number', ' Unit of Measure: Participants 81'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/81 (17.28%)', ' Neutropenia1/81 (1.23%)', ' Cataract1/81 (1.23%)', ' Ascites1/81 (1.23%)', ' Gastritis Hemorrhagic1/81 (1.23%)', ' Nausea1/81 (1.23%)', ' Stomatitis2/81 (2.47%)', ' Malaise1/81 (1.23%)', ' Oedema1/81 (1.23%)', ' Pain1/81 (1.23%)', ' Pyrexia1/81 (1.23%)', ' Infection2/81 (2.47%)', ' Upper Limb Fracture1/81 (1.23%)', ' Dehydration1/81 (1.23%)', ' Hypercalcemia1/81 (1.23%)']}

e2d4c56c-a68f-4751-907d-9c2355c9528b

Comparison

Eligibility

NCT00193050

NCT00232479

Patients must be over the age of 18 and have a life expectancy over 6 months to participate in the primary trial or the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00193050', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles', ' Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.', ' After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.', ' After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Adenocarcinoma of the breast confirmed by biopsy', ' Female Patients >18 years of age', ' Normal cardiac function', ' Ability to perform activities of daily living with minimal assistance', ' Chemotherapy naïve or have received prior chemotherapy > 5 years ago', ' Adequate bone marrow, liver and kidney function', ' Be informed of the investigational nature of this study', ' Sign an informed consent form', ' Sentinel lymph node and/or axillary dissection prior to enrollment', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Life expectancy of < than 6 months', ' History of significant heart disease', ' Prior chemotherapy or hormonal therapy', ' Concurrent Trastuzumab therapy', ' History of significant psychiatric disorders', ' History of active uncontrolled infection', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR)', ' For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles', ' Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.', ' After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.', ' After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Number', ' Unit of Measure: percentage of participants 18 (11 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/110 (15.45%)', ' Hemoglobin [1]1/110 (0.91%)', ' Esophagitis 1/110 (0.91%)', ' Dysphagia 1/110 (0.91%)', ' Nausea/Vomiting 1/110 (0.91%)', ' Nausea 1/110 (0.91%)', ' Fever 1/110 (0.91%)', ' Febrile Neutropenia 11/110 (10.00%)', ' Infection - Other [2]1/110 (0.91%)', ' Infection - Pneumonia 1/110 (0.91%)', ' Dyspnea 2/110 (1.82%)', ' Hypoxia 1/110 (0.91%)']}

{'Clinical Trial ID': 'NCT00232479', 'Intervention': ['INTERVENTION 1: ', ' Group 1', ' patients received dose dense herceptin, carboplatin and taxotere'], 'Eligibility': ['Inclusion Criteria:', ' HER-2 overexpressing breast cancer', ' Clinical stage 2-3B', ' Normal ejection fraction', 'Exclusion Criteria:', ' Metastatic disease', ' Low ejection fraction'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathologic Complete Response (pCR)', ' pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.', ' Time frame: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment', 'Results 1: ', ' Arm/Group Title: Group 1', ' Arm/Group Description: patients received dose dense herceptin, carboplatin and taxotere', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: participants 19'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/46 (2.17%)', ' hospitalization [1]1/46 (2.17%)']}

50f1c6c5-abe6-4178-93cf-32b5a8a3e9e9

Comparison

Adverse Events

NCT00243503

NCT00448279

the primary trial and the secondary trial did not observe any of the same adverse events in their patients.

Contradiction

{'Clinical Trial ID': 'NCT00243503', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Sunitinib', ' Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.', ' HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)', ' Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.', 'Exclusion Criteria:', ' Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted', ' Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.', ' Prior treatment on a SU11248 clinical trial.', ' Uncontrolled brain metastases.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Confirmed Objective Disease Response', ' Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.', ' Time frame: From start of treatment through 18 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Sunitinib', ' Arm/Group Description: Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.', ' Overall Number of Participants Analyzed: 57', ' Measure Type: Number', ' Unit of Measure: percentage of participants 36.8 (24.4 to 50.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 25/60 (41.67%)', ' Anaemia * 1/60 (1.67%)', ' Febrile neutropenia * 2/60 (3.33%)', ' Idiopathic thrombocytopenic purpura * 1/60 (1.67%)', ' Thrombocytopenia * 3/60 (5.00%)', ' Cardiac failure * 1/60 (1.67%)', ' Cardiac failure acute * 1/60 (1.67%)', ' Cardiogenic shock * 1/60 (1.67%)', ' Left ventricular dysfunction * 1/60 (1.67%)', ' Anal fistula * 1/60 (1.67%)']}

{'Clinical Trial ID': 'NCT00448279', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy Alone', " Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.", 'INTERVENTION 2: ', ' Chemotherapy + Trastuzumab', " Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death."], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' metastatic breast cancer;', ' HER2 overexpression (IHC 3+ and/or FISH positive);', ' disease progression during or after previous 1st line chemotherapy plus Herceptin;', ' scheduled to receive 2nd line chemotherapy.', 'Exclusion Criteria:', ' incompatibility with previous Herceptin therapy;', 'pregnancy.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) - Percentage of Participants With an Event', ' PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.', ' Time frame: Baseline (BL) and every 8 weeks thereafter', 'Results 1: ', ' Arm/Group Title: Chemotherapy Alone', " Arm/Group Description: Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.", ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.6', 'Results 2: ', ' Arm/Group Title: Chemotherapy + Trastuzumab', " Arm/Group Description: Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.", ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/26 (15.38%)', ' Febrile neutropenia * 1/26 (3.85%)', ' Gastric volvulus * 20/26 (0.00%)', ' General Malaise * 21/26 (3.85%)', ' Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)', ' Acute renal failure * 21/26 (3.85%)', 'Adverse Events 2:', ' Total: 1/28 (3.57%)', ' Febrile neutropenia * 0/28 (0.00%)', ' Gastric volvulus * 21/28 (3.57%)', ' General Malaise * 20/28 (0.00%)', ' Hospitalisation for intrapleuric chemotherapy and thoracentesis * 20/28 (0.00%)', ' Acute renal failure * 20/28 (0.00%)']}

9ad3444c-143d-4c28-a08a-e0c9cda44900

Comparison

Intervention

NCT01401959

NCT00852930

the primary trial designates specific interventions to its patients depending on their tumour response, patients with complete response go to cohort A and all other in cohort B, in contrast the secondary trial assigns interventions randomly.

Contradiction

{'Clinical Trial ID': 'NCT01401959', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Triple-negative Breast Cancer Patients', ' Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.', 'INTERVENTION 2: ', ' Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients', ' Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients >=18 years-of-age.', ' Histologically confirmed breast cancer prior to surgery with the following staging criteria: T1-T3, T4a, T4b, N0-N2, N3a and M0 (T1N0M0 patients are excluded). Inflammatory disease is excluded.', ' Previous treatment with a minimum of 4 cycles of neoadjuvant anthracycline and/or taxane containing chemotherapy (+trastuzumab in HER2-positive patients).', ' Patients must be 21 days and 84 days from breast surgery and fully recovered. Patients may have had mastectomy or breast conservation surgery with axillary node dissection.', ' Pathologic CR (pCR) not achieved following neoadjuvant treatment (i.e., residual invasive breast cancer (>5 mm) in the breast or presence of nodal disease at surgery [ypT0/T1a, N1-N3a, M0 or ypT1b-T4, N0-N3a, M0].', ' Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.', ' Recovery from any toxic effects of prior therapy to <=Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0) except fatigue or alopecia.', ' Peripheral neuropathy Grade <=2 per NCI CTCAE v4.0 at trial entry.', ' Normal left ventricular ejection fraction (LVEF), within the institutional limits of normal, as measured by echocardiography (ECHO) or multi-gated (MUGA) scan in patients to receive trastuzumab with eribulin (HER2-positive).', ' Adequate hematologic, hepatic, and renal function', ' Complete staging work-up to confirm localized disease should include computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan. (Note: a PET/CT is acceptable for baseline imaging in lieu of CT examinations or bone scan). Negative scans performed prior to the initiation of neoadjuvant therapy, or at any subsequent time, are acceptable and do not need to be repeated.', ' Female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum pregnancy test performed within 7 days prior to start of trial treatment.', ' Willingness and ability to comply with trial and follow-up procedures.', ' Ability to understand the investigative nature of this trial and give written informed consent.', ' Agree to delay in reconstruction in terms of implants placed in setting of expanders until chemotherapy is completed and the patient has recovered. Expansion of expanders may continue during trial treatment.', 'Exclusion Criteria:', ' Presence of other active cancers, or history of treatment for invasive cancer <3 years prior to trial entry (except thyroid, cervical cancer). Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.', ' Radiotherapy prior to the start of study treatment.', ' History or clinical evidence of central nervous system metastases or other metastatic disease.', ' Non-healed surgical wound.', ' Known or suspected allergy/hypersensitivity to eribulin.', ' Cardiac disease, including: congestive heart failure Class II-IV per New York Heart Association classification;cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months.', ' Chronic use of drugs that cause QTc prolongation.Patients must discontinue use of these drugs 7 days prior to the start of study treatment.', ' Women who are pregnant or lactating. All females of child-bearing potential must have negative serum pregnancy test within 48 hours prior to trial treatment.', ' Patients with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.', " Prolongation of heart rate-corrected QT interval (QTc) >480 msecs (using Bazett's formula).", ' Minor surgical procedures (with the exception of the placement of port-a-cath or other central venous access) performed less than 7 days prior to beginning protocol treatment.', ' History of cerebrovascular accident including transient ischemic attack (TIA), or untreated deep venous thrombosis (DVT)/ pulmonary embolism (PE) within the past 6 months. Note: Patients with recent DVT/PE receiving treatment with a stable dose of therapeutic anti-coagulating agents are eligible.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.', ' History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the trial participation or investigational product(s) administration or may interfere with the interpretation of the results.', ' Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy', ' The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. 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: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A: Triple-negative Breast Cancer Patients', ' Arm/Group Description: Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Number', ' Unit of Measure: percentage of patients 56 (42 to 69)', 'Results 2: ', ' Arm/Group Title: Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients', ' Arm/Group Description: Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of patients 83 (67 to 91)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/53 (15.09%)', ' Febrile neutropenia * 1/53 (1.89%)', ' Cardiac failure congestive * 1/53 (1.89%)', ' Ventricular arrhythmia * 1/53 (1.89%)', ' Cellulitis * 0/53 (0.00%)', ' Mastitis * 1/53 (1.89%)', ' Pneumonia * 1/53 (1.89%)', ' Sinusitis * 0/53 (0.00%)', ' Tracheobronchitis * 0/53 (0.00%)', ' Diabetes mellitus inadequate control * 0/53 (0.00%)', ' Hyperglycaemia * 1/53 (1.89%)', 'Adverse Events 2:', ' Total: 1/42 (2.38%)', ' Febrile neutropenia * 0/42 (0.00%)', ' Cardiac failure congestive * 0/42 (0.00%)', ' Ventricular arrhythmia * 0/42 (0.00%)', ' Cellulitis * 0/42 (0.00%)', ' Mastitis * 0/42 (0.00%)', ' Pneumonia * 0/42 (0.00%)', ' Sinusitis * 0/42 (0.00%)', ' Tracheobronchitis * 1/42 (2.38%)', ' Diabetes mellitus inadequate control * 0/42 (0.00%)', ' Hyperglycaemia * 0/42 (0.00%)']}

{'Clinical Trial ID': 'NCT00852930', 'Intervention': ['INTERVENTION 1: ', ' Laser Therapy Alone', ' therapist administered laser treatment', ' laser: therapist administered laser', 'INTERVENTION 2: ', ' Mld Alone', ' therapist administered manual lymphatic drainage', ' manual lymphatic drainage: therapist administered massage therapy'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer survivors will be included if they:', ' are age 21 or older;', ' require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;', ' have an order for lymphedema treatment; and', ' are willing and able to drive to the study sites.', 'Exclusion Criteria:', ' Individuals will not be included if they:', ' are actively undergoing intravenous chemotherapy or radiation therapy;', ' have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;', ' are unable to stand upright for measurement of height and weight;', ' have active/metastatic cancer;', ' are pregnant,:', ' have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or', ' have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.'], 'Results': ['Outcome Measurement: ', ' LDex Change-', ' Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.', ' Time frame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.', 'Results 1: ', ' Arm/Group Title: Laser Therapy Alone', ' Arm/Group Description: therapist administered laser treatment', ' laser: therapist administered laser', ' Overall Number of Participants Analyzed: 15', ' Median (Inter-Quartile Range)', ' Unit of Measure: LDex 28.0 (17 to 35)', 'Results 2: ', ' Arm/Group Title: Mld Alone', ' Arm/Group Description: therapist administered manual lymphatic drainage', ' manual lymphatic drainage: therapist administered massage therapy', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: LDex 17.8 (3 to 38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

43061a8b-c1b2-4b5e-b935-73733d674fb4

Single

Eligibility

NCT00416572

Patients suffering from ovarian or lung cancer are excluded from the primary trial.

Entailment

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

fc7369dc-0fc5-4823-a8eb-5ac85188fd60

Comparison

Intervention

NCT03475992

NCT03106077

Participants in the primary trial receive different interventions depending on their pre-diagnosis, whereas all patients in the secondary trial took the same intervention.

Entailment

{'Clinical Trial ID': 'NCT03475992', 'Intervention': ['INTERVENTION 1: ', ' Pre-diagnosed Breast Cancer - Biopsy Confirmed', ' Low-power microwave breast imaging system.', ' Core needle biopsy performed 14 days before the microwave breast investigation', ' Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump', 'INTERVENTION 2: ', ' Pre-diagnosed Breast Cyst', ' Low-power microwave breast imaging system.', ' No prior biopsy', ' Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump'], 'Eligibility': ['Inclusion Criteria:', ' Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol', ' Subject must have attended the Symptomatic Breast Unit with a palpable breast lump', ' Subjects must have had a mammogram in the clinical assessment period ( 6 weeks before the microwave breast investigation)', ' Subjects must be able to comfortably lie reasonably still in a prone position for up to 15 minutes', ' Subjects with bra size larger than 32B and cup size larger or equal to B.', ' Subjects whose breast size is adapted to the cylindrical container of the MBI system with sufficient margin to allow the presence of transition liquid around the breast. Final decision to be taken by the physicians based on their judgement.', 'Exclusion Criteria:', ' Subjects unable to provide written informed consent', ' Subjects who are pregnant or breast-feeding', ' Subjects who have had previous surgery to the breast', ' Subjects who have previously received chemotherapy or radiotherapy to the breast', ' Subjects who have had a breast biopsy less than two weeks prior to imaging', ' Subjects with any active or metallic implant (e.g. cardiac pacemaker, stents, internal cardiac defibrillator, cardiac resynchronisation device, nerve stimulator…), or subjects bearing any non-removable metallic object (e.g. piercing) on their torso', ' Post-biopsy patients whose breast tissue is not healed sufficiently for the imaging procedure, in the opinion of the investigator', ' Patients who have had or plan to have a breast cyst aspiration before MBI.', ' Subjects with significant co-morbidities which, in the opinion of the investigator, may influence the result of the study', ' Subjects with prior or concurrent malignancy', ' Subjects under the age of 18 years old', ' Subjects with evidence of inflammation and/or erythema of the breast as well as any subjects who have a break in the skin which would be in contact with the coupling fluid', ' Subjects who would be unsuitable for an MBI scan, unlikely to attend a follow up visit, or would otherwise be unsuitable for such an investigation, in the opinion of the Investigator'], 'Results': ['Outcome Measurement: ', ' Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device', ' To provide early safety information for the proposed investigational medical imaging device.', ' Time frame: Through study completion, up to 21 days', 'Results 1: ', ' Arm/Group Title: Pre-diagnosed Breast Cancer - Biopsy Confirmed', ' Arm/Group Description: Low-power microwave breast imaging system.', ' Core needle biopsy performed 14 days before the microwave breast investigation', ' Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Number', ' Unit of Measure: Serious Adverse Events 0', 'Results 2: ', ' Arm/Group Title: Pre-diagnosed Breast Cyst', ' Arm/Group Description: Low-power microwave breast imaging system.', ' No prior biopsy', ' Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: Serious Adverse Events 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/11 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT03106077', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)', ' 6 mg/kg IMGN853 IV Q3W'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Confirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and HER2 0-1+ by IHC or 2+, fluorescence in situ hybridization (FISH) < 2, gene copy number < 4', ' (For Cohort A) - Archived tissue available at pre-screening to confirm FR alpha+ breast cancer', ' (For Cohort A) Archived tissue available pre-screening to confirm FR alpha+ breast cancer. (For Cohort B) Confirmed FRalpha+ breast cancer defined as low FRalpha expression: >= 25% of cells having >= 1+ expression', ' (For Cohort A) Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). (For cohort B) Clinical or radiologic primary tumor size of at least 1.5 cm prior to enrollment onto protocol 2014-0185 (ARTEMIS). Primary tumor of at least 1.0 cm or evidence of continued lymph node involvement by imaging (ultrasound or magnetic resonance imaging [MRI]) after adriamycin-based neoadjuvant therapy', ' (For cohort B): Primary tumor sample collected before NACT started (on ARTEMIS) and underwent molecular testing for integral biomarkers including immunohistochemical assessment of FRalpha', ' (For cohort A): No limit on prior therapies for metastatic disease. (Relapse of disease within 6 months of adjuvant or neoadjuvant chemotherapy is considered 1 line of therapy for metastatic disease). (For cohort B): received at least one dose of an anthracycline-based NACT. Patients are eligible if therapy was discontinued due to disease progression or therapy intolerance. Patients with disease progression on anthracycline-based therapy should be evaluated by the surgical team. If the patient is deemed inoperable at the time of evaluation, the patient may continue to undergo protocol therapy with a goal of reduction in tumor size to become operable. If the patient is deemed at high risk of becoming inoperable by the surgical team based upon tumor size or location, the patient will be considered ineligible for study and will be recommended to go to surgery', ' (For cohort B): Primary tumor size of at least 1.0 cm by imaging (ultrasound or MRI) or evidence of continued lymph node involvement by imaging (ultrasound or MRI) after adriamycin-based neoadjuvant therapy', ' (For cohort B): Baseline multigated acquisition (MUGA) or echocardiogram showing left ventricular ejection fraction (LVEF) >= 50% within 6 weeks prior to initiation of NACT', ' (For both cohorts A and B): Absolute neutrophil count (ANC) >= 1.5 x 10^9/L', ' (For both cohorts A and B): Platelets >= 100 x 10^9/L', ' (For both cohorts A and B): Hemoglobin (Hb) > 9 G/dL', ' (For both cohorts A and B): Total serum bilirubin =< 2.0 mg/dL', ' (For both cohorts A and B): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN in patients with liver metastases)', ' (For both cohorts A and B): International normalized ratio (INR) =< 2', ' (For both cohorts A and B): Serum creatinine =< 1.5 x ULN', ' (For both cohorts A and B): Serum albumin > 2', ' Signed informed consent obtained prior to any screening procedures', ' (For cohort A only): Time from prior therapy: a. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter. Hormonal therapy is not considered anti-neoplastic therapy. b. Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment', ' (For cohort B only): Patients must have at least 3 and no more than 5 weeks between anthracycline-based therapy and start of treatment with mirvetuximab soravtansine', ' (For both cohorts A and B): Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy to grade 1 or less (except alopecia)', ' (For both cohorts A and B): Women of child-hearing potential (WCBP) must have a negative pregnancy test within 3 days prior to the first dose of study treatment', 'Exclusion Criteria:', ' Pregnant or lactating women', ' Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study', ' (For Cohort B only): Presence of metastatic disease or prior radiation therapy of the primary breast carcinoma or axillary lymph nodes', " Women of child-bearing potential (WCBP), defined as all women capable of becoming pregnant, won't use highly effective methods of contraception during the study and 12 weeks after. Highly effective contraception methods include combination of any two of the following:", ' Placement of an intrauterine device (IUD) or intrauterine system (IUS)', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository', ' Total abstinence or', ' Male/female sterilization', ' Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study entry. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential', ' Male patients whose sexual partner(s) are WCBP who are not willing to use adequate contraception, during the study and for 12 weeks after the end of treatment', ' Patients with > grade 1 peripheral neuropathy', " Active or chronic corneal disorder, including but not limited to the following: Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring on-going treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision", ' Serious concurrent illness or clinically-relevant active infection, including, but not limited to the following:', ' Known active hepatitis B or C', ' Known human immunodeficiency virus (HIV) infection', ' Varicella-zoster virus (shingles)', ' Cytomegalovirus infection', ' Any other known concurrent infectious disease, requiring IV antibiotics within 2 weeks of study enrollment', ' Clinically-significant cardiac disease:', ' Recent myocardial infarction (=< 6 months prior to day 1)', ' Unstable angina pectoris', ' Uncontrolled congestive heart failure (New York Heart Association > class II)', ' Uncontrolled hypertension (>= Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade 3)', ' Prior history of hypertensive crisis or hypertensive encephalopathy', ' Uncontrolled cardiac arrhythmias', ' Clinically-significant vascular disease (e.g. aortic aneurysm, or dissecting aneurysm)', ' Severe aortic stenosis', ' Clinically significant peripheral vascular disease', ' >= Grade 3 cardiac toxicity following prior chemotherapy', ' Corrected QT interval (QTc) > 470 for females and > 450 for males', ' History of neurological conditions that would confound assessment of treatment-emergent neuropathy', ' History of hemorrhagic or ischemic stroke within the last 6 months', ' History of cirrhotic liver disease', ' Previous clinical diagnosis of non-infectious pneumonitis or non-infectious interstitial lung disease', ' Prior hypersensitivity to monoclonal antibodies', ' Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 years', ' Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis. Patients with previously treated CNS metastasis (excluding carcinomatous meningitis) may participate if they are stable (without evidence of progression by imaging, using identical imaging modality at each assessment, for at least 4 weeks prior to first dose of study treatment), have no evidence of new or emerging CNS metastasis, and are not using steroids for at least 7 days prior to first dose of study treatment', ' History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment', ' Required used of folate-containing supplements (e.g. folate deficiency)'], 'Results': ['Outcome Measurement: ', ' Number of Metastatic Participants With Radiographic Response', ' Determine if Mirvetuximab Soravtansine as a Single Agent is Likely to Induce Response in at Least 20% of Patients With Metastatic Folate Receptor (FR) Alpha+ Triple Negative Breast Cancer (TNBC). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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: From the registration to the study until disease progression or death from any cause, whichever occurred first, assessed up to 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)', ' Arm/Group Description: 6 mg/kg IMGN853 IV Q3W', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)']}

25ec56f0-e472-4423-92ae-8d4840b067b5

Single

Intervention

NCT02286843

the primary trial is testing a novel radiotracer called PET/CT to evaluate its use for visualization of HER2+ lesions.

Contradiction

{'Clinical Trial ID': 'NCT02286843', 'Intervention': ['INTERVENTION 1: ', ' HER2-targeted PET/CT', ' Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.'], 'Eligibility': ['Inclusion Criteria:', ' Women age > 18', ' Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease.', ' 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT)', ' ECOG performance score of 0-2', 'Exclusion Criteria:', ' Life expectancy < 3months', ' Pregnancy or lactation', ' Patients who cannot undergo PET/CT scanning because of weight limits', ' CNS only disease on recent imaging'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases', ' Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: HER2-targeted PET/CT', ' Arm/Group Description: Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: % of participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/49 (12.24%)', ' Anemia 1/49 (2.04%)', ' Cardiac arrest 1/49 (2.04%)', ' Abdominal pain 1/49 (2.04%)', ' Duodenal ulcer 3/49 (6.12%)', ' Death NOS 1/49 (2.04%)', ' Pleural effusion 1/49 (2.04%)', ' Respiratory failure 1/49 (2.04%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2c9e9407-e990-41bd-a87b-9d294c78f727

Single

Adverse Events

NCT00693719

the primary trial recorded less than 5 different Adverse Events .

Entailment

{'Clinical Trial ID': 'NCT00693719', 'Intervention': ['INTERVENTION 1: ', ' Etoposide/Irinotecan', ' Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle', ' Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of locally advanced or metastatic breast cancer', ' Recurrent, refractory or progressive disease after receiving prior anthracycline, taxane, and capecitabine therapy', ' Prior anthracycline and taxane therapy may have been as neoadjuvant, or adjuvant therapy if disease progression is documented within a year of completing that agent', ' Received prior capecitabine therapy for metastatic or recurrent disease', ' Measurable disease', ' Bone metastases requires other disease present that can be measured', ' No brain metastases, unless documented to be controlled post-completion of local therapy (surgery and/or radiation therapy) for at least 4 weeks', ' No meningeal carcinomatosis', ' No malignant effusion as the only site of disease recurrence', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Performance status of 0-2', ' Creatinine 1.5 mg/dL OR creatinine clearance 40 mL/min', ' Hemoglobin 10 g/dL', ' ANC 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Bilirubin normal or hyperbilirubinemia < grade 1 (unless due to Gilbert syndrome with elevated total but normal levels of conjugated bilirubin)', ' Not pregnant or nursing', ' Fertile patients must use effective contraception', ' No other non-breast malignancy, except nonmelanoma skin cancer', " No other serious underlying medical condition, that in the opinion of the treating physician, would make study protocol unreasonably hazardous for the patient or would preclude the patient's ability to comply with the study protocol", ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristic', ' Recovered from all prior chemotherapy or radiotherapy to NCI CTC grade 1', ' Unlimited documented prior chemotherapy regimens allowed', ' No prior irinotecan hydrochloride or etoposide', " No Hypericum perforatum (St. John's wort) 14 days prior to, during, or 7 days after completion of study therapy", ' At least 7 days since prior and no concurrent phenytoin, carbamazepine, phenobarbital, or any other enzyme-inducing anticonvulsant drug (EIACD)', ' No concurrent aprepitant'], 'Results': ['Outcome Measurement: ', ' Median Time to Progression', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months', 'Results 1: ', ' Arm/Group Title: Etoposide/Irinotecan', ' Arm/Group Description: Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle', ' Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle', ' Overall Number of Participants Analyzed: 31', ' Median (Standard Error)', ' Unit of Measure: Days 149 (33.83)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/31 (12.90%)', ' Bleeding 1/31 (3.23%)', ' Pain 2/31 (6.45%)', ' Dehydration 1/31 (3.23%)', ' Dyspnea 1/31 (3.23%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

f3cebdf7-be0c-45ad-85bd-bde827524e20

Single

Adverse Events

NCT01705691

A patient in the primary trial suffered from Kidney stones.

Entailment

{'Clinical Trial ID': 'NCT01705691', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Paclitaxel Then AC', ' Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles', 'INTERVENTION 2: ', ' Arm 2: Eribulin Then AC', ' Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)', ' Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.', ' The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.', ' Patients must be female.', ' Patients must be > 18 years old.', ' The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then Progesterone Receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1, cT3 and cN0 or cN1, Any cT and cN2 or cN3, cT4', ' The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: Absolute Neutrophil Count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.', " The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to Upper Limit of Normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 1.5 x ULN for the lab; and Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.", ' Patients with alkaline phosphatase > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements in the criteria below for unexplained skeletal pain are met.', ' Patients with either unexplained skeletal pain or alkaline phosphatase that is > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.', ' Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.', ' Serum potassium and serum magnesium performed within 4 weeks prior to randomization must be Within Normal Limits (WNL).', " The Left Ventricular Ejection Fraction (LVEF) assessment by 2-D echocardiogram or Multigated acquisition (MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's Lower Limit of Normal (LLN).", ' ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.', 'Exclusion Criteria:', ' Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by in situ hybridization (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.', ' Fine Needle Aspiration (FNA) alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to randomization.', ' Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy Sentinal Node (SN) biopsy for patients with clinically negative axillary nodes.)', ' Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging is mandatory for all patients within 90 days prior to randomization. Other imaging [if required] must have been performed within 4 weeks prior to randomization.)', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral Ductal Carcinoma in Situ (DCIS) treated with Radiation Therapy (RT). (Patients with a history of Lobular Carcinoma in Situ (LCIS), contralateral DCIS [regardless of RT], or contralateral invasive breast cancer are eligible.)', ' History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.', ' Known metastatic disease from any malignancy (solid tumor or hematologic).', ' Previous therapy with anthracyclines, taxanes, cyclophosphamide, or eribulin for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.', ' Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)', ' Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.', ' Requirement for chronic use of any drugs known to prolong the QT interval, including Na+ and K+ channel blockers. (Patients are eligible if these medications and/or substances can be discontinued prior to the first dose of eribulin and will not need to be resumed until after the last dose of eribulin.)', ' Active hepatitis B or hepatitis C with abnormal liver function tests.', ' Intrinsic lung disease resulting in dyspnea.', ' Active infection; or chronic infection requiring chronic suppressive antibiotics.', ' Persistent greater than or equal to grade 2 diarrhea regardless of etiology.', ' Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.', ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).', ' Uncontrolled hypertension defined as a systolic BP > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)', ' Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular (LV) function; history of documented Congestive Heart Failure (CHF) documented cardiomyopathy; and congenital long QT syndrome.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Pregnancy or lactation at the time of randomization.', ' Any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.', ' Use of any investigation agent within 4 weeks prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes', ' Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.', ' Time frame: At the time of surgery approximately 24 to 28 weeks.', 'Results 1: ', ' Arm/Group Title: Arm 1: Paclitaxel Then AC', ' Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: percentage of participants 26.3', 'Results 2: ', ' Arm/Group Title: Arm 2: Eribulin Then AC', ' Arm/Group Description: Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles', ' Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles', ' Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles', ' Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16.7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/19 (15.79%)', ' Febrile neutropenia 1/19 (5.26%)', ' Colitis 1/19 (5.26%)', ' Pain in extremity 0/19 (0.00%)', ' Nephrolithiasis 0/19 (0.00%)', ' Pulmonary embolism 1/19 (5.26%)', ' Dyspnoea 0/19 (0.00%)', ' Haematoma 0/19 (0.00%)', 'Adverse Events 2:', ' Total: 4/30 (13.33%)', ' Febrile neutropenia 1/30 (3.33%)', ' Colitis 0/30 (0.00%)', ' Pain in extremity 1/30 (3.33%)', ' Nephrolithiasis 1/30 (3.33%)', ' Pulmonary embolism 0/30 (0.00%)', ' Dyspnoea 1/30 (3.33%)', ' Haematoma 1/30 (3.33%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b5c7bfd2-d491-400c-8444-8bc424cd5dbf

Single

Intervention

NCT00425672

Patients receiving intervention 1 of the primary trial undergo a 21 day treatment cycle, up to a total of 6 times, but will stop earlier if they suffer disease progression or unacceptable toxicity occurs.

Entailment

{'Clinical Trial ID': 'NCT00425672', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', ' ONTAK: Given IV', ' flow cytometry: Correlative studies', ' immunohistochemistry staining method: Correlative studies', ' enzyme-linked immunosorbent assay: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' protein expression analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients with advanced stage refractory breast cancer', ' Progressive or relapsed disease following standard therapy', ' Patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional CT techniques or >= 10 mm with spiral CT scan; measurable (bi-dimensional) chest wall disease will also be allowed', ' Patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible', ' White blood cell count (WBC) > 3.0 THOU/ul', ' ANC > 1.0 THOU/ul', ' Platelets >= 100 THOU/ul', ' Serum creatinine =< 2.0 mg/dL or creatinine clearance (calculated) >= 60 ml/min', ' ALT/AST =< 2.0 x upper limit of normal', ' Total bilirubin =< 1.5 x upper limit of normal', ' Albumin >= 3.0 g/dL', ' Subjects must have a Performance Status Score (ECOG Scale) =< 2', ' Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment', ' Men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ONTAK treatment is discontinued', 'Exclusion Criteria:', ' Prior treatment with ONTAK (DAB389 IL-2) or DAB486 IL-2', ' Known history of hypersensitivity to diphtheria toxin or IL-2', ' Active autoimmune disease', ' Known history of pulmonary disease except controlled asthma', ' History of or pre-existing, cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization', ' Pregnant or breast-feeding women'], 'Results': ['Outcome Measurement: ', ' Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0', ' Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.', ' Time frame: 7 Days after last dose of ONTAK', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', ' ONTAK: Given IV', ' flow cytometry: Correlative studies', ' immunohistochemistry staining method: Correlative studies', ' enzyme-linked immunosorbent assay: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' protein expression analysis: Correlative studies', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/15 (6.67%)', ' Severe Nausea and Vomiting 1/15 (6.67%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

53c62057-d6ea-4639-adaf-98cb1544a394

Comparison

Results

NCT01570036

NCT00021255

the primary trial and the secondary trial monitor the % of their patient cohorts with DFS < 6years.

Contradiction

{'Clinical Trial ID': 'NCT01570036', 'Intervention': ['INTERVENTION 1: ', ' Herceptin + NeuVax Vaccine', ' Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.', 'INTERVENTION 2: ', ' Herceptin + GM-CSF Only', ' Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.'], 'Eligibility': ['Patients will be included in the study based on the following criteria:', ' Women 18 years or older', ' Node-positive breast cancer (AJCC N1, N2, or N3)', ' Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR) receptors and have received chemotherapy as standard of care', ' Clinically cancer-free (no evidence of disease) after standard of care therapy (surgery, chemotherapy, radiation therapy as directed by NCCN guidelines). Hormonal therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.', ' Recovery from any toxicity(ies) associated with prior adjuvant therapy.', ' HER2 expression of 1+ or 2+ by IHC. FISH or Dual-ISH testing must be performed on IHC 2+ tumors and shown to be non-amplified by FISH ( 2.0) or by Dual-ISH ( 2.0).', ' HLA-A2, A3, A24, or A26 positive', " LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or Echo)", ' ECOG 0,1', ' Signed informed consent', ' Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)', ' Must start study treatment (receive first Herceptin infusion) 15between 3-12 weeks from completion of standard of care therapy.', ' 4.1.3 Exclusion Criteria', ' Patients will be excluded from the study based on the following criteria:', ' Node-negative breast cancer (AJCC N0 or N0(i+)) unless negative for both estrogen (ER) and progesterone (PR) receptors and has received chemotherapy as standard of care', ' Clinical or radiographic evidence of distant or residual breast cancer', ' HER2 negative (IHC 0) or HER2 3+ or FISHDual-ISH amplified (FISH >2.0); Dual-ISH >2.0', ' HLA-A2, A3, A24, A26 negative', ' History of prior Herceptin therapy', ' NYHA stage 3 or 4 cardiac disease', " LVEF <50%, or less than the normal limits of the institution's specific testing (MUGA or Echo)", ' Immune deficiency disease or HIV, HBV, HCV', ' Receiving immunosuppressive therapy including chemotherapy, chronic steroids, methotrexate, or other known immunosuppressive agents', ' ECOG 2', ' Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000', ' Pregnancy (assessed by urine HCG)', ' Breast feeding', ' Any active autoimmune disease requiring treatment, with the exception of vitiligo', ' Active pulmonary disease requiring medication to include multiple inhalers', ' Involved in other experimental protocols (except with permission of the other study PI)'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS)', " Disease-free survival (DFS) for all patients regardless of randomization will be determined by patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary objective of the study is disease-free survival (DFS) at 24 months.", ' Time frame: Disease-free survival at 24 months', 'Results 1: ', ' Arm/Group Title: Herceptin + NeuVax Vaccine', ' Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.', ' Overall Number of Participants Analyzed: 136', ' Measure Type: Number', ' Unit of Measure: Percentage of participants who survived 89.8', 'Results 2: ', ' Arm/Group Title: Herceptin + GM-CSF Only', ' Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.', ' Overall Number of Participants Analyzed: 139', ' Measure Type: Number', ' Unit of Measure: Percentage of participants who survived 83.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/136 (10.29%)', ' Anemia [1]1/136 (0.74%)', ' Atrial fibrillation [1]0/136 (0.00%)', ' Heart failure [1]1/136 (0.74%)', ' Sinus tachycardia [1]0/136 (0.00%)', ' Colonic hemorrhage [1]1/136 (0.74%)', ' Esophageal obstruction [1]0/136 (0.00%)', ' Pancreatitis [1]1/136 (0.74%)', ' Fever [1]1/136 (0.74%)', ' Other, specify [1]0/136 (0.00%)', ' Allergic reaction [1]0/136 (0.00%)', 'Adverse Events 2:', ' Total: 12/139 (8.63%)', ' Anemia [1]0/139 (0.00%)', ' Atrial fibrillation [1]1/139 (0.72%)', ' Heart failure [1]1/139 (0.72%)', ' Sinus tachycardia [1]1/139 (0.72%)', ' Colonic hemorrhage [1]0/139 (0.00%)', ' Esophageal obstruction [1]1/139 (0.72%)', ' Pancreatitis [1]0/139 (0.00%)', ' Fever [1]0/139 (0.00%)', ' Other, specify [1]1/139 (0.72%)', ' Allergic reaction [1]1/139 (0.72%)']}

{'Clinical Trial ID': 'NCT00021255', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)', ' Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.', 'INTERVENTION 2: ', ' AC Followed by Docetaxel + Herceptin (AC→TH)', ' Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.'], 'Eligibility': ['Inclusion criteria:', ' Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the participants for treatment and follow-up.', ' Accessible for treatment and follow-up at participating centers.', ' Histologically proven breast cancer with an interval between definitive surgery that included axillary lymph node involvement assessment and registration of less than or equal to 60 days. A central pathology review might be performed post randomization for confirmation of diagnosis and molecular studies. The same block used for HER2neu determination prior to randomization might be used for the central pathology review.', ' Definitive surgical treatment must be either mastectomy with axillary lymph node involvement assessment, or breast conserving surgery with axillary lymph node involvement assessment 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/or ductal carcinoma in situ (DCIS).', ' Participants must be either lymph node positive or high risk node negative. Lymph node positive participants were to be defined as participants having invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes. High risk lymph node negative participants were to be defined as participants having invasive adenocarcinoma with either 0 (pNo) among a minimum of 6 resected lymph nodes or negative sentinel node biopsy (pNo) and at least one of the following factors: tumor size > 2 cm, estrogen receptor (ER) and/or progesteron receptor (PR) status was negative, histologic and/or nuclear grade 2-3, or age < 35 years.', ' Tumor must show the presence of the HER2neu gene amplification by Fluorescence In-Situ Hybridization (FISH analysis) by a designated central laboratory.', ' Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.', ' Karnofsky Performance status index 80%.', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) (multiple-gated acquisition [MUGA] scan) and electrocardiogram (ECG) within 3 months prior to registration. The result of the MUGA must be equal to or above the lower limit of normal for the institution.', ' Laboratory requirements: (within 14 days prior to registration)', ' a) Hematology: i) Neutrophils 2.0 109/L ii) Platelets 100 109/L iii) Hemoglobin 10 g/Dl', ' b) Hepatic function: i) Total bilirubin 1 UNL ii) Aspartate aminotransferase (ASAT) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine amino transferase (ALAT) (Serum glutamic-pyruvic transaminase [SGPT]) 2.5 UNL iii) Alkaline phosphatase 5 UNL iv) Participants with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.', ' c) Renal function: i) Creatinine 175 µmol/L (2 mg/dL) ii) If creatinine was 140 - 175 μmol/L, the calculated creatinine clearance should be 60 mL/min.', ' Complete staging work-up within 3 months prior to registration. All participants had bilateral mammography, chest X-ray (posterioanterior [PA] and lateral) and/or computerized tomography (CT) and/or magnetic resonance imaging (MRI), abdominal ultrasound and/or CT scan and/or MRI, and bone scan. In cases of positive bone scans, bone X-ray evaluation was mandatory to rule out the possibility of metastatic bone scan positivity. 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.', ' An audiology assessment with normal results was to be performed within 4 weeks of registration. This was only for those centers who had selected cisplatin as their platinum salt of choice for the BCIRG 006 study.', 'Exclusion criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy, taxoids (paclitaxel, docetaxel) or platinum salts for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating participants. Participants of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must had 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 National Cancer Institute (NCI) criteria.', ' Cardiac disease that would preclude the use of doxorubicin, docetaxel and Herceptin:', ' any documented myocardial infarction', ' angina pectoris that required the use of antianginal medication', ' any history of documented congestive heart failure', ' Grade 3 or Grade 4 cardiac arrhythmia (NCI Common Terminology Criteria [CTC], version 2.0)', ' clinically significant valvular heart disease', ' participants with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG, unless they demonstrate by MUGA scan within the past 3 months that the LVEF was the lower limit of normal for the radiology facility;', ' participants with poorly controlled hypertension i.e. diastolic greater than 100 mm/Hg. (Participants who were well controlled on medication were eligible for entry)', ' participants who currently received medications (digitalis, beta-blockers, calcium channel-blockers, etc) that altered cardiac conduction, if these medications were administered for cardiac arrhythmia, angina or congestive heart failure. If these medications were administered for other reasons (ie hypertension), the participant was eligible.', ' Other serious illness or medical condition:', ' 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', ' impaired hearing (only for those participants treated at centers who had selected cisplatin as their platinum salt of choice)', ' Past or current history of neoplasm other than breast carcinoma, except for:', ' curatively treated non-melanoma skin cancer', ' in situ carcinoma of the cervix', ' other cancer curatively treated and with no evidence of disease for at least 10 years', ' ipsilateral DCIS of the breast', ' lobular carcinoma in-situ (LCIS) of the breast', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Participants must had discontinued these agents prior to randomization.', ' 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 must be stopped prior to randomization.', ' 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.', " The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Disease Free Survival at 5 Years', ' Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.', ' Time frame: From randomization until relapse or death or up to 5 years', 'Results 1: ', ' Arm/Group Title: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)', ' Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m IV infusion every 3 weeks for another 4 cycles.', ' Overall Number of Participants Analyzed: 1073', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.5 (72.8 to 78.2)', 'Results 2: ', ' Arm/Group Title: AC Followed by Docetaxel + Herceptin (AC→TH)', ' Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.', ' Overall Number of Participants Analyzed: 1074', ' Measure Type: Number', ' Unit of Measure: percentage of participants 83.2 (80.9 to 85.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 218/1018 (21.41%)', ' ANEMIA 1/1018 (0.10%)', ' LEUKOPENIA 21/1018 (2.06%)', ' LYMPHEDEMA 0/1018 (0.00%)', ' PANCYTOPENIA 1/1018 (0.10%)', ' THROMBOCYTOPENIA 0/1018 (0.00%)', ' ANGINA PECTORIS 0/1018 (0.00%)', ' AORTIC STENOSIS 0/1018 (0.00%)', ' ARRHYTHMIA 2/1018 (0.20%)', ' ARTERIAL ANOMALY 0/1018 (0.00%)', ' AV BLOCK 0/1018 (0.00%)', ' CARDIOMYOPATHY 0/1018 (0.00%)', 'Adverse Events 2:', ' Total: 298/1100 (27.09%)', ' ANEMIA 8/1100 (0.73%)', ' LEUKOPENIA 23/1100 (2.09%)', ' LYMPHEDEMA 1/1100 (0.09%)', ' PANCYTOPENIA 1/1100 (0.09%)', ' THROMBOCYTOPENIA 1/1100 (0.09%)', ' ANGINA PECTORIS 1/1100 (0.09%)', ' AORTIC STENOSIS 0/1100 (0.00%)', ' ARRHYTHMIA 3/1100 (0.27%)', ' ARTERIAL ANOMALY 0/1100 (0.00%)', ' AV BLOCK 0/1100 (0.00%)', ' CARDIOMYOPATHY 2/1100 (0.18%)']}

599b37cd-f380-48ac-864d-e766a7af963e

Single

Eligibility

NCT02222337

Participants for the primary trial must be in pairs, a breast cancer survivor and a caregiver, both must be ethnically Hispanic.

Contradiction

{'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': ''}

c428ec76-4d22-4d2d-8c06-1675bd431d41

Single

Intervention

NCT03283553

the primary trial has two cohorts.

Entailment

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6cbc1567-2b51-45c0-ab1b-cac0b5fc7c38

Comparison

Eligibility

NCT00089479

NCT02964234

Agatha had her 53rd birthday last week, she has a histologically confirmed adenocarcinoma of the breast, with no evidence of metastatic disease. Agatha is of white british origin. she is eligible for the primary trial but not the secondary trial, due to her age.

Contradiction

{'Clinical Trial ID': 'NCT00089479', 'Intervention': ['INTERVENTION 1: ', ' AC Then T', ' Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles', 'INTERVENTION 2: ', ' AC Then XT', ' Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' female patients 18-70 years of age;', ' adenocarcinoma of the breast;', ' previous invasive breast cancer if diagnosed >5 years before entering study;', ' no evidence of metastatic disease.', 'Exclusion Criteria:', ' history of severe hypersensitivity reaction to Taxotere;', ' previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;', ' treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival [Number of Events]', ' Number of patients with/without recurrence of breast cancer, or death due to any cause.', ' Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.', 'Results 1: ', ' Arm/Group Title: AC Then T', ' Arm/Group Description: Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 1304', ' Measure Type: Number', ' Unit of Measure: participants Patients with event: 164', ' Patients without events: 1140', 'Results 2: ', ' Arm/Group Title: AC Then XT', ' Arm/Group Description: Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 1307', ' Measure Type: Number', ' Unit of Measure: participants Patients with event: 140', ' Patients without events: 1167'], 'Adverse Events': ['Adverse Events 1:', ' Total: 264/1305 (20.23%)', ' FEBRILE NEUTROPENIA 118/1305 (9.04%)', ' NEUTROPENIA 10/1305 (0.77%)', ' ANAEMIA 0/1305 (0.00%)', ' LEUKOCYTOSIS 2/1305 (0.15%)', ' LEUKOPENIA 1/1305 (0.08%)', ' PANCYTOPENIA 0/1305 (0.00%)', ' MYOCARDIAL INFARCTION 1/1305 (0.08%)', ' SUPRAVENTRICULAR TACHYCARDIA 2/1305 (0.15%)', ' ANGINA UNSTABLE 0/1305 (0.00%)', ' ATRIAL FLUTTER 0/1305 (0.00%)', 'Adverse Events 2:', ' Total: 200/1283 (15.59%)', ' FEBRILE NEUTROPENIA 80/1283 (6.24%)', ' NEUTROPENIA 11/1283 (0.86%)', ' ANAEMIA 5/1283 (0.39%)', ' LEUKOCYTOSIS 0/1283 (0.00%)', ' LEUKOPENIA 0/1283 (0.00%)', ' PANCYTOPENIA 1/1283 (0.08%)', ' MYOCARDIAL INFARCTION 1/1283 (0.08%)', ' SUPRAVENTRICULAR TACHYCARDIA 0/1283 (0.00%)', ' ANGINA UNSTABLE 1/1283 (0.08%)', ' ATRIAL FLUTTER 1/1283 (0.08%)']}

{'Clinical Trial ID': 'NCT02964234', 'Intervention': ['INTERVENTION 1: ', ' Empowerment', ' Behavior: Empowerment', ' Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', 'INTERVENTION 2: ', ' Education', ' Behavior: Education', ' Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Age 52-75 years old;', ' Identification as Latina/Hispanic/Chicana female;', ' Residence in Pilsen, Little Village, East Side or South Chicago;', ' No history of health volunteerism;', ' No history of breast cancer; and', ' Lack of a mammogram within the last two years', 'Exclusion Criteria:', ' Not meeting all inclusion criteria;', ' Women will be excluded if they participated in formative focus groups'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Have Obtained Breast Cancer Screening', ' Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Empowerment', ' Arm/Group Description: Behavior: Empowerment', ' Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 49 90.7%', 'Results 2: ', ' Arm/Group Title: Education', ' Arm/Group Description: Behavior: Education', ' Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 29 51.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 0/69 (0.00%)']}

a9d5c664-896f-4bb1-95e7-1deaa88848ef

Comparison

Adverse Events

NCT00471276

NCT00951665

Gastrointestinal haemorrhage was more common in patients from cohort 1 of the primary trial than cohort 1 of the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00471276', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib', ' Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven diagnosis of breast cancer', ' Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy', ' Patients with at least one measurable lesion as per RECIST', 'Exclusion Criteria:', ' Inflammatory breast cancer', ' Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response', ' Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent ( 30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.', ' Time frame: Baseline, Week 9, and every 8 weeks up to Month 34', 'Results 1: ', ' Arm/Group Title: Sunitinib', ' Arm/Group Description: Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.', ' Overall Number of Participants Analyzed: 83', ' Measure Type: Number', ' Unit of Measure: Participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/83 (15.66%)', ' Cardiac failure congestive 1/83 (1.20%)', ' Hypothyroidism 1/83 (1.20%)', ' Nausea 2/83 (2.41%)', ' Vomiting 2/83 (2.41%)', ' Diarrhea 1/83 (1.20%)', ' Gastrointestinal Haemorrhage 1/83 (1.20%)', ' Asthenia 1/83 (1.20%)', ' Hyperbilirubinaemia 1/83 (1.20%)', ' Anal abscess 1/83 (1.20%)', ' Dehydration 3/83 (3.61%)', ' Decreased appetite 1/83 (1.20%)']}

{'Clinical Trial ID': 'NCT00951665', 'Intervention': ['INTERVENTION 1: ', ' Phase Ib Regimen 1', ' Participants received T-DM1 Q3W + paclitaxel QW intravenously.', 'INTERVENTION 2: ', ' Phase Ib Regimen 2', ' Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented HER2-positive locally advanced or metastatic breast cancer', ' Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments', ' Prior trastuzumab in any line of therapy (Phase Ib patients only)', ' No prior T-DM1 or pertuzumab therapy', ' Measurable or evaluable disease', ' Cardiac ejection fraction >=50% by either echocardiogram or multigated acquisition scan', ' Life expectancy >= 90 days as assessed by the investigator', 'Exclusion Criteria:', ' Fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving <=25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment', ' History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued', ' Peripheral neuropathy of Grade >= 2 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase Ib patients)', ' Peripheral neuropathy of Grade >/=1 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase IIa patients)', ' History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 500 mg/m^2; Liposomal doxorubicin > 900 mg/m^2; Epirubicin > 720 mg/m^2', ' History of clinically significant cardiac dysfunction', ' Brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment.', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent HER2-positive breast cancer or other malignancy with a similar expected curative outcome'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death', ' An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.', ' Time frame: Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later', 'Results 1: ', ' Arm/Group Title: Phase Ib Regimen 1', ' Arm/Group Description: Participants received T-DM1 Q3W + paclitaxel QW intravenously.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: participants Any AEs: 26', ' Any SAEs: 7', ' Death: 1', ' Any AEs Grade 3: 19', ' Any AEs Grade 4: 0', ' AEs leading to T-DM1 discontinuation: 3', ' AEs leading to paclitaxel discontinuation: 20', ' AEs leading to pertuzumab discontinuation: NA [1]', 'Results 2: ', ' Arm/Group Title: Phase Ib Regimen 2', ' Arm/Group Description: Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: participants Any AEs: 10', ' Any SAEs: 5', ' Death: 0', ' Any AEs Grade 3: 5', ' Any AEs Grade 4: 2', ' AEs leading to T-DM1 discontinuation: 1', ' AEs leading to paclitaxel discontinuation: 7', ' AEs leading to pertuzumab discontinuation: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/26 (26.92%)', ' Febrile neutropenia 1/26 (3.85%)', ' Neutropenia 0/26 (0.00%)', ' Thrombocytopenia 0/26 (0.00%)', ' Cardiac failure congestive 0/26 (0.00%)', ' Extrasystoles 0/26 (0.00%)', ' Nausea 1/26 (3.85%)', ' Abdominal pain 0/26 (0.00%)', ' Constipation 0/26 (0.00%)', ' Gastrointestinal haemorrhage 0/26 (0.00%)', ' Death - unknown cause 1/26 (3.85%)', ' Thrombosis in device 0/26 (0.00%)', 'Adverse Events 2:', ' Total: 5/10 (50.00%)', ' Febrile neutropenia 0/10 (0.00%)', ' Neutropenia 0/10 (0.00%)', ' Thrombocytopenia 1/10 (10.00%)', ' Cardiac failure congestive 0/10 (0.00%)', ' Extrasystoles 0/10 (0.00%)', ' Nausea 0/10 (0.00%)', ' Abdominal pain 0/10 (0.00%)', ' Constipation 0/10 (0.00%)', ' Gastrointestinal haemorrhage 0/10 (0.00%)', ' Death - unknown cause 0/10 (0.00%)', ' Thrombosis in device 0/10 (0.00%)']}

62b5fe62-470d-46e3-82a6-d57cd6cab452

Comparison

Results

NCT01106040

NCT01441596

the primary trial and the secondary trial are not studying patient PFS, ORR or DLTs.

Entailment

{'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%)']}

{'Clinical Trial ID': 'NCT01441596', 'Intervention': ['INTERVENTION 1: ', ' Afatinib Mono', ' Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.', 'INTERVENTION 2: ', ' Afatinib+Vino', ' Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.'], 'Eligibility': ['Inclusion criteria:', ' patients with HER2 positive breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after a HER2 inhibitor (Trastuzumab and/or Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)', ' at least one measurable and progressive lesion in the brain (=10 mm on T1-weighted, gadolinium-enhanced Magnetic Resonance Imaging). Measurable or non measurable extracranial metastases allowed.', ' previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).', ' previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.', ' Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade = 1 from any acute CTCAE v. 3.0 grade =2 side effects of previous treatments.', ' prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.', 'Exclusion criteria:', ' Prior treatment with HER2- tyrosine kinase inhibitor other than lapatinib', ' Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).', " Significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or Common Terminology Criteria (CTC) grade =2 diarrhoea of any aetiology."], 'Results': ['Outcome Measurement: ', ' Patient Benefit Rate at 12 Weeks', ' Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1', ' Time frame: 12 weeks from randomisation', 'Results 1: ', ' Arm/Group Title: Afatinib Mono', ' Arm/Group Description: Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)', 'Results 2: ', ' Arm/Group Title: Afatinib+Vino', ' Arm/Group Description: Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m administered intravenously on days 1, 8, 15 in a 3-weekly course.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34.2 (19.6 to 51.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/40 (45.00%)', ' Anaemia 0/40 (0.00%)', ' Febrile neutropenia 0/40 (0.00%)', ' Progressive cerebellar degeneration 0/40 (0.00%)', ' Vertigo 0/40 (0.00%)', ' Diarrhoea 3/40 (7.50%)', ' Dysphagia 0/40 (0.00%)', ' Enteritis 0/40 (0.00%)', ' Ileus 0/40 (0.00%)', ' Intestinal obstruction 0/40 (0.00%)', ' Nausea 1/40 (2.50%)', ' Stomatitis 1/40 (2.50%)', ' Subileus 0/40 (0.00%)', ' Vomiting 3/40 (7.50%)', 'Adverse Events 2:', ' Total: 24/37 (64.86%)', ' Anaemia 1/37 (2.70%)', ' Febrile neutropenia 3/37 (8.11%)', ' Progressive cerebellar degeneration 0/37 (0.00%)', ' Vertigo 0/37 (0.00%)', ' Diarrhoea 5/37 (13.51%)', ' Dysphagia 1/37 (2.70%)', ' Enteritis 1/37 (2.70%)', ' Ileus 1/37 (2.70%)', ' Intestinal obstruction 1/37 (2.70%)', ' Nausea 0/37 (0.00%)', ' Stomatitis 1/37 (2.70%)', ' Subileus 1/37 (2.70%)', ' Vomiting 2/37 (5.41%)']}

de349a2d-80ee-4c34-ab9f-38eb467c77d7

Comparison

Intervention

NCT00446030

NCT00975676

the primary trial and the secondary trial have no overlap in the drugs they use for their interventions.

Entailment

{'Clinical Trial ID': 'NCT00446030', 'Intervention': ['INTERVENTION 1: ', ' Stratum 1: TAC + Bevacizumab', ' HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.', 'INTERVENTION 2: ', ' Stratum 2: TCH + Bevacizumab', ' HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Participants who met the following criteria were eligible for this study:', ' Woman aged 18 to 70 years, inclusive', ' Had histologically proven breast cancer with the most recent surgery done for breast cancer up to 60 days prior to study registration', ' Had definitive surgical treatment - either mastectomy, or breast conserving surgery with axillary lymph node dissection (or sentinel lymph node biopsy) for operable breast cancer (T1-3, clinical N0-1, and M0)', ' Must have been either "lymph node positive" or "high risk lymph node negative"', ' Were lymph node positive participants who had at least 1 axillary lymph node involved by breast cancer. (with lymph node metastasis >0.2 mm)', ' Were high risk lymph node negative participants had no lymph node involvement and at least 1 of the following factors:', ' tumor size >2 cm', ' estrogen receptor (ER) and progesterone receptor (PR) status negative', ' histologic and/or nuclear Grade 2/3', ' age <35 years', ' Were participants with the Human Epidermal growth factor Receptor 2 (HER2/neu) status (positive or negative) known at the time of signing the informed consent', ' Had the estrogen and progesterone receptor status known prior to study registration', ' Had Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1', ' Had normal cardiac function, confirmed by left ventricular ejection fraction (LVEF) or shortening fraction (echocardiography [ECHO] or multiple-gated acquisition [MUGA] scan respectively)', ' Had the following hematology criteria confirmed within 2 weeks prior to study registration:', ' Absolute neutrophil count (ANC) >1,500/microL', ' Platelets >100,000/microL', ' Hemoglobin 9 g/dL', ' Met hepatic function evaluation criteria for bilirubin and AST levels within 2 weeks prior to study registration', ' Had completed staging work-up within 35 days (within 1 year for mammography or breast magnetic resonance imaging (MRI) prior to study registration', ' May have had MammoSite® brachytherapy radiation when performed immediately following surgery and prior to receiving chemotherapy. The balloon catheter must have been removed at least 28 days prior to the start of study treatment', ' May have had bilateral, synchronous breast cancer provided one primary tumor met the staging criteria', ' Women of child bearing potential must have had a negative pregnancy test within 14 days prior to day 1 cycle 1', ' Had consented to using an effective, non-hormonal method of contraception while receiving study treatment and for at least six (6) months following the last dose of bevacizumab, and must have been advised not to breast feed for at least six (6) months following the last dose of bevacizumab.', ' Signed an informed consent prior to beginning any protocol-specific procedures, and had documented expected cooperation during the study treatment and follow-up periods', 'Exclusion Criteria:', ' Participants with the following criteria were excluded from this study:', ' Had prior systemic anticancer therapy for invasive breast cancer (immunotherapy,hormonotherapy, chemotherapy)', ' Had prior anthracycline therapy, taxoids, or platinum salts for any malignancy', ' Had prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy', ' Was pregnant or lactating', ' Had pre-existing motor or sensory neurotoxicity of a severity >Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0', ' Had cardiac disease or risk for same as follows:', ' Any documented myocardial infarction', ' Angina pectoris that required the use of anti-anginal medication', ' Any history of documented congestive heart failure', ' Grade 3 or Grade 4 cardiac arrhythmia (NCI CTCAE, version 3.0)', ' Clinically significant valvular heart disease', ' Had cardiomegaly', ' Had poorly controlled hypertension, i.e., diastolic greater than 100 mmHg. (Participants who were well controlled on medication were eligible)', ' Were currently receiving medications administered for cardiac arrhythmia, angina or congestive heart failure (e.g., digitalis, beta-blockers, calcium channel-blockers), that alter cardiac conduction, unless the medications were administered for other reasons (e.g., hypertension)', ' Had other serious illness or medical conditions including', ' History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that prohibited the understanding and giving of informed consent', ' Active uncontrolled infection', ' Active peptic ulcer', ' Unstable diabetes mellitus', ' with symptomatic, intrinsic lung disease resulting in dyspnoea at rest', ' Clinically significant peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Urine protein:creatinine ratio >1.0 at screening', ' History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, inflammatory bowel disease or other gastrointestinal condition increasing the risk of perforation within 6 months of beginning chemotherapy', ' Serious, non-healing wound, ulcer, or bone fracture', ' Known central nervous system (CNS) disease', ' History of stroke or transient ischemic attack (TIA)', ' Known hepatic cirrhosis', ' Had past or current history of neoplasm other than breast carcinoma, except for:', ' Curatively treated non-melanoma skin cancer', ' In situ carcinoma of the cervix', ' Other cancer curatively treated and with no evidence of disease for at least 10 years', ' Ductal carcinoma in-situ (DCIS) of the breast', ' Lobular carcinoma in-situ (LCIS) of the breast', ' Was currently on therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer', ' Had chronic treatment with corticosteroids unless initiated >6 months prior to study registration and at low dose (<20 mg methylprednisolone or equivalent)', ' Had concurrent treatment with ovarian hormonal replacement therapy', ' Had concurrent treatment with other experimental drugs', ' Had concurrent treatment with any other anticancer therapy', ' Was male', ' Had known hypersensitivity to Chinese hamster ovary products or other recombinant human or humanized antibodies and/or hypersensitivity to any of the study drugs or their ingredients (e.g., polysorbate 80 in docetaxel)', ' Had minor surgical procedures within 7 days prior to day 1 of study treatment; or major surgical procedures within 28 days prior to day 1 of study treatment or had any anticipated a surgical procedure during the chemotherapy portion of this study', ' Was directly (or was a relative of the study staff) involved in the conduct of the protocol', ' Had a mental condition or psychiatric disorder rendering her unable to understand the nature, scope, and possible consequences of the study', ' Was unlikely to comply with protocol'], 'Results': ['Outcome Measurement: ', ' Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)', ' The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.', ' Time frame: up to 2 years', 'Results 1: ', ' Arm/Group Title: Stratum 1: TAC + Bevacizumab', ' Arm/Group Description: HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.', ' Overall Number of Participants Analyzed: 92', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percentage of Participants 4.3 (1.2 to 10.8)', 'Results 2: ', ' Arm/Group Title: Stratum 2: TCH + Bevacizumab', ' Arm/Group Description: HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.', ' Overall Number of Participants Analyzed: 34', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percentage of Participants 0 (0.0 to 10.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/92 (29.35%)', ' FEBRILE NEUTROPENIA *4/92 (4.35%)', ' NEUTROPENIA *3/92 (3.26%)', ' THROMBOCYTOPENIA *0/92 (0.00%)', ' CARDIAC FAILURE CONGESTIVE *3/92 (3.26%)', ' ATRIAL FIBRILLATION *1/92 (1.09%)', ' ABDOMINAL PAIN *1/92 (1.09%)', ' DUODENAL ULCER *1/92 (1.09%)', ' NAUSEA *1/92 (1.09%)', ' NEUTROPENIC COLITIS *1/92 (1.09%)', ' VOMITING *1/92 (1.09%)', ' ADVERSE DRUG REACTION *1/92 (1.09%)', 'Adverse Events 2:', ' Total: 7/34 (20.59%)', ' FEBRILE NEUTROPENIA *0/34 (0.00%)', ' NEUTROPENIA *0/34 (0.00%)', ' THROMBOCYTOPENIA *2/34 (5.88%)', ' CARDIAC FAILURE CONGESTIVE *0/34 (0.00%)', ' ATRIAL FIBRILLATION *0/34 (0.00%)', ' ABDOMINAL PAIN *0/34 (0.00%)', ' DUODENAL ULCER *0/34 (0.00%)', ' NAUSEA *0/34 (0.00%)', ' NEUTROPENIC COLITIS *0/34 (0.00%)', ' VOMITING *0/34 (0.00%)', ' ADVERSE DRUG REACTION *0/34 (0.00%)']}

{'Clinical Trial ID': 'NCT00975676', 'Intervention': ['INTERVENTION 1: ', ' Triptorelin Plus Tamoxifen', ' Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.', 'INTERVENTION 2: ', ' Triptorelin Plus Exemestane', ' Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed resected breast cancer', ' Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required', ' Randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane', ' Hormone receptor status:', ' Estrogen receptor- and/or progesterone receptor-positive tumor', ' PATIENT CHARACTERISTICS:', ' Premenopausal', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Estrogen Levels (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S]) at Different Time Points During the First 4 Years of Treatment With Triptorelin (Trip) in Combination With Either Tamoxifen (T) or Exemestane (E), IBCSG 24-02 SOFT-EST Substudy', ' Estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.', ' Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization', 'Results 1: ', ' Arm/Group Title: Triptorelin Plus Tamoxifen', ' Arm/Group Description: Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.', ' Overall Number of Participants Analyzed: 26', ' Mean (Standard Deviation)', ' Unit of Measure: pg/mL Estradiol (E2) levels at baseline (0 months): 26 participants', ' 109.81 (119.151)', ' Estradiol (E2) levels at 3 months: 25 participants', ' 4.876 (7.123)', ' Estradiol (E2) levels at 6 months: 24 participants', ' 3.761 (2.02)', ' Estradiol (E2) levels at 12 months: 20 participants', ' 4.013 (2.765)', ' Estradiol (E2) levels at 18 months: 20 participants', ' 7.306 (16.325)', ' Estradiol (E2) levels at 24 months: 15 participants', ' 4.453 (3.347)', ' Estradiol (E2) levels at 36 months: 14 participants', ' 3.704 (2.138)', ' Estradiol (E2) levels at 48 months: 14 participants', ' 5.914 (8.959)', ' Estrone (E1) levels at baseline (0 months): 26 participants', ' 60.27 (52.4)', ' Estrone (E1) levels at 3 months: 25 participants', ' 17.8 (6.73)', ' Estrone (E1) levels at 6 months: 24 participants', ' 18.66 (7.54)', ' Estrone (E1) levels at 12 months: 21 participants', ' 19.05 (8.4)', ' Estrone (E1) levels at 18 months: 20 participants', ' 18.64 (9.35)', ' Estrone (E1) levels at 24 months: 15 participants', ' 18.96 (7.63)', ' Estrone (E1) levels at 36 months: 14 participants', ' 19.49 (7.32)', ' Estrone (E1) levels at 48 months: 14 participants', ' 19.14 (7.24)', ' Estrone sulfate (E1S) levels at baseline (0 months): 26 participants', ' 1437 (1825.06)', ' Estrone sulfate (E1S) levels at 3 months: 25 participants', ' 281.4 (183.44)', ' Estrone sulfate (E1S) levels at 6 months: 24 participants', ' 259 (167.23)', ' Estrone sulfate (E1S) levels at 12 months: 21 participants', ' 278.5 (236.38)', ' Estrone sulfate (E1S) levels at 18 months: 20 participants', ' 281.8 (160.6)', ' Estrone sulfate (E1S) levels at 24 months: 14 participants', ' 242.6 (96.75)', ' Estrone sulfate (E1S) levels at 36 months: 14 participants', ' 249.4 (113.27)', ' Estrone sulfate (E1S) levels at 48 months: 13 participants', ' 231.1 (93.46)', 'Results 2: ', ' Arm/Group Title: Triptorelin Plus Exemestane', ' Arm/Group Description: Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.', ' Overall Number of Participants Analyzed: 83', ' Mean (Standard Deviation)', ' Unit of Measure: pg/mL Estradiol (E2) levels at baseline (0 months): 81 participants', ' 96.55 (151.235)', ' Estradiol (E2) levels at 3 months: 67 participants', ' 3.973 (8.439)', ' Estradiol (E2) levels at 6 months: 66 participants', ' 3.672 (8.006)', ' Estradiol (E2) levels at 12 months: 68 participants', ' 2.486 (5)', ' Estradiol (E2) levels at 18 months: 65 participants', ' 2.527 (6.204)', ' Estradiol (E2) levels at 24 months: 62 participants', ' 2.52 (6.566)', ' Estradiol (E2) levels at 36 months: 60 participants', ' 1.654 (2.764)', ' Estradiol (E2) levels at 48 months: 50 participants', ' 9.073 (57.307)', ' Estrone (E1) levels at baseline (0 months): 81 participants', ' 65.42 (78.12)', ' Estrone (E1) levels at 3 months: 67 participants', ' 2.93 (3.33)', ' Estrone (E1) levels at 6 months: 66 participants', ' 2.73 (3.12)', ' Estrone (E1) levels at 12 months: 68 participants', ' 3.71 (6.35)', ' Estrone (E1) levels at 18 months: 65 participants', ' 8.47 (33.42)', ' Estrone (E1) levels at 24 months: 62 participants', ' 4.69 (9.16)', ' Estrone (E1) levels at 36 months: 60 participants', ' 4.93 (9.16)', ' Estrone (E1) levels at 48 months: 50 participants', ' 8.53 (35.07)', ' Estrone sulfate (E1S) levels at baseline (0 months): 81 participants', ' 1371 (1763.84)', ' Estrone sulfate (E1S) levels at 3 months: 67 participants', ' 56.02 (133.71)', ' Estrone sulfate (E1S) levels at 6 months: 66 participants', ' 54.7 (97.66)', ' Estrone sulfate (E1S) levels at 12 months: 68 participants', ' 47.31 (130.45)', ' Estrone sulfate (E1S) levels at 18 months: 64 participants', ' 63.52 (175.19)', ' Estrone sulfate (E1S) levels at 24 months: 59 participants', ' 73.56 (258.29)', ' Estrone sulfate (E1S) levels at 36 months: 60 participants', ' 53.27 (151.03)', ' Estrone sulfate (E1S) levels at 48 months: 46 participants', ' 112 (556.81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

0d37bf26-bc74-4a01-9bc9-61e2fa3051da

Comparison

Results

NCT02425891

NCT00593827

the secondary trial and the primary trial both measure PFS of their patient cohorts.

Entailment

{'Clinical Trial ID': 'NCT02425891', 'Intervention': ['INTERVENTION 1: ', ' Placebo Plus Nab-Paclitaxel', ' Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Atezolizumab Plus Nab-Paclitaxel', ' Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression', ' No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC', ' Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)', ' A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor', ' Eastern Cooperative Oncology Group performance status of 0 or 1', ' Measurable disease as defined by RECIST v1.1', ' Adequate hematologic and end-organ function', 'Exclusion Criteria:', ' Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases', ' Leptomeningeal disease', ' Pregnancy or lactation', ' History of autoimmune disease', ' Prior allogeneic stem cell or solid organ transplantation', ' Positive test for human immunodeficiency virus', ' Active hepatitis B or hepatitis C', ' Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants', ' PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.', ' Time frame: Baseline up to approximately 34 months', 'Results 1: ', ' Arm/Group Title: Placebo Plus Nab-Paclitaxel', ' Arm/Group Description: Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 451', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.49 (5.32 to 5.59)', 'Results 2: ', ' Arm/Group Title: Atezolizumab Plus Nab-Paclitaxel', ' Arm/Group Description: Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 451', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.16 (5.59 to 7.46)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 110/460 (23.91%)', ' ANAEMIA 1/460 (0.22%)', ' FEBRILE NEUTROPENIA 5/460 (1.09%)', ' HAEMOLYSIS 0/460 (0.00%)', ' LEUKOCYTOSIS 0/460 (0.00%)', ' NEUTROPENIA 1/460 (0.22%)', ' PANCYTOPENIA 1/460 (0.22%)', ' ACUTE MYOCARDIAL INFARCTION 0/460 (0.00%)', ' ANGINA UNSTABLE 1/460 (0.22%)', ' ARRHYTHMIA 1/460 (0.22%)', ' ATRIAL FIBRILLATION 1/460 (0.22%)', ' CARDIAC FAILURE 0/460 (0.00%)', 'Adverse Events 2:', ' Total: 80/430 (18.60%)', ' ANAEMIA 1/430 (0.23%)', ' FEBRILE NEUTROPENIA 1/430 (0.23%)', ' HAEMOLYSIS 1/430 (0.23%)', ' LEUKOCYTOSIS 1/430 (0.23%)', ' NEUTROPENIA 0/430 (0.00%)', ' PANCYTOPENIA 0/430 (0.00%)', ' ACUTE MYOCARDIAL INFARCTION 1/430 (0.23%)', ' ANGINA UNSTABLE 0/430 (0.00%)', ' ARRHYTHMIA 1/430 (0.23%)', ' ATRIAL FIBRILLATION 2/430 (0.47%)', ' CARDIAC FAILURE 2/430 (0.47%)']}

{'Clinical Trial ID': 'NCT00593827', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 16 mg/m^2', ' ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest', 'INTERVENTION 2: ', ' Ixabepilone 40 mg/m^2', ' ixabepilone 40 mg/m^2 every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) 50', ' Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer', ' Prior chemotherapy is permitted with no limit on the number of prior regimens', ' Two weeks or more have elapsed since last chemotherapy or radiation treatment', ' Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2', ' Is female, 18 yrs of age', ' Protocol defined appropriate laboratory values', ' Negative pregnancy test within 7 calendar days prior to registration', ' Has signed a patient informed consent', 'Exclusion Criteria:', ' Had prior treatment with ixabepilone or other epothilones', ' Has HER2+ disease', ' Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)', ' Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy', ' Is receiving concurrent investigational therapy or has received such therapy within the past 30 days', ' Has peripheral neuropathy > Grade 1', ' Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible', ' Is pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months', ' PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.', ' Time frame: From the date of randomization to 6-months on study', 'Results 1: ', ' Arm/Group Title: Ixabepilone 16 mg/m^2', ' Arm/Group Description: ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest', ' Overall Number of Participants Analyzed: 85', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 28.6 (18.9 to 38.9)', 'Results 2: ', ' Arm/Group Title: Ixabepilone 40 mg/m^2', ' Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 91', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 42.7 (31.5 to 53.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 25/82 (30.49%)', ' neutropenia 1/82 (1.22%)', ' anemia 1/82 (1.22%)', ' thrombocytopenia 1/82 (1.22%)', ' febrile neutropenia 0/82 (0.00%)', ' tachycardia 3/82 (3.66%)', ' fibrillation atrial 0/82 (0.00%)', ' supraventricular tachycardia 1/82 (1.22%)', ' ventricular tachycardia 1/82 (1.22%)', ' angina attack 0/82 (0.00%)', ' congestive heart failure 0/82 (0.00%)', ' flutter atrial 0/82 (0.00%)', 'Adverse Events 2:', ' Total: 30/89 (33.71%)', ' neutropenia 5/89 (5.62%)', ' anemia 1/89 (1.12%)', ' thrombocytopenia 1/89 (1.12%)', ' febrile neutropenia 2/89 (2.25%)', ' tachycardia 1/89 (1.12%)', ' fibrillation atrial 1/89 (1.12%)', ' supraventricular tachycardia 0/89 (0.00%)', ' ventricular tachycardia 0/89 (0.00%)', ' angina attack 1/89 (1.12%)', ' congestive heart failure 1/89 (1.12%)', ' flutter atrial 1/89 (1.12%)']}

69f7a93d-7134-40ec-aff3-50acd7119d2c

Single

Eligibility

NCT01299038

Joe has a known history of Hepatitis. However as he is over the age of 18 is still eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01299038', 'Intervention': ['INTERVENTION 1: ', ' Rosuvastatin 20mg', ' Rosuvastatin 20mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', 'INTERVENTION 2: ', ' Rosuvastatin 40mg', ' Rosuvastatin 40mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Metastatic adenocarcinoma of the breast (Stage IV)', ' Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)', ' Minimum age 18 years', ' ECOG Performance status of 0, 1 or 2', ' Normal organ and marrow function as defined in the protocol', 'Exclusion Criteria:', ' Participants may not be receiving any other study agents', ' Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks', ' Any statin therapy within the last 3 weeks', ' Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)', ' Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors', ' Conditions predisposing to renal failure secondary to rhabdomyolysis', ' Recent history of heavy alcohol use as judged by the treating physician', ' Known to be pregnant (testing not required) or nursing', ' History of rhabdomyolysis on statin therapy', ' Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'], 'Results': ['Outcome Measurement: ', ' Mean Change of Tissue Factor Bearing Microparticles', ' Comparison of plasma microparticle concentration between baseline and week 4', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: Rosuvastatin 20mg', ' Arm/Group Description: Rosuvastatin 20mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', ' Overall Number of Participants Analyzed: 8', ' Mean (Standard Deviation)', ' Unit of Measure: microparticles per microliter 102 (586)', 'Results 2: ', ' Arm/Group Title: Rosuvastatin 40mg', ' Arm/Group Description: Rosuvastatin 40mg taken orally once a day for 4 weeks', ' rosuvastatin: Taken orally once a day for 4 weeks', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: microparticles per microliter -618 (624)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

8de31b0f-7127-4c8b-b5e0-060e7a83fae5

Comparison

Adverse Events

NCT01008150

NCT00375427

In total the secondary trial recorded only 1 more case of Mucosal inflammation than the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01008150', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Paclitaxel + Trastuzumab Then A C', ' 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Trastuzumab', ' Doxorubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm 2: Paclitaxel + Neratinib Then A C', ' 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Neratinib', ' Doxorubicin', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer.', ' Submission of a block from the diagnostic biopsy sample and from the surgical sample, if gross residual disease greater than or equal to 1.0 cm was removed at the time of surgery, is required for all patients', ' Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.', ' The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.', ' Patients must have the ability to swallow oral medication.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Breast cancer must be determined to be HER2-positive prior to randomization. Assays using FISH or CISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.', ' Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1; cT3 and cN0 or cN1; Any cT and cN2 or cN3; or cT4', ' The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL', " The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and aspartate aminotransferase (AST) and ALT must be less than or equal to 1.5 x ULN for the lab.", ' Patients with alkaline phosphatase greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements for adequate hepatic function are met.', ' Patients with either unexplained skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.', ' Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.', " The left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multiple gated acquisition(MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's LLN.", 'Exclusion Criteria:', ' fine-needle aspiration (FNA) alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to randomization.', ' Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.)', ' Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 90 days prior to randomization.)', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiation therapy (RT). (Patients with a history of LCIS are eligible.)', ' Contralateral invasive breast cancer at any time. (Patients with contralateral DCIS or lobular carcinoma in situ (LCIS) are eligible.)', ' History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.', ' Known metastatic disease from any malignancy (solid tumor or hematologic).', ' Previous therapy with anthracyclines, taxanes, cyclophosphamide, trastuzumab, or neratinib for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.', ' Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)', ' Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.', ' Active hepatitis B or hepatitis C with abnormal liver function tests.', ' Intrinsic lung disease resulting in dyspnea.', ' Active infection or chronic infection requiring chronic suppressive antibiotics.', ' Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function.', ' Persistent greater than or equal to grade 2 diarrhea regardless of etiology.', ' Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.', ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).', ' Uncontrolled hypertension defined as a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)', ' Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; history of documented congestive heart failure (CHF); and documented cardiomyopathy.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Pregnancy or lactation at the time of randomization.', ' The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.', ' Use of any investigational agent within 4 weeks prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response in Breast and Axillary Lymph Nodes.', ' Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy', ' Time frame: At time of surgery, approximately 7 months', 'Results 1: ', ' Arm/Group Title: Arm 1: Paclitaxel + Trastuzumab Then A C', ' Arm/Group Description: 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Trastuzumab', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 16 38.1%', 'Results 2: ', ' Arm/Group Title: Arm 2: Paclitaxel + Neratinib Then A C', ' Arm/Group Description: 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Neratinib', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 14 33.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/42 (16.67%)', ' Febrile neutropenia 1/42 (2.38%)', ' Left venrticular dysfunction 1/42 (2.38%)', ' Cardiac valve disease 1/42 (2.38%)', ' Diarrhoea 0/42 (0.00%)', ' Abdominal pain 1/42 (2.38%)', ' Colitis 0/42 (0.00%)', ' Nausea 0/42 (0.00%)', ' Vomiting 0/42 (0.00%)', ' Pyrexia 0/42 (0.00%)', ' Influenza like illness 1/42 (2.38%)', ' Oedema peripheral 1/42 (2.38%)', ' Fatigue 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 7/42 (16.67%)', ' Febrile neutropenia 0/42 (0.00%)', ' Left venrticular dysfunction 1/42 (2.38%)', ' Cardiac valve disease 0/42 (0.00%)', ' Diarrhoea 0/42 (0.00%)', ' Abdominal pain 0/42 (0.00%)', ' Colitis 0/42 (0.00%)', ' Nausea 0/42 (0.00%)', ' Vomiting 0/42 (0.00%)', ' Pyrexia 2/42 (4.76%)', ' Influenza like illness 0/42 (0.00%)', ' Oedema peripheral 0/42 (0.00%)', ' Fatigue 0/42 (0.00%)']}

{'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%)']}

207a1d82-a61b-4b5f-bebf-0706def6729d

Single

Adverse Events

NCT01491737

There were 4 cases of Febrile neutropenia and heart failure in cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01491737', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy', ' Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.', 'INTERVENTION 2: ', ' Arm B: Trastuzumab + AI +/- Chemotherapy', ' Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.'], 'Eligibility': ['Inclusion Criteria:', ' Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer', ' Post-menopausal status over 1 year', ' HER2-positive as assessed by local laboratory on primary or metastatic tumor', ' Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive', ' At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1', 'Exclusion Criteria:', ' Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting', ' Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting', ' Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment', ' History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0', ' Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months', ' Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma', ' Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Progression-free survival (PFS) was defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum of target lesion diameters must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment. The primary analysis of PFS was planned to be performed when a total of 165 PFS events had occurred, and the final analysis after at least 60 months follow-up.', ' Time frame: Median [full range] of follow-up time on study for: Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B; Final Analysis: 73.20 [0.03-88.34] months vs. 71.06 [0.03-88.97] months in Arm A vs. Arm B', 'Results 1: ', ' Arm/Group Title: Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy', ' Arm/Group Description: Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.', ' Overall Number of Participants Analyzed: 129', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 18.89 (14.09 to 27.66)', ' Final Analysis: 20.63 (14.39 to 28.35)', 'Results 2: ', ' Arm/Group Title: Arm B: Trastuzumab + AI +/- Chemotherapy', ' Arm/Group Description: Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.', ' Overall Number of Participants Analyzed: 129', ' Median (95% Confidence Interval)', ' Unit of Measure: months Primary Analysis: 15.80 (11.04 to 18.56)', ' Final Analysis: 15.80 (11.04 to 18.66)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 46/127 (36.22%)', ' Febrile neutropenia 4/127 (3.15%)', ' Neutropenia 1/127 (0.79%)', ' Atrial fibrillation 2/127 (1.57%)', ' Cardiac failure 0/127 (0.00%)', ' Left ventricular dysfunction 4/127 (3.15%)', ' Mitral valve disease 1/127 (0.79%)', ' Myocardial ischaemia 1/127 (0.79%)', ' Sinus tachycardia 1/127 (0.79%)', ' Myocardial infarction 1/127 (0.79%)', ' Adrenal haemorrhage 1/127 (0.79%)', 'Adverse Events 2:', ' Total: 28/124 (22.58%)', ' Febrile neutropenia 2/124 (1.61%)', ' Neutropenia 1/124 (0.81%)', ' Atrial fibrillation 0/124 (0.00%)', ' Cardiac failure 1/124 (0.81%)', ' Left ventricular dysfunction 0/124 (0.00%)', ' Mitral valve disease 0/124 (0.00%)', ' Myocardial ischaemia 0/124 (0.00%)', ' Sinus tachycardia 0/124 (0.00%)', ' Myocardial infarction 0/124 (0.00%)', ' Adrenal haemorrhage 0/124 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

968aeaf1-44b9-4454-8c99-e3c207037485

Single

Eligibility

NCT02988986

Patients must have AST, ALP and ALT < 1.5 ULN to participate in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02988986', 'Intervention': ['INTERVENTION 1: ', ' TAK-228 Plus Tamoxifen', ' TAK-228 will be orally administered at 30 mg weekly for 16 weeks.', ' Tamoxifen will be orally administered at 20 mg daily for 16 weeks.', ' TAK-228: MTORC1/2 inhibitor', ' Tamoxifen: Non-steroidal anti-estrogen'], 'Eligibility': ['Inclusion Criteria:', ' Female or male 18 years of age.', ' Newly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as 1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show:', ' IHC 1+ or 0', ' In situ hybridization negative based on:', ' Single-probe average HER2 copy number < 4.0 signals/cell', ' Dual-probe HER2/CEP17 ratio < 2 with an average HER2 copy number < 4.0 signals/cell.', ' Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation.', ' Eastern Cooperative Oncology Group performance status and/or other performance status of 1.', ' Female patients who:', ' Are postmenopausal for at least 1 year before the screening visit, OR', ' Are surgically sterile, OR', ' If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the ICF through 90 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International, summary of product characteristics, etc.] after the last dose of the study drugs, OR', ' Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).', ' Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:', ' Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of the study drugs, OR', ' Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient', ' Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs.', ' Screening clinical laboratory values as specified below:', ' Bone marrow reserve consistent with: absolute neutrophil count 1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 9 g/dL (without transfusion) within 1 week preceding the administration of the study drugs;', " Hepatic status: Serum total bilirubin 1 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 and alanine aminotransferase 1.5 x ULN, and alkaline phosphatase 1.5 x ULN;", ' Renal status: Creatinine clearance 50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour);', ' Metabolic status: HbA1c < 7.0%, fasting serum glucose 130 mg/dL, and fasting triglycerides 300 mg/dL.', ' Ability to swallow oral medications.', ' Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.', ' Negative serum pregnancy test within 7 days prior to the administration of the study drugs for female patients of childbearing potential.', ' Patient must be accessible for treatment and follow-up.', ' Patient must be willing to undergo breast biopsies as required by the study protocol.', 'Exclusion Criteria:', ' Any patient with metastatic disease.', " Other clinically significant comorbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.", ' Known human immunodeficiency virus infection.', ' Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.', " Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment.", ' Diagnosed or treated for another malignancy within 2 years before administration of the first dose of the study drugs or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.', ' Breastfeeding or pregnant.', ' Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or an unknown reason that may alter the absorption of TAK-228. Patients with enteric stomata are also excluded.', ' Treatment with any investigational products within 2 weeks before administration of the first dose of the study drugs.', ' Poorly controlled diabetes mellitus (defined as HbA1c > 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.', ' History of any of the following within the last 6 months before administration of the first dose of the study drugs:', ' Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures', ' Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures', ' Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, and ventricular tachycardia)', ' Placement of a pacemaker for control of rhythm', ' New York Heart Association Class III or IV heart failure', ' Pulmonary embolism', ' Significant active cardiovascular or pulmonary disease including:', ' Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed.', ' Pulmonary hypertension', ' Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air', ' Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement', ' Medically significant (symptomatic) bradycardia', ' History of arrhythmia requiring an implantable cardiac defibrillator', ' Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)', ' Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.', ' Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of the study drugs.', ' Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.', ' Patients unwilling or unable to comply with the study protocol.', ' Patients previously treated with hormonal therapy (tamoxifen, AI) or PI3K, AKT, dual PI3K/mTOR, TORC1/2, or mTORC1 inhibitors.', ' Patients who are currently being treated with cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) other than the trial therapy.', ' Patients with hypersensitivity to mTOR inhibitors or tamoxifen.'], 'Results': ['Outcome Measurement: ', ' Ki67 Expression', ' Ki67 expression change from baseline to 6 weeks', ' Time frame: Baseline to 6 weeks', 'Results 1: ', ' Arm/Group Title: TAK-228 Plus Tamoxifen', ' Arm/Group Description: TAK-228 will be orally administered at 30 mg weekly for 16 weeks.', ' Tamoxifen will be orally administered at 20 mg daily for 16 weeks.', ' TAK-228: MTORC1/2 inhibitor', ' Tamoxifen: Non-steroidal anti-estrogen', ' Overall Number of Participants Analyzed: 23', ' Median (Inter-Quartile Range)', ' Unit of Measure: Percentage of cells with Ki67 expression Ki67 expression at baseline: 15 (10 to 25)', ' Ki67 expression at 6 weeks: 10 (2 to 38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/28 (3.57%)', ' hyperglycemia 1/28 (3.57%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2b79f9cc-4262-4353-ad28-91cda07a9b9a

Single

Eligibility

NCT00723398

Patients with diabetes insipidusare not suitable for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00723398', 'Intervention': ['INTERVENTION 1: ', ' Group 1: Control', ' Control, no intervention', 'INTERVENTION 2: ', ' Group 2: Raloxifene 60 mg', ' Raloxifene 60 mg Orally Daily'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy', ' Breast density greater than 25%', ' No hormone replacement therapy for at least six months prior to entry into this study', ' Non-smokers.', 'Exclusion Criteria:', ' History of stroke, pulmonary embolism or deep vein thrombosis', ' History of atherosclerotic heart disease', ' Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)', ' Diabetes mellitus', ' Uncontrolled hypertension (BP 140/90)', ' Presence of a psychiatric condition that would interfere with adherence to the protocol.'], 'Results': ['Outcome Measurement: ', ' Change in Absolute Breast Density', ' Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Group 1: Control', ' Arm/Group Description: Control, no intervention', ' Overall Number of Participants Analyzed: 53', ' Mean (Standard Deviation)', ' Unit of Measure: cm squared Absolute density at baseline: 53 participants', ' 65.53 (59.43)', ' Absolute density at 1 year: 48 participants', ' 59.29 (40.72)', ' Absolute density at 2 years: 46 participants', ' 54.34 (20.11)', 'Results 2: ', ' Arm/Group Title: Group 2: Raloxifene 60 mg', ' Arm/Group Description: Raloxifene 60 mg Orally Daily', ' Overall Number of Participants Analyzed: 53', ' Mean (Standard Deviation)', ' Unit of Measure: cm squared Absolute density at baseline: 53 participants', ' 64.39 (39.95)', ' Absolute density at 1 year: 41 participants', ' 60.48 (38.89)', ' Absolute density at 2 years: 38 participants', ' 60.57 (35.10)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/53 (0.00%)', ' Endometrial Cancer [1]0/53 (0.00%)', 'Adverse Events 2:', ' Total: 1/53 (1.89%)', ' Endometrial Cancer [1]1/53 (1.89%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d56ffd81-4007-477b-b3c3-0fdb89806931

Comparison

Intervention

NCT01373671

NCT00686127

Lidoderm products are used in a intervention arm 1 of the secondary trial, and an FFDM product is used in arm 1 of the primary trial

Contradiction

{'Clinical Trial ID': 'NCT01373671', 'Intervention': ['INTERVENTION 1: ', ' FFDM and DBT', ' FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration', 'INTERVENTION 2: ', ' FFDM Only', 'FFDM exam only'], 'Eligibility': ['Inclusion Criteria:', ' All subjects enrolled into the collection study must:', ' Provide signed informed consent after receiving a verbal and written explanation of the purpose and nature of the study', ' be females, 40 years of age or older at the screening mammographic evaluation or age 30 or older presenting for a biopsy and have one of the following mammograms:', ' o Normal cases at screening (BI-RADS® 1, 2 and 3):', ' have a screening mammogram that includes the four standard screening views (RCC, RMLO, LCC and LMLO), as well as have both MLO and CC DBT scans of each breast,', ' o Actionable cases at screening (BI-RADS® 0, 4 or 5) with final BI-RADS® 1, 2, 3, 4 or 5:', ' have a screening mammogram with four SSVs and any clinically necessary diagnostic mammographic views, such as straight lateral projections, rolled, magnification view and spot compression views, and, both MLO and CC DBT scans of each breast plus 4 SSVs repeated at the diagnostic or biopsy visit if the screening images are unavailable or were acquired more than 45 days prior to DBT acquisition,', ' have supporting ground-truth documentation for the final BI-RADS® assessment as follows:', ' A one (1) year FFDM follow up without evidence of cancer for normal cases not undergoing biopsy', ' A six (6) or twelve (12) month FFDM follow up confirming benign status for biopsy proven benign cases', ' Pathology report for either benign or malignant biopsy finding', 'Exclusion Criteria:', ' Subjects with any of the following conditions or who have had the following procedures will be excluded from this study:', ' Pregnant women or women who believe they may be pregnant or are trying to become pregnant.', ' Mastectomy patients', ' Subjects who have had lumpectomy 5 years prior to the study entry', ' Inmates (in accordance with 45 CFR 46.306) or mentally disabled individuals', ' BI-RADS® Category 6 (e.g., for which the mammogram was performed for the purpose of planning cancer therapy)', ' BI-RADS® Category 4 or 5 without confirming pathology reports will be considered incomplete', ' Subjects with mammograms that lack the required views or with views judged to be technically inadequate will be considered incomplete and the cases will not be considered for the MRMC reader studies', ' Subjects being accrued from the screening population who know that they will not be in the United States or available for follow up mammograms in one year.'], 'Results': ['Outcome Measurement: ', ' Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone', ' The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: FFDM and DBT', ' Arm/Group Description: FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration', ' Overall Number of Participants Analyzed: 300', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Mean (Standard Error)Unit of Measure: unitless: 0.8527 (0.0268)', 'Results 2: ', ' Arm/Group Title: FFDM Only', ' Arm/Group Description: FFDM exam only', ' Overall Number of Participants Analyzed: 300', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Mean (Standard Error)Unit of Measure: unitless: 0.7516 (0.0281)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/764 (0.26%)', ' Ovarian cancer * [1]1/764 (0.13%)', ' Pneumonia * [2]1/764 (0.13%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00686127', 'Intervention': ['INTERVENTION 1: ', ' Lidocaine Patch', ' Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', 'INTERVENTION 2: ', ' Placebo Patch', ' Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women >18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery', ' Has a healed incision(s)', ' Has no recurrent disease in the painful area', ' Is able to read, write and understand English', 'Exclusion Criteria:', ' Presence of another type of pain that is more severe than the neuropathic pain', ' Use of an opioid analgesic of greater than 60 mg codeine/day', ' Is actively trying to become pregnant', ' Has a medical contraindication to the use of lidocaine', ' Has an allergy to lidocaine', ' Is taking a coanalgesic for neuropathic pain.'], 'Results': ['Outcome Measurement: ', ' Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks', ' Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).', ' Time frame: Baseline, 12 weeks', 'Results 1: ', ' Arm/Group Title: Lidocaine Patch', ' Arm/Group Description: Lidocaine patch 5% (Lidoderm , Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: units on a scale ', 'Results 2: ', ' Arm/Group Title: Placebo Patch', ' Arm/Group Description: Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: units on a scale 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)']}

f62e6c20-862b-4ce3-9121-0d93ff050839

Comparison

Results

NCT02162719

NCT02131064

the primary trial and the secondary trial investigate the effects of their intervention on patient tpCR.

Contradiction

{'Clinical Trial ID': 'NCT02162719', 'Intervention': ['INTERVENTION 1: ', ' Ipatasertib and Paclitaxel', ' Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', 'INTERVENTION 2: ', ' Placebo and Paclitaxel', ' Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization', ' Measurable disease, according to the RECIST v1.1', ' Adequate hematologic and organ function within 14 days before the first study treatment', ' For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment', 'Exclusion Criteria:', ' Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent', ' Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1', ' Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer', ' Previous therapy with Akt, PI3K, and/or mTOR inhibitors', ' Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study', ' Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.', ' Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)', 'Results 1: ', ' Arm/Group Title: Ipatasertib and Paclitaxel', ' Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 6.18 (4.57 to 7.33)', 'Results 2: ', ' Arm/Group Title: Placebo and Paclitaxel', ' Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 4.93 (3.58 to 5.36)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/61 (29.51%)', ' Pancytopenia 0/61 (0.00%)', ' Febrile Neutropenia 2/61 (3.28%)', ' Constipation 0/61 (0.00%)', ' Diarrhoea 3/61 (4.92%)', ' Nausea 1/61 (1.64%)', ' Pancreatitis 1/61 (1.64%)', ' Death 0/61 (0.00%)', ' Pyrexia 2/61 (3.28%)', ' Cholestasis 0/61 (0.00%)', ' Atypical Pneumonia 1/61 (1.64%)', ' Cystitis 0/61 (0.00%)', ' Gastroenteritis 0/61 (0.00%)', ' Influenza 0/61 (0.00%)', 'Adverse Events 2:', ' Total: 12/62 (19.35%)', ' Pancytopenia 1/62 (1.61%)', ' Febrile Neutropenia 0/62 (0.00%)', ' Constipation 1/62 (1.61%)', ' Diarrhoea 0/62 (0.00%)', ' Nausea 0/62 (0.00%)', ' Pancreatitis 0/62 (0.00%)', ' Death 1/62 (1.61%)', ' Pyrexia 1/62 (1.61%)', ' Cholestasis 1/62 (1.61%)', ' Atypical Pneumonia 0/62 (0.00%)', ' Cystitis 1/62 (1.61%)', ' Gastroenteritis 1/62 (1.61%)', ' Influenza 1/62 (1.61%)']}

{'Clinical Trial ID': 'NCT02131064', 'Intervention': ['INTERVENTION 1: ', ' TCH + P', ' Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).', 'INTERVENTION 2: ', ' T-DM1 + P', ' Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cm', ' HER2-positive breast cancer', ' Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive', ' Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system', ' Known hormone receptor status of the primary tumor', ' Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Baseline Left Ventricular Ejection Fraction (LVEF) >/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)', ' Effective contraception as defined by protocol', 'Exclusion Criteria:', ' Stage IV (metastatic) breast cancer', ' Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer', ' Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer', ' Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes', ' Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy', ' History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years', ' Treatment with any investigational drug within 28 days prior to randomization', ' Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0', " Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study", ' Current pregnancy or breastfeeding'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples', ' tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.', ' Time frame: Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)', 'Results 1: ', ' Arm/Group Title: TCH + P', ' Arm/Group Description: Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).', ' Overall Number of Participants Analyzed: 221', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 56.1 (49.29 to 62.76)', 'Results 2: ', ' Arm/Group Title: T-DM1 + P', ' Arm/Group Description: Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).', ' Overall Number of Participants Analyzed: 223', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 44.4 (37.76 to 51.18)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 70/219 (31.96%)', ' Anaemia * 0/219 (0.00%)', ' Febrile neutropenia * 26/219 (11.87%)', ' Neutropenia * 7/219 (3.20%)', ' Thrombocytopenia * 1/219 (0.46%)', ' Cardiac failure * 2/219 (0.91%)', ' Sinus tachycardia * 1/219 (0.46%)', ' Left ventricular dysfunction * 2/219 (0.91%)', ' Abdominal pain * 1/219 (0.46%)', ' Abdominal pain upper * 1/219 (0.46%)', ' Colitis * 3/219 (1.37%)', 'Adverse Events 2:', ' Total: 30/223 (13.45%)', ' Anaemia * 3/223 (1.35%)', ' Febrile neutropenia * 3/223 (1.35%)', ' Neutropenia * 0/223 (0.00%)', ' Thrombocytopenia * 1/223 (0.45%)', ' Cardiac failure * 1/223 (0.45%)', ' Sinus tachycardia * 0/223 (0.00%)', ' Left ventricular dysfunction * 0/223 (0.00%)', ' Abdominal pain * 0/223 (0.00%)', ' Abdominal pain upper * 0/223 (0.00%)', ' Colitis * 0/223 (0.00%)']}

833eeb4b-4921-468a-947d-bacfc7816ae6

Comparison

Adverse Events

NCT00006110

NCT00464646

the secondary trial records several gastrointestinal adverse events, whereas the primary trial doesn’t record any GI adverse events.

Entailment

{'Clinical Trial ID': 'NCT00006110', 'Intervention': ['INTERVENTION 1: ', ' Herceptin Regimen After AC', ' Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).', 'INTERVENTION 2: ', ' Herceptin Regimen After TP', ' Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.'], 'Eligibility': ['Inclusion Criteria', ' Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast', ' Fine needle aspiration, core needle biopsy, or incisional biopsy allowed', ' No excisional biopsy', ' Any of the following:', ' Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)', ' Any T with N2 (including axillary lymph nodes matted to one another) or N3', ' Any T4, including inflammatory breast cancer', ' Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor', ' Supraclavicular or infraclavicular positive lymph nodes without distant metastases', ' Distant metastases with measurable disease in breast or lymph nodes', ' Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria', ' Measurable or evaluable disease', ' PATIENT CHARACTERISTICS:', ' Age: Not specified', ' Sex: Female', ' Menopausal status: Not specified', 'Performance status: Not specified', ' Life expectancy: Not specified', ' Hematopoietic:', ' White cell count > 3000 / mm3 Platelet count > 100,000 / mm3', ' Hemoglobin > 9 mg / dl Bilirubin < 1.5 x normal Creatinine < 1.5 x normal left ventricular ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception', ' Exclusions', ' Prior malignancies except:', ' Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix that has been curatively treated by surgery alone Nonbreast malignancy from which patient has been disease-free for 5 years and is at low risk of recurrence'], 'Results': ['Outcome Measurement: ', ' Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.', ' Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.', ' Time frame: 78 weeks (1.5 years)', 'Results 1: ', ' Arm/Group Title: Herceptin Regimen After AC', ' Arm/Group Description: Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Asymptomatic LVEF < 50%: 1 1.9%', ' Congestive Heart Failure: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Herceptin Regimen After TP', ' Arm/Group Description: Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Asymptomatic LVEF < 50%: 8 16.0%', ' Congestive Heart Failure: 1 2.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/52 (13.46%)', ' Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 0/52 (0.00%)', ' Atrial Fibrillation * 1/52 (1.92%)', ' Sepsis * 1/52 (1.92%)', ' Muscle weakness upper limb * 1/52 (1.92%)', ' Dizziness * 1/52 (1.92%)', ' Seizure * 1/52 (1.92%)', ' Nervous system disorders - Other, specify * [1]1/52 (1.92%)', 'Adverse Events 2:', ' Total: 1/30 (3.33%)', ' Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1/30 (3.33%)', ' Atrial Fibrillation * 0/30 (0.00%)', ' Sepsis * 0/30 (0.00%)', ' Muscle weakness upper limb * 0/30 (0.00%)', ' Dizziness * 0/30 (0.00%)', ' Seizure * 0/30 (0.00%)', ' Nervous system disorders - Other, specify * [1]0/30 (0.00%)']}

{'Clinical Trial ID': 'NCT00464646', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)', 'INTERVENTION 2: ', ' Cohort B', ' Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer'], 'Eligibility': ['Inclusion Criteria:', ' Conditions for eligibility for patients with LABC (Cohort A):', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.', ' Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)', ' Patients must have undergone either a total mastectomy or a lumpectomy.', ' Patients must have completed one of the following procedures for evaluation of pathologic nodal status.', ' Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or', ' Axillary lymphadenectomy without SN isolation procedure.', ' The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.', ' By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.', ' For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)', ' For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.', ' Conditions for patient eligibility (ALL patients)', ' The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.', ' Patients must be female.', ' The patient must be greater than or equal to 18 years old.', " The patient's ECOG performance status must be 0 or 1.", ' The tumor must be invasive adenocarcinoma of the breast on histologic examination.', ' The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.', ' At the time of study entry, blood counts must meet the following criteria:', ' Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.', ' Platelet count must be greater than/equal to 100,000/mm3.', ' Hemoglobin must be greater than/equal to 10 g/dL.', ' The following criteria for evidence of adequate hepatic function must be met:', " total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", ' alkaline phosphatase must be less than 2.5 x ULN for the lab; and', ' AST must be less than/equal to 1.5 x ULN for the lab.', ' Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.', ' Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.', ' Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, MRI, or biopsy.', ' Serum creatinine less than/equal to ULN for the lab.', ' Urine protein/creatinine (UPC) ratio must be less than 1.0.', " All patients must have their LVEF assessed by 2-D echocardiogram within 3 months prior to study entry. (MUGA scan may be substituted for 2-D echocardiogram based on institutional preferences.) The LVEF must be greater than/equal to 55% regardless of the institution's LLN.", " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if trastuzumab and bevacizumab therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.", 'Exclusion Criteria:', ' Conditions for patient ineligibility (Cohort A)', ' FNA alone to diagnose the primary tumor.', ' Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.', ' Condition for patient ineligibility (Cohort B)', ' Breast reconstruction using tissue expanders or implants at the time of mastectomy.', ' Conditions for patient ineligibility (ALL patients)', ' Definitive clinical or radiologic evidence of metastatic disease.', ' Synchronous bilateral invasive breast cancer.', ' History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.', ' History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.', ' Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)', ' Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:', ' Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.', ' History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.', ' Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' History of TIA or CVA.', ' History of other arterial thrombotic event within 12 months before study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' History of GI perforation, abdominal fistulae, or intra-abdominal abscess.', ' Anticipation of need for major surgical procedures (other than the breast surgery required for patients in Cohort A) during study therapy and for at least 3 months following completion of bevacizumab.', ' Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's CTCAE v3.0.", ' Conditions that would prohibit administration of corticosteroids.', ' History of hypersensitivity reaction to drugs formulated with polysorbate 80.', ' Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed according to institutional standards for women of child-bearing potential.)', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)', ' The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.', ' Time frame: Assessed at time of surgery on average at 8 months', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: participants 34', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/76 (21.05%)', ' Hemoglobin 0/76 (0.00%)', ' Left ventricular systolic function 1/76 (1.32%)', ' Hypertension 0/76 (0.00%)', ' Dehydration 1/76 (1.32%)', ' Diarrhea 1/76 (1.32%)', ' Hemorrhage, GI - stomach 0/76 (0.00%)', ' Perforation, GI - colon 1/76 (1.32%)', ' Ulcer, GI - stomach 0/76 (0.00%)', ' Pain- head/headache 3/76 (3.95%)', ' Pain- back 2/76 (2.63%)', 'Adverse Events 2:', ' Total: 5/29 (17.24%)', ' Hemoglobin 1/29 (3.45%)', ' Left ventricular systolic function 0/29 (0.00%)', ' Hypertension 1/29 (3.45%)', ' Dehydration 1/29 (3.45%)', ' Diarrhea 0/29 (0.00%)', ' Hemorrhage, GI - stomach 1/29 (3.45%)', ' Perforation, GI - colon 0/29 (0.00%)', ' Ulcer, GI - stomach 1/29 (3.45%)', ' Pain- head/headache 0/29 (0.00%)', ' Pain- back 0/29 (0.00%)']}

6dea5ffa-066d-45bf-b7e5-df3ae5bca0b6

Comparison

Intervention

NCT01129622

NCT01156987

the secondary trial and the primary trial both used MRI for their interventions.

Entailment

{'Clinical Trial ID': 'NCT01129622', 'Intervention': ['INTERVENTION 1: ', ' Letrozole, Breast Enhancement, Safety', ' Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.'], 'Eligibility': ['Inclusion Criteria:', ' Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)', 'Exclusion Criteria:', ' History of bilateral mastectomy, osteoporosis or renal impairment.'], 'Results': ['Outcome Measurement: ', ' Number of Women With Reduced Breast Parenchymal Enhancement', ' Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc - SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.', ' Time frame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement', 'Results 1: ', ' Arm/Group Title: Letrozole, Breast Enhancement, Safety', ' Arm/Group Description: Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: Number of participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)']}

{'Clinical Trial ID': 'NCT01156987', 'Intervention': ['INTERVENTION 1: ', ' Healthy Volunteers', ' Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.', 'INTERVENTION 2: ', ' Breast Cancer Patients', ' Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar'], 'Eligibility': ['Inclusion Criteria:', ' Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.', 'Exclusion Criteria:', ' Pregnancy', ' Ferromagnetic implants', ' History of shotgun wounds and shrapnel', ' Obesity (>250 pounds)', ' Cardiac pacemaker', ' Incompatible implanted medical device', ' Severe claustrophobia', ' Major surgeries with potential of ferromagnetic implants', ' Severe asthma and allergies', ' i-STAT system, a handheld blood analyzer (I-STAT) creatinine test, estimated glomerular filtration rate (GFR) <30', ' Metallic object (greater than 2 cm in length) in the breast', ' Metallic ink tatoo within 20 cm of the breast (approximately 8 inches)'], 'Results': ['Outcome Measurement: ', ' Lesions', ' Number of lesions detected', ' Time frame: at time of read by two radiologiests, compared to biopsy within 7 days.', 'Results 1: ', ' Arm/Group Title: Healthy Volunteers', ' Arm/Group Description: Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: lesions 0', 'Results 2: ', ' Arm/Group Title: Breast Cancer Patients', ' Arm/Group Description: Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: lesions 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 0/23 (0.00%)']}

c317750d-6ef7-494d-8040-2c7fa3d777fb

Single

Adverse Events

NCT00567190

There was exactly the same proportion of anemic patinets in both cohorts of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00567190', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab + Docetaxel', ' Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.', 'INTERVENTION 2: ', ' Placebo + Trastuzumab + Docetaxel', ' Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Participants with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; participants with de novo Stage IV disease are eligible)', ' Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC)', ' Left ventricular ejection fraction (LVEF) 50 percent (%) at baseline (within 42 days of randomization)', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment', 'Exclusion Criteria:', ' History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC, which must be stopped prior to randomization)', ' History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting', ' History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than (<)12 months', ' History of persistent Grade 2 hematologic toxicity resulting from previous adjuvant therapy', ' Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0, Grade 3 at randomization', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' Computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain is mandatory in cases of clinical suspicion of brain metastases', ' History of exposure to cumulative doses of anthracyclines', ' Current uncontrolled hypertension or unstable angina', ' History of congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception: atrial fibrillation or paroxysmal supraventricular tachycardia)', ' History of myocardial infarction within 6 months of randomization', ' History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy', ' Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy', ' Inadequate organ function, as defined in the protocol, within 28 days prior to randomization', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment', ' Pregnant or lactating women', ' History of receiving any investigational treatment within 28 days of randomization', ' Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)', ' Receipt of IV antibiotics for infection within 14 days of randomization', ' Current chronic daily treatment with corticosteroids (excluding inhaled steroids)', ' Known hypersensitivity to any of the study drugs', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) Determined by an Independent Review Facility', ' PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of 1 new lesion. For non-target lesions, PD was defined as the appearance of 1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.', ' Time frame: Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Docetaxel', ' Arm/Group Description: Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.', ' Overall Number of Participants Analyzed: 402', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 18.5 (15 to 23)', 'Results 2: ', ' Arm/Group Title: Placebo + Trastuzumab + Docetaxel', ' Arm/Group Description: Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.', ' Overall Number of Participants Analyzed: 406', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 12.4 (10 to 13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 116/396 (29.29%)', ' Anaemia 3/396 (0.76%)', ' Febrile neutropenia 20/396 (5.05%)', ' Granulocytopenia 1/396 (0.25%)', ' Leukopenia 1/396 (0.25%)', ' Neutropenia 19/396 (4.80%)', ' Atrial fibrillation 3/396 (0.76%)', ' Cardiac failure congestive 0/396 (0.00%)', ' Coronary artery disease 0/396 (0.00%)', ' Left ventricular dysfunction 7/396 (1.77%)', ' Myocardial infarction 3/396 (0.76%)', 'Adverse Events 2:', ' Total: 160/408 (39.22%)', ' Anaemia 3/408 (0.74%)', ' Febrile neutropenia 46/408 (11.27%)', ' Granulocytopenia 0/408 (0.00%)', ' Leukopenia 0/408 (0.00%)', ' Neutropenia 18/408 (4.41%)', ' Atrial fibrillation 0/408 (0.00%)', ' Cardiac failure congestive 2/408 (0.49%)', ' Coronary artery disease 1/408 (0.25%)', ' Left ventricular dysfunction 6/408 (1.47%)', ' Myocardial infarction 0/408 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

87eca8d2-72fe-4285-9884-6d2ec7bae6df

Comparison

Intervention

NCT01000662

NCT02413008

the secondary trial is testing a Gel which is applied inside the vagina, and the primary trial is testing an intervention which requires daily radiation of the breast(s).

Entailment

{'Clinical Trial ID': 'NCT01000662', 'Intervention': ['INTERVENTION 1: ', ' ARM 1 Daily Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', 'INTERVENTION 2: ', ' ARM 2 Weekly Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.'], 'Eligibility': ['Inclusion Criteria:', ' Pre or post-menopausal women with stage 0,I, and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment)', ' At least 2 weeks from last chemotherapy', ' Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast', ' More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation', ' Active connective tissue disorders, such as lupus or scleroderma', ' Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)', ' Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects', 'Time frame: Day 60', 'Results 1: ', ' Arm/Group Title: ARM 1 Daily Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 202', ' Measure Type: Number', ' Unit of Measure: participants 22', 'Results 2: ', ' Arm/Group Title: ARM 2 Weekly Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 198', ' Measure Type: Number', ' Unit of Measure: participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/202 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT02413008', 'Intervention': ['INTERVENTION 1: ', ' 0.005% Estriol Vaginal Gel', ' Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', 'INTERVENTION 2: ', ' Placebo Vaginal Gel', ' Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', 'Placebo'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent prior to beginning specific protocol procedures.', ' Patients must have histological confirmation of breast adenocarcinoma with stage I-IIIA, documented at a local pathology department.', ' The breast tumors must be estrogen-receptor positive and/or progesterone receptor positive ( 1% of stained tumor cells by Immunohistochemistry (IHC) as determined by the local laboratory) with any Human Epidermal Growth Factor Receptor 2(HER2) status.', ' Postmenopausal status defined as: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 Milli-international units per milliliter (mIU/ml) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.', ' Patient must be receiving the non-steroidal aromatase inhibitors anastrozole or letrozole as breast cancer treatment in the adjuvant setting for a minimum of 6 months.', ' Women suffering from moderate to severe vaginal dryness according to the FDA guidelines for drug development in postmenopausal women (Center for Drug Evaluation and Research, (CDER) Jan 2003). A moderate symptom will be considered if the symptom is present, bothersome and annoying, and a severe symptom will be considered if the symptom is present, bothersome and annoying, and interferes with the normal patient activity.', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.', ' Adequate bone marrow as defined by the following laboratory values:', ' Absolute Neutrophil Count (ANC) 1.5 x 109/L.', ' Platelets (plt) 100 x 109/L.', ' Hemoglobin (Hgb) 10 g/dl.', ' Patient has adequate organ function as defined by the following laboratory values:', ' Serum creatinine 1.5 x Upper Limit of Normal (ULN).', ' Bilirubin 1.5 × ULN.', ' Alkaline phosphatase 2 × ULN.', ' Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2 × ULN.', ' Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.', 'Exclusion Criteria:', ' Stage IIIB-IV breast cancer or bilateral breast cancer.', ' Treatment with any other current anti-tumoral therapy (chemotherapy, anti-Her2…etc) besides the NSAI. Pamidronate or Alendronate are permitted.', ' Prior history of other malignancy within 5 years of study entry, aside from non-melanoma skin cancer or carcinoma-in-situ of the uterine cervix adequately treated.', ' Postmenopausal uterine bleeding. Vaginal bleeding of unknown etiology.', ' Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound.', ' Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study.', ' Use of any hormone, natural (phytoestrogens) or herbal products for the treatment of menopausal symptoms within the last 3 months.', ' Current or previous history of thromboembolic disease or coagulopathies.', ' Severe cardiovascular or respiratory diseases in the previous 6 months.', ' Renal Impairment.', ' Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function).', ' Known human immunodeficiency virus infection.', ' Known hypersensitivity to NSAI.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.', ' Previous investigational treatment for any condition or participation in any clinical trial within 4 weeks of inclusion date.'], 'Results': ['Outcome Measurement: ', ' Variation in Serum Levels of Follicle Stimulating Hormone (FSH)', ' Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)', ' Time frame: from baseline to 12 weeks of treatment', 'Results 1: ', ' Arm/Group Title: 0.005% Estriol Vaginal Gel', ' Arm/Group Description: Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', ' Overall Number of Participants Analyzed: 50', ' Median (Inter-Quartile Range)', ' Unit of Measure: mIU/ml -2.8 (-13.1 to 7.4)', 'Results 2: ', ' Arm/Group Title: Placebo Vaginal Gel', ' Arm/Group Description: Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', ' Placebo', ' Overall Number of Participants Analyzed: 11', ' Median (Inter-Quartile Range)', ' Unit of Measure: mIU/ml 1.4 (-5.4 to 15.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/50 (2.00%)', ' Lymphoma [1]1/50 (2.00%)', 'Adverse Events 2:', ' Total: 0/11 (0.00%)', ' Lymphoma [1]0/11 (0.00%)']}

7a87c605-fc41-4d0a-9291-85e88f6eb510

Comparison

Results

NCT01964924

NCT00524303

the primary trial and the secondary trial both report results on pathologic evidence of invasive disease withing their patient cohorts after their interventions, using different outcome measurements.

Entailment

{'Clinical Trial ID': 'NCT01964924', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Trametinib, Akt Inhibitor GSK2141795)', ' PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.', ' PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Akt Inhibitor GSK2141795: Given PO', ' Laboratory Biomarker Analysis: Correlative studies', ' Trametinib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and HER2 by institutional guidelines', ' Patients must have measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1])', ' Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer', ' Patients must consent to both a pretreatment and a post-treatment mandatory research biopsy prior to enrolling on trial, and therefore, must have tissue (excluding bone or brain) that is amenable to biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Life expectancy of greater than 3 months', ' Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels', ' All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) grade =< 1 (except alopecia) at the time of enrollment', ' Absolute neutrophil count >= 1,500/mcL', ' Platelets >= 75,000/mcL', ' Total bilirubin =< 1.5 × institutional upper limit of normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal', ' Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)', ' Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min', ' Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg; anti-hypertensive medications are permitted', ' Patients must be at least 4 weeks from last radiation dose; patients must be at least 4 weeks from last chemotherapy, targeted therapy, or biologic therapy (exception allowed for a 2 week washout for patients who were on chemotherapy at less than a standard of care dose, as long as all other eligibility criteria are met); patients must be at least 4 weeks from last surgical procedure and recovered from all post-operative complications', ' 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 she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib monotherapy or in combination with GSK2141795 administration', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' History of another malignancy', ' Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible', ' History of interstitial lung disease or pneumonitis', ' History of type I diabetes mellitus; if a patient has type II diabetes, they must have a hemoglobin (hemoglobin A1C) =< 8%; patients with a screening fasting glucose > 120 mg/dL will be excluded', ' Uncontrolled hypothyroidism; patients must have a normal thyroid-stimulating hormone (TSH) per institutional standards at baseline', ' Patients who are receiving any other investigational agents', ' Individuals with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 3 weeks after completion of local therapy; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 3 weeks prior to study enrollment', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to trametinib monotherapy or trametinib in combination with GSK2141795', ' Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:', ' Other anti-cancer therapy while on study treatment (megestrol if used as an appetite stimulant is allowed)', " The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, yohimbe, saw palmetto, or ginseng)", ' Patients receiving strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible', ' History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, history of hyperviscosity or hypercoagulability syndromes; visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm Hg', ' 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 trametinib monotherapy or trametinib in combination with GSK2141795', ' Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR), Defined as the Proportion of Patients Who Have Had a Partial Response (PR) or Complete Response (CR) (RECIST 1.1 Based) Within the First 6 Months After Initiation of Therapy With Trametinib', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795)', ' Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.', ' PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Akt Inhibitor GSK2141795: Given PO', ' Laboratory Biomarker Analysis: Correlative studies', ' Trametinib: Given PO', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 5.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/37 (81.08%)', ' Anemia 1/37 (2.70%)', ' Leukocytosis 1/37 (2.70%)', ' Cardiac arrest 1/37 (2.70%)', ' Vertigo 1/37 (2.70%)', ' Diarrhea 0/37 (0.00%)', ' Dysphagia 1/37 (2.70%)', ' Enterocolitis 0/37 (0.00%)', ' Vomiting 0/37 (0.00%)', ' Death NOS 1/37 (2.70%)', ' Edema face 1/37 (2.70%)', ' Edema limbs 1/37 (2.70%)', ' Fever 1/37 (2.70%)']}

{'Clinical Trial ID': 'NCT00524303', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', 'INTERVENTION 2: ', ' Lapatinib', ' Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'], 'Eligibility': ['Inclusion Criteria:', ' Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA).', ' Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2).', ' ErbB2 overexpressing breast cancer, defined as one of the following definitions:', ' 3+ staining by immunohistochemistry (IHC),', ' a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus', ' a FISH ratio of more than 2.2.', ' Have either measurable or evaluable disease.', ' Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (Refer to Section 11.4).', ' Have LVEF within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.', ' Be deemed able to tolerate 8 cycles of preoperative chemotherapy, including 4 cycles with an anthracycline (epirubicin).', ' Must be willing to undergo 2 mandatory core biopsies (4 passes each) after diagnosis to obtain tissue for biologic expression profiling. Any subject with clinically palpable residual disease may undergo an optional third biopsy to allow identification of presumed pathways of resistance to therapy. This information might be useful in providing the subject with options for other targeted therapies if definitive surgery confirms residual disease. Definitive local therapy with surgery and radiation therapy as indicated will be performed after completion of 12 weeks of paclitaxel-based chemotherapy.', ' Are able to swallow and retain oral medication (intact pill).', ' Are able to complete all screening assessments as outlined in the protocol.', ' Have adequate organ function as defined in Table 4:', ' Table 1 Baseline Laboratory Values', ' Hematologic:', ' ANC (absolute neutrophil count) >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L', ' Hepatic:', ' albumin >2.5 g/dL serum bilirubin <1.25 x ULN AST / ALT <3 x ULN if no documented liver metastases AST / ALT <3 x ULN with documented liver metastases', ' Renal:', ' serum creatinine <2.0 mg/dL', ' OR - calculated creatinine clearance >40 mL/min', ' Are subjects aged >18 years with any menopausal status:', ' Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal)', ' Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:', " Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide.", ' Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer [Albain, 2002]. Progestogen may also affect the proliferative rate of endocrine-responsive tumors.', 'Exclusion Criteria:', ' Have received any prior chemotherapy.', ' Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.', ' Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.', ' Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.', " Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.", ' Have an active or uncontrolled infection.', ' Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Have active cardiac disease, defined as one or more of the following:', ' History of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction <6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient', ' Are pregnant or breastfeeding.', ' Have received concurrent treatment with an investigational agent or participate in another clinical trial.', ' Have received concurrent treatment with prohibited medications (refer to Section 5.8.2 for details on prohibited medications).', ' Have used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.', ' Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients.', ' Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy', ' A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.', ' Time frame: Week 26', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 54.0', 'Results 2: ', ' Arm/Group Title: Lapatinib', ' Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 45.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/32 (21.88%)', ' Febrile nuetropenia 3/32 (9.38%)', ' Neutropenia 3/32 (9.38%)', ' Anaemia 1/32 (3.13%)', ' Diarrhoea 0/32 (0.00%)', ' Vomiting 0/32 (0.00%)', ' Nausea 0/32 (0.00%)', ' Stomatitis 0/32 (0.00%)', ' Pyrexia 0/32 (0.00%)', ' Chest discomfort 0/32 (0.00%)', ' Cellilitis 0/32 (0.00%)', ' Diverticulitis 0/32 (0.00%)', ' Gastroenteritis 0/32 (0.00%)', 'Adverse Events 2:', ' Total: 7/34 (20.59%)', ' Febrile nuetropenia 0/34 (0.00%)', ' Neutropenia 0/34 (0.00%)', ' Anaemia 0/34 (0.00%)', ' Diarrhoea 2/34 (5.88%)', ' Vomiting 1/34 (2.94%)', ' Nausea 0/34 (0.00%)', ' Stomatitis 0/34 (0.00%)', ' Pyrexia 3/34 (8.82%)', ' Chest discomfort 0/34 (0.00%)', ' Cellilitis 1/34 (2.94%)', ' Diverticulitis 1/34 (2.94%)', ' Gastroenteritis 0/34 (0.00%)']}

fbb853c9-bed4-4cde-a283-2d91b23d35bf

Single

Eligibility

NCT00482391

Patients with a QT interval longer than half a second are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00482391', 'Intervention': ['INTERVENTION 1: ', ' AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB', " The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate."], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast', ' Bilateral synchronous breast tumors allowed', ' Any nodal status or tumor size allowed', ' No stage IV disease', ' HER2/neu-positive disease', ' 3+ by IHC OR FISH-amplified', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' ECOG performance status 0-1', ' Absolute neutrophil count 1,000/mm³', ' Platelet count 100,000/mm³', ' Bilirubin 1.1 mg/dL', ' SGOT or SGPT 2.5 times upper limit of normal (ULN)', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception during and after completion of study therapy', ' LVEF 50% by MUGA scan', ' No peripheral neuropathy > grade 1', ' No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix', ' No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL', ' No psychiatric illness or concurrent medical conditions that would preclude study treatment', ' No other conditions, including any of the following:', ' Unstable angina', ' Congestive heart failure', ' Myocardial infarction within the past 12 months', ' High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)', ' No QT prolongation (> 500 ms)', ' No active unresolved infections', ' No sensitivity to E. coli derived proteins', ' PRIOR CONCURRENT THERAPY:', ' Prior hormonal therapy for chemoprevention allowed', ' No prior trastuzumab (Herceptin®)', ' No prior anthracyclines', ' No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)', ' No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer', ' No concurrent drugs that may prolong the QT'], 'Results': ['Outcome Measurement: ', ' Number of Patients Who Completed All Planned Therapy', ' The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB', " Arm/Group Description: The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.", ' Overall Number of Participants Analyzed: 92', ' Measure Type: Number', ' Unit of Measure: participants 45'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/95 (24.21%)', ' Edema: limb 1/95 (1.05%)', ' Hematoma 1/95 (1.05%)', ' Hemoglobin 2/95 (2.11%)', ' Leukocytes (total WBC) 1/95 (1.05%)', ' Hypertension 1/95 (1.05%)', ' Hypotension 2/95 (2.11%)', ' Left ventricular diastolic dysfunction 1/95 (1.05%)', ' Prolonged QTc interval 1/95 (1.05%)', ' Sinus tachycardia 1/95 (1.05%)', ' Ocular/Visual - Other (specify) 1/95 (1.05%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

c3cc3621-a8ce-4f0d-a150-7e627f36e7c5

Single

Intervention

NCT01441596

Patients in cohort 1 of the primary trial may receive gradually increasing doses of Afatinib monotherapy, up to 160% of the starting dose.

Contradiction

{'Clinical Trial ID': 'NCT01441596', 'Intervention': ['INTERVENTION 1: ', ' Afatinib Mono', ' Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.', 'INTERVENTION 2: ', ' Afatinib+Vino', ' Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.'], 'Eligibility': ['Inclusion criteria:', ' patients with HER2 positive breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after a HER2 inhibitor (Trastuzumab and/or Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)', ' at least one measurable and progressive lesion in the brain (=10 mm on T1-weighted, gadolinium-enhanced Magnetic Resonance Imaging). Measurable or non measurable extracranial metastases allowed.', ' previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).', ' previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.', ' Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade = 1 from any acute CTCAE v. 3.0 grade =2 side effects of previous treatments.', ' prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.', 'Exclusion criteria:', ' Prior treatment with HER2- tyrosine kinase inhibitor other than lapatinib', ' Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).', " Significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or Common Terminology Criteria (CTC) grade =2 diarrhoea of any aetiology."], 'Results': ['Outcome Measurement: ', ' Patient Benefit Rate at 12 Weeks', ' Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1', ' Time frame: 12 weeks from randomisation', 'Results 1: ', ' Arm/Group Title: Afatinib Mono', ' Arm/Group Description: Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)', 'Results 2: ', ' Arm/Group Title: Afatinib+Vino', ' Arm/Group Description: Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m administered intravenously on days 1, 8, 15 in a 3-weekly course.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34.2 (19.6 to 51.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/40 (45.00%)', ' Anaemia 0/40 (0.00%)', ' Febrile neutropenia 0/40 (0.00%)', ' Progressive cerebellar degeneration 0/40 (0.00%)', ' Vertigo 0/40 (0.00%)', ' Diarrhoea 3/40 (7.50%)', ' Dysphagia 0/40 (0.00%)', ' Enteritis 0/40 (0.00%)', ' Ileus 0/40 (0.00%)', ' Intestinal obstruction 0/40 (0.00%)', ' Nausea 1/40 (2.50%)', ' Stomatitis 1/40 (2.50%)', ' Subileus 0/40 (0.00%)', ' Vomiting 3/40 (7.50%)', 'Adverse Events 2:', ' Total: 24/37 (64.86%)', ' Anaemia 1/37 (2.70%)', ' Febrile neutropenia 3/37 (8.11%)', ' Progressive cerebellar degeneration 0/37 (0.00%)', ' Vertigo 0/37 (0.00%)', ' Diarrhoea 5/37 (13.51%)', ' Dysphagia 1/37 (2.70%)', ' Enteritis 1/37 (2.70%)', ' Ileus 1/37 (2.70%)', ' Intestinal obstruction 1/37 (2.70%)', ' Nausea 0/37 (0.00%)', ' Stomatitis 1/37 (2.70%)', ' Subileus 1/37 (2.70%)', ' Vomiting 2/37 (5.41%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

84aa97cf-efce-484e-825e-5af509e5988f

Comparison

Intervention

NCT03076190

NCT03196635

Molecular Breast Imaging is not applied in either the primary trial or the secondary trial interventions, however all participants taking part in these studies will need to receive stem cell transplants.

Contradiction

{'Clinical Trial ID': 'NCT03076190', 'Intervention': ['INTERVENTION 1: ', ' Active Control Group', ' Health Education Active Control Group', 'INTERVENTION 2: ', ' My Surgical Success Treatment Group', ' My Surgical Success Intervention Group'], 'Eligibility': ['Inclusion Criteria:', ' Age 18+', ' Scheduled for breast cancer surgery', ' English speaking', ' Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video', 'Exclusion Criteria:', ' Any conditions causing inability to complete study procedures (e.g. education, cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the investigator.', ' Known pregnancy', ' Ongoing legal action related to pain or disability claim'], 'Results': ['Outcome Measurement: ', ' Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning', ' Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.', ' Time frame: Immediately post-treatment', 'Results 1: ', ' Arm/Group Title: Active Control Group', ' Arm/Group Description: Health Education Active Control Group', ' Overall Number of Participants Analyzed: 32', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.3)', ' Relevant: 4.7 (1.51)', ' Useful: 4.67 (1.52)', ' Satisfaction: 4.67 (1.56)', ' Likely to Use: 5.03 (1.3)', 'Results 2: ', ' Arm/Group Title: My Surgical Success Treatment Group', ' Arm/Group Description: My Surgical Success Intervention Group', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Easy to Understand: 5.9 (.2)', ' Relevant: 5.0 (1.6)', ' Useful: 5.1 (1.3)', ' Satisfaction: 5.2 (1.2)', ' Likely to Use: 5.3 (1.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

{'Clinical Trial ID': 'NCT03196635', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants, PA Compression Image Sets', ' All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', 'INTERVENTION 2: ', ' All Study Participants, TC Compression Image Sets', ' All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for FFDM screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.', 'Exclusion Criteria:', ' Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;', ' Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years ( 5 years) of the study exam date;', ' Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;', ' Are currently lactating; or', ' Have breast implants.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets', ' One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.', ' Time frame: Through study completion, on average 1 month', 'Results 1: ', ' Arm/Group Title: All Study Participants, PA Compression Image Sets', ' Arm/Group Description: All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%', 'Results 2: ', ' Arm/Group Title: All Study Participants, TC Compression Image Sets', ' Arm/Group Description: All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' ']}

a40e172a-8839-499d-896d-be71a7ca4905

Single

Intervention

NCT02202252

The difference between cohort 1 and 2 of the primary trial is assesment by ultrasonography and the insertion of an additional negative pressure drain for patients in cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT02202252', 'Intervention': ['INTERVENTION 1: ', ' Single Drain', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', 'INTERVENTION 2: ', ' Double Drain', ' Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer', ' Modified radical mastectomy', 'Exclusion Criteria:', ' Distant metastasis', ' Male breast cancer', 'Bleeding diathesis'], 'Results': ['Outcome Measurement: ', ' Patient Comfort Scale', ' Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).', ' Time frame: Postoperative 5 days', 'Results 1: ', ' Arm/Group Title: Single Drain', ' Arm/Group Description: Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 8)', 'Results 2: ', ' Arm/Group Title: Double Drain', ' Arm/Group Description: Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.', ' Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.', ' Overall Number of Participants Analyzed: 30', ' Median (Full Range)', ' Unit of Measure: units on a scale 3 (1 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' Total: 0/30 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

9e972e33-9ecd-4a8b-8337-7bee209f790b

Comparison

Intervention

NCT01943916

NCT01653964

All subjects in the primary trial and the secondary trial will be adminstered 4 mCi Tc-99m sestamibi and undergo Molecular breast imaging.

Contradiction

{'Clinical Trial ID': 'NCT01943916', 'Intervention': ['INTERVENTION 1: ', ' Overall Population', ' Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' 18 years of age or older', ' suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.', 'Exclusion Criteria:', ' presence of a condition or impediment that may interfere with imaging.', ' pregnant or lactating', ' undergoing neoadjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)', ' Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 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)', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: Overall Population', ' Arm/Group Description: Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.', ' Overall Number of Participants Analyzed: 1739', ' Mean (99% Confidence Interval)', " Unit of Measure: % benign+TPB masses correctly Id'd 14.9 (12.9 to 16.9)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/1972 (0.25%)', ' Atrial fibrillation [1]1/1972 (0.05%)', ' Cardiac failure congestive [2]1/1972 (0.05%)', ' Device breakage [3]1/1972 (0.05%)', ' Uterine Leiomyoma [4]1/1972 (0.05%)', ' Non-small cell lung cancer Stage I [5]1/1972 (0.05%)', ' Haemothorax [6]1/1972 (0.05%)', ' Pneumothorax [7]1/1972 (0.05%)']}

{'Clinical Trial ID': 'NCT01653964', 'Intervention': ['INTERVENTION 1: ', ' Molecular Breast Imaging', ' Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.'], 'Eligibility': ['Inclusion Criteria:', ' Subgroup 1, Patients with breast lesions:', ' -At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.', ' OR', ' -At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.', ' AND', ' Age > 40 years', ' Negative pregnancy test, postmenopausal, or surgically sterilized', ' Subgroup 2, Patients without known breast lesions:', ' Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI', ' No signs or symptoms of breast disease', ' Age > 40 years', ' Negative pregnancy test, postmenopausal, or surgically sterilized', 'Exclusion Criteria:', ' Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor', ' MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings', ' Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end', ' Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end', ' Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views', ' Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test', ' Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period.'], 'Results': ['Outcome Measurement: ', ' Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.', ' [Not Specified]', ' Time frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)', 'Results 1: ', ' Arm/Group Title: Molecular Breast Imaging', ' Arm/Group Description: Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: cancers detected 8 mCi: 30', '4 mCi: 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/82 (0.00%)']}

f29768ba-5d79-4528-839f-933ab13faaa1

Comparison

Adverse Events

NCT00392392

NCT00503906

the primary trial records two different types of pain in its adverse events, in the abdomen and chest area, the secondary trial does not record any types of pain in its participants.

Entailment

{'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%)']}

343e0a32-aebe-4bbb-97c0-b2c597c36802

Single

Intervention

NCT00558103

All participants in the primary trial are administered with Lapatinib 1500 mg PO QD and Pazopanib 800 mg.

Contradiction

{'Clinical Trial ID': 'NCT00558103', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo', ' Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).', 'INTERVENTION 2: ', ' Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg', ' Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.'], 'Eligibility': ['Inclusion criteria:', ' Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact patient eligibility is provided in the pazopanib IB and lapatinib prescribing information (or the lapatinib IB).', ' For Cohort 1 of this study, eligible patients met inclusion criteria outlined in the original version of the protocol and protocol amendment 1.', ' For Cohort 2 of this study, eligible patients must meet all of the following criteria:', ' Patients must have evaluable Inflammatory Breast Cancer (IBC) substantiated by all of the following prior to randomization:', ' History of invasive breast cancer documented by a biopsy and accompanying pathology report', ' Current photographs* (global view and close-up views of all skin lesions) submitted at screening demonstrating unequivocal evidence of IBC as determined by either the medical monitor alone or in consultation with one or more of the study Principal Investigators.', " All patients must have photography at screening. Canfield Scientific Inc. will provide centralized monitoring, tracking, and collection of patients' photographs throughout the study. Screening photographs must be uploaded to the Canfield Scientific Inc website and approved by Canfield Scientific Inc, as the central photography vendor. The photographs, along with the completed Inflammatory Breast Cancer Skin Assessment Tool (IBSAT), must be reviewed and approved by GSK before a patient can be randomized. Sites should allow a minimum of 3 business days for this process. Sites submitting quality photographs and IBSATs on a regular basis will receive an exemption from this requirement for future patients.", ' Patients with secondary IBC are eligible.', ' Measurable lesions (cutaneous or radiographic) may be in the field of prior standard or palliative radiation therapy; however, there must be at least a 4 week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable. If the irradiated lesion is the only site of disease, documented progression of the irradiated lesion is required.', ' Disease progression or relapse following treatment for invasive breast cancer, which must have included a chemotherapy regimen. In regions where trastuzumab is available with no barriers to access*, patients must have received prior trastuzumab in addition to chemotherapy in order to be eligible. * (Barriers to access may include financial considerations.)', ' Unequivocal ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH/CISH, or ErbB2 gene amplification by FISH/CISH alone (in subjects whose tumor blocks were not assessed by IHC). ErbB2 gene amplification is defined by: > six (6) ErbB2 gene copies/nucleus for test systems without an internal control probe or an ErbB2/CEP 17 ratio of more than 2.2.', ' Sites must submit a copy of the laboratory report demonstrating unequivocal ErbB2 overexpression, if testing performed at a local laboratory, with the screening worksheet. Archived tumor must be provided for all patients for ErbB2 FISH testing by the central laboratory. Patients will remain on study based on local ErbB2 expression results. If archived tumor is not available, a biopsy must be obtained at screening and sent to TMD Laboratories for ErbB2 FISH testing.', " - Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.", ' Note: Informed consent may be obtained prior to the protocol-specified screening window (i.e. Day -14 to Day -1).', ' Females age 18 years, except in Tunisia. In Tunisia, patients must be 20 years to be eligible for this study.', ' Adequate organ function as defined below:', ' System (Laboratory Values)', ' Hematologic:Absolute neutrophil count (ANC)( 1.5 X 10^9/L)Hemoglobin1( 9 g/dL)Platelets( 100 X 10^9/L)International normalized ratio (INR)( 1.2 X upper limit of normal (ULN))Partial thromboplastin time (PTT)( 1.2 X ULN)', ' Hepatic:Total bilirubin2 ( 1.5 X upper limit of normal (ULN))AST and ALT( 2.5 X ULN)', ' Renal:Serum Creatinine ( 1.5 mg/dL)Or, if serum creatinine >1.5 mg/dL,', ' Calculated creatinine clearance( 50 mL/min)', ' Urine Protein to Creatinine Ratio(<1)', ' Patients may not have had a transfusion within 7 days of screening assessment.', ' Exception: Patients with elevated bilirubin levels due to Gilberts syndrome are eligible.', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive or where MUGA scans are the accepted standard. Patients with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' A female is eligible to enter and participate in this study if she is of:', ' Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:', ' A hysterectomy', ' A bilateral oophorectomy (ovariectomy)', ' A bilateral tubal ligation', ' Is post-menopausal', ' Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).', ' Patients must discontinue HRT prior to study enrollment due to the potential for inhibition of CYP enzymes that metabolize estrogens and progestins (See Section 8). For most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female patient is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below.', ' Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, has used adequate contraception since the pregnancy test and agrees to use adequate contraception as described below. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:', ' An intrauterine device with a documented failure rate of less than 1% per year.', " Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female.", ' Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.', ' Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).', ' Note: Oral contraceptives are not reliable due to potential drug drug interactions.', ' Female patients who are lactating should discontinue nursing prior to the first dose of investigational product and should refrain from nursing throughout the treatment period and for 14 days following the last dose of investigational product.', ' - French patients: In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.', 'Exclusion Criteria:', ' Patients meeting any of the following criteria must not be enrolled in the study:', ' Treatment in the 14 days prior to randomization with any cancer therapy (tumor embolization, chemotherapy, immunotherapy, biological therapy, or hormonal therapy) or treatment with mitomycin within 6 weeks prior to randomization. Such treatment may not be resumed or begun after study entry. Note: Patients receiving LH-RH analogue therapy prior to the study may continue to receive LH-RH analogues for the duration of study participation. Bisphosphonates are permitted if started prior to Day 1.', ' Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity (with the exception of alopecia).', ' Prior lapatinib therapy or other Her2/ErbB2 targeted therapy (except trastuzumab).', ' Prior therapy with an anti-VEGF antibody or other VEGF/VEGF-R targeted therapy.', ' Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.', ' Use of any prohibited medication within the timeframes listed in Section 8.1.3', ' History of another malignancy.', ' Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. If subject previously had breast cancer, it must have been HER2+ with either 3+ overexpression by IHC or unequivocal HER2 gene amplification by FISH or CISH.', ' History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.', ' Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding including, but not limited to:', ' Active peptic ulcer disease', ' Known intraluminal metastatic lesion/s with suspected bleeding', ' Inflammatory bowel disease', ' Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation', ' History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.', ' Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but limited to:', ' Malabsorption syndrome', ' Major resection of the stomach or small bowel.', ' Presence of uncontrolled infection.', ' Prolongation of corrected QT interval (QTc) > 480 msecs.', ' History of any one or more of the following cardiovascular conditions within the past 6 months:', ' Cardiac angioplasty or stenting', ' Myocardial infarction', ' Unstable angina', ' Arterial thrombosis', ' Symptomatic peripheral vascular disease', ' Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (see Section 15.9 Appendix 9 for description).', ' Poorly controlled hypertension [defined as systolic blood pressure (SBP) of 140mmHg or diastolic blood pressure (DBP) of 90mmHg].', " Note: Initiation or adjustment of antihypertensive medication(s) is permitted during the screening period, in order to control a patient's BP prior to randomization. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be < 140/90mmHg in order for a patient to be eligible for the study. See Section 6.2 and Section 6.4.2 for details on blood pressure control and reassessment prior to study enrollment.", ' History of cerebrovascular accident, including TIA, pulmonary embolism or deep venous thrombosis (DVT).', ' Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (other than ulcers due to inflammatory breast cancer).', ' Evidence of active bleeding or bleeding diathesis.', ' Hemoptysis within 6 weeks prior to first dose of investigational product.', ' Known endobronchial lesions or involvement of large pulmonary vessels by tumor.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.", ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.', " Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)."], 'Results': ['Outcome Measurement: ', ' Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions', ' RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.', ' Time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks', 'Results 1: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo', ' Arm/Group Description: Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants 11', 'Results 2: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg', ' Arm/Group Description: Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants 17'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/38 (15.79%)', ' Neutropenia 1/38 (2.63%)', ' Sinus tachycardia 0/38 (0.00%)', ' Bradycardia 0/38 (0.00%)', ' Cardiopulmonary failure 0/38 (0.00%)', ' Vomiting 1/38 (2.63%)', ' Diarrhea 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Abdominal pain 0/38 (0.00%)', ' Pancreatitis 0/38 (0.00%)', ' Sudden death 1/38 (2.63%)', ' Fatigue 0/38 (0.00%)', ' Asthenia 0/38 (0.00%)', ' Hepatotoxicity 0/38 (0.00%)', 'Adverse Events 2:', ' Total: 14/38 (36.84%)', ' Neutropenia 1/38 (2.63%)', ' Sinus tachycardia 0/38 (0.00%)', ' Bradycardia 0/38 (0.00%)', ' Cardiopulmonary failure 0/38 (0.00%)', ' Vomiting 2/38 (5.26%)', ' Diarrhea 2/38 (5.26%)', ' Nausea 0/38 (0.00%)', ' Abdominal pain 0/38 (0.00%)', ' Pancreatitis 0/38 (0.00%)', ' Sudden death 1/38 (2.63%)', ' Fatigue 0/38 (0.00%)', ' Asthenia 0/38 (0.00%)', ' Hepatotoxicity 1/38 (2.63%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4d51608c-b0d8-4019-9b9a-34cf1c3d5087

Comparison

Intervention

NCT00331552

NCT01306942

trastuzumab was used for the interventions in the primary trial and the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00331552', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Cyclophosphamide, Doxil, Trastuzumab', ' Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.', ' pegylated liposomal doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' trastuzumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must satisfy either a or b: a) Measurable disease by RECIST criteria; x-rays, scans or physical examinations used for tumor assessment must have been completed within 30 days prior to registration; any non-measurable disease must be assessed within 42 days prior to registration; b) Non-measurable disease only, but MUC-1 antigen level (either CA 27-29 or CEA) is > 2X ULN AND MUC-1 antigen has been documented to have increased by 1.5X prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration', ' ECOG performance status of =< 2', ' ANC >= 1,500 cells/mm^3', ' Platelet count >= 100,000 cells/mm^3', ' Hemoglobin >= 9.0g/dL', ' Creatinine =< 2.5 mg/dL', ' In the absence of liver metastases, AST / ALT, alkaline phosphatase and total bilirubin must not exceed 2 x upper limit of normal (i.e., must be =< 2 x upper limit of normal)', ' In the presence of liver metastases, AST / ALT, alkaline phosphatase and total bilirubin must not exceed 3 x upper limit of normal (i.e., must be =< 3 x upper limit of normal)', ' Have a MUGA scan or 2-d echocardiogram indicating an ejection fraction of >= 50% within 42 days prior to first dose of study drug (the method used at baseline must be used for later monitoring)', ' Use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment if of reproductive potential', ' 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', 'Exclusion Criteria:', ' Pregnant or lactating women', ' History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil', ' Patients who are HER2-neu positive with cardiac disease that would preclude the use of Doxil or Herceptin are not eligible, including active cardiac disease (i.e., angina pectoris that requires the use of antianginal medication, cardiac arrhythmia requiring medication, severe conduction abnormality, clinically significant valvular disease, cardiomegaly on chest x-ray, ventricular hypertrophy on EKG, uncontrolled hypertension [diastolic greater than 100 mm/Hg or systolic > 200 mm/hg], current use of digitalis or beta blockers for CHF, clinically significant pericardial effusion) and history of cardiac disease (i.e., myocardial infarction documented as a clinical diagnosis or by EKG or any other test, documented congestive heart failure, documented cardiomyopathy, documented arrhythmia or cardiac valvular disease that requires medication or is medically significant)', " Has anthracycline resistant disease defined as a) If anthracycline was given for non-metastatic disease: The cumulative dose of anthracycline exceeds 360 mg/m^ 2 for doxorubicin or 540 mg/m^2 for epirubicin AND the disease-free interval from discontinuation of anthracycline to diagnosis of metastatic disease is < 12 months; b) If anthracycline was given for metastatic disease: The cumulative dose of anthracycline exceeds 360 mg/m^2 for doxorubicin or 540 mg/m^2 for epirubicin AND the patient's disease progressed on anthracycline given as palliative therapy", ' Except for the following no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years', ' Any life-threatening illness other than the malignancy for which they are being treated', ' Mental illness', ' Have a life expectancy of less than 4 months', ' Unwillingness to participate or inability to comply with the protocol for the duration of the study'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)', ' The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment', ' Time frame: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Phase I: Cyclophosphamide, Doxil, Trastuzumab', ' Arm/Group Description: Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.', ' pegylated liposomal doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' trastuzumab: Given IV', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg/m^2 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/27 (0.00%)']}

{'Clinical Trial ID': 'NCT01306942', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', 'INTERVENTION 2: ', ' Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female with histologically confirmed breast cancer with documented metastasis.', ' Patients must have Human Epidermal Growth Factor Receptor 2 (HER2) overexpression by immunohistochemistry (3+, HercepTest®; DAKO) or a positive fluorescence in situ hybridization for HER2 amplification evaluated by central laboratory. It is recommended that a formalin-fixed paraffin embedded (FFPE) tumor tissue block from the metastatic site (or the primary tumor, if metastatic site not available) required for HER2 testing are provided.', ' Patients can have measurable or non measurable disease for the Phase I part. For the Phase II only patients with measurable disease defined per RECIST 1.1 will be included.', ' Signed Written Informed Consent.', ' Target Population:', ' Patients with Performance Status (ECOG) of 0 or 1.', ' Number of previous therapies allowed or previous therapies may have included:', ' Chemotherapy: no prior chemotherapy for MBC is permitted. Patients treated with adjuvant chemotherapy regimens based on taxanes are allowed to be included if they are fully recovered of any taxane associated toxicity and a minimum of 12 months have elapsed from the end of this therapy.', ' Hormonal Therapy: patients may have had prior hormonal therapy. All hormonal agents must be discontinued at least 3 weeks prior to study entry.', ' Radiation Therapy: patients may have had prior radiation therapy that has not exceeded 25% of the bone marrow reserve. A minimum of 21 days must have elapsed between the last dose of radiation and registration into the study. Patients must have recovered from any acute toxic effects from radiation prior to registration. Lesions that have been irradiated cannot be included as sites of measurable disease for the phase II unless clear tumor progression, according to RECIST criteria, has been documented in these lesions since the end of radiation therapy.', ' Previous Surgery: previous surgery is permitted provided that wound healing has occurred.', ' Anti-HER2 Therapies: no prior anti-HER2 therapy for MBC is permitted. Patients treated with adjuvant anti-HER2 therapies (including but not limited to trastuzumab and lapatinib) are allowed to be included if a minimum of 12 months have elapsed from the end of this therapy.', ' Adequate Organ Function (...).', ' Ability to take oral medication (dasatinib must be swallowed whole).', ' Concomitant Medications', ' i) Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib) ii) Biphosphonates must not be initiated within 28 days prior to study therapy', ' Age and sex:', ' f) Patient, age 18 years old. g) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. (...)', 'Exclusion Criteria:', ' Sex and reproductive status:', ' WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug', ' Women who are pregnant or breastfeeding.', ' Women with a positive pregnancy test', ' Target Disease Exceptions:', ' a) Central nervous system (CNS) metastases which are not well controlled. Eligible patients must be asymptomatic, cannot be receiving steroids or anticancer treatment, and must be enrolled at least 1 month after the end of the radiotherapy treatment', ' Medical History and Concurrent Diseases', ' No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.', ' Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade.', ' Cardiac Symptoms; any of the following should be considered for exclusion:', ' i) Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months) ii). Patients with intercurrent cardiac dysfunction or left ventricular ejection fraction (LVEF) < 50%.', ' iii) Diagnosed congenital long QT syndrome. iv) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).', ' v) Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (450 msec).', ' vi) Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.', " d) History of significant bleeding disorder unrelated to cancer, including: i) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease). ii) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).", ' iii) Ongoing or recent ( 3 months) significant gastrointestinal bleeding.', ' Allergies and Adverse Drug Reactions', ' a) Patients with known allergy to any of the study drugs or their components.', ' Prohibited Treatments and/or Therapies', ' a) Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) i) quinidine, procainamide, disopyramide ii) amiodarone, sotalol, ibutilide, dofetilide iii) erythromycin, clarithromycin iv) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide v) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.', ' b) Concurrent anti-cancer therapy c) Potent CYP3A4 inhibitors', ' Other exclusion criteria:', ' Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.', ' Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.', ' Patients unable or unwilling to give written informed consent prior to study participation.', ' Pre-existent motor or sensory neurotoxicity of severity grade 2 according to NCI common toxicity criteria (version 4.03).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I)', ' DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03), assessed as possibly, probably or definitively related to study drugs, occurring within the first cycle of study treatment: Need of any dose modification within the first cycle due to toxicity, grade 3 or 4 neutropenia complicated with fever 38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment related toxicity.', ' Time frame: Up to cycle 1', 'Results 1: ', ' Arm/Group Title: Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Angina * [1]0/6 (0.00%)', ' Diarrhea * [2]1/6 (16.67%)', ' Sudden death * [3]0/6 (0.00%)', ' Soft tissue and skin infection * [2]0/6 (0.00%)', ' Catheter related infection * [1]0/6 (0.00%)', ' Overdose * [4]0/6 (0.00%)', ' Dyspnea * [2]0/6 (0.00%)', ' Pneumonitis * [2]0/6 (0.00%)', ' Febrile syndrome respiratory focus * [5]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/4 (50.00%)', ' Angina * [1]0/4 (0.00%)', ' Diarrhea * [2]0/4 (0.00%)', ' Sudden death * [3]0/4 (0.00%)', ' Soft tissue and skin infection * [2]0/4 (0.00%)', ' Catheter related infection * [1]0/4 (0.00%)', ' Overdose * [4]0/4 (0.00%)', ' Dyspnea * [2]1/4 (25.00%)', ' Pneumonitis * [2]1/4 (25.00%)', ' Febrile syndrome respiratory focus * [5]0/4 (0.00%)']}

7bb88699-1536-4fdc-9cb2-c5ef350d559b

Comparison

Adverse Events

NCT02139358

NCT02574455

There was one case of hemorrhaging in the primary trial, and no recorded cases in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT02139358', 'Intervention': ['INTERVENTION 1: ', ' Dose Escalation / Phase II Treatment', ' Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.'], 'Eligibility': ['Inclusion Criteria:', ' Adult males or females (aged 18 or older) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (HER2)+ (by immunohistochemistry (IHC) 3+ or fluorescence in situ hydridization (FISH) ratio 2.0) breast cancer', ' Have progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. T-DM1 would count as a line of therapy and patients previously treated with T-DM1 are eligible.', ' Have not been treated with gemcitabine in the metastatic setting', ' Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 2 ', ' Left Ventricular Ejection Fraction (LVEF) 50% at baseline as determined by either echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)', ' Adequate bone marrow function as indicated by the following: absolute neutrophil count (ANC) >1500/µL; Platelets 100,000/µL; Hemoglobin >10 g/dL', ' Adequate renal function, as indicated by creatinine 1.5x upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin 1.5x ULN, aspartic transaminase (AST) or alanine transaminase (ALT) <2x ULN unless related to metastatic breast cancer to the liver (in which case AST/ALT < 5x ULN is allowed).', ' Signed informed consent', ' Adequate birth control in sexually active women of childbearing potential', 'Exclusion Criteria:', ' Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study', ' Uncontrolled central nervous system (CNS) metastases. Treated, non-progressing CNS disease (documented by brain magnetic resonance imaging [MRI]) off corticosteroids for at least 1 month potential participants are eligible.', ' Women who are pregnant or lactating', ' Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)', ' Other concomitant active malignancies', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to any of the study medications', ' Untreated psychiatric conditions preventing informed consent'], 'Results': ['Outcome Measurement: ', ' Phase I: Recommended Phase II Dose (RP2D)', ' The RP2D dose in mg/m^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.', ' Time frame: 6 Months', 'Results 1: ', ' Arm/Group Title: Dose Escalation / Phase II Treatment', ' Arm/Group Description: Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: dose in mg/m^2 1200'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/15 (46.67%)', ' Cardiac arrest * 1/15 (6.67%)', ' Chest pain - cardiac * 1/15 (6.67%)', ' Diarrhea * 1/15 (6.67%)', ' Duodenal hemorrhage * 1/15 (6.67%)', ' Fatigue * 1/15 (6.67%)', ' Fever * 1/15 (6.67%)', ' Sudden death NOS * 1/15 (6.67%)', ' Sepsis * 1/15 (6.67%)', ' Skin infection * 1/15 (6.67%)', ' Neutrophil count decreased * 1/15 (6.67%)', ' Platelet count decreased * 1/15 (6.67%)']}

{'Clinical Trial ID': 'NCT02574455', 'Intervention': ['INTERVENTION 1: ', ' Sacituzumab Govitecan', ' Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', 'INTERVENTION 2: ', " Treatment of Physician's Choice (TPC)", ' Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).', ' Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.', ' Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.', ' Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.'], 'Eligibility': ['Key Inclusion Criteria:', ' Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.', ' Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.', ' Prior exposure to a taxane in localized or advanced/metastatic setting.', ' Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.', ' Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.', ' Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted.', ' At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).', ' At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).', ' Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).', ' Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] 2.5 x IULN or 5 x IULN if known liver metastases and serum albumin 3 g/dL).', ' Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.', ' Participants with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.', ' Key Exclusion Criteria:', ' Women who are pregnant or lactating.', ' Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.', " Participants with Gilbert's disease.", ' Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.', ' Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.', ' Infection requiring antibiotic use within one week of randomization.', " Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.", ' Note: Other protocol defined Inclusion/Exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population', ' PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [ ] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.', ' Time frame: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)', 'Results 1: ', ' Arm/Group Title: Sacituzumab Govitecan', ' Arm/Group Description: Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Overall Number of Participants Analyzed: 235', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.3 to 6.3)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice (TPC)", ' Arm/Group Description: Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).', ' Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.', ' Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.', ' Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.', ' Overall Number of Participants Analyzed: 233', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.7 (1.5 to 2.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 69/258 (26.74%)', ' Anaemia 3/258 (1.16%)', ' Febrile neutropenia 13/258 (5.04%)', ' Neutropenia 5/258 (1.94%)', ' Thrombocytopenia 1/258 (0.39%)', ' Atrial fibrillation 0/258 (0.00%)', ' Mitral valve incompetence 1/258 (0.39%)', ' Pericardial effusion 0/258 (0.00%)', ' Sinus tachycardia 0/258 (0.00%)', ' Abdominal pain 3/258 (1.16%)', ' Abdominal pain upper 1/258 (0.39%)', ' Colitis 1/258 (0.39%)', 'Adverse Events 2:', ' Total: 64/224 (28.57%)', ' Anaemia 2/224 (0.89%)', ' Febrile neutropenia 4/224 (1.79%)', ' Neutropenia 1/224 (0.45%)', ' Thrombocytopenia 0/224 (0.00%)', ' Atrial fibrillation 1/224 (0.45%)', ' Mitral valve incompetence 0/224 (0.00%)', ' Pericardial effusion 2/224 (0.89%)', ' Sinus tachycardia 1/224 (0.45%)', ' Abdominal pain 3/224 (1.34%)', ' Abdominal pain upper 0/224 (0.00%)', ' Colitis 0/224 (0.00%)']}

c86ef61b-7565-465a-82ba-25e7ac050ccc

Comparison

Adverse Events

NCT02019277

NCT00863655

the primary trial and the secondary trial recorded three of the same types of adverse events

Entailment

{'Clinical Trial ID': 'NCT02019277', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Pertuzumab, and Taxane', " Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure."], 'Eligibility': ['Inclusion Criteria:', ' HER2-positive disease, with an immunohistochemistry score of 3+ or in situ hybridization (ISH)-positive on primary tumor or metastatic site', ' Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease with at least one measurable lesion and/or non-measurable disease according to RECIST Version 1.1', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for participants who will receive paclitaxel or nab-paclitaxel chemotherapy and ECOG 0-1 for participants who will receive docetaxel chemotherapy', ' LVEF of greater than or equal to (>=) 50 percent (%) measured by ECHO or MUGA scan before the first doses of pertuzumab and trastuzumab', ' Previous use of either adjuvant or neoadjuvant anti-HER2 therapy is allowed', ' Hormonal therapy will be allowed as per institutional guidelines. Hormonal therapy cannot be administered in combination with taxane therapy', 'Exclusion Criteria:', ' Previous systemic non-hormonal anticancer therapy for treatment of mBC', ' History of other cancers. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study', ' Pregnant or breastfeeding women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days before the first dose of pertuzumab and trastuzumab', ' Current peripheral neuropathy of Grade 3 or greater (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0)', ' Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment', ' Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness', ' Inadequate organ function', ' Serious cardiac illness or medical conditions that would preclude the use of trastuzumab', ' Participants with severe dyspnea at rest or requiring supplementary oxygen therapy', ' Concurrent enrollment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of trastuzumab and pertuzumab'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious AEs', ' An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs and SAEs was reported. AEs included both SAEs and non-SAEs. The 95% confidence interval (CI) was computed using Clopper-Pearson method.', ' Time frame: Baseline up to 28 days after last study drug administration (up to 36 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Pertuzumab, and Taxane', " Arm/Group Description: Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.", ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants AEs: 100.0 (92.9 to 100.0)', ' SAEs: 54.0 (39.3 to 68.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/50 (54.00%)', ' Febrile neutropenia * 4/50 (8.00%)', ' Anaemia * 1/50 (2.00%)', ' Neutropenia * 1/50 (2.00%)', ' Cardiac failure * 1/50 (2.00%)', ' Diarrhoea * 1/50 (2.00%)', ' Gastritis * 1/50 (2.00%)', ' Nausea * 1/50 (2.00%)', ' Oesophagitis * 1/50 (2.00%)', ' Pyrexia * 7/50 (14.00%)', ' Mucosal inflammation * 1/50 (2.00%)', ' Drug hypersensitivity * 1/50 (2.00%)', ' Cellulitis * 2/50 (4.00%)']}

{'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%)']}

58dec898-e0af-41c1-96f9-7163d3e3e855

Single

Adverse Events

NCT02291913

One patient in the primary trial suffered from an inflammation of the liver.

Contradiction

{'Clinical Trial ID': 'NCT02291913', 'Intervention': ['INTERVENTION 1: ', ' Everolimus', ' Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.', ' Everolimus', ' Exemestane: Anti-estrogen therapy', ' Tamoxifen: Anti-estrogen therapy', ' Fulvestrant: Anti-estrogen therapy', ' Anastrozole: Anti-estrogen therapy', ' Letrozole: Anti-estrogen therapy', ' Toremifine: Anti-estrogen therapy'], 'Eligibility': ['Inclusion Criteria:', ' Histologic diagnosis of unresectable, locally recurrent or MBC.', ' ER and/or PR-positive tumors with staining by immunohistochemistry (IHC) based on the most recent biopsy.', ' Only 1 previous chemotherapy regimen for MBC. Patients progressing while receiving adjuvant endocrine therapy or progressing <12 months from completion of adjuvant endocrine therapy are eligible.', ' Progressed on anti-estrogen therapy (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy) defined as:', ' Recurrence while on, or within 12 months of end of anti-estrogen therapy for early stage breast cancer, or', ' Progression while on, or within one month of anti-estrogen therapy for locally advanced or metastatic breast cancer.', ' Note: No washout for anti-estrogen therapy required. Anti-estrogen therapy does not have to be the last treatment prior to study entry.', ' Post-menopausal or pre/peri-menopausal women on tamoxifen. LHRH agonists may be used to render ovarian suppression with postmenopausal ranges of estradiol or FSH per institutional guidelines.', ' HER2-negative breast cancer, defined as follows:', ' Fluorescent In Situ Hybridization (FISH)-negative (FISH ratio <2.0), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.0).', ' Measureable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or evaluable bone lesions, lytic or mixed, in absence of measureable disease by RECIST criteria.', ' Adequate hematologic, hepatic and renal function.', ' International normalized ratio (INR) 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy).', ' Age 18 years.', ' ECOG Performance Status score of 0-2.', ' Life expectancy of 12 weeks.', 'Exclusion Criteria:', ' Previous therapy or known intolerance/hypersensitivity with any approved or investigational mTOR inhibitor (e.g., temsirolimus, everolimus, sirolimus).', ' Patients who are 21 days after their most recent chemotherapy and have not recovered from side effects.', ' Use of an investigational drug 21 days or 5 half-lives (whichever is shorter) prior to the first dose of everolimus. For investigational drugs for which 5 half-lives is 21 days, a minimum of 10 days between termination of the investigational drug and administration of everolimus is required.', ' Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered 28 days or limited field radiation for palliation 7 days for metastatic disease prior to first dose of everolimus or has not recovered from side effects of such therapy.', ' Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 2 weeks have elapsed since treatment. Patients are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs) during the study and should not be receiving chronic corticosteroid therapy for CNS metastases.', ' Patients with known active hepatitis B (HBV) or hepatitis C (HCV) infection. Patients with risk factors for hepatitis must have HBV DNA and HCV RNA testing by PCR, and are ineligible if these tests are positive.', ' Patients receiving immunization with attenuated live vaccines within 1 week of study entry or during study period.', ' NOTE: There are additional inclusion/exclusion criteria. The study center will determine patient eligibility and respond to any questions.'], 'Results': ['Outcome Measurement: ', ' Median Progression Free Survival (PFS)', ' PFS is defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, or death on study. Participants who are alive and free from disease progression will be censored at the date of last radiologic tumor assessment. Participants who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. Participants who do not have a post-baseline tumor assessment will be censored at the date of first treatment (Day 1).', ' Time frame: up to 3 years', 'Results 1: ', ' Arm/Group Title: Everolimus', ' Arm/Group Description: Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.', ' Everolimus', ' Exemestane: Anti-estrogen therapy', ' Tamoxifen: Anti-estrogen therapy', ' Fulvestrant: Anti-estrogen therapy', ' Anastrozole: Anti-estrogen therapy', ' Letrozole: Anti-estrogen therapy', ' Toremifine: Anti-estrogen therapy', ' Overall Number of Participants Analyzed: 36', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.2 (4.1 to 10.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/48 (31.25%)', ' Anemia * 1/48 (2.08%)', ' Cardiac failure congestive * 1/48 (2.08%)', ' Constipation * 2/48 (4.17%)', ' Esophagitis * 1/48 (2.08%)', ' Gastrointestinal hemorrhage * 1/48 (2.08%)', ' Non-Cardiac chest pain * 1/48 (2.08%)', ' Pain * 1/48 (2.08%)', ' Cholecystitis * 1/48 (2.08%)', ' Diverticulitis * 1/48 (2.08%)', ' Cellulitis * 1/48 (2.08%)', ' Gastroenteritis * 1/48 (2.08%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

5cf74526-9f91-498d-a13a-6393dcd45b7b

Single

Results

NCT00191269

the primary trial did not use PFS to evaluate the performance of its interventions.

Entailment

{'Clinical Trial ID': 'NCT00191269', 'Intervention': ['INTERVENTION 1: ', ' Dose Level 1', ' Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.', 'INTERVENTION 2: ', ' Dose Level 2', ' Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically and/or cytologically confirmed breast cancer', ' Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen', ' To have at least one measurable region', ' PS: 0-1', ' To have adequate organ function (bone marrow, liver and renal function)', 'Exclusion Criteria:', ' To have Interstitial pneumonia or pulmonary fibrosis', ' To have inflammatory carcinoma', ' Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery', ' To have brain metastasis with symptom', ' To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)'], 'Results': ['Outcome Measurement: ', ' 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: baseline to measured progressive disease', 'Results 1: ', ' Arm/Group Title: Dose Level 1', ' Arm/Group Description: Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 0', ' Long Stable Disease: 1', ' Stable Disease: 1', ' Progressive Disease: 2', 'Not Evaluable: 2', 'Results 2: ', ' Arm/Group Title: Dose Level 2', ' Arm/Group Description: Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 4', ' Long Stable Disease: 4', ' Stable Disease: 16', ' Progressive Disease: 32', 'Not Evaluable: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1', ' Cardiac failure acute 0/6 (0.00%)', ' Cataract 0/6 (0.00%)', ' Cellulitis 1/6 (16.67%)', ' Infection 0/6 (0.00%)', ' Blood lactate dehydrogenase increased 0/6 (0.00%)', ' Anorexia 0/6 (0.00%)', ' Femur fracture 0/6 (0.00%)', ' Brain oedema 0/6 (0.00%)', ' Dyspnoea 1/6 (16.67%)', ' Acute respiratory failure 0/6 (0.00%)', ' Catheterisation venous 0/6 (0.00%)', " Raynaud's phenomenon 0/6 (0.00%)", 'Adverse Events 2:', ' Total: 10', ' Cardiac failure acute 1/62 (1.61%)', ' Cataract 1/62 (1.61%)', ' Cellulitis 1/62 (1.61%)', ' Infection 1/62 (1.61%)', ' Blood lactate dehydrogenase increased 1/62 (1.61%)', ' Anorexia 1/62 (1.61%)', ' Femur fracture 1/62 (1.61%)', ' Brain oedema 1/62 (1.61%)', ' Dyspnoea 0/62 (0.00%)', ' Acute respiratory failure 1/62 (1.61%)', ' Catheterisation venous 2/62 (3.23%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

154caa20-3be1-4cee-a838-2d90b44566c4

Single

Adverse Events

NCT02001974

No cases of Oesophageal adenocarcinoma were recorded in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02001974', 'Intervention': ['INTERVENTION 1: ', ' Group 1', ' Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)', 'INTERVENTION 2: ', ' Group 2', ' Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)'], 'Eligibility': ['Inclusion Criteria:', ' Female aged 18 years.', ' Patients with histologic or cytologic diagnosis of breast cancer with evidence of metastatic disease with documented HER-2 negative status and eligible for treatment with paclitaxel.', ' Patients with at least one baseline measurable lesion according to RECIST version 1.1 criteria.', ' Zubrod (Eastern Co-operative Oncology Group [ECOG]) Performance Status (PS) of 0-1.', ' An electrocardiogram (ECG) with no clinically significant abnormalities indicative of myocardial ischemia.', ' Ongoing toxicity associated with prior anticancer therapy grade 1 Common Terminology Criteria for Adverse Events (CTCAE version 4.03) with the exception of alopecia.', ' Maximum of three prior chemotherapy lines for advanced breast cancer (not including neo/adjuvant chemotherapy). If prior treatment with paclitaxel, PD must have occurred > 12 months from the end of previous adjuvant treatment or for previous metastatic treatment no PD must have occurred during treatment or within 3 months of the end of treatment', ' Life expectancy of at least three months.', ' Patients must be able to swallow and retain oral medication (intact tablet).', ' Able to undergo all screening assessments outlined in the protocol following written informed consent.', ' Adequate organ function (defined by the following parameters):', ' Serum creatinine < 140 µmol/L or creatinine clearance > 60 mL/min.', ' Serum hemoglobin 9 g/dL; absolute neutrophil count 1.5 x 10**9/L; platelets 100 x 10**9/L.', ' Serum bilirubin 1.5 x upper normal limit (UNL).', ' Serum ALT, AST 2.5 x UNL but 5.0 x UNL in case of liver metastases; ALP UNL but 1.5 x ULN in case of liver metastases; albumin within normal limits. If ALP is greater than 1.5 x UNL (in the presence of liver metastases) the liver isoenzyme fraction will be measured. Liver isoenzyme fraction (absolute value) must be 1.5 x UNL.', ' No known hepatitis B virus (not due to immunization), hepatitis C virus, human immunodeficiency virus Ι and -ΙΙ positive status.', 'Exclusion Criteria:', ' Male.', ' Pregnancy or lactation or unwillingness to use adequate method of birth control.', ' HER-2 positive disease status.', ' Less than four weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than two weeks since last hormone or immunotherapy or signal transduction therapy.', ' Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.', ' Active or uncontrolled infection.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function.', ' Hypersensitivity to:', ' paclitaxel', ' ibuprofen or to more than one non-steroidal anti-inflammatory drug.', ' medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.', ' Presence of brain metastases (this does not include primary brain tumors) or leptomeningeal disease.'], 'Results': ['Outcome Measurement: ', ' Treatment-Emergent Adverse Events (TEAEs)', ' Monitoring of AEs throughout the study till the end/off-treatment visit.', ' Time frame: Up to 28 days following the last dose of study drug (up to 24 months).', 'Results 1: ', ' Arm/Group Title: Group 1', ' Arm/Group Description: Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Number', ' Unit of Measure: adverse events 106', 'Results 2: ', ' Arm/Group Title: Group 2', ' Arm/Group Description: Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: adverse events 99'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/4 (50.00%)', ' Abdominal pain 0/4 (0.00%)', ' Disease progression 0/4 (0.00%)', ' Dehydration 2/4 (50.00%)', ' Hyponatraemia 1/4 (25.00%)', ' Metastasis to central nervous system 1/4 (25.00%)', ' Oesophageal adenocarcinoma 0/4 (0.00%)', ' Intracranial hypotension 0/4 (0.00%)', ' Pneumothorax 0/4 (0.00%)', ' Dyspnoea 0/4 (0.00%)', ' Hypoxia 0/4 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' Abdominal pain 0/3 (0.00%)', ' Disease progression 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Hyponatraemia 0/3 (0.00%)', ' Metastasis to central nervous system 0/3 (0.00%)', ' Oesophageal adenocarcinoma 0/3 (0.00%)', ' Intracranial hypotension 0/3 (0.00%)', ' Pneumothorax 1/3 (33.33%)', ' Dyspnoea 0/3 (0.00%)', ' Hypoxia 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

c40d8532-4e66-4eef-9644-91f20a02066d

Comparison

Intervention

NCT01289353

NCT00429182

the primary trial and the secondary trial both administer bi-weekly oral Carboplatin to their test groups.

Contradiction

{'Clinical Trial ID': 'NCT01289353', 'Intervention': ['INTERVENTION 1: ', ' ChemoRT', ' Concurrent Carboplatin and Radiotherapy', ' Carboplatin: IV, weekly for 6 weeks, AUC of 2.0', ' 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy'], 'Eligibility': ['Inclusion Criteria:', ' Age older than 18', ' Pre- or post-menopausal women with Stage I and II breast cancer, triple negative tumors', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (Tumors < 5 mm in size do not require nodal assessment) or after mastectomy', ' No previous chemotherapy', ' Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast', ' Active connective tissue disorders, such as lupus or scleroderma', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT', ' [Not Specified]', ' Time frame: 60 days post-RT', 'Results 1: ', ' Arm/Group Title: ChemoRT', ' Arm/Group Description: Concurrent Carboplatin and Radiotherapy', ' Carboplatin: IV, weekly for 6 weeks, AUC of 2.0', ' 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy', ' Overall Number of Participants Analyzed: 90', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 8.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/90 (0.00%)']}

{'Clinical Trial ID': 'NCT00429182', 'Intervention': ['INTERVENTION 1: ', ' High-dose Chemotherapy', ' Carboplatin + Cyclophosphamide + Thiotepa', ' Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.', ' Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.', ' Stem Cell Transplant : Stem Cell Transplant on Day 0.', ' Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.'], 'Eligibility': ['Inclusion Criteria:', ' 18 to 55 years old', ' Metastatic breast carcinoma.', ' Histological confirmation of invasive breast carcinoma', ' Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.', ' Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).', ' Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.', ' Zubrod performance status 0 or 1.', ' Patients must have adequate hematological parameters (White Blood Count/WBC >= 3,000/mm3; platelet count >= 100,000/mm3)', ' Adequate renal function (serum creatinine <= 1.5mg/dl)', ' Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT) <= 2 times normal).', ' Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).', ' Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of predicted value).', ' Females of childbearing (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception.', ' Patients must sign an informed consent.', 'Exclusion Criteria:', ' Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.', ' History or presence of brain/leptomeningeal metastasis.', ' History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.', ' Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure.', ' Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).', ' HIV infection.', ' Pregnant or lactating women.', ' Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products', ' Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.', ' Time frame: Baseline to 1 month post AHST', 'Results 1: ', ' Arm/Group Title: High-dose Chemotherapy', ' Arm/Group Description: Carboplatin + Cyclophosphamide + Thiotepa', ' Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.', ' Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.', ' Stem Cell Transplant : Stem Cell Transplant on Day 0.', ' Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/32 (6.25%)', ' Thrombocytopenia 1/32 (3.13%)', ' Death 1/32 (3.13%)']}

3d450be5-4587-48e5-ae2e-745623606631

Single

Results

NCT00943670

The Change From Baseline in Mean Duration of the QTcF Interval for patients in the primary trial was at its highest on Day 1 of the third cycle, post T-DM1 intravenous (IV) infusion.

Entailment

{'Clinical Trial ID': 'NCT00943670', 'Intervention': ['INTERVENTION 1: ', ' T-DM1', ' Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted', ' HER2-positive disease', ' History of prior trastuzumab therapy', ' Life expectancy 90 days as assessed by the investigator', ' Negative urine pregnancy test 72 hours prior to Cycle 1 Day 1 for all women of childbearing potential', ' For patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of T-DM1 or 6 months after the last dose of pertuzumab, if applicable', 'Exclusion Criteria:', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment', ' Prior T-DM1 or pertuzumab therapy', ' History of intolerance (such as Grade 3-4 infusion reaction) and/or adverse events related to trastuzumab', ' Grade 2 (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment', ' Brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment', ' History of cardiac disease, unstable angina, symptomatic congestive heart failure (CHF) (Class II per the New York Heart Associate [NYHA] guidelines), myocardial infarction, or ventricular arrhythmia 6 months prior to Cycle 1, Day 1', ' Implantable pacemaker or automatic implantable cardioverter defibrillator', ' Congenital long QT syndrome or family history of long QT syndrome', ' Current uncontrolled hypertension', ' Current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (TdP)', ' Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment'], 'Results': ['Outcome Measurement: ', ' Change From Baseline in Mean Duration of the QTc Interval', " The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.", ' Time frame: Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.', 'Results 1: ', ' Arm/Group Title: T-DM1', ' Arm/Group Description: Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: milliseconds Cycle 1, Day 1, 15 minutes post-dose [N=44]: 1.2 (8.3)', ' Cycle 1, Day 1, 60 minutes post-dose [N=45]: -1.0 (6.3)', ' Cycle 1, Day 8 [N=43]: -4.0 (13.4)', ' Cycle 3, Day 1, 15 minutes pre-dose [N=35]: -0.1 (10.1)', ' Cycle 3, Day 1, 15 minutes post-dose [N=37]: 4.7 (9.6)', ' Cycle 3, Day 1, 60 minutes post-dose [N=37]: 4.7 (10.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/51 (7.84%)', ' Thrombocytopenia 2/51 (3.92%)', ' Anaemia 0/51 (0.00%)', ' Cardiac arrest 0/51 (0.00%)', ' Gastrointestinal haemorrhage 0/51 (0.00%)', ' Generalised oedema 1/51 (1.96%)', ' Aspartate aminotransferase increased 0/51 (0.00%)', ' Hypokalaemia 0/51 (0.00%)', ' Convulsion 1/51 (1.96%)', ' Renal failure 1/51 (1.96%)', ' Dyspnoea 1/51 (1.96%)', ' Skin haemorrhage 0/51 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

fa28753a-aa3b-4642-9fd4-a2414fd8a472

Comparison

Intervention

NCT01000662

NCT02413008

the secondary trial is testing a Gel which is applied to the breast, whereas the primary trial is testing an intervention which requires daily radiation of the breast.

Contradiction

{'Clinical Trial ID': 'NCT01000662', 'Intervention': ['INTERVENTION 1: ', ' ARM 1 Daily Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', 'INTERVENTION 2: ', ' ARM 2 Weekly Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.'], 'Eligibility': ['Inclusion Criteria:', ' Pre or post-menopausal women with stage 0,I, and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment)', ' At least 2 weeks from last chemotherapy', ' Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast', ' More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation', ' Active connective tissue disorders, such as lupus or scleroderma', ' Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)', ' Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects', 'Time frame: Day 60', 'Results 1: ', ' Arm/Group Title: ARM 1 Daily Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 202', ' Measure Type: Number', ' Unit of Measure: participants 22', 'Results 2: ', ' Arm/Group Title: ARM 2 Weekly Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 198', ' Measure Type: Number', ' Unit of Measure: participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/202 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT02413008', 'Intervention': ['INTERVENTION 1: ', ' 0.005% Estriol Vaginal Gel', ' Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', 'INTERVENTION 2: ', ' Placebo Vaginal Gel', ' Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', 'Placebo'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent prior to beginning specific protocol procedures.', ' Patients must have histological confirmation of breast adenocarcinoma with stage I-IIIA, documented at a local pathology department.', ' The breast tumors must be estrogen-receptor positive and/or progesterone receptor positive ( 1% of stained tumor cells by Immunohistochemistry (IHC) as determined by the local laboratory) with any Human Epidermal Growth Factor Receptor 2(HER2) status.', ' Postmenopausal status defined as: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 Milli-international units per milliliter (mIU/ml) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.', ' Patient must be receiving the non-steroidal aromatase inhibitors anastrozole or letrozole as breast cancer treatment in the adjuvant setting for a minimum of 6 months.', ' Women suffering from moderate to severe vaginal dryness according to the FDA guidelines for drug development in postmenopausal women (Center for Drug Evaluation and Research, (CDER) Jan 2003). A moderate symptom will be considered if the symptom is present, bothersome and annoying, and a severe symptom will be considered if the symptom is present, bothersome and annoying, and interferes with the normal patient activity.', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.', ' Adequate bone marrow as defined by the following laboratory values:', ' Absolute Neutrophil Count (ANC) 1.5 x 109/L.', ' Platelets (plt) 100 x 109/L.', ' Hemoglobin (Hgb) 10 g/dl.', ' Patient has adequate organ function as defined by the following laboratory values:', ' Serum creatinine 1.5 x Upper Limit of Normal (ULN).', ' Bilirubin 1.5 × ULN.', ' Alkaline phosphatase 2 × ULN.', ' Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2 × ULN.', ' Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.', 'Exclusion Criteria:', ' Stage IIIB-IV breast cancer or bilateral breast cancer.', ' Treatment with any other current anti-tumoral therapy (chemotherapy, anti-Her2…etc) besides the NSAI. Pamidronate or Alendronate are permitted.', ' Prior history of other malignancy within 5 years of study entry, aside from non-melanoma skin cancer or carcinoma-in-situ of the uterine cervix adequately treated.', ' Postmenopausal uterine bleeding. Vaginal bleeding of unknown etiology.', ' Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound.', ' Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study.', ' Use of any hormone, natural (phytoestrogens) or herbal products for the treatment of menopausal symptoms within the last 3 months.', ' Current or previous history of thromboembolic disease or coagulopathies.', ' Severe cardiovascular or respiratory diseases in the previous 6 months.', ' Renal Impairment.', ' Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function).', ' Known human immunodeficiency virus infection.', ' Known hypersensitivity to NSAI.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.', ' Previous investigational treatment for any condition or participation in any clinical trial within 4 weeks of inclusion date.'], 'Results': ['Outcome Measurement: ', ' Variation in Serum Levels of Follicle Stimulating Hormone (FSH)', ' Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)', ' Time frame: from baseline to 12 weeks of treatment', 'Results 1: ', ' Arm/Group Title: 0.005% Estriol Vaginal Gel', ' Arm/Group Description: Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', ' Overall Number of Participants Analyzed: 50', ' Median (Inter-Quartile Range)', ' Unit of Measure: mIU/ml -2.8 (-13.1 to 7.4)', 'Results 2: ', ' Arm/Group Title: Placebo Vaginal Gel', ' Arm/Group Description: Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', ' Placebo', ' Overall Number of Participants Analyzed: 11', ' Median (Inter-Quartile Range)', ' Unit of Measure: mIU/ml 1.4 (-5.4 to 15.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/50 (2.00%)', ' Lymphoma [1]1/50 (2.00%)', 'Adverse Events 2:', ' Total: 0/11 (0.00%)', ' Lymphoma [1]0/11 (0.00%)']}

5e700303-cd26-4024-a260-62f6a1c297ed

Comparison

Adverse Events

NCT00371345

NCT00475670

There is no overlap between adverse events obeserved in the primary trial and the secondary trial.

Entailment

{'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%)']}

4c4c191c-de68-44c8-a23c-2455acc43d46

Comparison

Intervention

NCT01818063

NCT00559507

In the primary trial and the secondary trial the only drugs administered orally are saracatinib and Veliparib.

Entailment

{'Clinical Trial ID': 'NCT01818063', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Paclitaxel, Carboplatin)', ' Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', 'INTERVENTION 2: ', ' Arm 2 (Veliparib, Paclitaxel, Carboplatin)', ' Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', ' Veliparib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent must be obtained prior to any study-related procedures.', ' Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative (<1%), progesterone receptor negative (<1%), and Her-2/neu negative (Her-2/neu 0-1+ IHC or FISH ratio <1.8 or average HER2 gene copy number of <four signal/nucleus for test systems without internal control probe).', ' Female 18 years old.', ' Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment.', ' Complete radiology or tumor assessment within 28 days prior to enrollment', ' Breast MRI', ' Unilateral Breast Ultrasound', ' Distant metastatic work-up completed with PET/CT.', ' If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer.', ' If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy.', ' ECOG Performance Status of 0 or 1', ' Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment:', ' Cardiac Ejection Fraction >/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.', ' Hematologic function, as follows: Absolute neutrophil count 1.5 x 109/L, Platelet count 100 x 109/L and 850 x 109/L, Hemoglobin 9 g/dL, PTT and INR < 1.5 x ULN.', ' Renal function, as follows: Serum creatinine </= 1.4 mg/dL).', ' Hepatic function, as follows:Aspartate aminotransferase (AST) 2.5 x ULN, Alanine aminotransferase (ALT) 2.5 x ULN , Total bilirubin 2 x ULN (except for patients with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to study enrollment. Patients enrolled with Gilbert syndrome must have total bilirubin < 3 ULN).', ' Patient must be willing and able to undergo MRI as outlined in protocol.', 'Exclusion Criteria:', ' Known hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, cremophor or medications containing cremophor(miconazole, docetaxel, sandimmune, nelfinavir mesylate, propofol, diazepam injection, vitamin K injection, ixabepilone, aci-jel) or carboplatin.', ' Known HIV or active Hepatitis B or C infection.', ' Prior treatment for the currently diagnosed breast cancer.', ' Prior treatment with doxorubicin up to 400 mg/m2.', ' Pre-existing Grade 3 or 4 sensory neuropathy.', ' History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.', ' Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).', ' Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.', ' Non-healing wound, ulcer or fracture.', ' Ongoing or active infection.', ' Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating', ' Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence. Contraception must be used during the study.', ' T0 tumors', ' Active dental infection'], 'Results': ['Outcome Measurement: ', ' Count of Participants That Achieve Pathologic Complete Response (PCR)', ' PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.', ' Time frame: 36 months following surgery', 'Results 1: ', ' Arm/Group Title: Arm 1 (Paclitaxel, Carboplatin)', ' Arm/Group Description: Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 60.0%', 'Results 2: ', ' Arm/Group Title: Arm 2 (Veliparib, Paclitaxel, Carboplatin)', ' Arm/Group Description: Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Paclitaxel: Given IV', ' Carboplatin: Given IV', ' Doxorubicin: Given IV', ' Cyclophosphamide: Given IV', ' Veliparib: Given PO', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 75.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/5 (20.00%)', ' Viral Meningitis *1/5 (20.00%)', 'Adverse Events 2:', ' Total: 0/4 (0.00%)', ' Viral Meningitis *0/4 (0.00%)']}

{'Clinical Trial ID': 'NCT00559507', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy)', ' Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Unresectable disease', ' Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage IV) disease', ' Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as < 10% expression by immunohistochemistry (IHC)', ' Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors [RECIST]) as 1 unidimensionally measurable lesion 20mm by conventional techniques or 10 mm by spiral computed tomography (CT) scan', ' Measurable target lesions must not be in a previously irradiated field', ' Patients with locally advanced, unresectable disease must have progression of disease following no more than one first-line chemotherapy regimen', ' Patients with evidence of recurrent disease during or within 6 months after adjuvant chemotherapy will be considered to have failed one line of chemotherapy for metastatic disease', ' Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification > 2.1, must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting and have had recurrence or progression of disease, respectively', ' No known brain metastases', ' Male and female patients eligible', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (Karnofsky PS 60-100%)', ' Life expectancy > 3 months', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Hemoglobin > 9 g/dL', ' Total bilirubin normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) 2.5 x institutional upper limit of normal', ' Creatinine normal OR creatinine clearance 60 mL/min', ' Urine protein creatinine (UPC) ratio must be 1.0', ' Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to be eligible for study', ' Not pregnant or nursing', ' Women of child-bearing potential and men must use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to, during, and for 8 weeks after completion of study therapy', ' Able to understand and willing to sign a written informed consent document', ' No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530', ' No QTc interval 500 msecs', ' No condition that impairs the ability to swallow AZD0530 tablets, including the following:', ' Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation', ' Prior surgical procedures affecting absorption', ' Active peptic ulcer disease', ' No intercurrent cardiac dysfunction including, but not limited to, any of the following:', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Uncontrolled cardiac arrhythmia', ' History of myocardial infarction within 6 months of treatment', ' No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements', ' No severe restrictive or obstructive lung disease according to baseline pulmonary function studies including any of the following pulmonary function test (PFT) parameters:', ' Total lung capacity < 60%', ' Forced vital capacity < 50%', ' Forced expiratory volume in one second (FEV_1) < 50%', ' Diffusion capacity of carbon monoxide (DLCO) < 50%', ' Resting room air O_2 saturation < 92% or a decline in O_2 saturation > 4% with exercise', ' Patients with metastatic disease may have received no more than 1 prior chemotherapy regimen', ' No unresolved toxicity grade 3 from agents received more than 3 weeks earlier', ' No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study', ' No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry', ' More than 7 days since prior and no concurrent use of specifically prohibited cytochrome P 450 3A4 (CYP3A4) agents', ' No concurrent megestrol acetate, even when prescribed for appetite stimulation', ' No other concurrent investigational or commercial agents for the treatment of breast cancer', ' No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients', ' No concurrent megestrol acetate'], 'Results': ['Outcome Measurement: ', ' Disease Control Rate (DCR)', " DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started", ' Time frame: After 24 weeks of study therapy', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy)', ' Arm/Group Description: Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Hypoxia 1/9 (11.11%)', ' Fatigue (asthenia, lethargy, malaise) 1/9 (11.11%)', ' Adrenal insufficiency 1/9 (11.11%)', ' Sodium, low (hyponatremia) 1/9 (11.11%)', ' Elevated liver enzymes 1/9 (11.11%)']}

e5a4cb11-2a00-4144-93ba-f5462d7efbf0

Comparison

Intervention

NCT01720602

NCT00082810

the primary trial participants receive more anastrozole, letrozole and exemestane than patients in the secondary trial.

Entailment

{'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%)']}

{'Clinical Trial ID': 'NCT00082810', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 250 mg + Tipifarnib 300 mg', ' Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed adenocarcinoma of the breast', ' Patients must be postmenopausal', ' Patients must have stage IV disease or inoperable locally advanced disease', ' Patients must have ER- and/or PR-positive disease as determined by their local pathology laboratory', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; all sites of disease should be noted and followed', ' Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted; patients previously treated with two or more prior doses of fulvestrant are not eligible; patients who have received one prior dose of fulvestrant within 28 days are eligible so long as they meet other eligibility criteria', ' Patients must have ECOG performance status 0-2 (Karnofsky >= 60%)', ' Patients must have life expectancy of greater than 3 months', ' Leukocytes >= 3,000/uL', ' Absolute neutrophil count >= 1,500/uL', ' Platelets >= 100,000/uL', ' Total bilirubin =< 2 mg/dL', ' AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal', ' Creatinine less than or equal to 1.5 times the institutional upper limits of normal', ' Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix', ' Patients must have the ability to understand and the willingness to sign a written informed consent document', ' Patients who have had previous therapy with farnesyltransferase inhibitor', 'Exclusion Criteria:', ' Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had prior chemotherapy for metastatic disease are not eligible; prior adjuvant or neoadjuvant chemotherapy is allowed', ' Patients may not be receiving any other investigational agents', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777, Zarnestra™) or other agents used in the study (e.g., imidazoles, quinolones)', ' Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (> 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement', ' Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued', ' Grade 2 or more peripheral neuropathy', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with tipifarnib or other agents administered during the study.; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)', ' Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.', ' Time frame: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg + Tipifarnib 300 mg', ' Arm/Group Description: Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Number', ' Unit of Measure: participants Partial response: 11', ' Stable disease: 5', ' Complete response: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/33 (60.61%)', ' Neutropenia 4/33 (12.12%)', ' Anemia 2/33 (6.06%)', ' Cardiac Ischemia 1/33 (3.03%)', ' Nausea 3/33 (9.09%)', ' Vomiting 2/33 (6.06%)', ' Diarrhea 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', ' Infection 1/33 (3.03%)', ' Anorexia 1/33 (3.03%)', ' Hyperglycemia 1/33 (3.03%)', ' Hypocalcemia 2/33 (6.06%)', ' Hypokalemia 1/33 (3.03%)', ' Ataxia 1/33 (3.03%)', ' Insomnia 1/33 (3.03%)']}

03d72e5f-b921-4aeb-802c-4dc4ee1a7e4c

Single

Results

NCT01945775

The shortest PFS in the Talazoparib group of the primary trial was over a month longer than the study duration.

Contradiction

{'Clinical Trial ID': 'NCT01945775', 'Intervention': ['INTERVENTION 1: ', ' Talazoparib', " Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", 'INTERVENTION 2: ', " Physician's Choice Treatment", " Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days."], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy', ' Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor', ' No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)', ' Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated', ' Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', 'Exclusion Criteria:', ' First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject', ' Prior treatment with a PARP inhibitor (not including iniparib)', " Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)", ' Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded', ' Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy', ' Cytotoxic chemotherapy within 14 days before randomization', ' Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization', ' HER2 positive breast cancer', ' Active inflammatory breast cancer', ' CNS metastases', ' Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.', ' Subjects with leptomeningeal carcinomatosis are not permitted', ' Prior malignancy except for any of the following:', ' Prior BRCA-associated cancer as long as there is no current evidence of the cancer', ' Carcinoma in situ or non-melanoma skin cancer', ' A cancer diagnosed and definitively treated 5 years before randomization with no subsequent evidence of recurrence', ' Known to be human immunodeficiency virus positive', ' Known active hepatitis C virus, or known active hepatitis B virus', ' Known hypersensitivity to any of the components of talazoparib'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment', ' IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.', ' Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)', 'Results 1: ', ' Arm/Group Title: Talazoparib', " Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 287', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.6 (7.2 to 9.3)', 'Results 2: ', " Arm/Group Title: Physician's Choice Treatment", " Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 144', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.2 to 6.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/286 (36.01%)', ' Anaemia * 18/286 (6.29%)', ' Neutropenia * 3/286 (1.05%)', ' Thrombocytopenia * 2/286 (0.70%)', ' Febrile neutropenia * 1/286 (0.35%)', ' Leukopenia * 1/286 (0.35%)', ' Pancytopenia * 2/286 (0.70%)', ' Pericardial effusion * 3/286 (1.05%)', ' Atrial flutter * 1/286 (0.35%)', ' Cardiac tamponade * 1/286 (0.35%)', ' Diplopia * 2/286 (0.70%)', ' Vomiting * 5/286 (1.75%)', 'Adverse Events 2:', ' Total: 39/126 (30.95%)', ' Anaemia * 0/126 (0.00%)', ' Neutropenia * 4/126 (3.17%)', ' Thrombocytopenia * 0/126 (0.00%)', ' Febrile neutropenia * 1/126 (0.79%)', ' Leukopenia * 0/126 (0.00%)', ' Pancytopenia * 0/126 (0.00%)', ' Pericardial effusion * 0/126 (0.00%)', ' Atrial flutter * 0/126 (0.00%)', ' Cardiac tamponade * 0/126 (0.00%)', ' Diplopia * 0/126 (0.00%)', ' Vomiting * 2/126 (1.59%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

27a4d1a8-185b-4483-85ce-0fbb3d323b99

Single

Results

NCT01743560

By week 48 of the primary trial none of the patients had Complete Response, 7 had partial response and 15 had progressive disease.

Entailment

{'Clinical Trial ID': 'NCT01743560', 'Intervention': ['INTERVENTION 1: ', ' Everolimus and Exemestane', ' Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.'], 'Eligibility': ['Inclusion Criteria:', ' Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.', ' Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).', ' Postmenopausal women. The investigator must confirm postmenopausal status. Postmenopausal status is defined either by:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH per local institutional standards', ' Prior hysterectomy and has postmenopausal levels of Follicle stimulating hormone (FSH) and Luteinizing Hormone (LH) per local institutional standards Surgical menopause with bilateral oophorectomy', ' Disease progression following prior therapy with NSAI, defined as:', ' Recurrence while on or after completion of an adjuvant treatment including letrozole or anastrozole, or', ' Progression while on or following the completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer', ' Note: Non-steroidal aromatase inhibitors (i.e. letrozole or anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. tamoxifen, fulvestrant, exemestane are also allowed. Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.', ' - Radiological evidence of recurrence or progression on last systemic therapy prior to enrollment.', 'Patients must have:', ' At least one lesion that can be accurately measured or', ' Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease', ' - Adequate bone marrow and coagulation function as shown by:', ' Absolute neutrophil count (ANC) 1.5 109/L', ' Platelets 100 ×109/L', ' Hemoglobin (Hb) 9.0 g/dL', ' International Normalized Ratio (INR) 2 .', ' - Adequate liver function as shown by:', ' Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 ULN (or 5 if hepatic metastases are present)', ' Total serum bilirubin 1.5 × ULN ( 3 × ULN for patients known to have Gilbert Syndrome)', ' - Adequate renal function as shown by:', ' Serum creatinine 1.5 × ULN', ' Fasting serum cholesterol 300 mg/dl or 7.75 mmol/L and fasting triglycerides 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved', ' Eastern Cooperative Oncology Group (ECOG) performance status of PS </ 2', ' Written informed consent obtained before any screening procedure and according to local guidelines.', 'Exclusion Criteria:', ' HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).', ' Pre-menopausal, pregnant, lactating women.', ' Known hypersensitivity to mammilian target of Rapamycin (mTOR) inhibitors, e.g. sirolimus (rapamycin) or to their excipients.', ' Known hypersensitivity to exemestane, to the active substance or to any of the excipients.', ' Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.', ' Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.', ' Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.', ' Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:', ' Prolonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) should not be given. However:', ' short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic)', ' low doses of corticosteroids for brain metastasis treatment is allowed', ' Patients with symptomatic visceral metastasis (e.g. significant dyspnoea related to pulmonary lymphangitic carcinomatosis and lung metastases or clinically meaningful symptomatic liver metastasis)', ' Symptomatic brain or other Central Nervous system (CNS) metastases.', ' Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin, low molecular weight heparin (LMWH) and acetylsalicylic acid or equivalent, as long as the INR is 2.0)', ' Any severe and / or uncontrolled medical conditions such as:', ' Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN', ' Acute and chronic, active infectious disorders (except for Hep B and Hep C positive patients) and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)', ' Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.', ' Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment', ' History of non-compliance to medical regimens', ' Patients unwilling to or unable to comply with the protocol', ' Another 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'], 'Results': ['Outcome Measurement: ', ' Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer', ' The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.', ' Time frame: At 48 weeks', 'Results 1: ', ' Arm/Group Title: Everolimus and Exemestane', ' Arm/Group Description: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants Patients with measurable disease at baseline: 39', ' Patients with non-measurable disease at baseline: 10', ' Best at WK 48 - Complete Response (CR): 0', ' Best at WK 48 - Partial Response (PR): 7', ' Best at WK 48 - Stable Disease (SD): 18', ' Best at WK 48 - Progressive Disease (PD): 15', 'Unknown: 1', 'Missing: 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/49 (44.90%)', ' Anaemia 2/49 (4.08%)', ' Pericardial effusion 1/49 (2.04%)', ' Tachycardia 1/49 (2.04%)', ' Abdominal pain 1/49 (2.04%)', ' Abdominal pain upper 1/49 (2.04%)', ' Colitis 1/49 (2.04%)', ' Duodenal ulcer 1/49 (2.04%)', ' Gastric ulcer 1/49 (2.04%)', ' Haematemesis 1/49 (2.04%)', ' Oral pain 1/49 (2.04%)', ' Vomiting 2/49 (4.08%)', ' Mucosal inflammation 1/49 (2.04%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ff797dd4-0b4d-42fc-808d-27c439563ce2

Single

Eligibility

NCT00494481

Paula recently had fell down a flight of stairs and fractured her hip, she is excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00494481', 'Intervention': ['INTERVENTION 1: ', ' Vandetanib Plus Docetaxel', ' vandetanib 100 mg plus docetaxel', 'INTERVENTION 2: ', ' Placebo Plus Docetaxel', ' placebo plus docetaxel'], 'Eligibility': ['Inclusion Criteria:', ' Females with histological/cytological confirmation of breast cancer.', ' Subjects with a measurable lesion or bone lesions', 'Exclusion Criteria:', ' Previous radiotherapy within 6 weeks', ' Significant cardiac events, arrhythmias or other cardiac conditions'], 'Results': ['Outcome Measurement: ', ' Number of Patients With a Disease Progression Event', ' Number of patients with objective disease progression or death (by any cause in the absence of objective progression)', ' Time frame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off', 'Results 1: ', ' Arm/Group Title: Vandetanib Plus Docetaxel', ' Arm/Group Description: vandetanib 100 mg plus docetaxel', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: Participants 24', 'Results 2: ', ' Arm/Group Title: Placebo Plus Docetaxel', ' Arm/Group Description: placebo plus docetaxel', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: Participants 18'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/33 (42.42%)', ' Neutropenia 4/33 (12.12%)', ' Febrile Neutropenia 3/33 (9.09%)', ' Granulocytopenia 0/33 (0.00%)', ' Atrial Fibrillation 1/33 (3.03%)', ' Vertigo 1/33 (3.03%)', ' Keratitis 1/33 (3.03%)', ' Diarrhoea 3/33 (9.09%)', ' Colitis 0/33 (0.00%)', ' Ileus 1/33 (3.03%)', ' Nausea 1/33 (3.03%)', ' Stomatitis 1/33 (3.03%)', ' Asthenia 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', 'Adverse Events 2:', ' Total: 12/29 (41.38%)', ' Neutropenia 2/29 (6.90%)', ' Febrile Neutropenia 1/29 (3.45%)', ' Granulocytopenia 1/29 (3.45%)', ' Atrial Fibrillation 1/29 (3.45%)', ' Vertigo 0/29 (0.00%)', ' Keratitis 0/29 (0.00%)', ' Diarrhoea 0/29 (0.00%)', ' Colitis 1/29 (3.45%)', ' Ileus 0/29 (0.00%)', ' Nausea 0/29 (0.00%)', ' Stomatitis 0/29 (0.00%)', ' Asthenia 0/29 (0.00%)', ' Fatigue 0/29 (0.00%)', ' Pyrexia 1/29 (3.45%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

9f666667-0fde-4d79-b53c-33c0ffbbed90

Single

Eligibility

NCT00494481

Paula recently had a heart attack, she is excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00494481', 'Intervention': ['INTERVENTION 1: ', ' Vandetanib Plus Docetaxel', ' vandetanib 100 mg plus docetaxel', 'INTERVENTION 2: ', ' Placebo Plus Docetaxel', ' placebo plus docetaxel'], 'Eligibility': ['Inclusion Criteria:', ' Females with histological/cytological confirmation of breast cancer.', ' Subjects with a measurable lesion or bone lesions', 'Exclusion Criteria:', ' Previous radiotherapy within 6 weeks', ' Significant cardiac events, arrhythmias or other cardiac conditions'], 'Results': ['Outcome Measurement: ', ' Number of Patients With a Disease Progression Event', ' Number of patients with objective disease progression or death (by any cause in the absence of objective progression)', ' Time frame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off', 'Results 1: ', ' Arm/Group Title: Vandetanib Plus Docetaxel', ' Arm/Group Description: vandetanib 100 mg plus docetaxel', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: Participants 24', 'Results 2: ', ' Arm/Group Title: Placebo Plus Docetaxel', ' Arm/Group Description: placebo plus docetaxel', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: Participants 18'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/33 (42.42%)', ' Neutropenia 4/33 (12.12%)', ' Febrile Neutropenia 3/33 (9.09%)', ' Granulocytopenia 0/33 (0.00%)', ' Atrial Fibrillation 1/33 (3.03%)', ' Vertigo 1/33 (3.03%)', ' Keratitis 1/33 (3.03%)', ' Diarrhoea 3/33 (9.09%)', ' Colitis 0/33 (0.00%)', ' Ileus 1/33 (3.03%)', ' Nausea 1/33 (3.03%)', ' Stomatitis 1/33 (3.03%)', ' Asthenia 1/33 (3.03%)', ' Fatigue 1/33 (3.03%)', 'Adverse Events 2:', ' Total: 12/29 (41.38%)', ' Neutropenia 2/29 (6.90%)', ' Febrile Neutropenia 1/29 (3.45%)', ' Granulocytopenia 1/29 (3.45%)', ' Atrial Fibrillation 1/29 (3.45%)', ' Vertigo 0/29 (0.00%)', ' Keratitis 0/29 (0.00%)', ' Diarrhoea 0/29 (0.00%)', ' Colitis 1/29 (3.45%)', ' Ileus 0/29 (0.00%)', ' Nausea 0/29 (0.00%)', ' Stomatitis 0/29 (0.00%)', ' Asthenia 0/29 (0.00%)', ' Fatigue 0/29 (0.00%)', ' Pyrexia 1/29 (3.45%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

47084742-d031-4e59-865c-d8687282c782

Single

Adverse Events

NCT00454805

In the primary trial there were no cases of subendocardial myocardial infarction in cohort 1 or 2.

Entailment

{'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%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ae583ea3-36a5-472c-acda-825cd7d513b6

Single

Adverse Events

NCT00206427

A patient in the primary trial had a vaginal fungal infection.

Contradiction

{'Clinical Trial ID': 'NCT00206427', 'Intervention': ['INTERVENTION 1: ', ' GW572016 1500mg', ' patients received GW572016 1500mg daily'], 'Eligibility': ['Inclusion Criteria:', ' All patients must be female.', ' Signed informed consent.', ' Locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size >/- 5 cm, and/or are deemed surgically inoperable, with Stage IIIb, IIIc, or IV disease.', " HER2 overexpressing tumors defined as HercepTest score of 3+, or >/- 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >/- 5 (in Dr. Allred's laboratory) or gene amplified.", ' Negative serum pregnancy test (BHCG) within 7 days of starting study, if of child-bearing potential.', " Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.", ' Performance status (WHO scale) less than 2 and life expectancy greater than 6 months.', ' Age greater than 18 years.', ' No brain or leptomeningeal disease.', ' No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.', 'Exclusion Criteria:', ' Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.', ' Severe underlying chronic illness or disease.', ' Cardiomyopathy or baseline LVEF <50%.', ' Other investigational drugs while on study.', ' Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.', ' Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in protocol) within 7 days of first dose of study medications.'], 'Results': ['Outcome Measurement: ', ' Clinical Response', ' Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).', ' Time frame: at the end of week 6.', 'Results 1: ', ' Arm/Group Title: GW572016 1500mg', ' Arm/Group Description: patients received GW572016 1500mg daily', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: participants cCR: 3', ' cPR: 30', 'cSD: 11', 'cPD: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/49 (6.12%)', ' Neutrophils/ANC *1/49 (2.04%)', ' Leukocytes *1/49 (2.04%)', ' Hypocalcemia *1/49 (2.04%)', ' Febrile neutropenia *1/49 (2.04%)', ' Left Ventricular Systolic Dysfunction *1/49 (2.04%)', ' Constipation *1/49 (2.04%)', ' Mucositis-oral *1/49 (2.04%)', ' Infection-oral thrush *1/49 (2.04%)', ' rash *1/49 (2.04%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a18c447b-de08-48ef-8e65-0ecaa775c2b0

Single

Eligibility

NCT00050167

Patients with metastasis in four or more axillary lymph nodes are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00050167', 'Intervention': ['INTERVENTION 1: ', ' Weekly Paclitaxel (WP)', ' Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles', 'INTERVENTION 2: ', ' Docetaxel and Capecitabine (DX)', ' Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.', ' Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.', " High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.", " Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).", ' Patients with bilateral breast cancers are eligible.', ' Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.', ' Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound', ' Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.', ' Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.', ' Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.', ' Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.', ' In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockcroft and Gault Equation: Cockcroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body weight [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value', ' Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.', ' Patients who have overexpression of the her-2/neu oncogene are eligible for the study.', 'Exclusion Criteria:', ' Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.', ' Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.', ' Severe hypersensitivity reactions to agents formulated in either cremophor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.', ' Those patients with history of other malignancies will be excluded, except non-melanoma skin cancer and non-invasive cervical cancer.', ' Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.', ' Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.', ' Patients who have had an organ allograft are ineligible.', ' Patients with serious concurrent infections are ineligible.', ' Sexually active male patients unwilling to practice contraception during the study are ineligible.', ' Patients with pre-existing peripheral neuropathy > grade 1.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Reoccurrence', ' Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).', ' Time frame: Median of 50 months', 'Results 1: ', ' Arm/Group Title: Weekly Paclitaxel (WP)', ' Arm/Group Description: Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 301', ' Log Mean (95% Confidence Interval)', ' Unit of Measure: participants 90.7 (86.4 to 93.7)', 'Results 2: ', ' Arm/Group Title: Docetaxel and Capecitabine (DX)', ' Arm/Group Description: Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.', ' Overall Number of Participants Analyzed: 300', ' Log Mean (95% Confidence Interval)', ' Unit of Measure: participants 87.5 (82.7 to 91.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 81/301 (26.91%)', ' Neutropenia 2/297 (0.67%)', ' Fluid retention 1/297 (0.34%)', ' Nausea 5/297 (1.68%)', ' Vomiting 0/297 (0.00%)', ' Diarrhea 12/297 (4.04%)', ' Constipation 2/297 (0.67%)', ' Fatigue 25/297 (8.42%)', ' Alopecia 0/297 (0.00%)', ' Allergic reaction 2/297 (0.67%)', ' Stomatitis 0/297 (0.00%)', ' Neutropenic Infection 2/297 (0.67%)', ' Neutropenic Fever 0/297 (0.00%)', 'Adverse Events 2:', ' Total: 293/300 (97.67%)', ' Neutropenia 45/293 (15.36%)', ' Fluid retention 0/293 (0.00%)', ' Nausea 12/293 (4.10%)', ' Vomiting 5/293 (1.71%)', ' Diarrhea 17/293 (5.80%)', ' Constipation 6/293 (2.05%)', ' Fatigue 66/293 (22.53%)', ' Alopecia 0/293 (0.00%)', ' Allergic reaction 4/293 (1.37%)', ' Stomatitis 5/293 (1.71%)', ' Neutropenic Infection 20/293 (6.83%)', ' Neutropenic Fever 13/293 (4.44%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

18b900fb-b071-43df-b37d-c68a89ef78c0

Single

Eligibility

NCT00932373

Patients with Grade III peripheral neuropathy or above are eliminated from participation in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00932373', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks', ' Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks', 'INTERVENTION 2: ', ' Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks', ' Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented, incurable, locally advanced or metastatic breast cancer', ' Evaluable or measurable HER2-positive disease', ' History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer', ' Previous treatment with chemotherapy for MBC', ' Granulocyte count 1,500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL', ' Serum bilirubin 1.5 mg/dL; AST, ALT, and alkaline phosphatase 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN', ' Serum creatinine 1.5 mg/dL or creatinine clearance of 60 mL/min based on a 24-hour urine collection', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2', ' Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment', 'Exclusion Criteria:', ' History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication', ' History of Grade 3 hypersensitivity reaction to trastuzumab', ' History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued', ' Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment', ' Require supplemental oxygen for daily activities', ' Grade 2 peripheral neuropathy', ' Bisphosphonate therapy for symptomatic hypercalcemia', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment', ' Any experimental therapy within 4 weeks of first study treatment', ' Any major surgical procedure within 4 weeks of first study treatment', ' History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis', ' Pregnancy or lactation', ' Cardiac troponin I 0.2 ng/mL', ' Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan', ' Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment', ' The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.', ' The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.', ' Time frame: Study treatment initiation until 30 or 90 days after last administration of study treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks', ' Arm/Group Description: Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: percentage of participants At least 1 AE: 100', 'AEs with Grade >=3: 33.3', ' At least 1 SAE: 33.3', ' AEs related to treatment: 66.7', 'Results 2: ', ' Arm/Group Title: Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks', ' Arm/Group Description: Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: percentage of participants At least 1 AE: 100', 'AEs with Grade >=3: 100', ' At least 1 SAE: 100', ' AEs related to treatment: 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Pain 0/3 (0.00%)', ' Cellulitis 0/3 (0.00%)', ' Influenza 0/3 (0.00%)', ' Osteomyelitis 0/3 (0.00%)', ' Pneumonia 0/3 (0.00%)', ' Humerus Fracture 0/3 (0.00%)', ' Brain Oedema 0/3 (0.00%)', ' Cerebral Haemorrhage 0/3 (0.00%)', ' Convulsion 0/3 (0.00%)', ' Dysarthria 0/3 (0.00%)', ' Hepatic Encephalopathy 0/3 (0.00%)', ' Confusional State 0/3 (0.00%)', ' Dyspnoea 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 1/1 (100.00%)', ' Pain 0/1 (0.00%)', ' Cellulitis 0/1 (0.00%)', ' Influenza 0/1 (0.00%)', ' Osteomyelitis 0/1 (0.00%)', ' Pneumonia 0/1 (0.00%)', ' Humerus Fracture 0/1 (0.00%)', ' Brain Oedema 0/1 (0.00%)', ' Cerebral Haemorrhage 0/1 (0.00%)', ' Convulsion 0/1 (0.00%)', ' Dysarthria 0/1 (0.00%)', ' Hepatic Encephalopathy 0/1 (0.00%)', ' Confusional State 0/1 (0.00%)', ' Dyspnoea 0/1 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ebdf2841-b5e0-431a-8dc7-e100c5d27ccf

Single

Adverse Events

NCT00670982

Acute coronary syndrome was the most prevalent adverse event in the primary trial, other than Thrombocytopenia .

Contradiction

{'Clinical Trial ID': 'NCT00670982', 'Intervention': ['INTERVENTION 1: ', ' First Line Treatment', ' Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week', 'INTERVENTION 2: ', ' Second Line Treatment', ' Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, with metastatic disease.', ' HER2-positive tumor', ' Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan', ' 18 years of age or older', ' Life expectancy of more than 12 weeks', ' ECOG Performance Status of 0 or 1', ' Normal organ and marrow function as outlined in the protocol', ' Left ventricular ejection fraction 50% or greater as determined by RVG or echocardiogram within 30 days prior to initiation of protocol therapy', ' Patients with stable or previously treated CNS metastases are eligible for study participation, provided there is no history of clinically significant CNS bleeding', ' Men and women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation', ' COHORT A:', ' No prior chemotherapy for treatment of metastatic breast cancer', ' May NOT have received prior treatment with trastuzumab for recurrent or metastatic breast cancer', ' No prior vinorelbine for treatment of breast cancer', ' No prior bevacizumab for treatment of breast cancer', ' May have received prior radiation therapy and/or any number of lines of hormonal therapy', ' Prior trastuzumab therapy in the adjuvant setting is also allowed, providing that relapse occured at least 12 months following the last dose', ' Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment', ' COHORT B:', ' One prior line of chemotherapy for treatment of metastatic breast cancer or recurrence of breast cancer within 12 months of completion of adjuvant trastuzumab', ' No prior vinorelbine for treatment of breast cancer', ' No prior bevacizumab for treatment of breast cancer', ' May have received prior radiation therapy and/or any number of lines of hormonal therapy', ' Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment', 'Exclusion Criteria:', ' Patients who have had chemotherapy within 14 days prior to entering the study, ot those who have not recovered adequately from adverse events due to agents administered earlier', ' Concurrent radiation therapy', ' History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in this study', ' Prior therapy with bevacizumab or vinorelbine', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study', ' Inadequately controlled hypertension', ' Prior history of hypertensive crisis of hypertensive encephalopathy', ' NHYA Grade II or greater congestive heart failure', ' History of myocardial infarction of unstable angina within 6 months prior to study enrollment', ' History of stroke or transient ischemic attack within 6 months prior to study enrollment', ' Progressive or untreated CNS metastases', ' Significant vascular disease within 6 months prior to study enrollment', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study', ' Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious non-healing wound, active ulcer, or untreated bone fracture', ' Proteinuria at screening', ' Pregnant or lactating', ' Current and ongoing treatment with full-dose warfarin or its equivalent'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.', ' Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: First Line Treatment', ' Arm/Group Description: Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: percentage of participants 36 (17 to 59)', 'Results 2: ', ' Arm/Group Title: Second Line Treatment', ' Arm/Group Description: Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: percentage of participants 29 (4 to 71)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/29 (31.03%)', ' Neutropenia 5/29 (17.24%)', ' Cataracts 1/29 (3.45%)', ' Abdominal Pain 1/29 (3.45%)', ' Perforated Appendix 1/29 (3.45%)', ' Surgical Intervention 1/29 (3.45%)', ' Deep Vein Thrombosis 1/29 (3.45%)', ' Cerebrovascular Ischemia 1/29 (3.45%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d56745c3-ba0b-4b42-b3cf-ac060f658d83

Single

Adverse Events

NCT01446159

the primary trial only had a total of 6 patients in across both its cohorts.

Entailment

{'Clinical Trial ID': 'NCT01446159', 'Intervention': ['INTERVENTION 1: ', ' MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'INTERVENTION 2: ', ' MEDI-573 30 mg/kg + AI', ' Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy', ' Tumors are positive for ER, PgR, or both', ' Tumors must be negative for HER2 (by FISH, CISH or IHC)', ' Female gender and age 18 years at time of study entry', ' Postmenopausal', ' Karnofsky Performance Status 70', ' Life expectancy of 6 months', 'Exclusion Criteria:', ' Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:', ' Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573', ' Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed', ' Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)', ' Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573', ' Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis', ' Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to Grade 1 at the time of starting study treatment', ' Previous treatment with agents that target the IGF receptor', ' History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI', ' History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix', ' Poorly controlled diabetes mellitus'], 'Results': ['Outcome Measurement: ', ' Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', ' An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', ' Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'Results 1: ', ' Arm/Group Title: MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Arm/Group Description: Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 2 66.7%', 'Results 2: ', ' Arm/Group Title: MEDI-573 30 mg/kg + AI', ' Arm/Group Description: Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Febrile neutropenia 1/3 (33.33%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 1/3 (33.33%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/3 (0.00%)', ' Febrile neutropenia 0/3 (0.00%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 0/3 (0.00%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0ef77b5d-684a-4a87-bf61-8d4bc9975b7f

Single

Results

NCT00375505

In the primary trial patients in control group had a Z-score of 0.037, higher than the test group score.

Contradiction

{'Clinical Trial ID': 'NCT00375505', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).', 'INTERVENTION 2: ', ' Zometa', ' Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)', ' Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.', ' Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)', ' Patient receives adjuvant standard chemoendocrine or endocrine therapy', ' Bone density at study entry > -2.5 T-Score', 'Exclusion Criteria:', " History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D", ' Abnormal renal function', ' Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)', ' Pregnancy or lactation', ' Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24', " Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.", ' Time frame: baseline, month 24', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).', ' Overall Number of Participants Analyzed: 36', ' Mean (Standard Deviation)', ' Unit of Measure: Z-score -0.075 (0.041)', 'Results 2: ', ' Arm/Group Title: Zometa', ' Arm/Group Description: Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).', ' Overall Number of Participants Analyzed: 34', ' Mean (Standard Deviation)', ' Unit of Measure: Z-score 0.037 (0.042)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/36 (8.33%)', ' VERTIGO 0/36 (0.00%)', ' DENTAL CARIES 1/36 (2.78%)', ' GASTROINTESTINAL OEDEMA 1/36 (2.78%)', ' HAEMATOCHEZIA 0/36 (0.00%)', ' PANCREATITIS 1/36 (2.78%)', ' PYREXIA 1/36 (2.78%)', ' DRUG HYPERSENSITIVITY 0/36 (0.00%)', ' FEBRILE INFECTION 0/36 (0.00%)', ' SUBCUTANEOUS ABSCESS 1/36 (2.78%)', ' OSTEONECROSIS 0/36 (0.00%)', ' BREAST CANCER 1/36 (2.78%)', ' OSTEOMA 1/36 (2.78%)', 'Adverse Events 2:', ' Total: 6/34 (17.65%)', ' VERTIGO 1/34 (2.94%)', ' DENTAL CARIES 0/34 (0.00%)', ' GASTROINTESTINAL OEDEMA 0/34 (0.00%)', ' HAEMATOCHEZIA 1/34 (2.94%)', ' PANCREATITIS 0/34 (0.00%)', ' PYREXIA 0/34 (0.00%)', ' DRUG HYPERSENSITIVITY 1/34 (2.94%)', ' FEBRILE INFECTION 1/34 (2.94%)', ' SUBCUTANEOUS ABSCESS 0/34 (0.00%)', ' OSTEONECROSIS 1/34 (2.94%)', ' BREAST CANCER 1/34 (2.94%)', ' OSTEOMA 0/34 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

03c7f31f-788c-4edb-a885-b6cb0fca05da

Single

Results

NCT01997333

The minimum Progression Free Survival for patients in cohort 1 the primary trial was 1.6 months.

Entailment

{'Clinical Trial ID': 'NCT01997333', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine', ' Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.', 'INTERVENTION 2: ', ' CDX-011', ' CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.'], 'Eligibility': ['Inclusion Criteria:', ' Among other criteria, patients must meet all of the following conditions to be eligible for the study:', ' Diagnosed with metastatic (i.e., cancer that has spread) TNBC', ' minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry', ' HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell', ' Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.', ' Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.', ' Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.', ' Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).', ' ECOG performance status of 0 - 1.', ' Adequate bone marrow, liver and renal function.', ' Exclusion:', ' Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:', ' Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.', ' Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.', ' Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.', ' Significant cardiovascular disease.', ' Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.', ' Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.', ' Chronic use of systemic corticosteroids.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.', ' Time frame: Evaluated every 6 - 9 weeks following treatment initiation', 'Results 1: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.', ' Overall Number of Participants Analyzed: 109', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.8 (1.6 to 3.2)', 'Results 2: ', ' Arm/Group Title: CDX-011', ' Arm/Group Description: CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.', ' Overall Number of Participants Analyzed: 218', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.9 (2.8 to 3.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/92 (20.65%)', ' Anemia 0/92 (0.00%)', ' Febrile neutropenia 0/92 (0.00%)', ' Leukopenia 0/92 (0.00%)', ' Neutropenia 1/92 (1.09%)', ' Pericardial effusion 0/92 (0.00%)', ' Sinus tachycardia 0/92 (0.00%)', ' Cataract nuclear 0/92 (0.00%)', ' Abdominal pain 2/92 (2.17%)', ' Colitis 0/92 (0.00%)', ' Constipation 0/92 (0.00%)', ' Diarrhoea 5/92 (5.43%)', ' Enterocolitis 2/92 (2.17%)', 'Adverse Events 2:', ' Total: 71/213 (33.33%)', ' Anemia 2/213 (0.94%)', ' Febrile neutropenia 3/213 (1.41%)', ' Leukopenia 1/213 (0.47%)', ' Neutropenia 2/213 (0.94%)', ' Pericardial effusion 2/213 (0.94%)', ' Sinus tachycardia 1/213 (0.47%)', ' Cataract nuclear 1/213 (0.47%)', ' Abdominal pain 6/213 (2.82%)', ' Colitis 1/213 (0.47%)', ' Constipation 4/213 (1.88%)', ' Diarrhoea 6/213 (2.82%)', ' Enterocolitis 0/213 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

e43c01e9-20a2-4435-a32b-224d5f460d7c

Comparison

Results

NCT00369655

NCT00091832

One patient in the primary trial had a Confirmed tumor partial response, No patients in the secondary trial were evaluated for tumor response.

Entailment

{'Clinical Trial ID': 'NCT00369655', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Ziv-afibercept)', ' Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast', ' Clinical evidence of metastatic disease', ' No more than 2 prior chemotherapy regimens for metastatic disease', ' Prior neoadjuvant or adjuvant chemotherapy allowed*', ' At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline', ' Measurable disease, defined as 1 lesion whose longest diameter can be accurately measured per RECIST criteria', ' No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter < 20 mm) and truly nonmeasurable lesions, including 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 with HER2-positive tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization [FISH]) must have received 1 prior trastuzumab (Herceptin®)-containing regimen in either the adjuvant or metastatic setting, unless there was a contraindication', ' No known CNS metastases', ' No evidence of leptomeningeal involvement', ' Hormone receptor status not specified', ' Male or female', ' Menopausal status not specified', ' ECOG performance status 0-1', ' Life expectancy > 3 months', ' WBC 3,000/mm³', ' Absolute neutrophil count 1,500/mm³', ' Platelet count 75,000/mm³', ' Hemoglobin > 8.0 g/dL', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 3 times ULN', ' AST and ALT 2.5 times ULN', ' Creatinine 1.5 times ULN', ' Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 6 months after completion of study treatment', ' No significant traumatic injury within the past 4 weeks', ' No history of allergy or hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, drug product excipients, or agents chemically or biologically similar to VEGF Trap', ' No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days', ' No nonhealing wound, fracture, or ulcer', ' No stage III or IV invasive, nonbreast malignancy within the past 5 years', ' No history of lung carcinoma of squamous cell type', ' No clinically significant cardiovascular disease, including any of the following:', ' Cerebrovascular accident or stroke within the past 6 months', ' Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg if diastolic blood pressure < 90 mm Hg on 2 separate occasions within the past 3 months', ' Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months', ' New York Heart Association class III or IV cardiovascular disease', ' Serious cardiac arrhythmia requiring medication', ' Peripheral vascular disease grade 2 within the past 6 months', ' Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months', ' No evidence of bleeding diathesis or uncontrolled coagulopathy', ' No active, unresolved infection', ' No serious concurrent medical condition that would preclude study participation', ' No other condition or circumstance that would preclude compliance with study requirements', ' See Disease Characteristics', ' Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed', ' No prior bevacizumab', ' More than 4 weeks since prior chemotherapy, endocrine therapy, experimental drug therapy, or immunotherapy and recovered', ' More than 4 weeks since prior major surgery or open biopsy', ' More than 7 days since prior core biopsy', ' More than 2 weeks since prior radiotherapy, except if to a nontarget lesion only', ' Prior radiotherapy to a target lesion allowed only if there has been clear progression of the lesion since radiotherapy was completed', ' Prior single-dose palliative radiotherapy within the past 2 weeks allowed', ' No concurrent major surgery', ' No concurrent trastuzumab', ' Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:', ' INR in-range (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin', ' No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No concurrent participation in another investigational clinical trial', ' No other concurrent chemotherapeutic agents, endocrine therapy, biologic agents, radiotherapy, or other nonprotocol antitumor therapy'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients With Confirmed Tumor Response', ' Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Treatment (Ziv-afibercept)', ' Arm/Group Description: Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: Participants Confirmed tumor partial response: 1', ' No Confirmed reponse: 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/21 (47.62%)', ' Left ventricular failure 2/21 (9.52%)', ' Sinus tachycardia 1/21 (4.76%)', ' Abdominal pain 1/21 (4.76%)', ' Disease progression 1/21 (4.76%)', ' Platelet count decreased 1/21 (4.76%)', ' Anorexia 1/21 (4.76%)', ' Headache 2/21 (9.52%)', ' Ischemia cerebrovascular 1/21 (4.76%)', ' Proteinuria 1/21 (4.76%)', ' Dyspnea 2/21 (9.52%)', ' Hypertension 2/21 (9.52%)']}

{'Clinical Trial ID': 'NCT00091832', 'Intervention': ['INTERVENTION 1: ', ' Bisphosphonate IV Q4W', ' Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion', 'INTERVENTION 2: ', ' Denosumab 30 mg Q4W', ' Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'], 'Eligibility': ['Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma', ' At least one bone metastasis'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)', ' Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.', ' Time frame: Baseline and Week 13', 'Results 1: ', ' Arm/Group Title: Bisphosphonate IV Q4W', ' Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion', ' Overall Number of Participants Analyzed: 38', ' Mean (Standard Deviation)', ' Unit of Measure: Percent change -10.19 (208.84)', 'Results 2: ', ' Arm/Group Title: Denosumab 30 mg Q4W', ' Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: Percent change -52.87 (95.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/43 (34.88%)', ' Anaemia 0/43 (0.00%)', ' Febrile bone marrow aplasia 0/43 (0.00%)', ' Febrile neutropenia 1/43 (2.33%)', ' Leukopenia 0/43 (0.00%)', ' Neutropenia 1/43 (2.33%)', ' Thrombocytopenia 0/43 (0.00%)', ' Angina pectoris 0/43 (0.00%)', ' Cardiac tamponade 0/43 (0.00%)', ' Cardio-respiratory arrest 0/43 (0.00%)', ' Cardiopulmonary failure 1/43 (2.33%)', ' Pericardial effusion 0/43 (0.00%)', 'Adverse Events 2:', ' Total: 11/42 (26.19%)', ' Anaemia 1/42 (2.38%)', ' Febrile bone marrow aplasia 1/42 (2.38%)', ' Febrile neutropenia 0/42 (0.00%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 0/42 (0.00%)', ' Thrombocytopenia 0/42 (0.00%)', ' Angina pectoris 1/42 (2.38%)', ' Cardiac tamponade 0/42 (0.00%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Cardiopulmonary failure 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)']}

c55f34ab-b883-465e-89dc-75bbeb8afa77

Comparison

Intervention

NCT01925170

NCT00324259

Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol, and no Mammography.

Entailment

{'Clinical Trial ID': 'NCT01925170', 'Intervention': ['INTERVENTION 1: ', ' Mammography Only', ' For this reporting arm, the interpretation and analysis was done with mammography only.', 'INTERVENTION 2: ', ' Mammography With Adjunct MBI', ' For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.'], 'Eligibility': ['Inclusion Criteria:', ' Past prior SM interpreted as negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]', ' Past prior SM interpreted as heterogeneously dense or extremely dense', 'Exclusion Criteria:', ' Subject is unable to understand and sign the consent form', ' Subject is pregnant or lactating', ' Subject is physically unable to sit upright and still for 40 minutes', ' Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)', ' Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study', ' Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.'], 'Results': ['Outcome Measurement: ', ' Cancer Detection Rate Per 1000 Women Screened, by Breast Density', ' The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.', ' Time frame: Within 21 days of mammography', 'Results 1: ', ' Arm/Group Title: Mammography Only', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with mammography only.', ' Overall Number of Participants Analyzed: 1585', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened All densities: 3.2 (1.3 to 7.4)', ' Scattered fibroglandular densities: 0 (0 to 26.2)', ' Heterogeneously dense: 3.3 (1.3 to 8.4)', ' Extremely dense: 4.5 (0.2 to 25.2)', 'Results 2: ', ' Arm/Group Title: Mammography With Adjunct MBI', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.', ' Overall Number of Participants Analyzed: 1585', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened All densities: 12.0 (7.7 to 18.6)', ' Scattered fibroglandular densities: 21.0 (7.2 to 59.9)', ' Heterogeneously dense: 10.6 (6.2 to 18.1)', ' Extremely dense: 13.6 (4.6 to 39.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/1585 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00324259', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (6 mg Estradiol)', ' 6 mg of estradiol daily (2 mg tid).', 'INTERVENTION 2: ', ' Arm 2 (30 mg Estradiol)', ' 30 mg of estradiol. (10 mg tid)'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with advanced hormone receptor positive (ER and or PgR) breast cancer, has received prior treatment with an aromatase inhibitor in the advanced disease setting, and experienced at least 24 weeks of progression free survival. As long as the patient experienced an aromatase inhibitor response as defined this way, she is still eligible even if she has received further lines of endocrine therapy, which may include other aromatase inhibitors or tamoxifen, even if these subsequent lines of treatment were unsuccessful (see below for permitted chemotherapy and trastuzumab therapy).', ' OR', ' Postmenopausal women with systemic or unresectable local relapse after taking at least two years of adjuvant aromatase inhibitor therapy.', ' Clinical diagnosis of postmenopausal status is defined as either:', ' Age greater than 50 years and amenorrhea for 1 year', ' Bilateral Surgical ovariectomy', ' Serum FSH and estradiol level in the postmenopausal range before the initiation of AI therapy.', ' If the patient was receiving an LHRH agonist to maintain a postmenopausal state during AI therapy this should be continued since recovery of menses would lead to uncontrolled estrogen exposure and pregnancy during estrogen therapy is contraindicated.', ' Tumor cell expression of ER and/or PgR can be ascertained on either the primary or the metastatic site. However when both types of tissue are available, the metastatic site should be used to determine eligibility. ER and/or PgR positive are defined as at least 10% of malignant cells with positive nuclear staining.', ' The patients may have received adjuvant and/or neoadjuvant chemotherapy.', ' Prior radiotherapy is permitted as long as it was planned before the start of the study medication and is completed within 3 weeks of trial medication starting.', ' Prior tamoxifen therapy is also permitted as adjuvant or advanced disease therapy.', ' Patients with ER+ HER2+ disease are eligible even of they have received trastuzumab in the past (and even if it was administered in combination with endocrine treatment) as long as they meet all other eligibility criteria. Trastuzumab therapy must be held during estradiol treatment.', ' Use of prior experimental agents alone or in combination with endocrine therapy is also permissible, but a wash out of one month is required if the immediate prior therapy involved a study medication that had not been subject to regulatory approval.', ' Prior adjuvant chemotherapy is permitted as well as one line of chemotherapy for advanced disease.', ' Patient must have at least one measurable lesion defined by RECIST criteria. To be considered measurable, a baseline lesion must have a minimum diameter to compensate for measurement error: 1 cm for soft tissue lesions, 1 cm for lung lesions including pleural lesions measured by CT scan, 1 cm for liver lesions measured by CT scan.', ' Patients with bone only disease can also be enrolled if they meet the following criteria:', ' Four or more lesions more than one cm, measurable on CT scan bone windows.', ' At least one tumor marker that is elevated to at least two times the upper limit of normal.', ' All patients should have a baseline bone scan with X-ray evaluation of all hot spots, CT chest abdomen and pelvis (with bone windows), and tumor marker assessment. Also CT scan of the extremities should be done on suspicious areas seen on X-ray evaluation of all hot spots if these extremity lesions are to be followed for response.', ' The patient must have an ECOG performance status of 0-2', ' The patient should have a life expectancy of > 6 months.', ' The patient must have adequate hematologic function, defined as ANC >1000/mm3 and platelets > 75,000/mm3.', ' The patient must have adequate renal function, defined as serum creatinine less than or equal to 1.5 times the upper limit of normal.', ' The patient must have adequate liver function defined as serum bilirubin less than or equal to 1.5 times the upper limit of normal (three times the upper limit of normal for patients with hereditary benign hyperbilirubinaemia), transaminases (ALT, AST) less than or equal to 2.5 times the upper limit of normal in patients without liver metastasis or less than or equal to 5 times the upper limit of normal in patients with liver metastasis.', ' For patients with bone metastasis, treatment with i.v. bisphosphonates during the trial is mandatory because of the risk of hypercalcemia. Bisphosphonate therapy must be started before the patient begins protocol therapy.', ' Preexisting hypercalcemia should be treated and calcium normalized prior to study entry.', ' The patient must give written informed consent prior to initiation of any invasive study-related procedures that would otherwise not be performed, and must be able to comply with scheduled visits and evaluations.', ' Inclusion of Women and Minorities: Entry to this study is open to women of all racial and ethnic subgroups.', ' Patients with fasting blood glucose level 200 mg/dL. If greater, hyperglycemia must be treated before initiation of study investigations.', 'Exclusion Criteria:', ' Patients with CNS involvement with metastatic breast cancer or life threatening lymphangitic or large volume lung or liver disease that threatens organ function.', ' Patients with history of deep venous thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension.', ' Ischemic changes on a baseline EKG or other evidence of ischemic heart disease.', ' Undiagnosed abnormal genital bleeding', ' Untreated cholelithiasis', ' Fasting serum triglycerides greater than 400. Patients should be treated and triglycerides controlled prior to study entry.', ' Treatment with fulvestrant within 12 months of study initiation (fulvestrant has been shown to antagonize estradiol induced apoptosis in preclinical models (5).', " The patient's only qualifying lesion (s) have been previously irradiated or are scheduled for irradiation following study entry.", ' Severe or uncontrolled concomitant disease from other causes.', ' EGOG Performance status 3 or 4.', ' The patient has previous malignancies other than breast cancer except a) adequately treated in situ carcinoma of the cervix, b) localized basal or squamous cell carcinoma of the skin c) any previous malignancy treated with curative intent with a recurrence risk of less than 30%.', ' The patient is unable to understand the informed consent or is unlikely to be compliant with the protocol.', ' More than one line of palliative chemotherapy for advanced disease.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CR Plus PR Plus SD)', ' Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0', ' CR = disappearance of all target lesions', ' PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter', ' SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease', ' SD is defined as lack of disease progression by 24 weeks.', ' Time frame: 24 weeks after start of treatment', 'Results 1: ', ' Arm/Group Title: Arm 1 (6 mg Estradiol)', ' Arm/Group Description: 6 mg of estradiol daily (2 mg tid).', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants Complete response (CR): 0', ' Partial response (PR): 3', ' Stable disease (SD): 7', 'CR+PR+SD: 10', 'Results 2: ', ' Arm/Group Title: Arm 2 (30 mg Estradiol)', ' Arm/Group Description: 30 mg of estradiol. (10 mg tid)', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants Complete response (CR): 0', ' Partial response (PR): 1', ' Stable disease (SD): 8', 'CR+PR+SD: 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/34 (23.53%)', ' Hemoglobin 0/34 (0.00%)', ' Eye pain 0/34 (0.00%)', ' Vison loss 0/34 (0.00%)', ' Abdominal pain 2/34 (5.88%)', ' Constipation 0/34 (0.00%)', ' Diarrhea 2/34 (5.88%)', ' GI hemorrhage 1/34 (2.94%)', ' Nausea 2/34 (5.88%)', ' Vomiting 2/34 (5.88%)', ' Fatigue 0/34 (0.00%)', ' Fever 2/34 (5.88%)', ' Pain 0/34 (0.00%)', ' Pneumonia 1/34 (2.94%)', ' Neutropenia 0/34 (0.00%)', 'Adverse Events 2:', ' Total: 8/32 (25.00%)', ' Hemoglobin 1/32 (3.13%)', ' Eye pain 1/32 (3.13%)', ' Vison loss 1/32 (3.13%)', ' Abdominal pain 1/32 (3.13%)', ' Constipation 2/32 (6.25%)', ' Diarrhea 1/32 (3.13%)', ' GI hemorrhage 0/32 (0.00%)', ' Nausea 3/32 (9.38%)', ' Vomiting 3/32 (9.38%)', ' Fatigue 1/32 (3.13%)', ' Fever 0/32 (0.00%)', ' Pain 1/32 (3.13%)', ' Pneumonia 0/32 (0.00%)', ' Neutropenia 1/32 (3.13%)']}

0ee36ceb-5790-440e-b6ad-10a0b7a23f43

Comparison

Eligibility

NCT02419807

NCT00777101

Patients with HER2 + breast cancer stage 1-4 are eligible for both the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT02419807', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)', ' Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.'], 'Eligibility': ['Inclusion Criteria:', ' Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer', ' Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy', ' Participants with planned axillary sentinel node biopsy procedure', 'Exclusion Criteria:', ' Participants with cancer > 3 cm', ' Participants with clinically positive nodes', ' Participants with prior surgery for breast cancer in the index breast', ' Participants who have had bilateral breast surgeries', ' Thyroid dysfunction', ' Hypersensitivity to iodine', ' Hepatic insufficiency', ' Renal insufficiency'], 'Results': ['Outcome Measurement: ', ' Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods', ' Let A be the number of Tc-positive and ICG-positive sentinel nodes (SNs) detected, B be the number of Tc-positive and ICG-negative SNs detected, and C be the number of Tc-negative and ICG-positive SNs detected. The total number (N) of SNs detected is therefore N = (A + B + C); the proportion of SNs detected by the Tc method (PTc) is (A + B)/N; and the proportion of SNs detected by the ICG method (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.', ' Time frame: Baseline', 'Results 1: ', ' Arm/Group Title: Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)', ' Arm/Group Description: Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.', ' Overall Number of Participants Analyzed: 92', ' Measure Type: Number', ' Unit of Measure: proportion of nodes Proportion of SNs (PTc) detected by Tc method: 0.86', ' Proportion of SNs (PICG) detected by ICG method: 0.95'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/102 (0.00%)']}

{'Clinical Trial ID': 'NCT00777101', 'Intervention': ['INTERVENTION 1: ', ' Neratinib', ' Neratinib', ' Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Lapatinib+Capecitabine', ' Lapatinib plus Capecitabine', ' Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.', ' Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer', ' Prior use of Herceptin (trastuzumab), and a taxane', ' Adequate cardiac and renal function', 'Exclusion Criteria:', ' More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]', ' Bone as the only site of disease', ' Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)', ' Significant gastrointestinal disorder with diarrhea as major symptom'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.', ' Time frame: From randomization date to progression or death, assessed up to 69 months', 'Results 1: ', ' Arm/Group Title: Neratinib', ' Arm/Group Description: Neratinib', ' Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 117', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.53 (3.12 to 5.65)', 'Results 2: ', ' Arm/Group Title: Lapatinib+Capecitabine', ' Arm/Group Description: Lapatinib plus Capecitabine', ' Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.', ' Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 116', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.83 (5.85 to 8.21)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/116 (26.72%)', ' Neutropenia 1/116 (0.86%)', ' Thrombocytopenia 1/116 (0.86%)', ' Acute myocardial infarction 1/116 (0.86%)', ' Myocardial infarction 0/116 (0.00%)', ' Pericardial effusion 0/116 (0.00%)', ' Abdominal pain 3/116 (2.59%)', ' Ascites 1/116 (0.86%)', ' Diarrhoea 3/116 (2.59%)', ' Gingival bleeding 1/116 (0.86%)', ' Intestinal haemorrhage 1/116 (0.86%)', ' Nausea 2/116 (1.72%)', 'Adverse Events 2:', ' Total: 24/115 (20.87%)', ' Neutropenia 1/115 (0.87%)', ' Thrombocytopenia 0/115 (0.00%)', ' Acute myocardial infarction 0/115 (0.00%)', ' Myocardial infarction 1/115 (0.87%)', ' Pericardial effusion 1/115 (0.87%)', ' Abdominal pain 0/115 (0.00%)', ' Ascites 0/115 (0.00%)', ' Diarrhoea 4/115 (3.48%)', ' Gingival bleeding 0/115 (0.00%)', ' Intestinal haemorrhage 0/115 (0.00%)', ' Nausea 3/115 (2.61%)']}

2535da13-e0f7-44df-aa02-89765d8d51cb

Single

Results

NCT00548184

The majority of breast cancer patients in the primary trial treated with Lapatinib + Trastuzumab experienced at least Near Complete Pathologic Response, or better, after 12 weeks.

Entailment

{'Clinical Trial ID': 'NCT00548184', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib + Trastuzumab', ' All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week'], 'Eligibility': ['Inclusion Criteria:', ' All patients must be female.', ' Signed informed consent.', ' Locally advanced breast cancers or primary breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement. (If tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).', ' HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or Allred semi-quantitative score of >5, or gene amplified.', ' Negative serum pregnancy test (HCG) within 7 days of starting study, if of child-bearing potential.', " Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.", ' Performance status (WHO scale) less than 2 and life expectancy more than 6 months.', ' Age at least 18 years.', ' No brain or leptomeningeal disease.', ' 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.', ' Note: The presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.', 'Exclusion Criteria:', ' Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.', ' Severe underlying chronic illness or disease.', ' Cardiomyopathy or baseline LVEF less than 50%.', ' Other investigational drugs while on study.', ' Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded', ' Taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (See Prohibited Medications List in protocol.)'], 'Results': ['Outcome Measurement: ', ' Pathologic Assessment After Study Treatment', ' Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Lapatinib + Trastuzumab', ' Arm/Group Description: All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: participants Complete Pathologic Response: 18', ' Near Complete Pathologic Response: 16', ' Not Pathologic response: 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/65 (3.08%)', ' Cholecystitis 1/65 (1.54%)', ' Hepatobiliary/Pancreas 1/65 (1.54%)', ' ALT, SGPT (serum glutamic pyruvic transaminase) 1/65 (1.54%)', ' AST, SGOT(serum glutamic oxaloacetic transaminase) 2/65 (3.08%)', ' Alkaline phosphatase 1/65 (1.54%)', ' Bilirubin (hyperbilirubinemia) 1/65 (1.54%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

94fc6e05-8a73-43d9-a48c-531d36dfbbcd

Single

Intervention

NCT01306942

Participants of cohort 1 in the primary trial received more Dasatinib than those in cohort 2.

Entailment

{'Clinical Trial ID': 'NCT01306942', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', 'INTERVENTION 2: ', ' Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female with histologically confirmed breast cancer with documented metastasis.', ' Patients must have Human Epidermal Growth Factor Receptor 2 (HER2) overexpression by immunohistochemistry (3+, HercepTest®; DAKO) or a positive fluorescence in situ hybridization for HER2 amplification evaluated by central laboratory. It is recommended that a formalin-fixed paraffin embedded (FFPE) tumor tissue block from the metastatic site (or the primary tumor, if metastatic site not available) required for HER2 testing are provided.', ' Patients can have measurable or non measurable disease for the Phase I part. For the Phase II only patients with measurable disease defined per RECIST 1.1 will be included.', ' Signed Written Informed Consent.', ' Target Population:', ' Patients with Performance Status (ECOG) of 0 or 1.', ' Number of previous therapies allowed or previous therapies may have included:', ' Chemotherapy: no prior chemotherapy for MBC is permitted. Patients treated with adjuvant chemotherapy regimens based on taxanes are allowed to be included if they are fully recovered of any taxane associated toxicity and a minimum of 12 months have elapsed from the end of this therapy.', ' Hormonal Therapy: patients may have had prior hormonal therapy. All hormonal agents must be discontinued at least 3 weeks prior to study entry.', ' Radiation Therapy: patients may have had prior radiation therapy that has not exceeded 25% of the bone marrow reserve. A minimum of 21 days must have elapsed between the last dose of radiation and registration into the study. Patients must have recovered from any acute toxic effects from radiation prior to registration. Lesions that have been irradiated cannot be included as sites of measurable disease for the phase II unless clear tumor progression, according to RECIST criteria, has been documented in these lesions since the end of radiation therapy.', ' Previous Surgery: previous surgery is permitted provided that wound healing has occurred.', ' Anti-HER2 Therapies: no prior anti-HER2 therapy for MBC is permitted. Patients treated with adjuvant anti-HER2 therapies (including but not limited to trastuzumab and lapatinib) are allowed to be included if a minimum of 12 months have elapsed from the end of this therapy.', ' Adequate Organ Function (...).', ' Ability to take oral medication (dasatinib must be swallowed whole).', ' Concomitant Medications', ' i) Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib) ii) Biphosphonates must not be initiated within 28 days prior to study therapy', ' Age and sex:', ' f) Patient, age 18 years old. g) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. (...)', 'Exclusion Criteria:', ' Sex and reproductive status:', ' WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug', ' Women who are pregnant or breastfeeding.', ' Women with a positive pregnancy test', ' Target Disease Exceptions:', ' a) Central nervous system (CNS) metastases which are not well controlled. Eligible patients must be asymptomatic, cannot be receiving steroids or anticancer treatment, and must be enrolled at least 1 month after the end of the radiotherapy treatment', ' Medical History and Concurrent Diseases', ' No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.', ' Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade.', ' Cardiac Symptoms; any of the following should be considered for exclusion:', ' i) Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months) ii). Patients with intercurrent cardiac dysfunction or left ventricular ejection fraction (LVEF) < 50%.', ' iii) Diagnosed congenital long QT syndrome. iv) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).', ' v) Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (450 msec).', ' vi) Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.', " d) History of significant bleeding disorder unrelated to cancer, including: i) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease). ii) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).", ' iii) Ongoing or recent ( 3 months) significant gastrointestinal bleeding.', ' Allergies and Adverse Drug Reactions', ' a) Patients with known allergy to any of the study drugs or their components.', ' Prohibited Treatments and/or Therapies', ' a) Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) i) quinidine, procainamide, disopyramide ii) amiodarone, sotalol, ibutilide, dofetilide iii) erythromycin, clarithromycin iv) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide v) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.', ' b) Concurrent anti-cancer therapy c) Potent CYP3A4 inhibitors', ' Other exclusion criteria:', ' Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.', ' Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.', ' Patients unable or unwilling to give written informed consent prior to study participation.', ' Pre-existent motor or sensory neurotoxicity of severity grade 2 according to NCI common toxicity criteria (version 4.03).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I)', ' DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03), assessed as possibly, probably or definitively related to study drugs, occurring within the first cycle of study treatment: Need of any dose modification within the first cycle due to toxicity, grade 3 or 4 neutropenia complicated with fever 38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment related toxicity.', ' Time frame: Up to cycle 1', 'Results 1: ', ' Arm/Group Title: Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Angina * [1]0/6 (0.00%)', ' Diarrhea * [2]1/6 (16.67%)', ' Sudden death * [3]0/6 (0.00%)', ' Soft tissue and skin infection * [2]0/6 (0.00%)', ' Catheter related infection * [1]0/6 (0.00%)', ' Overdose * [4]0/6 (0.00%)', ' Dyspnea * [2]0/6 (0.00%)', ' Pneumonitis * [2]0/6 (0.00%)', ' Febrile syndrome respiratory focus * [5]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/4 (50.00%)', ' Angina * [1]0/4 (0.00%)', ' Diarrhea * [2]0/4 (0.00%)', ' Sudden death * [3]0/4 (0.00%)', ' Soft tissue and skin infection * [2]0/4 (0.00%)', ' Catheter related infection * [1]0/4 (0.00%)', ' Overdose * [4]0/4 (0.00%)', ' Dyspnea * [2]1/4 (25.00%)', ' Pneumonitis * [2]1/4 (25.00%)', ' Febrile syndrome respiratory focus * [5]0/4 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0057172f-d019-401b-a516-993a7b46a67b

Comparison

Eligibility

NCT03096847

NCT01840163

Female Patients recently prescribed Rapamycin are not eligible for the primary trial, but may be eligible for the secondary trial as long as they have a stage 1 to 2 Ductal carcinoma in situ and can speak english.

Entailment

{'Clinical Trial ID': 'NCT03096847', 'Intervention': ['INTERVENTION 1: ', ' Ribociclib + Letrozole Cohort A', ' postmenopausal women, or men; naïve.', ' All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.', 'INTERVENTION 2: ', ' Ribociclib + Letrozole Cohort B1', ' premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly'], 'Eligibility': ['Inclusion Criteria:', ' Patient is an adult, 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines', ' Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.', ' Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.', ' Patient must have either:', ' Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).', ' Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease', ' Non-measurable disease', ' Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 2', ' Exclusion Criteria', ' Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.', ' Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole', ' Patients with current inflammatory breast cancer.', ' Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer', ' Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer', ' Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.', ' completed prior therapy (including radiation and/or surgery) for CNS metastases 28 days prior to the start of study and', ' CNS tumor is clinically stable at the time of screening and', ' Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases', ' Patient has active cardiac disease or a history of cardiac dysfunction'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole', ' Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with Complete Response (CR), Partial response (PR) or Stable disease (SD) lasting 24 weeks or longer as well as patients with Non-complete response, nonprogressive disease (NCRNPD).', ' Time frame: At 24 weeks after last patient enrolled in trial', 'Results 1: ', ' Arm/Group Title: Ribociclib + Letrozole Cohort A', ' Arm/Group Description: postmenopausal women, or men; naïve.', ' All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.', ' Overall Number of Participants Analyzed: 307', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants CBR by week 24 (= BOR of CR or PR or SD or NCRNPD(Confirmed Best Overall Response (BOR)): 63.2 (57.5 to 68.6)', ' CBR by week 24 (= BOR of CR or PR or SD or NCRNPD (non-confirmed BOR): 71.7 (66.3 to 76.6)', 'Results 2: ', ' Arm/Group Title: Ribociclib + Letrozole Cohort B1', ' Arm/Group Description: premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants CBR by week 24 (= BOR of CR or PR or SD or NCRNPD(Confirmed Best Overall Response (BOR)): 57.7 (36.9 to 76.6)', ' CBR by week 24 (= BOR of CR or PR or SD or NCRNPD (non-confirmed BOR): 69.2 (48.2 to 85.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 97/319 (30.41%)', ' ANAEMIA 4/319 (1.25%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/319 (0.31%)', ' FEBRILE NEUTROPENIA 0/319 (0.00%)', ' HYPERFIBRINOLYSIS 0/319 (0.00%)', ' LEUKOPENIA 2/319 (0.63%)', ' NEUTROPENIA 2/319 (0.63%)', ' PANCYTOPENIA 1/319 (0.31%)', ' THROMBOCYTOPENIA 3/319 (0.94%)', ' ATRIAL FIBRILLATION 2/319 (0.63%)', ' BRADYARRHYTHMIA 1/319 (0.31%)', ' CARDIAC ARREST 1/319 (0.31%)', 'Adverse Events 2:', ' Total: 50/183 (27.32%)', ' ANAEMIA 4/183 (2.19%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/183 (0.00%)', ' FEBRILE NEUTROPENIA 3/183 (1.64%)', ' HYPERFIBRINOLYSIS 1/183 (0.55%)', ' LEUKOPENIA 0/183 (0.00%)', ' NEUTROPENIA 2/183 (1.09%)', ' PANCYTOPENIA 0/183 (0.00%)', ' THROMBOCYTOPENIA 0/183 (0.00%)', ' ATRIAL FIBRILLATION 2/183 (1.09%)', ' BRADYARRHYTHMIA 0/183 (0.00%)', ' CARDIAC ARREST 0/183 (0.00%)']}

{'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%)']}

bb23e8b8-c7d6-4e58-80a2-0555db5645e9

Single

Intervention

NCT00545077

Only cohort 2 of the primary trial receive Bevacizumab, but both cohorts undergo Endocrine Therapy .

Entailment

{'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': ''}

c4588d2c-b0d4-428d-a958-29787b9d4ec5

Single

Eligibility

NCT00364611

Patients with clinically significant grade 3 PVD are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00364611', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and Bevacizumab', ' Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', 'INTERVENTION 2: ', ' Docetaxel, Bevacizumab and Trastuzumab', ' Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met'], 'Eligibility': ['The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.', 'INCLUSION CRITERIA:', ' Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis', ' Stage IV disease with at least one measurable lesion according to the RECIST criteria', ' HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors', ' Life expectancy of >/= 24 weeks', ' No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).', ' Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)', ' At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions', ' It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.', ' Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response', 'EXCLUSION CRITERIA:', ' Prior chemotherapy for metastatic breast cancer', ' Prior treatment with bevacizumab or other anti-VEGF therapy', ' Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy', ' Current or prior history of brain or leptomeningeal metastases', ' Presence of neuropathy >/= 2', ' Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix', ' Clinically significant cardiovascular disease', ' Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy', ' History of bleeding diathesis or coagulopathy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Rate: Percentage of Participants With PFS', ' PFS was the time from registration to first documentation of', ' progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance', ' symptomatic deterioration', ' death due to any cause (in absence of PD).', ' The Percentage of participants with PFS is reported.', ' For the analysis, participants were censored', ' on the last available tumor assessment date on study treatment if they', ' had no PFS event', ' were on anticancer therapy not related to study treatment', ' on the registration date if they', ' did not receive study drug', ' had no post baseline tumor assessment', ' Time frame: Up to 6 months and 12 months after treatment initiation', 'Results 1: ', ' Arm/Group Title: Docetaxel and Bevacizumab', ' Arm/Group Description: Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 59.6 (45.1 to 73.0)', ' PFS rate at 12 months: 30.8 (18.7 to 45.1)', 'Results 2: ', ' Arm/Group Title: Docetaxel, Bevacizumab and Trastuzumab', ' Arm/Group Description: Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 90.5 (69.6 to 98.8)', ' PFS rate at 12 months: 81.0 (58.1 to 94.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/52 (26.92%)', ' Febrile neutropenia * 1/52 (1.92%)', ' Tachycardia * 1/52 (1.92%)', ' Atrial fibrillation * 0/52 (0.00%)', ' Duodenal ulcer * 1/52 (1.92%)', ' Gastric ulcer * 1/52 (1.92%)', ' Nausea * 1/52 (1.92%)', ' Abdominal pain * 0/52 (0.00%)', ' Asthenia * 1/52 (1.92%)', ' Disease progression * 1/52 (1.92%)', ' Mucosal inflammation * 1/52 (1.92%)', ' Appendicitis * 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 4/20 (20.00%)', ' Febrile neutropenia * 0/20 (0.00%)', ' Tachycardia * 0/20 (0.00%)', ' Atrial fibrillation * 1/20 (5.00%)', ' Duodenal ulcer * 0/20 (0.00%)', ' Gastric ulcer * 0/20 (0.00%)', ' Nausea * 0/20 (0.00%)', ' Abdominal pain * 1/20 (5.00%)', ' Asthenia * 0/20 (0.00%)', ' Disease progression * 0/20 (0.00%)', ' Mucosal inflammation * 0/20 (0.00%)', ' Appendicitis * 0/20 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ee1f81d1-7e99-44dc-bb6a-ed002a78c9f6

Comparison

Intervention

NCT02504424

NCT03708393

the primary trial and the secondary trial both require the patients to activate the interventions by remote control.

Contradiction

{'Clinical Trial ID': 'NCT02504424', 'Intervention': ['INTERVENTION 1: ', ' AeroForm Tissue Expander', ' AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.'], 'Eligibility': ['Inclusion Criteria:', ' Subject is female between the ages of 18-70', ' Subject requires tissue expansion as part of breast reconstruction', ' Subject is able to provide written informed consent', ' Subject is able and willing to comply with all of the study requirements', ' Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen', 'Exclusion Criteria:', " Subject's tissue integrity is unsuitable for tissue expansion", ' Subject has residual gross malignancy at the intended expansion site', ' Subject has current or prior infection at the intended expansion site', ' Subject has a history of failed tissue expansion or breast reconstruction', ' Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)', ' Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).'], 'Results': ['Outcome Measurement: ', ' Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event', ' The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: AeroForm Tissue Expander', ' Arm/Group Description: AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', ' Overall Number of Participants Analyzed: 48', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: breasts: 80 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/50 (22.00%)', ' neutropenic fever, weakness 1/50 (2.00%)', ' urinary tract infection 1/50 (2.00%)', ' cellulitis 4/50 (8.00%)', ' wound dehiscence 1/50 (2.00%)', ' hematoma 1/50 (2.00%)', ' seroma 1/50 (2.00%)', ' inflammation (red breast syndrome) 2/50 (4.00%)']}

{'Clinical Trial ID': 'NCT03708393', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' - Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status', 'Exclusion Criteria:', ' - Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status'], 'Results': ['Outcome Measurement: ', ' The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1', ' Primary effectiveness endpoint was the specificity of Imagio [IUS+OA] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for 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).', ' Time frame: Baseline to 12 month follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 80.9 (69.1 to 92.7)', ' fSp (96.0%): 78.7 (65.7 to 91.7)', ' fSp (97.0%): 75.8 (61.4 to 90.3)', ' fSp (97.5%): 74 (58.7 to 89.4)', ' fSp (98.0%): 71.8 (55.4 to 88.3)', ' fSp (99.0%): 65.2 (45.8 to 84.6)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 75.4 (61.5 to 89.3)', ' fSp (96.0%): 71.4 (55.8 to 87.0)', ' fSp (97.0%): 66.1 (48.6 to 83.7)', ' fSp (97.5%): 62.8 (44.1 to 81.6)', ' fSp (98.0%): 58.9 (38.8 to 79)', ' fSp (99.0%): 47.7 (24.5 to 71.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/155 (0.00%)', 'Adverse Events 2:', ' ']}

00466f98-52b8-41f3-9bf1-2edaad950be9

Comparison

Adverse Events

NCT02445586

NCT02115984

More than half of patients in the primary trial experienced adverse events, and 100% of patients in the secondary trial did not experience an adverse event.

Contradiction

{'Clinical Trial ID': 'NCT02445586', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.'], 'Eligibility': ['Inclusion Criteria:', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner', ' Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible', ' Known and documented HER2-positive', ' Known and documented LVEF of at least 50 percent (%)', ' Adequate organ function', ' A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease', ' Pregnant or lactating women', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting', ' History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant', ' The number of participants with serious adverse events was counted in the four following categories for number of events reported per participant: greater than or equal to ( ) 1, 1, greater than (>) 1, or 0 serious adverse events. Participants with multiple occurrences of events (the 1 and >1 serious adverse event categories) were only counted once per category.', ' Time frame: From Baseline until end of study (up to approximately 3 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Arm/Group Description: Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 Serious Adverse Event: 31 59.6%', ' 1 Serious Adverse Event: 17 32.7%', ' >1 Serious Adverse Events: 14 26.9%', ' 0 Serious Adverse Events: 21 40.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/52 (59.62%)', ' Febrile neutropenia 2/52 (3.85%)', ' Left ventricular dysfunction 2/52 (3.85%)', ' Sinus tachycardia 1/52 (1.92%)', ' Congenital arterial malformation 1/52 (1.92%)', ' Diarrhoea 5/52 (9.62%)', ' Salivary hypersecretion 1/52 (1.92%)', ' Enteritis 1/52 (1.92%)', ' Abdominal pain 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Stomatitis 1/52 (1.92%)', ' Haematemesis 1/52 (1.92%)']}

{'Clinical Trial ID': 'NCT02115984', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy & Panagen', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', 'INTERVENTION 2: ', ' Chemotherapy & Placebo', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).'], 'Eligibility': ['Inclusion Criteria:', ' Signed and dated written informed consent', ' Women at an age of 18 years', ' Stage II-IV breast cancer (with distant metastases)', ' The patients will be subject to chemotherapy with cyclophosphan/doxorubicin/ fluorouracil as a standard chemotherapy for treating breast cancer', ' The patients have not been earlier subject to chemotherapy', ' Functional status according to the Eastern Cooperative Oncology Group (ECOG) 2', ' Leukocyte counts of 3 × 109/L before the treatment course', ' Neutrophil counts of 1.5 × 109/L before the treatment course', ' Platelet counts of 100 × 109/L before the treatment course', ' Adequate heart function', ' Adequate liver function, that is, alanine aminotransferase / aspartate aminotransferase (ALT / AST) activity < 2.5 × upper limit of normal (ULN); acid phosphatase activity < 5 × ULN; and bilirubin concentration < 5 × ULN; and', ' Adequate renal function, that is, the creatinine concentration in the blood serum < 1.5 × ULN; urea concentration < ULN; and endogenous creatinine clearance', 'Exclusion Criteria:', ' Participation in clinical trials less than 30 days before sequential randomization', ' Previous exposure to Panagen or any other leukostimulatory drugs at a stage of clinical development', ' Known hypersensitivity to cyclophosphan, doxorubicin, or fluorouracil', ' Therapy with systemically active antibiotics less than 72 h before the beginning of chemotherapy', ' Long-term oral intake of corticosteroids', ' Previous X-ray therapy performed less than 4 weeks before randomization', ' Previous transplantation of hematopoietic stem cells', ' Other malignant neoplasms during the last 5 years except for basal cell or flat cell carcinoma or intraepithelial carcinoma of the uterine cervix', " Any disease or state that according to the opinion of researcher can influence patient's safety or the estimation of a final trial point; and", ' Pregnant and nursing women; the fertile patients should use chemical or barrier contraceptives during the period of trials'], 'Results': ['Outcome Measurement: ', ' The Quantity of Leukocytes and Neutrophils in the Blood of Patients', ' [Not Specified]', ' Time frame: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)', 'Results 1: ', ' Arm/Group Title: Chemotherapy & Panagen', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 51', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 8.1 (6.5 to 8.8)', ' Leukocytes after the 2nd chemotherapy: 6.6 (5.9 to 7.2)', ' Leukocytes after the 3rd chemotherapy: 5 (4.6 to 5.5)', ' Neutrophils baseline: 5.33 (4.42 to 6.36)', ' Neutrophils after the 2nd chemotherapy: 4.62 (3.43 to 4.82)', ' Neutrophils after the 3rd chemotherapy: 3.19 (1.81 to 3.58)', 'Results 2: ', ' Arm/Group Title: Chemotherapy & Placebo', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 7.2 (6.5 to 7.9)', ' Leukocytes after the 2nd chemotherapy: 4.8 (4.1 to 5.6)', ' Leukocytes after the 3rd chemotherapy: 4.1 (3.8 to 4.4)', ' Neutrophils baseline: 5.2 (4.2 to 6.05)', ' Neutrophils after the 2nd chemotherapy: 2.76 (2.22 to 3.27)', ' Neutrophils after the 3rd chemotherapy: 2.44 (2.31 to 2.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 57/57 (100.00%)', ' Dry eyes 13/33 (39.39%)', ' Heartburn 9/33 (27.27%)', ' Nausea after the CT (before day 7) 57/57 (100.00%)', ' Herpetic eruption 0/33 (0.00%)', ' Dry skin 15/33 (45.45%)', ' Alopecia 57/57 (100.00%)', 'Adverse Events 2:', ' Total: 23/23 (100.00%)', ' Dry eyes 2/11 (18.18%)', ' Heartburn 2/11 (18.18%)', ' Nausea after the CT (before day 7) 23/23 (100.00%)', ' Herpetic eruption 3/11 (27.27%)', ' Dry skin 9/11 (81.82%)', ' Alopecia 23/23 (100.00%)']}

50a524ae-2135-45f7-ae9b-515fd4e2e404

Single

Eligibility

NCT01688609

Patients must have histologically or cytologically confirmed ERBB2+ invasive breast cancer, with Primary tumor > 2 cm in diameter to participate in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01688609', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)', ' Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.', ' Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.', ' lapatinib ditosylate: Given PO', ' paclitaxel: Given IV', ' trastuzumab: Given IV', ' therapeutic conventional surgery: Undergo lumpectomy or mastectomy', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed primary invasive breast cancer', ' Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound', ' Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+', ' Patients have not received prior therapies for breast cancer', ' Patients have Karnofsky >= 70%', ' Leukocytes >= 3,000/mcL', ' Absolute neutrophil count >= 1,500/mcL', ' Hemoglobin >= 9.0 g/dL', ' Platelets >= 75,000/mcL', ' Total bilirubin =< 1.5 times institutional upper limit of normal', ' Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase[SGPT]) =< 2.5 times institutional ULN', ' Creatinine =< 1.5 times institutional upper limit of normal (ULN)', ' Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi-gated acquisition (MUGA) or echocardiography', ' Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)', ' Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab', ' Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document', ' Only Japanese women are eligible for the trial', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy', ' Patients who are receiving any other investigational agents', ' Patients have distal metastasis (stage IV disease)', ' Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study', ' Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible', ' Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women', ' Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes', ' Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)', ' Patients who have neuropathy >= grade 2 of any cause', ' Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer'], 'Results': ['Outcome Measurement: ', ' Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks', " For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar's test in all patients and separately in patients with and without pCR.", ' Time frame: From baseline to 18 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)', ' Arm/Group Description: Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.', ' Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.', ' lapatinib ditosylate: Given PO', ' paclitaxel: Given IV', ' trastuzumab: Given IV', ' therapeutic conventional surgery: Undergo lumpectomy or mastectomy', ' pharmacological study: Correlative studies', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Count of Participants', ' Unit of Measure: Participants baseline CD44v expression : pCR: 5 27.8%', ' baseline CD44v expression : non-pCR: 3 16.7%', ' CD44v expression at 6 weeks : pCR: 0 0.0%', ' CD44v expression at 6 weeks : non-pCR: 4 22.2%', ' CD44v expression at 18 weeks : pCR: 0 0.0%', ' CD44v expression at 18 weeks : non-pCR: 5 27.8%', ' baseline ALDH1 expression : pCR: 8 44.4%', ' baseline ALDH1 expression : non-pCR: 10 55.6%', ' ALDH1 expression at 6 weeks : pCR: 7 38.9%', ' ALDH1 expression at 6 weeks : non-pCR: 10 55.6%', ' ALDH1 expression at 18 weeks : pCR: 8 44.4%', ' ALDH1 expression at 18 weeks : non-pCR: 9 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b2062e01-0ea6-4ee8-94a1-b59dc40901d3

Single

Intervention

NCT00826267

Cohort 1 and 2 of the primary trial receive different quantities of different drugs.

Entailment

{'Clinical Trial ID': 'NCT00826267', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg', ' Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', 'INTERVENTION 2: ', ' Lapatinib 1500 mg', ' Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.'], 'Eligibility': ['Inclusion criteria:', ' Female, age 18 years or older.', ' Histologically proven breast cancer who have not received any prior therapy.', ' Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.', ' HER2-positive.', 'Exclusion criteria:', ' Absolute neutrophil count (ANC) less than 1500/mm3.', ' Platelet count less than 100 000/ mm3.', ' Hemoglobin level less than 9.0 g/dl.', ' Bilirubin greater than 1.5 mg/dI.', ' Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.', ' Serum creatinine greater than 1.5 times of the upper normal limit.', ' Significant or recent acute gastrointestinal disorders with diarrhea', ' Pregnancy or breast-feeding.', ' Organ system dysfunction including cardiac (LVEF < 50%).', ' Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.', ' Other malignancies diagnosed within the past five years.', ' Serious active infection. HIV, active hepatitis B or C.'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.', ' Time frame: Tumour assessments were performed at screening, day 22 and day 43.', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 80.0 (44.4 to 97.5)', 'Results 2: ', ' Arm/Group Title: Lapatinib 1500 mg', ' Arm/Group Description: Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 75.0 (34.9 to 96.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/8 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4dbce51b-1cfc-4d5f-82bb-ce9319ace3af

Single

Results

NCT02447328

In the primary trial 11 patients had serious adverse events, no patients had serious Adverse Drug Reactions, and over half of patients passed away from Unexpected adverse events.

Contradiction

{'Clinical Trial ID': 'NCT02447328', 'Intervention': ['INTERVENTION 1: ', ' Single Arm', ' fulvestrant (Faslodex®)'], 'Eligibility': ['Inclusion Criteria:', ' Post menopausal status women', ' Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.', ' Estrogen receptor positive', ' Radiographic progression of disease after the prior therapy', ' Patients who agree to participate in this study and sign the informed consent', 'Exclusion Criteria:', ' Patients who are treated with fulvestrant', ' Patients who are being treated with the other antitumor agents', ' Pregnancy or lactating women', ' History of hypersensitivity to any of included ingredients (eg. Castor oil)', ' Patients who are considered not fit for the study by investigators', ' Patients who have severe dysfunction of liver or kidney'], 'Results': ['Outcome Measurement: ', ' Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)', ' Percentage of patients with AEs.', ' Time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.', 'Results 1: ', ' Arm/Group Title: Single Arm', ' Arm/Group Description: fulvestrant (Faslodex )', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Number', ' Unit of Measure: Percentage of participants Adverse Events(AE): 81.5 (71.3 to 89.3)', ' ADR; based on current South Korea label.: 38.3 (27.7 to 49.7)', ' Serious AE: 11.1 (5.2 to 20.1)', ' Serious ADR: 0 (0 to 4.4)', ' Unexpected AE: 71.6 (60.5 to 81.1)', ' Unexpected ADR: 24.7 (15.8 to 35.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/81 (11.11%)', ' CHOLANGITIS 1/81 (1.23%)', ' contusion of brain 1/81 (1.23%)', ' Joint Dislocation 1/81 (1.23%)', ' Blood creatinine increased 1/81 (1.23%)', ' Bone Pain 1/81 (1.23%)', ' Acute lymphocytic leukaemia (in remission) 1/81 (1.23%)', ' Hydronephrosis 1/81 (1.23%)', ' pelvic pain 1/81 (1.23%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

43a9cc96-4020-459c-8fa4-4bbde7173f7a

Single

Eligibility

NCT03045653

Sharone had a hip replacement 3 weeks prior, she is not elgible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT03045653', 'Intervention': ['INTERVENTION 1: ', ' Treatment Arm', ' receiving a treatment of tamoxifen 100 mg/d'], 'Eligibility': ['Inclusion Criteria:', ' - Female 18 years, 70 years. ECOG 0-1 with no deterioration over previous 2 weeks Minimum life expectancy 3 months Histological confirmation of hormone receptor-high expressed breast cancer(IHC:ER 60% and PR 60%) on primary tumour at diagnosis/on biopsy of metastasis Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis The disease-free time of relapsed patients is more than 12 months Once received standard hormone treatment and progressed Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection At least one evaluative focus according to RECIST creterion or non-measurable disease but only bone metastasis Adequate bone marrow and organ function Progressive disease whilst receiving endocrine therapy for locally advanced or metastatic BC or relapsed with metastatic disease whilst receiving endocrine therapy Radiological or objective clinical evidence of recurrence or progression on or after last systemic therapy prior to enrolment', ' 4 prior lines of endocrine therapy for ABC', ' 3 line of cytotoxic chemotherapy for ABC Suitable for further endocrine therapy Availability of archival tumour sample or fresh biopsy Informed consent Normal organ function', 'Exclusion Criteria:', ' Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment Last dose of palliative radiotherapy <7 days prior to study treatment Rapidly progressive visceral disease not suitable for further endocrine therapy Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for 4 weeks study treatment Creatinine clearance <30 ml/min. Patients with creatinine clearance <50 mL/min will start at a permanently reduced vandetanib dose of 200 mg.', ' Major surgery (excluding placement of vascular access) within 4 weeks before study treatment Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment Elevated ALP in absence of bone metastasis Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent Participation in another study with investigational product during last 30 days Inability or unwillingness to comply with study procedures, including inability to take regular oral medication'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' [Not Specified]', ' Time frame: 36months', 'Results 1: ', ' Arm/Group Title: Treatment Arm', ' Arm/Group Description: receiving a treatment of tamoxifen 100 mg/d', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5 (2.6 to 7.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ff319fa6-89b6-4f1a-871d-456edb91b69b

Single

Adverse Events

NCT00274456

There are a total of 14 cases of neutropenia related adverse events in the primary trial across both cohorts.

Entailment

{'Clinical Trial ID': 'NCT00274456', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 300 mg/m^2 q3w', ' ABI-007 300 mg/m^2 administered once every third week (q3w).', 'INTERVENTION 2: ', ' ABI-007 100 mg/m^2 Weekly', ' ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest'], 'Eligibility': ['Inclusion Criteria:', ' Patients had to meet the following criteria to be eligible for the study:', ' Pathologically confirmed adenocarcinoma of the breast.', ' No prior chemotherapy for metastatic breast cancer.', ' Stage IV disease.', ' Measurable disease (must have been 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were 1.0 cm).', ' At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.', ' At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.', ' At least 4 weeks since major surgery, with full recovery.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Age 18 years.', ' Patient had the following blood counts at Baseline:', ' Absolute neutrophil count (ANC) 1.5*10^9 cells/L', ' Platelets 100*10^9 cells/L', ' Hemoglobin (Hgb) 9 g/dL.', ' Patient had the following baseline blood chemistry levels:', ' Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) 2.5x upper limit of normal (ULN) range', ' Total bilirubin normal', ' Alkaline phosphatase 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL.', ' Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).', ' If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).', ' If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.', ' Informed consent had been obtained.', 'Exclusion Criteria:', ' Patients who met any of the following criteria were excluded from the study:', ' Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.', ' Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.', ' Concurrent immunotherapy or hormonal therapy for breast cancer.', ' Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.', ' Serious intercurrent medical or psychiatric illness, including serious active infection.', ' History of class II-IV congestive heart failure.', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.', ' Patients who had received an investigational drug within the previous 3 weeks.', ' Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.', ' Pregnant or nursing women', ' Patients with prior hypersensitivity to either Taxol or Taxotere.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator', ' Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.', ' Time frame: Day 1 up to 95 weeks', 'Results 1: ', ' Arm/Group Title: ABI-007 300 mg/m^2 q3w', ' Arm/Group Description: ABI-007 300 mg/m^2 administered once every third week (q3w).', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 37 (26.0 to 47.7)', ' Investigator assessed ORR: 46 (34.8 to 57.3)', 'Results 2: ', ' Arm/Group Title: ABI-007 100 mg/m^2 Weekly', ' Arm/Group Description: ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 45 (33.6 to 55.9)', ' Investigator assessed ORR: 63 (52.3 to 74.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/76 (18.42%)', ' Neutropenia 10/76 (13.16%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 0/76 (0.00%)', ' Optic ischaemic neuropathy 0/76 (0.00%)', ' Bowel peristalsis increased 1/76 (1.32%)', ' Colitis 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 12/76 (15.79%)', ' Neutropenia 2/76 (2.63%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 1/76 (1.32%)', ' Optic ischaemic neuropathy 1/76 (1.32%)', ' Bowel peristalsis increased 0/76 (0.00%)', ' Colitis 1/76 (1.32%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 1/76 (1.32%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a321acf0-2296-4588-bf96-85b22bf1420f

Single

Eligibility

NCT02027376

A patient was treated with Pertuzumab for 6 months, and this treatment was discontinued 2 months prior to study entry and the patient has fully recovered from the entailing side effects, hence this patient is eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02027376', 'Intervention': ['INTERVENTION 1: ', ' LDE225 (Sonidegib) 400mg in Combination With Docetaxel', ' Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.', 'INTERVENTION 2: ', ' LDE225 (Sonidegib) 600mg in Combination With Docetaxel', ' Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.'], 'Eligibility': ['Inclusion Criteria:', ' The patient is capable to understand and comply with the protocol and has signed the informed consent document.', ' Females with histologically confirmed advanced breast cancer.', ' TN breast cancer by local laboratory determination. Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR), and HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH (Note: patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity.', ' Measurable or non-measurable disease according to RECIST 1.1 criteria.', ' Patient is at least 18 years of age.', ' World Health Organization (WHO) Performance Status 1.', ' Life expectancy 12 weeks.', ' Common laboratory values within normal range (…)', ' A negative serum pregnancy test 72 hours before starting study treatment for pre-menopausal women and for women < 1 year from the last menstruation date.', 'Exclusion Criteria:', ' Have received more than 3 prior chemotherapy regimens for ABC.', ' Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy.', ' Patients with acute or chronic liver or renal disease or pancreatitis.', ' Patients with a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.', ' Patients unable to swallow tablets.', ' History of a positive HIV test (HIV testing is not mandatory).', ' History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (Hepatitis B or C testing is not mandatory).', ' Impairment of gastrointestinal (GI) function or GI disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade 2 diarrhea, malabsorption syndrome or small bowel resection).', ' Peripheral vascular disease requiring active therapy or having had surgery < 12 months prior to starting study drug.', ' Impaired cardiac function or clinically significant heart disease (…)', ' A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome', ' Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)', ' Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 (listed in Protocol Attachment 3) or drugs metabolized by CYP2B6 or CYP2C9 (listed in Protocol Attachment 3) that cannot be discontinued prior to study entry and for the duration of the study. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days, and strong CYP3A4/5 inducers for at least 1 week prior to initiating LDE225 dosing.', ' Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. < 3 weeks for fluorouracil, doxorubicine, epirubicin) prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have received biologic therapy (e.g. antibodies) 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have been treated with a small molecule therapeutic 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have received any other investigational agents 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) 4 weeks or limited field radiation for palliation 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.', ' Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin) who cannot discontinue this treatment at least 5 days prior to starting study drug.', ' Patients who are currently receiving immunosuppressive treatment and in whom the treatment cannot be discontinued prior to starting study drug, except in the case of patients with basal cell carcinoma (BCC). Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing.', '…'], 'Results': ['Outcome Measurement: ', ' Incidence Rate of DLT Within the First Two Cycles of LDE225 (Sonidegib) in Combination With Docetaxel', ' DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory values (graded according to the NCI-CTCAE version 4.0) assessed as possibly, probably or definitively related to study drugs, occurring within the first two cycles of treatment: Neutropenia grade 4 lasting more than one week, febrile neutropenia, thrombocytopenia grade 3 with bleeding more than grade 2, thrombocytopenia grade 4, Increased plasma creatinine phosphokinase (CK) grade 3-4, any non-hematologic grade 4 toxicity, or grade 3 toxicity except nausea and vomiting, Grade 2 GI toxicity (except nausea and vomiting) lasting more than 2 weeks, Inability to resume dosing for cycles 2 or 3 at the current dose level within 14 days, due to treatment-related toxicity. Dose reductions in cycles 1 and 2 will be considered a DLT', ' Time frame: Up to cycle 2', 'Results 1: ', ' Arm/Group Title: LDE225 (Sonidegib) 400mg in Combination With Docetaxel', ' Arm/Group Description: Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: LDE225 (Sonidegib) 600mg in Combination With Docetaxel', ' Arm/Group Description: Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/5 (0.00%)', ' Overdose * [1]0/5 (0.00%)', 'Adverse Events 2:', ' Total: 1/4 (25.00%)', ' Overdose * [1]1/4 (25.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b841dfd8-4676-4d3c-a57d-6ba1055b8597

Single

Results

NCT01042535

The Maximum Tolerated Dose (MTD) of of 1-Pemetrexed-d-tryptophan (indoximod) observed in the primary trial was 800 mg.

Contradiction

{'Clinical Trial ID': 'NCT01042535', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)', ' Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)', ' 1-methyl-d-tryptophan: Given orally (PO)', ' Laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' In the phase I patients with any solid tumor positive for p53 by IHC (>= 5% of cells with any degree of nuclear staining) staining; for the phase II, patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is positive for p53 staining by IHC (>= 5% of cells with any degree of nuclear staining); patients will sign a separate consent for the p53 testing, and those that meet the above requirements will then be allowed to sign the vaccine trial consent', ' 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', ' There are no restrictions on prior therapies for the phase I part of the trial; for the phase II, patients may have received up to 2 prior lines of chemotherapy (not counting endocrine therapy lines) with the last dose of chemotherapy given 3 weeks (6 weeks for nitrosoureas and mitomycin C) prior to initiation on this study', ' Life expectancy of greater than 4 months', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)', ' Leukocytes >= 3,000/μL', ' Absolute neutrophil count >= 1,500/μL', ' Platelets >= 100,000/μL', " Total bilirubin within normal institutional limits unless patient has Gilbert's disease", ' Aspartate aminotransferase (AST) /serum glutamic oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT) /serum glutamic pyruvate transaminase (SGPT) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal', ' Thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), adrenocorticotropic hormone (ACTH) showing normal pituitary function; these values may deviate if in the opinion of the investigator these are normal pituitary responses to another endocrine condition such as suboptimally treated hypothyroidism', ' Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids', " No history of gastrointestinal disease causing malabsorption or obstruction such as but not limited to Crohn's disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resection", ' Sexually active women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; males should use barrier contraception or abstinence during the study; use of contraception or abstinence should continue for a minimum of 1 month after completion of the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should discontinue the study drug and inform her treating physician immediately; a pregnancy test is required prior to study enrollment and monthly while on treatment with 1-MT for all women of child-bearing potential; also men should be discouraged from fathering children while on treatment', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 3 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 3 weeks earlier', ' Patients may not receive any other investigational agents or chemotherapy to treat their underlying malignancy while on study; patients who are stable on prior endocrine therapies (i.e. aromatase inhibitors, tamoxifen, and fulvestrant) may stay on these treatments', ' Patients with known untreated brain metastases are excluded from this clinical trial; patients with stable previously treated lesions in a patient off steroids and radiation for 1 month are not excluded', ' History of allergic reactions (significant urticaria, angioedema, anaphylaxis) attributed to compounds of similar chemical or biologic composition to 1-methyl-D-tryptophan; this would include L-tryptophan or 5-hydroxy-tryptophan supplements', ' No supplements containing L-tryptophan or derivatives thereof are allowed to be taken while on study; also ingestion of antacid compounds should be timed a minimum of 2 hours before or after ingestion of 1-MT', ' Patients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease ([IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study; any patient with an allo-transplant of any kind would be excluded as well; this would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration; mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded', " Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction or percutaneous coronary interventions within the last 6 months, cardiac arrhythmia, active autoimmune diseases, or major psychiatric illness/social situations that would limit compliance with study requirements as judged by the primary investigator at each site; those with well controlled, chronic medical conditions under the supervision of the patient's primary physician (i.e. hypertension, hyperlipidemia, coronary heart disease, diabetes mellitus) would not be excluded", ' Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with 1-methyl-D-tryptophan', ' Human immunodeficiency virus (HIV)-positive patients and those with other acquired/inherited immunodeficiencies are ineligible', ' Patients with more than one active malignancy at the time of enrollment', ' Patients who have received any prior experimental active immunotherapy consisting of targeted monoclonal antibodies or pharmaceutical compounds are excluded; prior experimental vaccine patients may be enrolled if approved by the principal investigator (PI); patients who have received commercially available active immunotherapies such as adjuvant interferon must have completed therapy over 1 year prior to enrollment and have no evidence of autoimmune sequelae; prior therapy with approved monoclonal antibodies such as bevacizumab, cetuximab, panitumumab, or trastuzumab is allowed; concurrent treatment with these agents and the study treatment is not allowed', ' Human epidermal growth factor receptor 2 positive (HER2+) patients (IHC 3+ and/or fluorescent in situ hybridization [FISH] HER2/centromere portion of chromosome 17 [CEP17] ratio > 2) who require treatment with trastuzumab or lapatinib are not eligible for this study'], 'Results': ['Outcome Measurement: ', ' Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)', ' MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).', ' Time frame: Up to 4 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)', ' Arm/Group Description: Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)', ' 1-methyl-d-tryptophan: Given orally (PO)', ' Laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: indoximod dose in mg 1600'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/41 (34.15%)', ' Anemia 1/41 (2.44%)', ' Febrile neutropenia 1/41 (2.44%)', ' Eye disorders - Other, Visual disturbance 1/41 (2.44%)', ' Abdominal pain 1/41 (2.44%)', ' Constipation 1/41 (2.44%)', ' Nausea 1/41 (2.44%)', ' Fever 1/41 (2.44%)', ' Pain 1/41 (2.44%)', ' Skin infection 2/41 (4.88%)', ' Alkaline phosphatase increased 1/41 (2.44%)', ' Aspartate aminotransferase increased 1/41 (2.44%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

1dd4acd1-657c-40c0-b5ab-9c7adbe4ebf4

Single

Intervention

NCT01209195

Lower doses of MM-121 are utilised in cohort1 of the primary trial than in cohort 2, Paclitaxel doses are the same for both cohorts.

Entailment

{'Clinical Trial ID': 'NCT01209195', 'Intervention': ['INTERVENTION 1: ', ' Part 1: Dose Escalation: Cohort 1', ' MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV', 'INTERVENTION 2: ', ' Part 1: Dose Escalation: Cohort 2', ' MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV', ' Paclitaxel - 80mg/m2 weekly IV'], 'Eligibility': ['Inclusion Criteria:', ' Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer', ' Eighteen years of age or above', ' Candidates for chemotherapy', ' Able to understand and sign an informed consent (or have a legal representative who is able to do so)', ' Measurable disease according to RECIST v1.1', ' ECOG Performance Score (PS) of 2', ' Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-121', 'Exclusion Criteria:', ' Prior radiation therapy to >25% of bone marrow-bearing areas', ' Evidence of any other active malignancy', ' Active infection or fever> 38.5°C during screening visits or on the first scheduled day of dosing', ' Symptomatic CNS disease', ' Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies', ' Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state', ' Pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)', ' To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.', ' Time frame: From date of first dose to 30 days after termination, the longest 163 weeks', 'Results 1: ', ' Arm/Group Title: Part 1: Dose Escalation: Cohort 1', ' Arm/Group Description: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants reporting DLTs 0', 'Results 2: ', ' Arm/Group Title: Part 1: Dose Escalation: Cohort 2', ' Arm/Group Description: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV', ' Paclitaxel - 80mg/m2 weekly IV', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants reporting DLTs 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/10 (40.00%)', ' SMALL INTESTINAL OBSTRUCTION * [1]3/10 (30.00%)', ' INTESTINAL OBSTRUCTION * [1]1/10 (10.00%)', ' INTESTINAL PERFORATION * [1]1/10 (10.00%)', ' ABDOMINAL PAIN * [1]0/10 (0.00%)', ' DIARRHOEA * [1]0/10 (0.00%)', ' GASTRITIS * [1]0/10 (0.00%)', ' PEPTIC ULCER * [1]0/10 (0.00%)', ' DEATH * [1]1/10 (10.00%)', ' DISEASE PROGRESSION * [1]0/10 (0.00%)', 'Adverse Events 2:', ' Total: 12/31 (38.71%)', ' SMALL INTESTINAL OBSTRUCTION * [1]0/31 (0.00%)', ' INTESTINAL OBSTRUCTION * [1]0/31 (0.00%)', ' INTESTINAL PERFORATION * [1]0/31 (0.00%)', ' ABDOMINAL PAIN * [1]1/31 (3.23%)', ' DIARRHOEA * [1]1/31 (3.23%)', ' GASTRITIS * [1]1/31 (3.23%)', ' PEPTIC ULCER * [1]1/31 (3.23%)', ' DEATH * [1]0/31 (0.00%)', ' DISEASE PROGRESSION * [1]3/31 (9.68%)', ' FATIGUE * [1]2/31 (6.45%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

48d40c7e-3514-43c3-a31a-7b391727f012

Single

Eligibility

NCT01305941

Patients must present IHC 3+ or FISH amplified results to participate in the primary trial, meaning their cancer is Histologically-confirmed as being HER2-positive.

Entailment

{'Clinical Trial ID': 'NCT01305941', 'Intervention': ['INTERVENTION 1: ', ' Everolimus +Vinorelbine + Trastuzumab', ' daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab', ' Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets', ' Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.', ' Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly'], 'Eligibility': ['Inclusion Criteria', ' Histologically-confirmed HER2-positive (IHC 3+ or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumor) adenocarcinoma of the breast with at least one progressive and/or new metastatic brain lesion (>/=5 mm on radiographic imaging) after receipt of intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife, or equivalent). Patients in whom brain metastases (BM) are asymptomatic and detected during routine brain MRI screening per institutional protocols are eligible.', ' Prior intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife or equivalent) is allowed but not required.', ' Patients with no prior treatment with intracranial Response (ICR) may be included unless ICR is emergently indicated (in consultation with a local therapist, ie neurosurgeon or radiation oncologist)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' Life expectancy >12 weeks.', ' At least 21 years of age.', ' No prior mTOR inhibitors', ' Prior navelbine allowed provided navelbine therapy discontinued >/= 12 months from Day 1 of treatment under this protocol.', ' Last anti-cancer treatment (including any investigational drug) >/= 2 weeks from initiation of protocol based therapy, provided all adverse events (AEs) (other than alopecia) have resolved to grade 1 at baseline.', ' No active serious infection or other comorbid illness which would impair ability to participate in the trial.', ' Left ventricular ejection fraction assessment (echocardiogram or multigated acquisition scan (MUGA) scan) performed within 4 weeks prior to study initiation, showing a Left ventricular ejection fraction (LVEF) value lower limit of normal (LLN).', ' If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for 7 days. If patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment. Refer to dose modification of everolimus for patients taking dexamethasone.', ' Interval 4 weeks between open brain biopsy and initiation of protocol-based therapy.', ' international normalized ratio (INR) 2.0. Anticoagulation is allowed if target INR 2.0 on a stable dose of warfarin or if patient on a stable dose of Low-molecular-weight (LMW) heparin for >1 weeks at time of enrollment.', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', ' Patients must have adequate organ function as evidenced by:', ' Absolute neutrophil count 1.5/µL', ' Platelet count 100,000/µL', ' Hg 9 g/dL', ' Bilirubin 1.5 x upper limit of normal (ULN)', ' aspartate aminotransferase (AST) or Alanine transaminase (ALT) 2.5 x ULN ( 5 x ULN if liver metastases are present)', ' Serum creatinine 1.5 x ULN', ' Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies is required.', ' Signed, institutional review board (IRB)-approved written informed consent.', ' Exclusion Criteria', ' Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus); patients who have received prior treatment with navelbine within prior 12 months.', ' patients with a known hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus) or to its excipients.', ' Patients requiring treatment with any other systemic glucocorticoid. Note: This restriction regarding choice of glucocorticoid does not apply should patient need <2 week course of glucocorticoid for treatment of non-infectious pneumonitis during study (see section 4.5.2).', ' Patients with a known hypersensitivity to vinorelbine or to its excipients.', ' Prior allergic reaction to trastuzumab for the treatment of metastatic breast cancer.', ' Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.', ' Peripheral neuropathy grade 3.', ' Evidence of frank hemorrhage or impending herniation on baseline brain imaging. Note: asymptomatic micro-hemorrhage is allowed.', ' Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented Cerebrospinal fluid (CSF) cytology. Note: discrete dural metastases are permitted.', ' Active cardiac disease including any of the following:', ' Angina pectoris that requires the use of anti-anginal medication;', ' Ventricular arrhythmias except for benign premature ventricular contractions;', ' Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;', ' Conduction abnormality requiring a pacemaker;', ' Valvular disease with documented compromise in cardiac function;', ' Symptomatic pericarditis', ' History of cardiac dysfunction including any one of the following:', ' Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;', ' History of documented congestive heart failure (New York Heart Association functional classification III-IV);', ' Documented cardiomyopathy', ' Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.', ' Patients should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella, and Typhoid Vaccine Live Oral (TY21a) typhoid vaccines.', ' Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.', ' Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:', ' severely impaired lung function, defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% at rest on room air', ' uncontrolled diabetes, defined as fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy)', ' active (acute or chronic) or uncontrolled severe infections', ' liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).', ' Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B Virus (HBV) DNA and hepatitis C Virus (HCV) RNA polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.', ' A known history of HIV seropositivity.', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).', ' Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR 2.0).', ' Unable or unwilling to discontinue use of prohibited fruit (or its juices) and prohibited medications listed in Appendices II and III for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.', ' Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to everolimus initiation.', ' Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment', ' Contraindication to gadolinium-enhanced MRI imaging.', ' Inability to comply with study and/or follow-up procedures.', ' History of noncompliance to medical regimens.'], 'Results': ['Outcome Measurement: ', ' Intracranial Objective Response Rate- Modified RECIST Criteria', ' response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria.', ' Complete Response (CR) - Disappearance of all target and nontarget lesions', ' Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.', ' Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.', ' Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Everolimus +Vinorelbine + Trastuzumab', ' Arm/Group Description: daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab', ' Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets', ' Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.', ' Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 0 0.0%', ' Partial Response: 1 3.8%', ' Stable Disease: 17 65.4%', ' Progressive Disease: 8 30.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/32 (40.63%)', ' Anemia * 1/32 (3.13%)', ' Adrenal Insufficiency * 1/32 (3.13%)', ' Vomiting * 1/32 (3.13%)', ' Fever * 2/32 (6.25%)', ' Infusion related reaction * 1/32 (3.13%)', ' Pain * 1/32 (3.13%)', ' Anaphylaxis * 1/32 (3.13%)', ' Lung Infection * 1/32 (3.13%)', ' Sepsis * 3/32 (9.38%)', ' Upper Respiratory Infection * 1/32 (3.13%)', ' Creatinine Increased * 2/32 (6.25%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

dd98fca1-27a7-41c2-ba0c-3ff90aceab54

Single

Adverse Events

NCT01989676

the primary trial only records GI adverse events.

Contradiction

{'Clinical Trial ID': 'NCT01989676', 'Intervention': ['INTERVENTION 1: ', ' PF-05280014', ' Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.', 'INTERVENTION 2: ', ' Trastuzumab-EU', ' Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of breast cancer.', ' Presence of metastatic disease.', ' Documentation of HER2 gene amplification or overexpression.', ' Available tumor tissue for central review of HER2 status.', ' At least 1 measurable lesion as defined by RECIST 1.1.', ' Eastern Cooperative Oncology Group status of 0 to 2.', ' Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.', 'Exclusion Criteria:', ' Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.', ' Prior systemic therapy for metastatic disease (except endocrine therapy).', ' Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.', ' Inflammatory breast cancer.', ' Active uncontrolled or symptomatic central nervous system metastases.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population', ' ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size [short axis <10 mm]) or partial response (PR, >=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.', ' Time frame: From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit', 'Results 1: ', ' Arm/Group Title: PF-05280014', ' Arm/Group Description: Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.', ' Overall Number of Participants Analyzed: 352', ' Measure Type: Number', ' Unit of Measure: percentage of participants 62.5 (57.2 to 67.6)', 'Results 2: ', ' Arm/Group Title: Trastuzumab-EU', ' Arm/Group Description: Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.', ' Overall Number of Participants Analyzed: 355', ' Measure Type: Number', ' Unit of Measure: percentage of participants 66.5 (61.3 to 71.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 67/349 (19.20%)', ' Anaemia * 3/349 (0.86%)', ' Leukopenia * 1/349 (0.29%)', ' Neutropenia * 3/349 (0.86%)', ' Thrombocytopenia * 1/349 (0.29%)', ' Atrial fibrillation * 2/349 (0.57%)', ' Cardiac arrest * 1/349 (0.29%)', ' Cardiac failure * 0/349 (0.00%)', ' Cardiac failure acute * 0/349 (0.00%)', ' Cardio-respiratory arrest * 2/349 (0.57%)', ' Cardiovascular insufficiency * 0/349 (0.00%)', 'Adverse Events 2:', ' Total: 69/353 (19.55%)', ' Anaemia * 2/353 (0.57%)', ' Leukopenia * 1/353 (0.28%)', ' Neutropenia * 1/353 (0.28%)', ' Thrombocytopenia * 1/353 (0.28%)', ' Atrial fibrillation * 0/353 (0.00%)', ' Cardiac arrest * 1/353 (0.28%)', ' Cardiac failure * 4/353 (1.13%)', ' Cardiac failure acute * 1/353 (0.28%)', ' Cardio-respiratory arrest * 0/353 (0.00%)', ' Cardiovascular insufficiency * 1/353 (0.28%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b975dc12-757e-4ef5-af33-83dfce12e6cc

Comparison

Eligibility

NCT02658734

NCT02073487

Female Patients with LVEF > 50%, who have previously undergone treatment with trastuzumab emtansine or lapatinib are still eligible for the secondary trial but are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02658734', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site', ' Documented progression of unresectable, locally advanced, or mBC, determined by the investigator', ' Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)', ' For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 7 months after the last dose of study drug', ' For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.', 'Exclusion Criteria:', ' Prior treatment with trastuzumab emtansine', ' Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab', " Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])", ' History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of exposure to cumulative doses of anthracyclines, as defined in the protocol', ' History of radiation therapy within 14 days of enrollment', ' Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment', ' CNS only disease', ' History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment', ' History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction or unstable angina within 6 months of enrollment', ' Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease', ' Pregnancy or lactation', ' Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines', ' Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis', ' History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol'], 'Results': ['Outcome Measurement: ', ' Severity of Adverse Events', ' Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.', ' Time frame: From cycle 1 up to approximately 3 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 1: 53 75.7%', ' Grade 2: 40 57.1%', ' Grade 3: 18 25.7%', ' Grade 4: 2 2.9%', ' Grade 5: 12 17.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/70 (40.00%)', ' THROMBOCYTOPENIA 4/70 (5.71%)', ' CARDIAC ARREST 1/70 (1.43%)', ' CARDIO-RESPIRATORY ARREST 1/70 (1.43%)', ' CATARACT 1/70 (1.43%)', ' VISION BLURRED 1/70 (1.43%)', ' ABDOMINAL PAIN 1/70 (1.43%)', ' DEATH 4/70 (5.71%)', ' PYREXIA 1/70 (1.43%)', ' URINARY TRACT INFECTION 1/70 (1.43%)', ' FRACTURE DISPLACEMENT 1/70 (1.43%)', ' SUBDURAL HAEMATOMA 1/70 (1.43%)']}

{'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%)']}

2c4254c9-9c40-492f-aa45-2a9ab47579b3

Comparison

Intervention

NCT01575522

NCT00181363

the primary trial and the secondary trial are testing completely different modalities of interventions.

Entailment

{'Clinical Trial ID': 'NCT01575522', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Tivantinib)', ' Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically or cytologically confirmed invasive breast cancer, with recurrent or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation', ' Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' Participants must have recent evidence of progressive disease', ' Participants must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days before enrollment in the study', ' Participants must have discontinued all biologic therapy (including vaccines) at least 14 days before enrollment in the study', ' Participants must have discontinued any investigational therapy at least 14 days before enrollment in the study', ' Participants may have received prior radiation therapy in either the metastatic or early-stage setting', ' Radiation therapy must be completed at least 14 days before enrollment in the study', ' Participant must not have received radiation to > 25% of his or her bone marrow within 30 days of starting study treatment', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Hemoglobin >= 9.0 g/dL', ' Absolute neutrophil count >= 1,500/mcL', ' Platelets >= 100,000/mcL', ' Total bilirubin =< 1.5 times upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN; for participants with documented liver metastases, AST/ALT =< 5.0 times ULN', ' Serum creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal', ' Either the primary tumor and/or the metastasis must be triple-negative; the invasive tumor must be hormone-receptor poor, defined as estrogen-receptor negative (ER-) and progesterone-receptor negative (PR-), or staining < 10% by immunohistochemistry (IHC)', ' Human epidermal growth factor receptor 2 (HER2) status: the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC, or FISH < 2.0', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the study and for 90 days after the last investigational drug dose received', ' Female subjects of childbearing potential must have a negative serum pregnancy test within 21 days of cycle 1 day 1', ' Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment; bisphosphonate therapy may also be initiated on study treatment if needed', ' Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Participants who have received chemotherapy, biologic, investigational, or radiotherapy within 14 days prior to entering the study', ' Participants who are receiving any other investigational agents', ' Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms', ' Participants with a history of treated central nervous system (CNS) metastases are eligible', ' Treated brain metastases are defined as those having no evidence of progression or hemorrhage for >= 2 months after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) during the screening period', ' Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician', ' Participants may be taking anti-convulsant medications, which must be non-enzyme-inducing anti-epileptic drugs', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197', ' History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study', ' Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible'], 'Results': ['Outcome Measurement: ', ' PFS Status', ' Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Time from start of treatment to time of progression or death, assessed up to 6 months', 'Results 1: ', ' Arm/Group Title: Treatment (Tivantinib)', ' Arm/Group Description: Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO', ' Overall Number of Participants Analyzed: 22', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.2 (1.0 to 1.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/22 (59.09%)', ' Constipation 1/22 (4.55%)', ' Death [1]3/22 (13.64%)', ' Neutropenia 1/22 (4.55%)', ' Anxiety 1/22 (4.55%)', ' Pleural effusion 1/22 (4.55%)', ' Cough 1/22 (4.55%)', ' Dyspnea 3/22 (13.64%)', ' Cellulitis 1/22 (4.55%)', ' Thromboembolic event 1/22 (4.55%)']}

{'Clinical Trial ID': 'NCT00181363', 'Intervention': ['INTERVENTION 1: ', ' Prone', 'Prone position', 'INTERVENTION 2: ', ' Supine', 'Supine position'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)', ' No indication for radiotherapy of regional nodes', ' Large, pendulous breasts (bra size D and over)', 'Exclusion Criteria:', ' Regional radiotherapy is indicated', ' Unable to lie in prone position'], 'Results': ['Outcome Measurement: ', ' Dose Homogeneity 1: PTV', ' Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position', ' Time frame: 1 day after treatment planning', 'Results 1: ', ' Arm/Group Title: Prone', ' Arm/Group Description: Prone position', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: Gy Dmin (Gy) PTV: 9.8 (6.7)', ' Dmean (Gy) PTV: 48.2 (1.2)', ' Dmax (Gy) PTV: 53.6 (0.6)', 'Results 2: ', ' Arm/Group Title: Supine', ' Arm/Group Description: Supine position', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: Gy Dmin (Gy) PTV: 8.2 (5.6)', ' Dmean (Gy) PTV: 49.8 (0.8)', ' Dmax (Gy) PTV: 54.8 (1.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' ']}

e140b055-b7fc-4802-a79b-9dfe7d136876

Single

Results

NCT02581839

At least 8 participants in the primary trial had a Central Nervous System (CNS) Progression Free Survival (PFS) >= 3 months.

Entailment

{'Clinical Trial ID': 'NCT02581839', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.', ' MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician', ' Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician'], 'Eligibility': ['Inclusion Criteria:', ' Female with histologically confirmed breast cancer.', ' Patients must have evidence of metastatic disease (non measurable disease is eligible).', ' Radiologically confirmed metastatic brain lesion by MRI.', ' Brain metastases from breast cancer with or without prior WBRT, STS of surgical resection. Progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT.', ' Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment.', ' No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months.', ' Patients may not be on any cytotoxic chemotherapy or hormonal treatment for breast cancer during protocol treatment. Trastuzumab is allowed in HER2 positive patients).', ' Able to comprehend and willing to sign an Informed Consent Form (ICF)', ' Karnofsky performance status 60', ' No brain radiation therapy > 4 weeks', ' No chemotherapy for > 3 weeks before planned start of protocol treatment', ' Adequate bone marrow, renal, and hepatic function, per local reference laboratory ranges as follows:', ' Absolute neutrophil count (ANC) 1,500/mm3', ' Platelet count 100,000/mm3', ' Hemoglobin 9 g/dL', ' Calculated creatinine clearance (CrCl) 30mL/min (Cockcroft-Gault method)', ' Patients with normal, mild or moderate hepatic dysfunction are eligible.', ' Calcium <10.1 mg/dL (corrected to serum albumin as follows: Corrected Calcium = (0.8 x (4 - patient albumin)) + serum Ca', ' Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment', ' Able to undergo MRI evaluation with and without gadolinium contrast', 'Exclusion Criteria:', ' Patients with the presence of an active infection, abscess or fistula', ' Known leptomeningeal disease or CNS midline shifts.', ' Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.', ' Severe conduction abnormality including significant QTc prolongation >450ms.', ' Patients with grade 3/4 peripheral neuropathy.', ' Patients with pacemaker or an ICD devices.', ' Previous treatment with eribulin mesylate.'], 'Results': ['Outcome Measurement: ', ' Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)', " The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.", ' Time frame: At 12 weeks', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.', ' MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate', ' Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician', ' Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.9 (51 to 99.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Febrile neutropenia * 1/9 (11.11%)', ' Fatigue * 1/9 (11.11%)', ' Lung infection * 1/9 (11.11%)', ' Neutrophil count decreased * 1/9 (11.11%)', ' Platelet count decreased * 1/9 (11.11%)', ' White blood cell decreased * 1/9 (11.11%)', ' Pain in extremity * 1/9 (11.11%)', ' worsening pseudomeningeocele * 1/9 (11.11%)', ' Dyspnea * 1/9 (11.11%)', ' Thromboembolic event * 1/9 (11.11%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0a6418c8-63a6-4900-bfc9-1659acbe1ad7

Comparison

Adverse Events

NCT00789581

NCT02445586

the secondary trial reported more cases of Haematemesis, but the primary trial had more cases of Sinus tachycardia.

Contradiction

{'Clinical Trial ID': 'NCT00789581', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', ' Ixabepilone (Ixempra): 40 mg/m2', 'INTERVENTION 2: ', ' Paclitaxel', ' Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', 'Paclitaxel (Taxol): 80 mg/m2'], 'Eligibility': ['Inclusion Criteria:', ' Female patients greater than or equal to18 years of age.', ' Histologically confirmed invasive unilateral breast cancer (regardless of', ' histology).', ' Early-stage breast cancer, defined as:', ' Node-positive disease: >0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR', ' Node-negative, with primary tumor >1.0 cm (T1c-T3).', ' Definitive loco-regional surgery must have been completed as specified', ' below:', ' Patients must have undergone either breast conservation surgery', ' (i.e., lumpectomy) or total mastectomy.', ' Surgical margins of the resected section must be histologically free of', ' invasive adenocarcinoma and ductal carcinoma in situ.', ' Surgical margins involved with lobular carcinoma in situ (LCIS) will not', ' be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.', ' Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below:', ' Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.', ' Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.', ' Patients with synchronous bilateral cancers are eligible only if:', ' All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.', ' Eligibility based on the highest stage grouping.', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the', ' following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2).', ' Estrogen receptor negative (<10% staining by IHC for estrogen receptor).', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.', ' Patient must be <= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).', ' MammoSite brachytherapy radiation is acceptable if it is performed', ' immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter.', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count (ANC) >1500/mm3', ' Platelet count >=100,000/mm3', ' Hemoglobin >9 g/dL', ' Adequate liver function, defined by:', ' AST and ALT <=2.5 x the upper limit of normal (ULN)', ' Total bilirubin <=1.5 x ULN (unless the patient has grade 1 bilirubin', " elevation due to Gilbert's disease or a similar syndrome involving slow", ' conjugation of bilirubin).', ' Adequate renal function, defined by:', ' Serum creatinine <=1.5 x ULN', ' Complete staging work-up <=12 weeks prior to initiation of study treatment', ' with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan.', ' Adequate cardiac function, defined by a left ventricular ejection fraction', ' (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).', ' Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).', ' Patients with previous history of invasive cancers (including breast cancer)', ' are eligible if definitive treatment was completed more than 5 years prior to', ' initiating current study treatment, and there is no evidence of recurrent disease.', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.', ' Patient must be accessible for treatment and follow-up.', ' Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.', ' All patients must be able to understand the investigational nature of the', ' study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' Women who are pregnant or breastfeeding.', ' History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.', ' Any evidence or suspicion of metastatic disease other than ipsilateral', ' axillary lymph nodes.', ' Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).', ' Previous anthracycline chemotherapy.', ' Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of', ' study treatment until the end of treatment with ixabepilone.', ' Previous treatment for this breast cancer (including neoadjuvant', ' chemotherapy).', ' Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).', ' Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0.', ' Cardiac disease, including: congestive heart failure (CHF) > Class II per', ' New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.', ' History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or', ' a drug formulated in CremophorEL such as paclitaxel.', ' Use of any investigational agent within 30 days of administration of the first dose of study drug.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Concurrent severe, uncontrolled infection or intercurrent illness including,', ' but not limited to, ongoing or active infection, or psychiatric illness/social', ' situations that would limit compliance with study requirements.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Inability to comply with study and/or follow-up procedures.'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.', ' Time frame: up to 5.25 years (63 months)', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', ' Ixabepilone (Ixempra): 40 mg/m2', ' Overall Number of Participants Analyzed: 306', ' Measure Type: Number', ' Unit of Measure: percentage of participants 3-year DFS: 88.6 (84.3 to 91.8)', ' 5-year DFS: 87.1 (82.6 to 90.5)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.', ' Doxorubicin: 60 mg/m2', ' Cyclophosphamide: 600 mg/m2', 'Paclitaxel (Taxol): 80 mg/m2', ' Overall Number of Participants Analyzed: 308', ' Measure Type: Number', ' Unit of Measure: percentage of participants 3-year DFS: 88.8 (84.6 to 91.9)', ' 5-year DFS: 84.7 (79.7 to 88.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 58/305 (19.02%)', ' FEBRILE NEUTROPENIA * 12/305 (3.93%)', ' NEUTROPENIA * 4/305 (1.31%)', ' ANAEMIA * 2/305 (0.66%)', ' LEUKOPENIA * 1/305 (0.33%)', ' PANCYTOPENIA * 1/305 (0.33%)', ' THROMBOCYTOPENIA * 1/305 (0.33%)', ' DISSEMINATED INTRAVASCULAR COAGULATION * 0/305 (0.00%)', ' ATRIAL FIBRILLATION * 1/305 (0.33%)', ' DIASTOLIC DYSFUNCTION * 1/305 (0.33%)', ' PERICARDIAL EFFUSION * 1/305 (0.33%)', 'Adverse Events 2:', ' Total: 50/304 (16.45%)', ' FEBRILE NEUTROPENIA * 12/304 (3.95%)', ' NEUTROPENIA * 1/304 (0.33%)', ' ANAEMIA * 0/304 (0.00%)', ' LEUKOPENIA * 0/304 (0.00%)', ' PANCYTOPENIA * 0/304 (0.00%)', ' THROMBOCYTOPENIA * 0/304 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION * 1/304 (0.33%)', ' ATRIAL FIBRILLATION * 1/304 (0.33%)', ' DIASTOLIC DYSFUNCTION * 0/304 (0.00%)', ' PERICARDIAL EFFUSION * 0/304 (0.00%)']}

{'Clinical Trial ID': 'NCT02445586', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.'], 'Eligibility': ['Inclusion Criteria:', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner', ' Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible', ' Known and documented HER2-positive', ' Known and documented LVEF of at least 50 percent (%)', ' Adequate organ function', ' A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease', ' Pregnant or lactating women', ' Current clinical or radiographic evidence of central nervous system (CNS) metastases', ' Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting', ' History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant', ' The number of participants with serious adverse events was counted in the four following categories for number of events reported per participant: greater than or equal to ( ) 1, 1, greater than (>) 1, or 0 serious adverse events. Participants with multiple occurrences of events (the 1 and >1 serious adverse event categories) were only counted once per category.', ' Time frame: From Baseline until end of study (up to approximately 3 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab in Combination With Trastuzumab and Docetaxel', ' Arm/Group Description: Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 Serious Adverse Event: 31 59.6%', ' 1 Serious Adverse Event: 17 32.7%', ' >1 Serious Adverse Events: 14 26.9%', ' 0 Serious Adverse Events: 21 40.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/52 (59.62%)', ' Febrile neutropenia 2/52 (3.85%)', ' Left ventricular dysfunction 2/52 (3.85%)', ' Sinus tachycardia 1/52 (1.92%)', ' Congenital arterial malformation 1/52 (1.92%)', ' Diarrhoea 5/52 (9.62%)', ' Salivary hypersecretion 1/52 (1.92%)', ' Enteritis 1/52 (1.92%)', ' Abdominal pain 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Stomatitis 1/52 (1.92%)', ' Haematemesis 1/52 (1.92%)']}

2db9e0c7-d94b-47d2-a61f-55a0896d714e

Single

Adverse Events

NCT01644890

Throughout the primary trial, one patient in cohort 1 developed issues with their vision.

Contradiction

{'Clinical Trial ID': 'NCT01644890', 'Intervention': ['INTERVENTION 1: ', ' NK105', ' received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', 'INTERVENTION 2: ', ' Paclitaxel', ' received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent of the patient signed by herself.', ' Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.', ' Aged 20 to 74 at the time of informed consent.', 'Exclusion Criteria:', ' Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.', ' Assessment period was from the day of randomisation until the first observation of lesion progression or death', ' Time frame: Baseline, every 6 weeks of study treatment period, and end of study,', 'Results 1: ', ' Arm/Group Title: NK105', ' Arm/Group Description: received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', ' Overall Number of Participants Analyzed: 211', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.4 (7.0 to 9.9)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle', ' Overall Number of Participants Analyzed: 211', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.5 (6.9 to 11.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 34/214 (15.89%)', ' Leukocytosis 0/214 (0.00%)', ' Atrial fibrillation 0/214 (0.00%)', ' Cardiac failure congestive 0/214 (0.00%)', ' Pericardial effusion 1/214 (0.47%)', ' Cataract 0/214 (0.00%)', ' Macular fibrosis 0/214 (0.00%)', ' Constipation 2/214 (0.93%)', ' Diarrhoea 2/214 (0.93%)', ' Enterocolitis 0/214 (0.00%)', ' Ileus 1/214 (0.47%)', ' Nausea 3/214 (1.40%)', 'Adverse Events 2:', ' Total: 27/213 (12.68%)', ' Leukocytosis 1/213 (0.47%)', ' Atrial fibrillation 1/213 (0.47%)', ' Cardiac failure congestive 1/213 (0.47%)', ' Pericardial effusion 0/213 (0.00%)', ' Cataract 1/213 (0.47%)', ' Macular fibrosis 1/213 (0.47%)', ' Constipation 1/213 (0.47%)', ' Diarrhoea 1/213 (0.47%)', ' Enterocolitis 1/213 (0.47%)', ' Ileus 0/213 (0.00%)', ' Nausea 0/213 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

3129e58d-0c16-42a5-90b4-f26e048dfe58