Type
stringclasses 2
values | Section_id
stringclasses 4
values | Primary_id
stringlengths 11
11
| Secondary_id
stringlengths 0
11
| Statement
stringlengths 34
385
| Label
stringclasses 2
values | Primary_evidence_index
listlengths 1
65
| Secondary_evidence_index
listlengths 0
73
| Primary_ct
stringlengths 1.11k
16.3k
| Secondary_ct
stringlengths 101
16.3k
| __index_level_0__
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36
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|---|---|---|---|---|---|---|---|---|---|---|
Single
|
Results
|
NCT01091168
|
Patients in the control group of the primary trial had a median Overall Survival of less than a year.
|
Entailment
|
[
0,
1,
2,
3,
11,
12,
13,
14,
15,
9,
17
] |
[] |
{'Clinical Trial ID': 'NCT01091168', 'Intervention': ['INTERVENTION 1: ', ' Vinflunine', ' Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.', ' vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks', 'INTERVENTION 2: ', ' Alkylating Agent', ' Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.', ' Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin'], 'Eligibility': ['Inclusion Criteria:(main conditions)', ' Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,', ' Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.', 'Exclusion Criteria:', ' Concurrent serious uncontrolled medical disorder,', ' known or clinical evidence of brain metastases or leptomeningeal involvement,', ' pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,', ' history of second primary malignancy,', ' HIV infection, preexisting neuropathy,', ' pregnancy or breast feeding.'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.', ' Time frame: From baseline up to 3 years 1 month', 'Results 1: ', ' Arm/Group Title: Vinflunine', ' Arm/Group Description: Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.', ' vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks', ' Overall Number of Participants Analyzed: 298', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.7 to 10.4)', 'Results 2: ', ' Arm/Group Title: Alkylating Agent', ' Arm/Group Description: Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.', ' Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin', ' Overall Number of Participants Analyzed: 296', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.3 (7.5 to 10.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 82/297 (27.61%)', ' Neutropenia 6/297 (2.02%)', ' Anaemia 6/297 (2.02%)', ' Febrile neutropenia 3/297 (1.01%)', ' Thrombocytopenia 1/297 (0.34%)', ' Endocardititis staphylococcal 1/297 (0.34%)', ' Arteriospasm coronary 1/297 (0.34%)', ' Atrial fibrillation 1/297 (0.34%)', ' Cardiac failure 0/297 (0.00%)', ' Constipation 5/297 (1.68%)', ' Vomiting 6/297 (2.02%)', ' Abdominal pain 4/297 (1.35%)', 'Adverse Events 2:', ' Total: 66/290 (22.76%)', ' Neutropenia 0/290 (0.00%)', ' Anaemia 0/290 (0.00%)', ' Febrile neutropenia 1/290 (0.34%)', ' Thrombocytopenia 2/290 (0.69%)', ' Endocardititis staphylococcal 0/290 (0.00%)', ' Arteriospasm coronary 0/290 (0.00%)', ' Atrial fibrillation 1/290 (0.34%)', ' Cardiac failure 1/290 (0.34%)', ' Constipation 0/290 (0.00%)', ' Vomiting 3/290 (1.03%)', ' Abdominal pain 1/290 (0.34%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5bc0d21d-a040-4d30-b0c7-8793cba6aba8
|
|
Comparison
|
Intervention
|
NCT00952731
|
NCT00956813
|
Cohort 2 in the primary trial and the secondary trial but receive daily placebo doses.
|
Entailment
|
[
5,
6,
7,
8,
9
] |
[
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00952731', 'Intervention': ['INTERVENTION 1: ', ' Treatment Gel + Oral Placebo', ' 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', 'INTERVENTION 2: ', ' Placebo Gel + Oral Treatment', ' Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of hormone receptor positive (more than 5% cells staining for ER + and/ or PR +), any grade (using definition of Page and Lagios) ductal carcinoma in situ (DCIS) with or without evidence of microinvasion on diagnostic core needle biopsy within the previous 60 days.', ' Women of age 18 years. Because no dosing or adverse event data are currently available on the use of 4-hydroxytamoxifen in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.', ' ECOG performance status 1 (Karnofsky 70%)', ' Participants must have normal organ and marrow function as defined below:', ' Leukocytes 3,000/uL', ' Absolute neutrophil count (ANC) 1,500/uL', ' Platelets 100,000/uL', ' Total bilirubin within normal institutional limits', ' AST (SGOT)/ALT (SGPT) 1.5 X institutional ULN', ' Creatinine within normal institutional limits', ' Women of child-bearing potential must agree to practice barrier birth control, abstinence, or use non-hormonal IUDs from the time that the first pregnancy test is performed throughout the duration of the study and for three months after cessation of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', ' Ability and willingness to schedule surgical resection of DCIS lesion for 4-10 weeks (28-70 days) following the start of study agent.', ' Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the 4-10 weeks of study agent dosing.', 'Exclusion Criteria:', ' Prior history of, or at high risk to develop, thromboembolic disease will be excluded.', ' Must not have taken exogenous sex hormones since biopsy diagnosing DCIS and must agree not to use exogenous sex hormones while on study.', ' Must not have taken tamoxifen or other selective estrogen receptor modulators (SERMs) within 2 years prior to entering the study. Women who have discontinued SERM therapy because of thromboembolic or uterine toxicity, will be excluded regardless of duration of use.', ' May not be receiving any other investigational agents.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-hydroxytamoxifen or tamoxifen.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because tamoxifen and 4-hydroxytamoxifen has the potential for teratogenic or abortifacient effects. Women are excluded from enrolling within 3 months of the most recent pregnancy. Women must avoid becoming pregnant in the 3 months following the use of study agent.', ' Women must not have breastfed within three months prior to DCNB. Women who are breast feeding are excluded from entry into this trial because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tamoxifen or 4-hydroxytamoxifen. Women must agree to forego breastfeeding for three months following the use of study agent.', ' Must not have any dermatologic conditions resulting in skin breakdown in the area of gel application.', ' Must not have a history of previous ipsilateral radiation to the affected breast.', ' Must not have had a breast reduction or augmentation within the 6 months prior to first dose of study agents. Patients who have had breast implants more than 6 months prior to first dose of study agents will be eligible.'], 'Results': ['Outcome Measurement: ', ' Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment', ' Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).', ' Time frame: Baseline and after 4-10 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Treatment Gel + Oral Placebo', ' Arm/Group Description: 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.', ' oral placebo: Oral placebo taken daily for 4-10 weeks.', ' afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -3.4 (5.0)', 'Results 2: ', ' Arm/Group Title: Placebo Gel + Oral Treatment', ' Arm/Group Description: Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).', ' tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.', ' placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.', ' Overall Number of Participants Analyzed: 9', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of 300 DCIS cells -5.1 (5.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00956813', 'Intervention': ['INTERVENTION 1: ', ' Flaxseed', ' Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.', 'INTERVENTION 2: ', ' Placebo', ' Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.'], 'Eligibility': ['Bothersome hot flashes, defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention', ' Presence of hot flashes for 1 month', ' Meets 1 of the following criteria:', ' History of breast cancer or other cancer (currently without malignant disease)', ' No history of breast cancer and wishes to avoid estrogen due to a perceived increased risk of breast cancer', ' Hormone receptor status not specified', ' Postmenopausal as defined by 1 of the following*:', ' NOTE: *Women with 1 ovary but without a uterus should be deemed postmenopausal by either age > 55 OR a combination of estrogen within a postmenopausal range (per local lab) and follicle-stimulating hormone > 40 mIU/mL', ' Absence of a period in the past 12 months', ' Bilateral oophorectomy', ' ECOG performance status 0-1', ' Life expectancy 6 months', ' Able to complete questionnaire(s) alone or with assistance', ' No diabetes requiring oral or injectable antihyperglycemics', ' No hypotension', ' No history of allergic or other adverse reaction to flaxseed', ' No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal condition where the patient should not consume and/or has an intolerance/allergies to seeds or nuts', ' At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents', ' Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for 4 weeks and is not expected to stop the medication during study treatment', ' At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind', ' Trastuzumab allowed', ' No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies', ' No concurrent ( 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal)', ' Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is 800 IU/day, it was started > 30 days before study initiation, and is to be continued through study period', ' Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible', ' No concurrent anticoagulants or anti-platelets (1 mg of Coumadin for central line patency allowed)', ' Aspirin allowed ( 81 mg)', ' No concurrent anti-hypertensives', ' No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk)'], 'Results': ['Outcome Measurement: ', ' To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.', ' The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.', ' The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7.', ' The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.', ' Time frame: Baseline and 7 weeks', 'Results 1: ', ' Arm/Group Title: Flaxseed', ' Arm/Group Description: Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.', ' Overall Number of Participants Analyzed: 69', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -4.9 (6.41)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.', ' Overall Number of Participants Analyzed: 77', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -3.5 (6.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/101 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
9bcbadcc-ae56-4254-ac8b-ab5d35e80eba
|
Single
|
Adverse Events
|
NCT00091442
|
There were more cases of Febrile neutropenia than leukopenia observed in the primary trial, but less cases of neutropenia than leukopenia.
|
Contradiction
|
[
0,
2,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT00091442', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel', ' Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.', 'INTERVENTION 2: ', ' DOXIL+Docetaxel', ' DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study', ' Participants who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease', ' Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction', 'Exclusion Criteria:', ' More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer', ' Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)', ' Less than 2 months since the last dose of trastuzumab', ' Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy', ' Radiation to areas of disease within 30 days before study enrollment', ' History of New York Heart Association Class II or greater cardiac disease or other clinical evidence of congestive heart failure'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.', ' Time frame: From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled', 'Results 1: ', ' Arm/Group Title: Docetaxel', ' Arm/Group Description: Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.', ' Overall Number of Participants Analyzed: 373', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.0 (5.9 to 7.7)', 'Results 2: ', ' Arm/Group Title: DOXIL+Docetaxel', ' Arm/Group Description: DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.', ' Overall Number of Participants Analyzed: 378', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.8 (8.1 to 10.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 59/373 (15.82%)', ' Neutropenia 14/373 (3.75%)', ' Febrile neutropenia 10/373 (2.68%)', ' Leukopenia 1/373 (0.27%)', ' Anaemia 2/373 (0.54%)', ' Lymphadenopathy 0/373 (0.00%)', ' cardiac failure 2/373 (0.54%)', ' Atrial fibrillation 1/373 (0.27%)', ' Pericardial effusion 2/373 (0.54%)', ' Cardiac failure congestive 1/373 (0.27%)', ' Cardiomyopathy 0/373 (0.00%)', 'Adverse Events 2:', ' Total: 69/377 (18.30%)', ' Neutropenia 17/377 (4.51%)', ' Febrile neutropenia 10/377 (2.65%)', ' Leukopenia 4/377 (1.06%)', ' Anaemia 2/377 (0.53%)', ' Lymphadenopathy 1/377 (0.27%)', ' cardiac failure 1/377 (0.27%)', ' Atrial fibrillation 1/377 (0.27%)', ' Pericardial effusion 0/377 (0.00%)', ' Cardiac failure congestive 0/377 (0.00%)', ' Cardiomyopathy 1/377 (0.27%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5a1358af-f51b-49f8-b1c0-99a0b108b0a2
|
|
Single
|
Eligibility
|
NCT02635737
|
Patients with implantable cardioverter defibrillators are excluded from the primary trial.
|
Entailment
|
[
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT02635737', 'Intervention': ['INTERVENTION 1: ', ' Sentimark Device Placement', ' Sentimark device placed in women having mastectomy surgery', ' Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation'], 'Eligibility': ['Inclusion Criteria:', ' Participant is willing and able to give informed consent for participation in the study;', ' Female, aged 18 years or above;', ' Diagnosed with breast cancer (invasive or dcis);', ' Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study;', ' Undergoing mastectomy breast surgery.', 'Exclusion Criteria:', ' Patients with a Pacemaker or implanted device;', ' Patients requiring an MRI scan prior to surgery;', ' Patients with known coagulopathy or receiving anticoagulant medication including warfarin, heparin, clopidogrel or rivaroxaban;', ' Patients receiving Neoadjuvant chemotherapy;', ' Patients who are pregnant or lactating;', ' Patients scheduled for immediate breast reconstruction;', ' Patients who have received Sienna (iron oxide) injection in the previous six months;', ' Patients with an existing breast haematoma close to the target lesion.'], 'Results': ['Outcome Measurement: ', ' Migration of Sentimark Device', ' Migration of the device>10mm between mammograms, clip position >40mm from target lesion', ' Time frame: 1-4 weeks from placement', 'Results 1: ', ' Arm/Group Title: Sentimark Device Placement', ' Arm/Group Description: Sentimark device placed in women having mastectomy surgery', ' Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of Magseed migrating >10mm 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/29 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
ed0e1b04-aea7-4da0-922f-2be69c768c09
|
|
Single
|
Results
|
NCT01439711
|
One patient in the primary trial had a 0.98 cm3 increase in Total MRI Functional Tumor Volume (FTV) over 3 months, almost 1cm3 less than average.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01439711', 'Intervention': ['INTERVENTION 1: ', ' Letrozole + MRI', ' Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.'], 'Eligibility': ['Eligibility Criteria:', ' Histologic documentation: Pathologic confirmation of ductal carcinoma in situ (DCIS) of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration. Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study.', ' Patients with microinvasion on diagnostic core biopsy, defined as tumor 1 mm in greatest dimension, will be allowed to participate.', ' All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment.', ' Tissue samples: Patient has diagnostic tissue available for correlative studies.', ' Clinical stage: Tis or T1mi N0, M0', " Hormone receptor status: DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol. Greater than or equal to 1% cells will be considered to be positive.", ' Menopausal status: Patients must be postmenopausal defined as:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more amenorrhea, with an estradiol assay < 20pg/ml', ' Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)', ' The use of GnRH analogs to achieve post menopausal status is not allowed.', ' Prior treatment:', ' No prior surgical excision in the index breast for current DCIS diagnosis of DCIS', ' Any exogenous hormone therapy must be completed 4 weeks prior to registration', ' Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible', ' No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis', ' Contraindication to MRI: No contraindications to breast MRI', 'Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion 1 cm and 7 cm', ' DCIS must be visible on MRI based on central review.', ' Patients with palpable DCIS or adenopathy are not eligible to participate.', ' Patients with multifocal or bilateral disease are eligible.', ' History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy.', ' Age: Patients 18 years of age', 'Performance Status: ECOG performance status 0 or 1', ' Pregnancy/nursing status: Not pregnant or nursing', ' Required Initial Laboratory Values:', ' ANC 1,000/μL', ' Platelet count 100,000/μL', ' Serum creatinine 1.7 mg/dL', ' Bilirubin 2.0 mg/dL', ' AST/ALT 2.5 times upper limit of normal', ' Serum estradiol level assay < 20 pg/mL *Required for patients < 55 years of age and one year or more of amenorrhea'], 'Results': ['Outcome Measurement: ', ' Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)', ' Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.', ' Time frame: up to 3 months from start of treatment', 'Results 1: ', ' Arm/Group Title: Letrozole + MRI', ' Arm/Group Description: Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.', ' Overall Number of Participants Analyzed: 68', ' Mean (95% Confidence Interval)', ' Unit of Measure: cubic centimeters -1.93 (-2.87 to -0.98)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/90 (2.22%)', ' Heart failure 1/90 (1.11%)', ' Restrictive cardiomyopathy 1/90 (1.11%)', ' Fever 1/90 (1.11%)', ' Hypokalemia 1/90 (1.11%)', ' Arthralgia 1/90 (1.11%)', ' Myalgia 1/90 (1.11%)', ' Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify 1/90 (1.11%)', ' Hypertension 2/90 (2.22%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
73d323e7-1a38-49d4-97f4-a15f1664fb3e
|
|
Single
|
Eligibility
|
NCT02010021
|
A patient has recently had an oophorectomy,they are excluded from the primary trial.
|
Contradiction
|
[
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT02010021', 'Intervention': ['INTERVENTION 1: ', ' No Drug Treatment', ' Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.', 'INTERVENTION 2: ', ' Letrozole-presurgical', ' Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic Documentation of invasive breast cancer by core needle or incisional biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.', ' The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% staining of invasive cancer cells by IHC.', ' The invasive cancer must be human epidermal growth factor receptor 2 (HER2) negative (IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done).', ' Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Tumor must be 2cm to provide adequate tissue.', ' Patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. Samples from all available tumors are requested for research purposes.', ' Women age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. Women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.', ' Patients must meet the following clinical laboratory criteria:', ' Absolute neutrophil count (ANC) 1000/mm3 and platelet count 75,000/mm3. Total bilirubin 1.5 X the upper limit of normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 x ULN.', ' - Ability to give informed consent.', 'Exclusion Criteria:', ' Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior endocrine therapy that was administered 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.', ' Systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.', ' Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides Letrozole (10-21)days before surgical resection of the primary tumor).'], 'Results': ['Outcome Measurement: ', ' Change in Insulin Receptor Substrate 1 (IRS-1) / Phosphoinositide 3-kinase (PI3K) / Serine-threonine Protein Kinase (AKT) Pathway Activation', ' The Primary Endpoint is to determine the effect of ex vivo mTORC1 inhibition with everolimus (RAD001) on IRS-1/PI3K/AKT pathway activation (as measured by phospho-AKT-T308 and phospho-AKT-S473) in ER+/human epidermal growth factor receptor 2 (HER2)- breast tumors treated with presurgical letrozole compared to ER+/HER2- breast tumors not treated with presurgical therapy.', ' Time frame: baseline and surgery, approximately 30 days', 'Results 1: ', ' Arm/Group Title: No Drug Treatment', ' Arm/Group Description: Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: % change phospho-AKT-T308: 388 (623)', ' phospho-AKT-S473: 157 (35)', 'Results 2: ', ' Arm/Group Title: Letrozole-presurgical', ' Arm/Group Description: Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: % change phospho-AKT-T308: -10 (38)', ' phospho-AKT-S473: 135 (91)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
02dea6a3-d94f-4650-bf4f-be8fdb0a382f
|
|
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, before T-DM1 intravenous (IV) infusion.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'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': ''}
|
4c8a124b-f015-42e2-8ad3-6168f21fe705
|
|
Single
|
Adverse Events
|
NCT00130533
|
Nobody in cohort 1 of the primary trial suffered from Hyperbilirrubinemia.
|
Contradiction
|
[
0,
3
] |
[] |
{'Clinical Trial ID': 'NCT00130533', 'Intervention': ['INTERVENTION 1: ', ' Xeloda (Capecitabine)', ' 1000 mgrs/m2 twice a day, tablets, 8 cycles', 'Capecitabine', 'INTERVENTION 2: ', ' Observation', ' Observation. No intervention.'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks.', ' Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.', ' Node negative patients with tumour size > 2 cm.', ' Positive axillary lymph nodes defined as at least 1 out of 6 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: pN1a (Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm), pN2a (Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2 mm)), pN3a (Metastases in 10 or more axillary lymph nodes [at least one tumor deposit greater than 2 mm]; or metastases to the infraclavicular [level III axillary lymph] nodes).', ' Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy.', ' Patients must not present evidence of metastatic disease.', ' Negative status of HER2 in primary tumour, known before randomization.', ' Adjuvant chemotherapy consisting of a minimum of 6 courses with anthracyclines and/or taxanes.', ' Age >= 18 and <= 70 years old.', ' Performance status (Karnofsky index) >= 80.', ' Laboratory results (within 14 days prior to randomization):', ' Hematology:', ' neutrophils >= 1.5 x 10e9/l;', ' platelets >= 100x 10e9/l;', ' hemoglobin >= 10 mg/dl', ' Hepatic function:', ' total bilirubin <= 1 upper normal limit (UNL);', ' Aspartate aminotransferase (AST or SGOT) and Alanine aminotransferase (ALT or SGPT) <= 2.5 UNL;', ' alkaline phosphatase <= 2.5 UNL.', ' If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible.', ' Renal Function:', ' creatinine <= 175 µmol/l (2 mg/dl).', ' creatinine clearance >= 60 ml/min.', ' Pharmacogenetics:', ' one blood sample is needed for single nucleotide polymorphism (SNP) assessment.', ' Patients able to comply with treatment and study follow-up.', ' Negative pregnancy test done in the 14 previous days to randomization.', 'Exclusion Criteria:', ' Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.', ' Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.', ' Bilateral invasive breast cancer.', ' Any T4 or M1 tumour.', ' Axillary lymph nodes: patients belonging to the following classifications are excluded: pN1b (Metastases in internal mammary nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN1c (Metastases in 1-3 axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN2b (Metastases in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases), pN3b (Metastases in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN3c (Metastases in ipsilateral supraclavicular lymph nodes).', ' Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.', ' History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.', ' Active uncontrolled infection.', ' Active peptic ulcer, unstable diabetes mellitus.', ' Previous or current history of neoplasms different to breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' History of hypersensitivity to capecitabine, fluorouracil.', ' Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.', ' History of dihydropyrimidine dehydrogenase (DPD) deficiency.', ' Anticoagulant treatment with coumadin anticoagulants.', ' Current treatment with sorivudine or its chemical family.', ' Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.', ' Concomitant treatment with other therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival (DFS) Events', ' DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Xeloda (Capecitabine)', ' Arm/Group Description: 1000 mgrs/m2 twice a day, tablets, 8 cycles', ' Capecitabine', ' Overall Number of Participants Analyzed: 448', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 105 23.4%', 'Results 2: ', ' Arm/Group Title: Observation', ' Arm/Group Description: Observation. No intervention.', ' Overall Number of Participants Analyzed: 428', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 120 28.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/436 (5.28%)', ' Neutropenia G 3; Leucopenia G2 1/436 (0.23%)', ' Hyperbilirrubinemia [1]1/436 (0.23%)', ' Supraventricular arrhythmia NOS [2]1/436 (0.23%)', ' Heart failure [2]0/436 (0.00%)', ' Infarction and cardiac arrest 0/436 (0.00%)', ' Ischemia cardiac/Infarction [3]1/436 (0.23%)', ' Coronary vasospam [3]1/436 (0.23%)', ' Gastroenteritis and renal insuficience 1/436 (0.23%)', 'Adverse Events 2:', ' Total: 6/425 (1.41%)', ' Neutropenia G 3; Leucopenia G2 0/425 (0.00%)', ' Hyperbilirrubinemia [1]0/425 (0.00%)', ' Supraventricular arrhythmia NOS [2]0/425 (0.00%)', ' Heart failure [2]1/425 (0.24%)', ' Infarction and cardiac arrest 1/425 (0.24%)', ' Ischemia cardiac/Infarction [3]0/425 (0.00%)', ' Coronary vasospam [3]0/425 (0.00%)', ' Gastroenteritis and renal insuficience 0/425 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fb43432d-6c1b-4ff7-aea8-72bc2519a12d
|
|
Single
|
Eligibility
|
NCT00005879
|
There are criteria for PRIOR CONCURRENT THERAPY, PATIENT CHARACTERISTICS and DISEASE CHARACTERISTICS for entry to the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
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18,
19,
20,
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32,
33,
34,
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40,
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42,
43,
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46,
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48,
49,
50,
51,
52,
53,
54,
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56,
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60,
61,
62,
63,
64
] |
[] |
{'Clinical Trial ID': 'NCT00005879', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Placebo', ' Placebo: matched tablet dialy', 'INTERVENTION 2: ', ' Arzoxifene', ' LY353381, 20 mg daily', ' arzoxifene: one tablet daily'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Current random fine needle breast aspiration (FNA) evidence of 1 of the following:', ' Hyperplasia with atypia', ' Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%', ' Hyperplasia without atypia but with a BRCAPRO risk of at least 25%', ' Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2', ' Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer', ' FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women', ' Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal', " No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram", ' Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2', ' No active cancer (e.g., detectable disease)', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 and over', ' Sex:', ' Female', ' Menopausal status:', ' Any', 'Performance status:', ' Not specified', ' Life expectancy:', ' At least 12 months', ' Hematopoietic:', ' Hemoglobin greater than 10 g/dL', ' Granulocyte count greater than 1,000/mm^3', ' No deficiencies in protein C, protein S, or antithrombin III', ' No activated protein C resistance', ' Hepatic:', ' Albumin greater than 3.0 g/dL', ' Bilirubin less than 1.5 mg/dL', ' AST less than 100 U/L', ' Alkaline phosphatase less than 200 U/L', ' Renal:', ' Creatinine less than 1.5 mg/dL', ' Cardiovascular:', ' No history of deep venous thrombosis not related to trauma or pregnancy', ' No severe coronary artery disease', ' No history of prior stroke', ' Other:', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 3 months after study', ' No other active cancer', ' No retinal vein thrombosis', ' No concurrent severe poorly controlled migraine', ' No factor V Leiden mutation carrier', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' At least 12 months since prior immunotherapy', ' Chemotherapy:', ' At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration', ' At least 12 months since prior chemotherapy', ' Endocrine therapy:', ' Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration', ' Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration', ' At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy', ' Radiotherapy:', ' At least 3 months since prior radiotherapy', ' Surgery:', ' At least 6 months between prior oophorectomy and baseline aspiration', ' Other:', ' At least 2 weeks since the start of other new medication that would be ingested for 1 or more months'], 'Results': ['Outcome Measurement: ', ' Change in Masood Score', ' Change in the semi-quantitative score assigned by the designated cytopathologist.', ' Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo', ' Placebo: matched tablet dialy', ' Overall Number of Participants Analyzed: 84', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -1.1 (1.9)', 'Results 2: ', ' Arm/Group Title: Arzoxifene', ' Arm/Group Description: LY353381, 20 mg daily', ' arzoxifene: one tablet daily', ' Overall Number of Participants Analyzed: 82', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -0.8 (2.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/101 (4.95%)', ' BILATERAL CATARACTS * 0/101 (0.00%)', ' APPENDICITIS * 2/101 (1.98%)', ' ISCHEMIC COLITIS * 1/101 (0.99%)', ' SLIPPED DISK * 0/101 (0.00%)', ' RIGHT BIMALLEOLAR ANKLE FRACTURE * 0/101 (0.00%)', ' ACUTE MYELOID LEUKEMIA * 0/101 (0.00%)', ' BREAST CANCER * 0/101 (0.00%)', ' PRIMARY DCIS IN BREAST * 0/101 (0.00%)', ' OVARIAN CYST * 1/101 (0.99%)', 'Adverse Events 2:', ' Total: 9/98 (9.18%)', ' BILATERAL CATARACTS * 1/98 (1.02%)', ' APPENDICITIS * 0/98 (0.00%)', ' ISCHEMIC COLITIS * 0/98 (0.00%)', ' SLIPPED DISK * 1/98 (1.02%)', ' RIGHT BIMALLEOLAR ANKLE FRACTURE * 1/98 (1.02%)', ' ACUTE MYELOID LEUKEMIA * 1/98 (1.02%)', ' BREAST CANCER * 1/98 (1.02%)', ' PRIMARY DCIS IN BREAST * 1/98 (1.02%)', ' OVARIAN CYST * 1/98 (1.02%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d6df95f5-472f-4b14-9cd4-5d5ef238175a
|
|
Single
|
Eligibility
|
NCT00553410
|
A 55 year old postmenopausal patient with sarcoidosis would be excluded from the primary trial due to her age.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33
] |
[] |
{'Clinical Trial ID': 'NCT00553410', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Continuous Letrozole', ' Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)', ' Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously', 'INTERVENTION 2: ', ' Arm B: Intermittent Letrozole', ' Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months', ' Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:', ' Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy', ' Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease', ' Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes', ' Clinically disease-free', ' Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both', ' When calculating 4-6 years, neoadjuvant endocrine therapy should not be included', ' No evidence of recurrent disease or distant metastatic disease', ' No prior bilateral breast cancer', ' PATIENT CHARACTERISTICS:', ' Female', ' Must be postmenopausal by any of the following criteria:', ' Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)', ' Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)', ' Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)', ' Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above', ' Clinically adequate hepatic function', ' No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy', ' No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma', ' No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up', ' No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' More than 12 months since prior and no other concurrent endocrine SERM/AI therapy', ' Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:', ' Neoadjuvant chemotherapy', ' Neoadjuvant endocrine therapy', ' Adjuvant chemotherapy', ' Trastuzumab (Herceptin®)', ' Ovarian ablation', ' Gonadotropin releasing hormone analogues', ' Lapatinib ditosylate', ' No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS)', ' Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.', ' Time frame: 5-year estimates, reported at a median follow-up of 60 months', 'Results 1: ', ' Arm/Group Title: Arm A: Continuous Letrozole', ' Arm/Group Description: Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)', ' Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously', ' Overall Number of Participants Analyzed: 2426', ' Measure Type: Number', ' Unit of Measure: percentage of patients 87.5 (86 to 88.8)', 'Results 2: ', ' Arm/Group Title: Arm B: Intermittent Letrozole', ' Arm/Group Description: Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months', ' Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months', ' Overall Number of Participants Analyzed: 2425', ' Measure Type: Number', ' Unit of Measure: percentage of patients 85.8 (84.2 to 87.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1004/2411 (41.64%)', ' Hemoglobin 1/2411 (0.04%)', ' Cardiac Arrhythmia-Other (Specify) 2/2411 (0.08%)', ' Cardiac-ischemia/infarction 21/2411 (0.87%)', ' Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach) 0/2411 (0.00%)', ' Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block) 2/2411 (0.08%)', 'Adverse Events 2:', ' Total: 1052/2417 (43.53%)', ' Hemoglobin 1/2417 (0.04%)', ' Cardiac Arrhythmia-Other (Specify) 2/2417 (0.08%)', ' Cardiac-ischemia/infarction 22/2417 (0.91%)', ' Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach) 2/2417 (0.08%)', ' Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block) 0/2417 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
bd8c39c6-96a3-40f8-80e6-6cbb6bdaecb5
|
|
Single
|
Eligibility
|
NCT00982319
|
Only Post menopausal women can enter the primary trial, as long as they do not have prior hormone replacement therapy.
|
Contradiction
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00982319', 'Intervention': ['INTERVENTION 1: ', ' Broccoli Sprout Extract and Mango Juice', ' Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).', 'INTERVENTION 2: ', ' Mango Juice Without Extract', ' Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).'], 'Eligibility': ['Inclusion Criteria:', ' Female 18 + years of age', ' Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery', ' Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening', ' Agree to avoid cruciferous vegetable/condiment intake for 14 days', ' Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes', 'Exclusion Criteria:', ' Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ', ' Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening', ' Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)', ' Smoked within the past 12 months prior to eligibility screening;', ' Active infection or inflammation of the breast at time of eligibility screening', ' Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range'], 'Results': ['Outcome Measurement: ', ' Absolute Change in Mean Proliferative Rate Measured by Ki67%', ' Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.', ' Time frame: Change from baseline to 14 days post-intervention', 'Results 1: ', ' Arm/Group Title: Broccoli Sprout Extract and Mango Juice', ' Arm/Group Description: Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).', ' Overall Number of Participants Analyzed: 15', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of Ki67 -1.15 (2.08)', 'Results 2: ', ' Arm/Group Title: Mango Juice Without Extract', ' Arm/Group Description: Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).', ' Overall Number of Participants Analyzed: 15', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of Ki67 4 (17.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
52ae415a-d8ab-48f5-abcb-9e8c5bb4fc83
|
|
Comparison
|
Intervention
|
NCT01425268
|
NCT01373671
|
CO2 is utilised as part of the intervention in a single one of the study groups in the primary trial, and saline is used in both of the study groups in the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT01425268', 'Intervention': ['INTERVENTION 1: ', ' AeroForm Tissue Expansion', ' AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', 'INTERVENTION 2: ', ' Saline Tissue Expansion', ' Saline Tissue Expansion inflated by needle injections of saline', ' Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'], 'Eligibility': ['Inclusion Criteria:', ' Subject is a woman between the ages of 18-70.', ' Subject needs to have tissue expansion as part of her breast reconstruction.', ' Subject is able to provide written informed consent.', ' Subject is able and willing to comply with all of the study requirements.', ' Subject is able to understand and manage at home dosing regimen.', 'Exclusion Criteria:', ' Subjects skin is not suitable for tissue expansion.', ' Subject has remaining tumor cells following her mastectomy.', ' Subject has a current or prior infection at the intended expansion site.', ' Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.', ' 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.', ' 5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.', ' 6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).', ' 7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).', ' 8. Subject is currently participating in a concurrent investigational drug or device study.', ' 9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.', ' 12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.', ' 13. Subject is pregnant or planning on becoming pregnant during the study period.', ' 14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.'], 'Results': ['Outcome Measurement: ', ' Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event', ' The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: AeroForm Tissue Expansion', ' Arm/Group Description: AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', ' Overall Number of Participants Analyzed: 98', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: Breasts: 149 96.1%', 'Results 2: ', ' Arm/Group Title: Saline Tissue Expansion', ' Arm/Group Description: Saline Tissue Expansion inflated by needle injections of saline', ' Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.', ' Overall Number of Participants Analyzed: 52', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: Breasts: 82 98.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/99 (21.21%)', ' Neutropenic Fever [1]1/99 (1.01%)', ' Extrusion [2]1/99 (1.01%)', ' Deflation [3]1/99 (1.01%)', ' Under-Expansion [4]1/99 (1.01%)', ' Exposure [5]1/99 (1.01%)', ' Cellulitis [6]5/99 (5.05%)', ' Wound Infection [7]1/99 (1.01%)', ' Hematoma, Breast [8]1/99 (1.01%)', ' Seroma [9]1/99 (1.01%)', ' Hematoma, Chest VAP Site [10]1/99 (1.01%)', 'Adverse Events 2:', ' Total: 7/52 (13.46%)', ' Neutropenic Fever [1]0/52 (0.00%)', ' Extrusion [2]1/52 (1.92%)', ' Deflation [3]1/52 (1.92%)', ' Under-Expansion [4]0/52 (0.00%)', ' Exposure [5]0/52 (0.00%)', ' Cellulitis [6]2/52 (3.85%)', ' Wound Infection [7]2/52 (3.85%)', ' Hematoma, Breast [8]1/52 (1.92%)', ' Seroma [9]0/52 (0.00%)', ' Hematoma, Chest VAP Site [10]0/52 (0.00%)']}
|
{'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:', ' ']}
|
3bb3f3d5-e2e8-4cde-9d4f-dfc4b25c0b70
|
Comparison
|
Intervention
|
NCT01289353
|
NCT00429182
|
the primary trial and the secondary trial share at least one drug in their chemotherapy regiment.
|
Entailment
|
[
0,
3
] |
[
0,
2,
3
] |
{'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%)']}
|
f820384b-0bf5-4f2e-96fd-2c8b13a4646c
|
Single
|
Adverse Events
|
NCT00448591
|
Only two types of adverse events occurred in more than 1% of patient in cohort 1 of the primary trial.
|
Entailment
|
[
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00448591', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab', ' Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed'], 'Eligibility': ['Inclusion Criteria:', ' patients, >=18 years of age;', ' HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;', ' candidates for chemotherapy.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic or locally recurrent breast cancer;', ' concomitant hormonal therapy for metastatic or locally recurrent disease;', ' concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;', ' previous radiotherapy for treatment of metastatic disease;', ' evidence of CNS metastases.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)', ' Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.', ' Time frame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion', 'Results 1: ', ' Arm/Group Title: Bevacizumab', ' Arm/Group Description: Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed', ' Overall Number of Participants Analyzed: 2264', ' Measure Type: Number', ' Unit of Measure: percentage of participants Any AE: 95.4', ' CTC grade 3, 4 or 5 AE: 57.6', ' Bevacizumab-related AE: 64.2', ' Any Serious AE: 29.7', ' Bevacizumab-related serious SAE: 7.6', ' All deaths: 53.1', 'AESIs: 71.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 672/2264 (29.68%)', ' Febrile neutropenia * 117/2264 (5.17%)', ' Neutropenia * 98/2264 (4.33%)', ' Febrile bone marrow aplasia * 14/2264 (0.62%)', ' Anaemia * 8/2264 (0.35%)', ' Leukopenia * 8/2264 (0.35%)', ' Thrombocytopenia * 6/2264 (0.27%)', ' Disseminated intravascular coagulation * 3/2264 (0.13%)', ' Agranulocytosis * 1/2264 (0.04%)', ' Bone marrow failure * 1/2264 (0.04%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f7410166-82a7-4d15-8a04-47287ef6884c
|
|
Single
|
Eligibility
|
NCT00121836
|
Patients that are not willing to sign and give written informed consent for participation of the primary trial will still be included.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[] |
{'Clinical Trial ID': 'NCT00121836', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev', ' First Study Treatment Phase:', ' Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.', ' Second Study Treatment Phase:', ' Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.', ' Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.', ' Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Women >=18 years of age', ' HER2-negative metastatic breast cancer', ' Previous adjuvant chemotherapy or hormonal treatment', ' >=1 measurable target lesion', 'Exclusion Criteria:', ' Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer', ' Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy', ' Central nervous system metastases', ' Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix', ' Serious concurrent infection'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death', ' Time frame: approximately 505 days (Median Time to Death)', 'Results 1: ', ' Arm/Group Title: Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev', ' Arm/Group Description: First Study Treatment Phase:', ' Capecitabine 1000 mg/m oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.', ' Second Study Treatment Phase:', ' Paclitaxel 80 mg/m 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.', ' Vinorelbine 25 mg/m IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.', ' Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.', ' Overall Number of Participants Analyzed: 109', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 505 (420 to 672)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/109 (35.78%)', ' Febrile Neutropenia1/109 (0.92%)', ' Left Ventricular Failure1/109 (0.92%)', ' Nausea3/109 (2.75%)', ' Vomiting3/109 (2.75%)', ' Abdominal Pain1/109 (0.92%)', ' Caecitis1/109 (0.92%)', ' Diarrhoea1/109 (0.92%)', ' Enterovesical Fistula1/109 (0.92%)', ' Gastric Ulcer1/109 (0.92%)', ' Pancreatitis1/109 (0.92%)', ' Pain6/109 (5.50%)', ' Chest Pain3/109 (2.75%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
80726ab0-e8e4-4c42-860b-fdedad407517
|
|
Comparison
|
Intervention
|
NCT02725801
|
NCT04030104
|
Neither the primary trial or the secondary trial have placebo groups.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT02725801', 'Intervention': ['INTERVENTION 1: ', ' One-port', ' intervention is placement of one-port tissue expander at time of reconstruction', ' Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', 'INTERVENTION 2: ', ' Two-port', ' intervention is placement of two-port tissue expander at time of reconstruction', ' AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction'], 'Eligibility': ['Inclusion Criteria:', ' patient agrees to immediate tissue expander breast reconstruction', ' a suitable patient for tissue expander reconstruction', 'Exclusion Criteria:', ' not a surgical candidate for immediate breast reconstruction', ' age less than 18', ' patient declines tissue expander reconstruction', ' patient anticipated to need radiation therapy postoperatively'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant', ' The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: One-port', ' Arm/Group Description: intervention is placement of one-port tissue expander at time of reconstruction', ' Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 100.0%', 'Results 2: ', ' Arm/Group Title: Two-port', ' Arm/Group Description: intervention is placement of two-port tissue expander at time of reconstruction', ' AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 12 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/8 (12.50%)', ' re-operation [1]1/8 (12.50%)', 'Adverse Events 2:', ' Total: 4/12 (33.33%)', ' re-operation [1]4/12 (33.33%)']}
|
{'Clinical Trial ID': 'NCT04030104', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)', ' Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol', ' Patient age, indication for study entry and available medical history', ' Evaluable mammograms and OA and IUS video loops and stills for each mass', 'Exclusion Criteria:', ' Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers', ' Reader-02 Proficiency Test and training cases'], 'Results': ['Outcome Measurement: ', ' Gain in Specificity at Fixed 98% Sensitivity (fSp)', ' Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.', ' Time frame: Baseline to 12 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 38.22 (24.85 to 51.59)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 480', ' Mean (95% Confidence Interval)', ' Unit of Measure: % benign+TPB masses correctly identified 47.20 (35.91 to 58.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/480 (0.42%)', ' Device breakage [1]1/480 (0.21%)', ' Lung cancer [2]1/480 (0.21%)', 'Adverse Events 2:', ' ']}
|
f2e1c4f6-2f62-4a5e-b033-d798ba781d1d
|
Single
|
Results
|
NCT00036270
|
In total Less than 10% of patients in the primary trial either had a disease relapse or died.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00036270', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Exemestane (Aromasin®) 25 mg QD for 5 years.', 'INTERVENTION 2: ', ' Tamoxifen Followed by Exemestane', ' Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.', ' Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.', 'Exclusion Criteria:', ' Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:', ' Inflammatory breast cancer', ' Histologically positive supraclavicular nodes', ' Ulceration/infiltration of local skin metastasis', ' Neoadjuvant chemotherapy', ' Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion', ' ER and PR negative primary tumor or ER/PR unknown status.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years', ' Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.', ' Time frame: Baseline (Month 0) up to 2.75 years', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Exemestane (Aromasin ) 25 mg QD for 5 years.', ' Overall Number of Participants Analyzed: 4898', ' Measure Type: Number', ' Unit of Measure: Events (disease relapse or death) 352', 'Results 2: ', ' Arm/Group Title: Tamoxifen Followed by Exemestane', ' Arm/Group Description: Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.', ' Overall Number of Participants Analyzed: 4868', ' Measure Type: Number', ' Unit of Measure: Events (disease relapse or death) 388'], 'Adverse Events': ['Adverse Events 1:', ' Total: 784/4814 (16.29%)', ' Anaemia * 5/4814 (0.10%)', ' Anaemia vitamin B12 deficiency * 1/4814 (0.02%)', ' Coagulopathy * 1/4814 (0.02%)', ' Febrile neutropenia * 0/4814 (0.00%)', ' Haemorrhagic anaemia * 0/4814 (0.00%)', ' Iron deficiency anaemia * 1/4814 (0.02%)', ' Leukocytosis * 1/4814 (0.02%)', ' Leukopenia * 1/4814 (0.02%)', ' Lymphadenopathy * 1/4814 (0.02%)', ' Neutropenia * 0/4814 (0.00%)', 'Adverse Events 2:', ' Total: 831/4852 (17.13%)', ' Anaemia * 12/4852 (0.25%)', ' Anaemia vitamin B12 deficiency * 0/4852 (0.00%)', ' Coagulopathy * 0/4852 (0.00%)', ' Febrile neutropenia * 2/4852 (0.04%)', ' Haemorrhagic anaemia * 1/4852 (0.02%)', ' Iron deficiency anaemia * 0/4852 (0.00%)', ' Leukocytosis * 0/4852 (0.00%)', ' Leukopenia * 1/4852 (0.02%)', ' Lymphadenopathy * 3/4852 (0.06%)', ' Neutropenia * 1/4852 (0.02%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d42054cd-deb6-4436-941c-9e3a06c713cc
|
|
Comparison
|
Results
|
NCT02041429
|
NCT00068588
|
the primary trial and the secondary trial use Maximum Tolerated Dose Determined by Dose-limiting Toxicities as their outcome measurements.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02041429', 'Intervention': ['INTERVENTION 1: ', ' All Phase I Participants', ' Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles', ' 1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Phase I', ' Participants must meet the following criteria on screening examination to be eligible to participate in the study:', ' Participants must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.', ' Patients may not have received > 2 prior chemotherapies for advanced disease.', ' Either measurable or evaluable disease is allowed.', ' Age 18 years. Because no dosing or adverse event data are currently available on the use of ruxolitinib in participants <18 years of age, children are excluded from this study.', ' Life expectancy of greater than 3 months.', ' ECOG performance status 2 (see Appendix A).', ' Participants must have normal organ and marrow function as defined below:', ' Leukocytes 3,000/mcL', ' Absolute neutrophil count 1,500/mcL', ' Platelets 100,000/mcL', ' Total bilirubin within normal institutional limits', ' AST (SGOT)/ALT (SGPT) 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits or creatinine clearance 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal', ' Both men and women are allowed.', ' The effects of ruxolitinib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Phase I', ' Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.', ' Participants may not be receiving any other study agents within 2 weeks of initiating treatment.', ' Participants with untreated or uncontrolled brain metastases are excluded from this clinical trial. Patients with treated and stable (> 4 weeks) brain metastasis are allowed.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib.', ' Participants receiving any medications or substances that are strong inhibitors of CYP3A4 are ineligible. (Please refer to Appendix B for list and washout periods).', ' Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily.', ' Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because ruxolitinib is a JAK inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib. These potential risks may also apply to other agents used in this study.', ' Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.', ' Clinically significant malabsorption syndrome.', ' Prior chemotherapy or radiation administered within 2 weeks from initiating study treatment.'], 'Results': ['Outcome Measurement: ', ' Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I]', ' Ruxolitinib MTD in combination with paclitaxel 80 mg/m2 intravenously (IV) weekly is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition', ' If a DLT was observed in 0 of 3 patients in a cohort, then 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.', ' If a DLT was observed in 1 of 3 patients in a cohort, then 3 additional patients were added, and then if no further DLTs were observed, 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.', ' The MTD is identified as the level BELOW the cohort where DLT occurred in less than one third of patients within the cohort.', " If no DLT's are observed, the MTD is not reached.", ' Time frame: Participants were assessed prior to each dose of paclitaxel with ruxolitinib; The observation period for MTD evaluation was the first 2 cycles of treatment. (Up to 8 weeks).', 'Results 1: ', ' Arm/Group Title: All Phase I Participants', ' Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles', ' 1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: mg 15'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Anemia 0/3 (0.00%)', ' Anemia 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Neutrophil count decreased 0/3 (0.00%)', ' Lymphedema 0/3 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00068588', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', 'INTERVENTION 2: ', ' Arm 2', ' Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the breast', ' Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan', ' Patients must have progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease; patients must not have received prior capecitabine or 5-fluorouracil; patients with hormone-sensitive tumors should have received hormone treatment and any prior number of hormonal agents will be allowed; patients with tumors that overexpress HER-2/neu (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received herceptin, either in the adjuvant or metastatic setting, unless there is a contraindication to herceptin therapy; all prior therapies must have been completed 4 weeks before treatment', ' Life expectancy of greater than 3 months', ' ECOG performance status =< 2 (Karnofsky >= 50%)', ' Leukocytes >= 3,000/μL', ' Absolute neutrophil count >= 1,500/μL', ' Platelets >= 100,000/μL', ' Total bilirubin within normal institutional limits', ' AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min', ' Patients must have completed radiation treatment > 4 weeks prior to study entry; previously radiated area(s) must not be the only site of disease', ' All major surgical procedures must be completed > 4 weeks prior to study entry; placement of vascular access device or tissue biopsy will not be considered major surgery', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Ability to understand and the willingness to sign a written informed consent document', ' Patients must agree to the placement of a central venous catheter in order to receive the continuous infusion treatment', 'Exclusion Criteria:', ' Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following:', ' bone lesions', ' leptomeningeal disease', ' ascites', ' pleural/pericardial effusion', ' inflammatory breast disease', ' lymphangitis cutis/pulmonis', ' abdominal masses that are not confirmed and followed by imaging techniques', ' cystic lesions', ' Patients who have had chemotherapy, hormone therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier', ' Patients may not be receiving any other investigational agents; patients may not have received prior GTI-2040', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GTI-2040 or to capecitabine or 5-fluorouracil', ' Patients requiring anticoagulant therapy; low-dose anticoagulant (warfarin 1 mg per day) for the primary prophylaxis of venous catheter-associated thrombosis is permitted', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study because GTI-2040 and capecitabine have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GTI-2040 and capecitabine, breastfeeding should be discontinued if the mother is treated', ' Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GTI-2040 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose Determined by Dose-limiting Toxicities', ' 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0', ' Time frame: 21 days', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT ', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Diarrhea * 0/3 (0.00%)', ' Nausea * 0/3 (0.00%)', ' Vomiting * 0/3 (0.00%)', ' Fatigue * 0/3 (0.00%)', ' Catheter related infection * 1/3 (33.33%)', ' Infection NOS * 1/3 (33.33%)', ' Aspartate aminotransferase increased * 1/3 (33.33%)', ' Dehydration * 0/3 (0.00%)', ' Hypercalcemia * 0/3 (0.00%)', ' Hypokalemia * 0/3 (0.00%)', ' Hypophosphatemia * 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 6/21 (28.57%)', ' Diarrhea * 2/21 (9.52%)', ' Nausea * 1/21 (4.76%)', ' Vomiting * 1/21 (4.76%)', ' Fatigue * 1/21 (4.76%)', ' Catheter related infection * 0/21 (0.00%)', ' Infection NOS * 1/21 (4.76%)', ' Aspartate aminotransferase increased * 1/21 (4.76%)', ' Dehydration * 1/21 (4.76%)', ' Hypercalcemia * 1/21 (4.76%)', ' Hypokalemia * 2/21 (9.52%)', ' Hypophosphatemia * 2/21 (9.52%)']}
|
0507fbf8-3557-4ace-b015-5e106b96f6a9
|
Single
|
Eligibility
|
NCT00825734
|
Patients with any of the following conditions will be excluded from the primary trial; grade 1 infection, unstable angina or a grade 4 hemorrhage within the last month.
|
Contradiction
|
[
87,
94,
95,
108,
117,
118,
119,
120
] |
[] |
{'Clinical Trial ID': 'NCT00825734', 'Intervention': ['INTERVENTION 1: ', ' Sorafenib and Ixabepilone', ' Oral targeted therapy and Systemic Chemotherapy'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 years.', ' Histologically or cytologically confirmed breast cancer diagnosis', ' with metastatic disease. Patients without pathologic or cytologic', ' confirmation of metastatic disease should have unequivocal', ' evidence of metastasis.', ' 3. Measurable disease, as per RECIST criteria (Therasse et al.', ' 2000). Measurable disease cannot be previously irradiated', ' unless progression was documented. Measurable disease is', ' defined as: at least one lesion that can be accurately measured in', ' at least one dimension [longest diameter to be recorded] as', ' >20 mm with conventional techniques, or as >10 mm with spiral', ' computed tomography (CT) scan. Disease must be measurable,', ' i.e., bone-only disease or evaluable-only disease is not eligible.', ' 4. Patients with brain metastasis may participate if they:', ' have undergone appropriate treatment,', ' are at least 1 month post-treatment,', ' have no neurologic symptoms,', ' are not on steroids,', ' have a follow-up magnetic resonance imaging (MRI) scan that', ' demonstrates no residual active lesions, and', ' have no new untreated lesions.', ' 5 The following prior therapies are allowed:', ' No prior chemotherapy in the metastatic setting. However,', ' patients must have received prior adjuvant or neo-adjuvant', ' chemotherapy.', ' Prior radiation therapy in either the metastatic or early-stage', ' setting, as long as <25% of the bone marrow has been', ' treated. Radiation therapy must be completed at least', ' 14 days prior to study registration, and all radiation-related', ' toxicities must be resolved to grade 1 before the patient is', ' eligible for study inclusion.', ' Any number of hormonal therapies in the neo-adjuvant,', ' adjuvant, or metastatic setting is allowed. Patients must', ' discontinue hormonal therapy at least 1 week prior to starting', ' study treatment.', 'Prior bevacizumab administered >4 weeks before initiation of', ' study treatment is allowed.', ' 6 HER2-negative status. Documentation of HER2 results must be', ' available at the time of study enrollment. HER2-negative is', ' defined as:', ' Immunohistochemical (IHC) 0 or IHC 1+ OR', ' Fluorescence in situ hybridization (FISH) negative (defined by', ' FISH ratio <2.2) OR', ' Silver in-situ hybridization (SISH) negative (defined by SISH', ' ratio <2.2).', ' Patients with an IHC 2+ will need to be validated as HER2-negative', ' by FISH.', ' 7 An Eastern Cooperative Oncology Group (ECOG) performance', ' status of < or = to 2.', ' 8. Normal bone marrow function as defined by:', ' absolute neutrophil count (ANC) >1,500/μL;', ' platelets >100,000/μL;', ' hemoglobin >9 g/dL.', ' 9 Normal hepatic function as defined by:', ' total bilirubin within normal institutional limits;', ' aspartate aminotransferase (AST) and alanine', ' aminotransferase (ALT) <2.5 × the institutional upper limit of', ' normal (ULN) for patients without liver metastasis; <5.0 × ULN', ' for patients with liver metastasis.', ' 10. Normal renal function as defined by creatinine <1.5 × ULN.', ' 11. Left ventricular ejection fraction (LVEF) within institutional limits of', ' normal.', ' 12. International normalized ratio (INR) <1.5 or a prothrombin', ' time/partial thromboplastin time (PT/PTT) within normal limits.', ' Patients receiving anti-coagulation treatment with an agent such', ' as warfarin or heparin may be allowed to participate. The INR', ' should be measured prior to initiation of sorafenib, and for', ' patients on warfarin, INR should be monitored at least weekly', ' following initiation of protocol treatment, until the INR is stable and', ' therapeutic.', ' 13. Life expectancy of >6 months.', ' 14. For women of childbearing potential, negative serum pregnancy', ' test within 7 days prior to starting treatment.', ' 15. For women of childbearing potential and men, agreement to use a', ' method of contraception that is acceptable to their physician from', ' time of first signing the informed consent and for the study', ' duration. Men should use adequate birth control for at least three', ' months after the last administration of sorafenib. If a woman', ' becomes pregnant or suspects she is pregnant while participating', ' in this study, she must agree to inform her treating physician', ' immediately. As applicable, patients must agree to discontinue', ' breast-feeding until at least 3 weeks after their last dose of study', ' drug.', ' 16. Recovery to < grade 1 toxicity due to prior therapy.', ' 17. Ability to understand and willingness to sign a written informed', ' consent document.', ' Exclusion Criteria', ' More than one (>1) prior chemotherapy regimen.', ' Treatment with chemotherapy, biologic agents, or targeted agents', ' within the previous 4 weeks.', ' Previous treatment with sorafenib or ixabepilone.', ' Women who are pregnant or breastfeeding.', ' Neuropathy (motor or sensory) greater than grade 1.', ' Uncontrolled intercurrent illness including (but not limited to)', ' ongoing or active infection >grade 2.', ' Known history of human immunodeficiency virus (HIV), Hepatitis', ' B, or Hepatitis C infection.', ' History of other non-breast cancer malignancy treated with', ' curative intent within the 5 years preceding study enrollment with', ' the exception of carcinoma in situ of the cervix, non-melanoma', ' skin cancer, or follicular thyroid cancer.', ' Concurrent hormonal therapy, chemotherapy other than', ' ixabepilone, or radiation treatments while on study as well as', ' treatment with other investigational agents while on study.', ' Cardiac disease:', 'Congestive heart failure (CHF) greater than New York Heart Association', ' (NYHA) Class II (see Appendix B).', ' Unstable angina (anginal symptoms at rest) or new onset angina', ' (i.e., began within the last 3 months).', ' Myocardial infarction within the past 6 months.', ' Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.', ' Uncontrolled hypertension (systolic blood pressure >150 mmHg', ' or diastolic pressure >100 mmHg despite optimal medical', ' management).', ' Thrombolic or embolic events such as cerebrovascular accident,', ' including transient ischemic attacks, within the past 6 months.', ' Pulmonary hemorrhage or bleeding event grade 2 within', ' 4 weeks of the first dose of study treatment, or any other', ' hemorrhage or bleeding event grade 3 within 4 weeks of the', ' first dose of study treatment.', ' 14. Serious non-healing wound, ulcer, or bone fracture.', ' 15. Evidence or history of bleeding diathesis or coagulopathy.', ' 16. Major surgery, open biopsy or significant traumatic injury within', ' 4 weeks of the first dose of study drugs or anticipation of the need', ' for major surgical procedure.', ' 17. Chronic use of CYP3A4 inducers and use of the following strong', ' CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin,', ' atazanavir, nefazodone, saquinavir, telithromycin, ritonavir,', ' amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole.', ' Use of these agents should be discontinued at least 72 hours', ' prior to initiation of study treatment.', " 18. Use of St. John's Wort or rifampin (rifampicin).", " 19. Any condition that impairs patient's ability to swallow whole pills or", ' gastrointestinal (GI) tract disease that involves an inability to take', ' oral medication, malabsorption syndrome, a requirement for', ' intravenous (IV) alimentation, prior surgical procedures affecting', " absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's", ' disease or ulcerative colitis).', ' 20. Psychiatric illness/social situations that would limit compliance', ' with study requirements.', ' 21. Known or suspected allergy to sorafenib, Cremophor EL', ' (polyoxyethylated castor oil) or a drug formulated in', ' Cremophor EL such as paclitaxel or any other agent given in the', ' course of this trial.', 'Exclusion Criteria:'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: every 9 weeks until treatment discontinuation or death on study', 'Results 1: ', ' Arm/Group Title: Sorafenib and Ixabepilone', ' Arm/Group Description: Oral targeted therapy and Systemic Chemotherapy', ' Overall Number of Participants Analyzed: 76', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.8 (3.5 to 6.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/76 (7.89%)', ' ANEMIA 1/76 (1.32%)', ' DEATH 1/76 (1.32%)', ' INFECTION 1/76 (1.32%)', ' WEIGHT LOSS 1/76 (1.32%)', ' BACK PAIN 1/76 (1.32%)', ' ACUTE RENAL FAILURE 1/76 (1.32%)', ' DYSPNEA 2/76 (2.63%)', ' PNEUMONIA 1/76 (1.32%)', ' PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME 1/76 (1.32%)', 'RASH 1/76 (1.32%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
49ecc5a6-89be-48b6-85c5-c809c83f5baf
|
|
Comparison
|
Intervention
|
NCT00343382
|
NCT00798135
|
Cohort 2 of the primary trial recieves a lower dose of Pilocarpine than cohort 2 of the secondary trial recieves of oral itraconazole.
|
Entailment
|
[
3,
4,
5
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT00343382', 'Intervention': ['INTERVENTION 1: ', ' Collective Placebo', ' Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.', 'INTERVENTION 2: ', ' Pilocarpine 2 Times Per Day', ' Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.'], 'Eligibility': ['Required Characteristics:', ' Adult post menopausal women or women with no childbearing potential ( 18 years) with a history of breast cancer (currently no evidence of disease) or women who do not want to take vaginal estrogen for a fear of an increased risk of breast cancer. Postmenopausal status will be determined by the primary physician.', ' Significant vaginal complaints defined as persistent vaginal dryness and/or itching of sufficient severity to make a patient desire therapeutic intervention. Symptoms should have been present 2 months prior to randomization.', ' Life expectancy > 6 months', ' Ability to complete questionnaire(s) by themselves or with assistance.', ' Contraindications:', ' Initiation or discontinuation of tamoxifen or aromatase inhibitors 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 6-week study.', ' Active vaginal infection', ' Concurrent chemotherapy', ' Acute iritis', ' Current or past use of pilocarpine (regardless of purpose)', ' Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Lubricants used during sexual intercourse are permitted.', ' Use of any vaginal preparations 1 week prior to study entry (Exception: If patient has used vaginal preparations during the previous week but will stop, then they can be placed on study with plans to start with pretreatment questionnaire one week later). Note: Lubricants used during sexual intercourse are permitted.', ' Current ( 4weeks prior to randomization), or planned during the study period, use of any estrogen product.', ' A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.', ' Hepatic or renal insufficiency defined as a history of an elevation of SGOT 1.5 x ULN or creatinine 1.5 x ULN within the past year.', ' Concurrent use of other anticholinergics', ' Use of pharmacologic soy preparations', " Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do not require treatment are eligible.)", ' Prior or concurrent pelvic radiation therapy', ' Prior radical pelvic surgery (TAH/BSO is allowed)', ' Use of beta adrenergic antagonists', ' Diagnosis of any of the following conditions:', ' Vulvar and vaginal dysplasia', ' Essential vulvodynia', ' Vulvar vestibulitis', ' Vaginal prolapse', ' Bartholin cyst/abscess', ' History of Bartholin gland surgery', ' Lichen sclerosis', ' Lichen planus of the vulvovaginal region', ' Desquamative vaginitis'], 'Results': ['Outcome Measurement: ', ' Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics', ' Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.', ' Time frame: Baseline to Week 6', 'Results 1: ', ' Arm/Group Title: Collective Placebo', ' Arm/Group Description: Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.', ' Overall Number of Participants Analyzed: 61', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 63.6 (24.04)', 'Results 2: ', ' Arm/Group Title: Pilocarpine 2 Times Per Day', ' Arm/Group Description: Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.', ' Overall Number of Participants Analyzed: 61', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 55.8 (27.69)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/65 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00798135', 'Intervention': ['INTERVENTION 1: ', ' Itraconazole', ' oral itraconazole 200mg a day until disease progression or unacceptable toxicities.'], 'Eligibility': ['Inclusion Criteria:', ' - Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast. - Patients must carry a diagnosis of metastatic breast cancer. - Patients must be able to swallow oral medications. - Patients with HER 2+ tumors must have received trastuzumab in the past and may have had lapatinib. - Patients must have an ECOG performance status of 0-1. - Patients must be informed of the investigational nature of the study and must sign and give written informed consent. - Patients must have recovered to grade <1 from all acute toxicity of previous therapy for breast cancer with the exception of alopecia. - Adequate hematologic and hepatic function: 1)Absolute neutrophil count >= 1,500 mm3 2) Platelet count >= 100,000 mm3 3) Bilirubin <= 1.5mg/dL x ULN 4) AST and/or ALT <= 2 x ULN (< 5 x ULN in presence of known liver metastasis). - Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and must practice an effective method of birth control. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should also practice an effective method of birth control. - All WOCBP MUST have a negative serum or urine pregnancy test within 4 weeks prior to the start of study drug administration.', 'Exclusion Criteria:', ' Use of the following concomitant medications within 14 days of starting protocol therapy is prohibited: Cisapride, dofetilide, ergot derivatives, levomethadyl, lovastatin, midazolam, pimozide, quinidine, simvastatin, or triazolam.', ' Patients who are taking alprazolam (Xanax) are excluded from the trial.', ' Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics is allowed.', ' Hypersensitivity to itraconazole, any component of the formulation, or to other azoles.', ' Patients with uncontrolled CNS metastasis are excluded. If patients have CNS metastasis they must have completed brain radiation at least 2 weeks prior to registration and must be off steroids for CNS metastasis.', ' Known preexisting congestive heart failure or left ventricular dysfunction. Patients with risk factors (ex. uncontrolled hypertension with BP >160/90) for cardiac dysfunction but no preexisting diagnosis of congestive heart failure or left ventricular dysfunction will have a screening EKG prior to enrollment. Subsequently, those patients with an abnormal EKG, as judged by the treating physician, will be excluded from the study.'], 'Results': ['Outcome Measurement: ', ' Pharmacokinetics (PK) of Oral Itraconazole', ' To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.', ' Time frame: pre-dose at Weeks 2 and 4', 'Results 1: ', ' Arm/Group Title: Itraconazole', ' Arm/Group Description: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Week 2 Intraconazole Concentration: 230.7 (216.8)', ' Week 4 Intraconazole Concentration: 305.8 (334.8)', ' Week 2 6-OH Itraconazole Concentration: 454.8 (429.3)', ' Week 4 6-OH Itraconazole Concentration: 501.6 (502.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/13 (23.08%)', ' NAUSEA *1/13 (7.69%)', ' PAIN - ABDOMEN NOS *1/13 (7.69%)', ' VOMITING *1/13 (7.69%)', ' HEMORRHAGE, GI - UPPER GI NOS *1/13 (7.69%)', ' PAIN - BACK *1/13 (7.69%)', ' MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER *1/13 (7.69%)', ' PLEURAL EFFUSION (NON-MALIGNANT) *1/13 (7.69%)', ' THROMBOSIS/THROMBUS/EMBOLISM *1/13 (7.69%)']}
|
68792f63-d7b5-4570-bf8e-95e4cb8094e9
|
Comparison
|
Adverse Events
|
NCT00483223
|
NCT00811135
|
There are more cases of Intestinal perforation, Chest pain, death, Erysipelas and Pneumonia in the secondary trial than in the primary trial
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6
] |
[
0,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00483223', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin or Carboplatin', ' Cisplatin or carboplatin (1 arm, 2 cohorts)', ' Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.', ' carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed invasive breast cancer with stage IV disease, according to AJCC 6th edition (American Joint Committee on Cancer), either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study', ' All tumors must be ER-, PGR- and HER2-negative', ' 18 years of age or older', ' Paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse', ' Measurable disease by RECIST', ' Performance status of 0,1 or 2 by ECOG criteria (Eastern Cooperative Oncology Group)', ' Life expectancy greater than 12 weeks', ' Normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol', 'Exclusion Criteria:', ' More than 1 prior chemotherapy for the treatment of recurrent or metastatic breast cancer', ' Prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents', ' Active brain metastases or unevaluated neurological symptoms suggestive of brain metastases', ' Intercurrent illness or other major medical condition or comorbid condition that might affect study participation', ' Significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%', ' Renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe', ' Pregnant or nursing women', ' History or other malignancy that was not treated with curative intent'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Objective response rate (ORR) (complete response [CR]+ partial response [PR]) by RECIST (Response Evaluation Criteria In Solid Tumors).', ' Complete Response (CR): Disappearance of all target lesions', ' Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD', ' Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started', ' 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', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Cisplatin or Carboplatin', ' Arm/Group Description: Cisplatin or carboplatin (1 arm, 2 cohorts)', ' Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.', ' carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.', ' Overall Number of Participants Analyzed: 86', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 3 3.5%', ' Partial Response: 19 22.1%', ' Stable Disease > 6 Months: 4 4.7%', ' Progressive Disease: 57 66.3%', ' Not Evaluable: 3 3.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/86 (9.30%)', ' Hypersensitivity reaction to Cisplatin 1/86 (1.16%)', ' Infection with normal ANC 4/86 (4.65%)', ' Neutrophil Count 1/86 (1.16%)', ' Hyperglycemia 1/86 (1.16%)', ' Hypertension 1/86 (1.16%)']}
|
{'Clinical Trial ID': 'NCT00811135', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Bevacizumab + Capecitabine', ' Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' breast cancer with measurable locally recurrent or metastatic lesions;', ' candidate for chemotherapy;', ' HER2-positive disease;', ' ECOG PS of <=2.', 'Exclusion Criteria:', ' previous anticancer therapy for metastatic breast cancer;', ' previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);', ' chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);', ' other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;', ' uncontrolled hypertension or significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)', ' Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.', ' Time frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Bevacizumab + Capecitabine', ' Arm/Group Description: Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.', ' Overall Number of Participants Analyzed: 88', ' Measure Type: Number', ' Unit of Measure: percentage of participants 75.0 (64.6 to 83.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/88 (22.73%)', ' Cardiac Failure * 2/88 (2.27%)', ' Intracardiac thrombus * 1/88 (1.14%)', ' Abdominal pain * 1/88 (1.14%)', ' Diarrhoea * 2/88 (2.27%)', ' Enteritis * 1/88 (1.14%)', ' Intestinal perforation * 1/88 (1.14%)', ' Chest pain * 1/88 (1.14%)', ' Death * 1/88 (1.14%)', ' Erysipelas * 1/88 (1.14%)', ' Pneumonia * 1/88 (1.14%)', ' Abdominal wound dehiscence * 1/88 (1.14%)']}
|
2ddd64c7-98ef-4b06-9f01-e59d3731e8ca
|
Comparison
|
Intervention
|
NCT01852032
|
NCT01118624
|
We cannot compare the doses and frequencies provided in the intervention sections of the secondary trial and the primary trial.
|
Entailment
|
[
0,
1,
2
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT01852032', 'Intervention': ['INTERVENTION 1: ', ' Breast Cancer Patients', ' Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'], 'Eligibility': ['Inclusion Criteria:', ' 35 years of age or older', ' While male patients will not be explicitly excluded, it is expected that all patients in this study will be women', ' Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5', ' Scheduled for ultrasound or stereotactic core biopsy', ' Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.', ' Ability to understand risks, procedures, and benefits involved', 'Exclusion Criteria:', ' Recent breast biopsy', ' History of breast augmentation implant', ' Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding', ' History of moderate or severe adverse reaction to iodinated contrast injection', ' Recent serum creatinine 1.5 mg/dL', ' History of Diabetes Mellitus', ' Currently taking Glucophage or Glucovance (Metformin)', ' History of chronic asthma', ' History of allergy to iodine', ' Multiple food and/or drug allergy', ' Renal disease', ' History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold'], 'Results': ['Outcome Measurement: ', ' Beta of CT Coronal View', ' frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.', ' beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'Time frame: Day 1', 'Results 1: ', ' Arm/Group Title: Breast Cancer Patients', ' Arm/Group Description: Tomosynthesis Breast Scanning is done and breast CT Scanning is done.', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: power-law slope(B) 1.75 (0.424)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01118624', 'Intervention': ['INTERVENTION 1: ', ' Pralatrexate', ' Study drug 190 mg/m^2 for 2 to 4 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' HER-2 negative advanced or metastatic breast cancer', ' Disease has become worse after at least 1 prior chemotherapy regimen for advanced or metastatic disease', ' Advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen, or resistant to taxanes and for whom further anthracycline therapy is not indicated', ' Patients with controlled brain metastases must have finished receiving radiation therapy and if on corticosteroids, be on a stable or tapering dose of 10 mg/day of prednisone or equivalent for at least 28 days prior to study entry', ' Measurable disease', ' Female 18 years of age or older', ' Performance status less than or equal to 2', ' Life expectancy of more than 3 months', ' Blood, liver and kidney laboratory test results that meet protocol requirements', ' Patients must have a negative serum pregnancy test within 14 days before enrollment and agree to use medically acceptable and effective birth control from enrollment until at least 30 days after the last dose of pralatrexate. Patients who are postmenopausal for at least 1 year (more than 12 months since last menses) or are surgically sterilized do not require this test.', ' Willing to attend visits for repeat dosing and follow up', ' Give written informed consent', 'Exclusion Criteria:', ' Patients with only bone metastasis', ' Patients with a single metastatic site without histological proof that the lesion is metastatic breast cancer', ' Patients with inflammatory breast cancer', ' Treatment with systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, except for the following:', ' Bisphosphonates, if ongoing', ' Prior treatment with methotrexate', ' Prior treatment with anti-angiogenics within 6 months prior to enrollment', ' Have received more than 2 prior chemotherapy regimens (more than 3 if one of the treatments was neoadjuvant or adjuvant chemotherapy)', ' Have previously received pralatrexate', ' Have received more than the allowed maximum total dose of anthracycline', ' Prior radiation therapy on more than 30% of bone marrow reserve or prior bone marrow/stem cell transplantation', ' Congestive heart failure Class III/IV', ' Uncontrolled hypertension (high blood pressure)', ' Active infection or any serious medical condition, which would impair the ability of the patient to receive protocol treatment', ' Females who are pregnant or breastfeeding', ' Major surgery within 14 days of enrollment', ' Another active cancer in addition to advanced or metastatic breast cancer, except well treated in situ cervical cancer and basal cell skin cancer', ' Dementia or other altered mental status that would prevent the patient from understanding and giving informed consent or limit her ability to follow the study requirements', ' Patients who are human immunodeficiency virus (HIV)-positive and have a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and is receiving anti-retroviral therapy', ' Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) who have a detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.', ' Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.', 'Results 1: ', ' Arm/Group Title: Pralatrexate', ' Arm/Group Description: Study drug 190 mg/m^2 for 2 to 4 weeks.', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' THROMBOCYTOPENIA 2/22 (9.09%)', ' MUCOSAL INFLAMMATION 2/22 (9.09%)', ' PLEURAL EFFUSION 2/22 (9.09%)']}
|
a1a5767f-07e7-4a33-a26f-586cf71a208d
|
Single
|
Eligibility
|
NCT01326481
|
Patients with Myocardial Infarction or Deep vein thrombosis within the last 3 months are excluded from the primary trial.
|
Entailment
|
[
10,
18
] |
[] |
{'Clinical Trial ID': 'NCT01326481', 'Intervention': ['INTERVENTION 1: ', ' Carotuximab (TRC105) Plus Capecitabine', ' All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)', ' Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)', ' Measurable disease by RECIST 1.1 criteria (Part 2 only)', ' Willing and able to consent for self to participate in study', ' Progressive or recurrent disease after prior systemic chemotherapy regimen', ' Age 18 years', ' ECOG performance status of 0 or 1', ' Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade 1 or baseline (except alopecia)', ' Adequate organ function', 'Exclusion Criteria:', ' Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.', ' Prior treatment with TRC105', ' History of hypersensitivity reaction to antimetabolite therapy', ' Receipt of an investigational agent within 28 days of starting study treatment', ' Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment', ' Minor surgical procedures within 14 days prior to first dose of TRC105', ' History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease', ' Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months', ' Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy', ' Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia', ' Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105', ' Cardiac dysrhythmias of NCI CTCAE Grade 2 within the last month', ' Hemorrhage within 28 days of starting study treatment', ' Unhealed wounds within 28 days of starting study treatment', ' History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment', ' Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness', ' Known active viral or nonviral hepatitis', ' History of hypersensitivity reaction to human or mouse antibody products', ' Lung cancer with central chest lesions', ' Pregnancy or breastfeeding'], 'Results': ['Outcome Measurement: ', ' Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine', ' Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.', ' Time frame: 1.5 years', 'Results 1: ', ' Arm/Group Title: Carotuximab (TRC105) Plus Capecitabine', ' Arm/Group Description: All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Patients with DLT at 7.5 mg/kg: 0 0.0%', ' Patients without DLT at 7.5 mg/kg: 3 50.0%', ' Patients with DLT at 10 mg/kg: 0 0.0%', ' Patients without DLT at 10 mg/kg: 3 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/19 (31.58%)', ' Febrile neutropenia [1]1/19 (5.26%)', ' Fatigue [1]1/19 (5.26%)', ' Pyrexia [1]1/19 (5.26%)', ' Fracture [1]1/19 (5.26%)', ' Hip Fracture [1]1/19 (5.26%)', ' Headache [2]1/19 (5.26%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9c80fb61-66dc-4b3d-82b9-4fb62db89422
|
|
Single
|
Intervention
|
NCT00181363
|
The only difference between the interventions used in the primary trial is the patients location.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'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:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
6755a378-08bf-4e9b-a6de-166733d0307b
|
|
Comparison
|
Intervention
|
NCT00262834
|
NCT01106898
|
In the secondary trial and the primary trial Her-2 neu positive breast cancer patients receive additional maintenance therapy compared to other patients.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4
] |
{'Clinical Trial ID': 'NCT00262834', 'Intervention': ['INTERVENTION 1: ', ' Vorinostat', ' Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).'], 'Eligibility': ['Inclusion Criteria:', ' No prior or concurrent hormonal therapy for breast cancer', ' Histologically confirmed breast cancer, stage I-III disease, scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer', ' ECOG 0-2 OR Karnofsky 60-100%', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Bilirubin normal', ' AST and ALT 2.5 times upper limit of normal', ' PT 14 seconds', ' Creatinine normal', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No ongoing or active infection', ' No psychiatric illness or social situation that would preclude study compliance', ' No other uncontrolled intercurrent illness', ' No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat', ' At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)', ' Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed', ' No concurrent birth control pills', ' No prior radiotherapy to the ipsilateral breast', ' No prior or concurrent radiotherapy for breast cancer', ' No prior or concurrent novel therapy for breast cancer', ' At least 14 days since prior valproic acid or another histone deacetylase inhibitor', ' No other concurrent investigational agents', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent therapy for this cancer', ' WBC 3,000/mm^3', 'Exclusion criteria:', ' Patients must not be recieving any other investigational agents', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA.', ' Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA.', ' Women who are pregnant.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery. 17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.', ' Time frame: After 3 days of vorinostat', 'Results 1: ', ' Arm/Group Title: Vorinostat', ' Arm/Group Description: Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: participants 17'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/25 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01106898', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Chemotherapy With or Without Maintenance Therapy)', ' SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide, paclitaxel, trastuzumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed newly diagnosed stage I-II breast cancer', ' Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment', ' Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Absolute neutrophil count greater than or equal to 1,500/mcl', ' Platelet count equal to or greater than 150,000/mcl', ' Hemoglobin > 11 gm/dl', ' Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)', ' Total bilirubin equal to or less than 1.5 times the ULN', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN', ' Creatinine less than 1.5 times the ULN', ' Able to give informed consent', ' All included patients must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram', ' Able to return for treatment and follow-up on the specified days', 'Exclusion Criteria:', ' Prior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas', ' Patients with preexisting grade II peripheral neuropathy', ' Patients with prior chemotherapy', ' Stage IV or metastatic breast cancer', ' Pregnant or nursing women', ' Inability to cooperate with treatment protocol', ' No active serious infections or other conditions precluding chemotherapy', ' Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol (e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.)', ' Known hypersensitivity to any component of required drugs in the study', ' Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis', ' Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form', ' Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiograph (ECG) abnormality at screening has to be documented by the investigator as not medically relevant'], 'Results': ['Outcome Measurement: ', ' Recurrence-free Survival', ' Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.', ' Time frame: Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years', 'Results 1: ', ' Arm/Group Title: Treatment (Chemotherapy With or Without Maintenance Therapy)', ' Arm/Group Description: SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide, paclitaxel, trastuzumab: Given IV', ' Overall Number of Participants Analyzed: 100', ' Measure Type: Number', ' Unit of Measure: percentage of subjects 98 (92.2 to 99.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/102 (15.69%)', ' Febrile Neutropenia 3/102 (2.94%)', ' SinusTachycardia 1/102 (0.98%)', ' Abdominal pain 2/102 (1.96%)', ' Duodenal perforation 1/102 (0.98%)', ' Constipation 1/102 (0.98%)', ' Diarrhea 1/102 (0.98%)', ' Fever 1/102 (0.98%)', ' Anaphylaxis 1/102 (0.98%)', ' Skin Infection [1]1/102 (0.98%)', ' Urinary Tract Infection 1/102 (0.98%)', ' Sepsis 1/102 (0.98%)']}
|
b7f3e657-638b-4463-9639-4fb0da2be042
|
Comparison
|
Adverse Events
|
NCT00546156
|
NCT00398567
|
There are no cases of Vertigo, Abdominal distension or Neutropenia in the primary trial or the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
{'Clinical Trial ID': 'NCT00546156', 'Intervention': ['INTERVENTION 1: ', ' HR+, HER2-', ' Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.', 'INTERVENTION 2: ', ' Triple Negative Breast Cancer Cohort', ' Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.'], 'Eligibility': ['Inclusion Criteria:', ' Documented primary invasive breast cancer by histologic assessment', ' Tumors must express estrogen (ER) and/or progesterone receptors (PR) by standard immunohistochemical methods. Tumors must be negative for HER2. There must be sufficient sample for further protocol-specified immunohistochemical analysis', ' Patients must have high risk ER+ or PR+ breast cancer as defined by criteria listed in protocol', ' 18 year of age or older', ' Performance status of 0 or 1 by ECOG criteria', ' Use of an effective means of contraception in subjects of childbearing potential', ' Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting therapy.', ' Patients taking exogenous sex-steroid hormone treatments for any reason at the time of diagnosis must discontinue all hormonal treatments at least 2 weeks prior to enrollment', ' Patients must have preoperative treatment within 60 days of initial diagnosis of breast cancer', ' No other malignancy that requires on-going treatment', ' Normal organ function as outlined in the protocol', 'Exclusion Criteria:', ' Prior cytotoxic chemotherapy or radiation for the current breast cancer', ' Patients with inflammatory breast cancer', ' HER2 positive disease defined as HER2-amplified by FISH or IHC 3+. HER2 2+ must be negative by FISH', ' Known metastatic (Stage IV) disease', ' Other investigational agents within 4 weeks prior to the start of study treatment', ' Life expectancy of less than 6 months', ' Peripheral neuropathy greater than or equal to grade 2', ' Inadequately controlled hypertension', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' NYHA grade II or greater congestive heart failure', ' History of prior myocardial infarction', ' History of unstable angina within 12 months prior to study enrollment', ' Any history of stroke or transient ischemic attack at any time', ' Known CNS disease', ' Significant vascular disease', ' Symptomatic peripheral vascular disease', ' Evidence of significant bleeding within 6 months of study; any serious non-healing wound, skin ulcers, or bone fracture; any abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; any major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during course of study.', ' Known HIV positive', ' Unwilling to undergo pretreatment biopsy and consent to acquisition of archival tissue', ' Pregnant of lactating', ' Known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.', ' Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery', ' Time frame: 3 Years', 'Results 1: ', ' Arm/Group Title: HR+, HER2-', ' Arm/Group Description: Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.', ' Overall Number of Participants Analyzed: 84', ' Measure Type: Number', ' Unit of Measure: percentage of participants 8', 'Results 2: ', ' Arm/Group Title: Triple Negative Breast Cancer Cohort', ' Arm/Group Description: Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage of participants 44'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/104 (3.85%)', ' Neutropenia 1/104 (0.96%)', ' Leukopenia 2/104 (1.92%)', ' paranasal sinus reaction 1/104 (0.96%)', ' cellulitis 1/104 (0.96%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': 'NCT00398567', 'Intervention': ['INTERVENTION 1: ', ' Part 2 - Expanded MTD Cohort', ' All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter'], 'Eligibility': ['Inclusion Criteria:', ' Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy', ' Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)', ' HER2 positive breast cancer', ' At least one measurable target lesion', ' Adequate performance status', ' Adequate cardiac, kidney, and liver function', ' Adequate blood counts', ' Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control', 'Exclusion Criteria:', ' More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease', ' Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1', ' Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2', ' Extensive visceral disease', ' Active central nervous system metastases', ' Pregnant or breast feeding women', ' Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom', ' Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)', ' Significant cardiac disease or dysfunction', ' History of life-threatening hypersensitivity to Herceptin', ' Inability or unwillingness to swallow HKI-272 capsules', ' Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin'], 'Results': ['Outcome Measurement: ', ' 16-week Progression-free Survival (PFS) Rate', ' 16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population.', ' Time frame: From first dose date to progression status (PD or death) at 16-week', 'Results 1: ', ' Arm/Group Title: Part 2 - Expanded MTD Cohort', ' Arm/Group Description: All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of population 44.8 (25.9 to 62.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/4 (25.00%)', ' Vertigo 0/4 (0.00%)', ' Abdominal adhesions 0/4 (0.00%)', ' Abdominal distension 0/4 (0.00%)', ' Abdominal pain 0/4 (0.00%)', ' Diarrhoea 0/4 (0.00%)', ' Nausea 0/4 (0.00%)', ' Vomiting 0/4 (0.00%)', ' Disease progression 0/4 (0.00%)', ' Influenza 0/4 (0.00%)', ' Nasopharyngitis 0/4 (0.00%)', ' Lumbar vertebral fracture 0/4 (0.00%)', ' Hyponatraemia 0/4 (0.00%)', ' Ataxia 0/4 (0.00%)']}
|
5498a85b-a086-4d5d-b677-9ae44646a382
|
Single
|
Eligibility
|
NCT00418457
|
antibiotics within 10 days prior to beginning is acceptable for patients entering the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT00418457', 'Intervention': ['INTERVENTION 1: ', ' General Anesthesia and Opioid', ' General anesthesia followed by opioid administration', ' General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia', 'INTERVENTION 2: ', ' Regional Analgesia and Propofol', ' Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol', ' Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'], 'Eligibility': ['Inclusion Criteria:', ' Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)', ' Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)', ' Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)', ' Written informed consent, including willingness to be randomized to morphine or regional analgesia', 'Exclusion Criteria:', ' Previous surgery for breast cancer (except diagnostic biopsies)', ' Inflammatory breast cancer', ' Age < 18 or > 85 years old', ' Scheduled free flap reconstruction', ' ASA Physical Status 4', ' Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)', ' Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine', ' Other cancer not believed by the attending surgeon to be in long-term remission', ' Systemic disease believed by the attending surgeon to present 25% two-year mortality'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery', ' time to breast cancer recurrence from the end of surgery.', ' Time frame: up to 10 years', 'Results 1: ', ' Arm/Group Title: General Anesthesia and Opioid', ' Arm/Group Description: General anesthesia followed by opioid administration', ' General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia', ' Overall Number of Participants Analyzed: 1065', ' Measure Type: Number', ' Unit of Measure: participants 111', 'Results 2: ', ' Arm/Group Title: Regional Analgesia and Propofol', ' Arm/Group Description: Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol', ' Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia', ' Overall Number of Participants Analyzed: 1043', ' Measure Type: Number', ' Unit of Measure: participants 102'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/1065 (0.00%)', 'Adverse Events 2:', ' Total: 0/1043 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f3d2337e-6cd9-4e8c-b327-cbc48557b8dd
|
|
Single
|
Results
|
NCT00068588
|
between the two Arms of the primary trial, cohort 1 vastly outperformed cohort 2 in terms of the number of patients with complete tumor response.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00068588', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', 'INTERVENTION 2: ', ' Arm 2', ' Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the breast', ' Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan', ' Patients must have progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease; patients must not have received prior capecitabine or 5-fluorouracil; patients with hormone-sensitive tumors should have received hormone treatment and any prior number of hormonal agents will be allowed; patients with tumors that overexpress HER-2/neu (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received herceptin, either in the adjuvant or metastatic setting, unless there is a contraindication to herceptin therapy; all prior therapies must have been completed 4 weeks before treatment', ' Life expectancy of greater than 3 months', ' ECOG performance status =< 2 (Karnofsky >= 50%)', ' Leukocytes >= 3,000/μL', ' Absolute neutrophil count >= 1,500/μL', ' Platelets >= 100,000/μL', ' Total bilirubin within normal institutional limits', ' AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min', ' Patients must have completed radiation treatment > 4 weeks prior to study entry; previously radiated area(s) must not be the only site of disease', ' All major surgical procedures must be completed > 4 weeks prior to study entry; placement of vascular access device or tissue biopsy will not be considered major surgery', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Ability to understand and the willingness to sign a written informed consent document', ' Patients must agree to the placement of a central venous catheter in order to receive the continuous infusion treatment', 'Exclusion Criteria:', ' Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following:', ' bone lesions', ' leptomeningeal disease', ' ascites', ' pleural/pericardial effusion', ' inflammatory breast disease', ' lymphangitis cutis/pulmonis', ' abdominal masses that are not confirmed and followed by imaging techniques', ' cystic lesions', ' Patients who have had chemotherapy, hormone therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier', ' Patients may not be receiving any other investigational agents; patients may not have received prior GTI-2040', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GTI-2040 or to capecitabine or 5-fluorouracil', ' Patients requiring anticoagulant therapy; low-dose anticoagulant (warfarin 1 mg per day) for the primary prophylaxis of venous catheter-associated thrombosis is permitted', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study because GTI-2040 and capecitabine have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GTI-2040 and capecitabine, breastfeeding should be discontinued if the mother is treated', ' Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GTI-2040 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose Determined by Dose-limiting Toxicities', ' 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0', ' Time frame: 21 days', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT ', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Diarrhea * 0/3 (0.00%)', ' Nausea * 0/3 (0.00%)', ' Vomiting * 0/3 (0.00%)', ' Fatigue * 0/3 (0.00%)', ' Catheter related infection * 1/3 (33.33%)', ' Infection NOS * 1/3 (33.33%)', ' Aspartate aminotransferase increased * 1/3 (33.33%)', ' Dehydration * 0/3 (0.00%)', ' Hypercalcemia * 0/3 (0.00%)', ' Hypokalemia * 0/3 (0.00%)', ' Hypophosphatemia * 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 6/21 (28.57%)', ' Diarrhea * 2/21 (9.52%)', ' Nausea * 1/21 (4.76%)', ' Vomiting * 1/21 (4.76%)', ' Fatigue * 1/21 (4.76%)', ' Catheter related infection * 0/21 (0.00%)', ' Infection NOS * 1/21 (4.76%)', ' Aspartate aminotransferase increased * 1/21 (4.76%)', ' Dehydration * 1/21 (4.76%)', ' Hypercalcemia * 1/21 (4.76%)', ' Hypokalemia * 2/21 (9.52%)', ' Hypophosphatemia * 2/21 (9.52%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f25d63c8-9033-4db6-9c15-2151d82e2a6d
|
|
Comparison
|
Eligibility
|
NCT00209092
|
NCT00631852
|
A patient with a Histologically confirmed breast cancer would be accepted for the primary trial and the secondary trial.
|
Contradiction
|
[
0,
1
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT00209092', 'Intervention': ['INTERVENTION 1: ', ' Arm A:Sequential Therapy', ' Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).', 'INTERVENTION 2: ', ' Arm B:Concurrent Therapy', ' Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast carcinoma.', ' Early stage breast cancer (stage 1, 2, 3).', ' No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.', ' 18 years of age or older.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.', 'Exclusion Criteria:', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.', ' Major surgery within 28 days of study entry.', ' Evidence of central nervous system (CNS) metastases.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.', ' Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.', ' Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)', ' Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.', ' Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Arm A:Sequential Therapy', ' Arm/Group Description: Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: participants Pathologic Complete Response-Overall population: 2', ' Overall Clinical Response: 15', ' Stable disease: 3', ' Progressive Disease: 7', 'Results 2: ', ' Arm/Group Title: Arm B:Concurrent Therapy', ' Arm/Group Description: Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: participants Pathologic Complete Response-Overall population: 3', ' Overall Clinical Response: 23', ' Stable disease: 1', ' Progressive Disease: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/25 (24.00%)', ' Neutropenia *3/25 (12.00%)', ' Anemia *0/25 (0.00%)', ' Febrile Neutropenia *0/25 (0.00%)', ' Chest Pain *0/25 (0.00%)', ' Diarrhea *1/25 (4.00%)', ' Fatigue *1/25 (4.00%)', ' Liver Tests *0/25 (0.00%)', ' Neuropathy *0/25 (0.00%)', ' Syncope *0/25 (0.00%)', ' Hand and Foot Syndrome *1/25 (4.00%)', 'Adverse Events 2:', ' Total: 11/26 (42.31%)', ' Neutropenia *3/26 (11.54%)', ' Anemia *1/26 (3.85%)', ' Febrile Neutropenia *1/26 (3.85%)', ' Chest Pain *1/26 (3.85%)', ' Diarrhea *1/26 (3.85%)', ' Fatigue *0/26 (0.00%)', ' Liver Tests *1/26 (3.85%)', ' Neuropathy *1/26 (3.85%)', ' Syncope *1/26 (3.85%)', ' Hand and Foot Syndrome *1/26 (3.85%)']}
|
{'Clinical Trial ID': 'NCT00631852', 'Intervention': ['INTERVENTION 1: ', ' American Ginseng Root', ' four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery'], 'Eligibility': ['Inclusion Criteria:', ' Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging', ' Surgical patients undergoing lumpectomy, subtotal or total mastectomy', ' 18 years of age or greater', ' female', ' available tissue blocks from diagnostic biopsy', ' negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal', ' must be willing to forego surgery for minimum of 5 days', ' ability and willingness to sign written consent', ' if hypertensive, on stable dose of medication at least 30 days', ' if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days', ' ECOG status < 2 or Karnofsky of 60% or greater', 'Exclusion Criteria:', ' previous or current malignancy, excluding non-melanomic skin cancer', ' evidence of distant metastatic disease', ' history of chemotherapy, biologic or radiotherapy with 6 months of biopsy', ' usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug', ' history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG', ' history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications', ' active bleeding or a pathological condition that carries a high risk of bleeding', ' any swallowing dysfunction', ' uncontrolled intercurrent illness', ' poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)', ' known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.', ' uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)', ' pregnant or breast feeding women Women must be willing to use birth control throughout study duration.', ' current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy', ' current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy', ' current monoamine oxidase inhibitors treatment'], 'Results': ['Outcome Measurement: ', ' Adiponectin', ' Change from baseline to completion of treatment with LEAG.', ' Time frame: mean of 11.8 days', 'Results 1: ', ' Arm/Group Title: American Ginseng Root', ' Arm/Group Description: four, 250mg tablets daily 5-14 days prior to surgery', ' American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 1308 (11,985)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/16 (6.25%)', ' hemorrhage/ bleeding * [1]1/16 (6.25%)']}
|
5ab5f2e8-d1cf-4789-86b4-e2f6dbf443ea
|
Single
|
Results
|
NCT02308020
|
There were 23 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.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'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': ''}
|
4fd10abc-81d1-44f4-825a-26e2eaeae979
|
|
Single
|
Intervention
|
NCT00089973
|
the primary trial uses a 3 week cycle for SB-715992 administration, and the study lasts for 21 cycles.
|
Contradiction
|
[
0,
1,
2
] |
[] |
{'Clinical Trial ID': 'NCT00089973', 'Intervention': ['INTERVENTION 1: ', ' SB-715992', ' The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IIIB or Stage IV breast cancer', ' Previously received anthracycline and taxane therapy', 'Exclusion criteria:', ' Actively receiving anti-cancer therapy agent(s).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib', ' Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; 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; 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 cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months', 'Results 1: ', ' Arm/Group Title: SB-715992', ' Arm/Group Description: The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/50 (46.00%)', ' Febrile neutropenia 5/50 (10.00%)', ' Neutropenia 2/50 (4.00%)', ' Pericardial effusion 1/50 (2.00%)', ' Vomiting 3/50 (6.00%)', ' Diarrhoea 2/50 (4.00%)', ' Abdominal pain 1/50 (2.00%)', ' Ascites 1/50 (2.00%)', ' Chest pain 2/50 (4.00%)', ' Pyrexia 2/50 (4.00%)', ' Hyperbilirubinaemia 1/50 (2.00%)', ' Catheter related infection 1/50 (2.00%)', ' Neutropenic sepsis 1/50 (2.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a12a46de-9d3e-4c6a-becb-d43653040bf0
|
|
Comparison
|
Intervention
|
NCT01017549
|
NCT01390064
|
the secondary trial has 5 more patients cohorts than the primary trial.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4,
5,
6,
7
] |
{'Clinical Trial ID': 'NCT01017549', 'Intervention': ['INTERVENTION 1: ', ' Electronic Brachytherapy', ' Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.'], 'Eligibility': ['Inclusion Criteria:', ' Age >50 years', ' Tumor with Tis, T1, N0, M0 - (AJC Classification)', ' Invasive ductal carcinoma or ductal carcinoma in situ', ' Negative microscopic surgical margins of at least 1mm in all directions', ' Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)', 'Exclusion Criteria:', ' Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)', ' Scleroderma, systemic sclerosis and active lupus', ' Infiltrating lobular histology'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Delivery of 34 Gy in 10 Fractions', ' Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)', ' Time frame: measured at end of 10th fraction, usually within 7 days', 'Results 1: ', ' Arm/Group Title: Electronic Brachytherapy', ' Arm/Group Description: Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: Participants 42'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/44 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01390064', 'Intervention': ['INTERVENTION 1: ', ' Initial Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', 'INTERVENTION 2: ', ' Escalation Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects of all races with histologically or cytologically confirmed stage IV breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed after primary or adjunctive therapy and must not have required a treatment change for 2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The chemotherapy regimen cannot contain steroids in the pre or post supportive care medications. If a subject is on an investigational drug, the drug must be cleared from the body over a period of 4 weeks.', ' Disease staging will be done according to the American Joint Commission on Cancer (AJCC), sixth edition.', ' Age 18 years and older of all races and ethnicity.', ' ECOG Performance Status 0 or 1.', ' Subjects must not have an active infection requiring treatment with antibiotics.', ' Subjects must not have other significant medical, surgical or psychiatric conditions, or require any medication or treatment, which may interfere with compliance of the treatment regimen.', ' Subjects must not have a diagnosis or evidence of organic brain syndrome, significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol.', ' Subjects must have no other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for 5 years prior to the time of registration.', ' Subjects must not have autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.', ' Women of childbearing potential must not be pregnant (negative serum pregnancy test must be done 48 hours prior to receiving the first dose of study drug) or breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or infant.', ' Women of childbearing potential must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods include oral contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.', ' Subjects must have obtained a white blood cell (WBC) count 3,000/mm3 and platelet count 100,000/mm3 within 2 weeks prior to registration.', ' Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase test (AST) and bilirubin 2 x institutional upper limit (IUL) of normal and serum creatinine 1.8 mg/dl, all obtained within 2 weeks prior to registration.', ' Subjects must be immunocompetent as measured by responsiveness to two recall antigens by skin testing.', ' All subjects who wish to participate in the study must sign an informed consent approved by the UAMS Institutional Review Board (IRB).', ' Laboratory tests must be completed within 2 weeks before the first dose.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Dose-limiting Toxicity (Defined as an Adverse Event of Grade 3 or Higher)', ' The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', ' Time frame: 9 weeks per subject', 'Results 1: ', ' Arm/Group Title: Initial Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Escalation Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
66ee10ac-1bfe-44d6-9b91-8a2bb1983606
|
Single
|
Adverse Events
|
NCT02115984
|
A total of 3 patients in cohort 1 of the primary trial experience a Herpes related adverse event.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT02115984', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy & Panagen', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', 'INTERVENTION 2: ', ' Chemotherapy & Placebo', ' Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).'], 'Eligibility': ['Inclusion Criteria:', ' Signed and dated written informed consent', ' Women at an age of 18 years', ' Stage II-IV breast cancer (with distant metastases)', ' The patients will be subject to chemotherapy with cyclophosphan/doxorubicin/ fluorouracil as a standard chemotherapy for treating breast cancer', ' The patients have not been earlier subject to chemotherapy', ' Functional status according to the Eastern Cooperative Oncology Group (ECOG) 2', ' Leukocyte counts of 3 × 109/L before the treatment course', ' Neutrophil counts of 1.5 × 109/L before the treatment course', ' Platelet counts of 100 × 109/L before the treatment course', ' Adequate heart function', ' Adequate liver function, that is, alanine aminotransferase / aspartate aminotransferase (ALT / AST) activity < 2.5 × upper limit of normal (ULN); acid phosphatase activity < 5 × ULN; and bilirubin concentration < 5 × ULN; and', ' Adequate renal function, that is, the creatinine concentration in the blood serum < 1.5 × ULN; urea concentration < ULN; and endogenous creatinine clearance', 'Exclusion Criteria:', ' Participation in clinical trials less than 30 days before sequential randomization', ' Previous exposure to Panagen or any other leukostimulatory drugs at a stage of clinical development', ' Known hypersensitivity to cyclophosphan, doxorubicin, or fluorouracil', ' Therapy with systemically active antibiotics less than 72 h before the beginning of chemotherapy', ' Long-term oral intake of corticosteroids', ' Previous X-ray therapy performed less than 4 weeks before randomization', ' Previous transplantation of hematopoietic stem cells', ' Other malignant neoplasms during the last 5 years except for basal cell or flat cell carcinoma or intraepithelial carcinoma of the uterine cervix', " Any disease or state that according to the opinion of researcher can influence patient's safety or the estimation of a final trial point; and", ' Pregnant and nursing women; the fertile patients should use chemical or barrier contraceptives during the period of trials'], 'Results': ['Outcome Measurement: ', ' The Quantity of Leukocytes and Neutrophils in the Blood of Patients', ' [Not Specified]', ' Time frame: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)', 'Results 1: ', ' Arm/Group Title: Chemotherapy & Panagen', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 51', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 8.1 (6.5 to 8.8)', ' Leukocytes after the 2nd chemotherapy: 6.6 (5.9 to 7.2)', ' Leukocytes after the 3rd chemotherapy: 5 (4.6 to 5.5)', ' Neutrophils baseline: 5.33 (4.42 to 6.36)', ' Neutrophils after the 2nd chemotherapy: 4.62 (3.43 to 4.82)', ' Neutrophils after the 3rd chemotherapy: 3.19 (1.81 to 3.58)', 'Results 2: ', ' Arm/Group Title: Chemotherapy & Placebo', ' Arm/Group Description: Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.', ' Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: 10^9 cells/L Leukocytes baseline: 7.2 (6.5 to 7.9)', ' Leukocytes after the 2nd chemotherapy: 4.8 (4.1 to 5.6)', ' Leukocytes after the 3rd chemotherapy: 4.1 (3.8 to 4.4)', ' Neutrophils baseline: 5.2 (4.2 to 6.05)', ' Neutrophils after the 2nd chemotherapy: 2.76 (2.22 to 3.27)', ' Neutrophils after the 3rd chemotherapy: 2.44 (2.31 to 2.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 57/57 (100.00%)', ' Dry eyes 13/33 (39.39%)', ' Heartburn 9/33 (27.27%)', ' Nausea after the CT (before day 7) 57/57 (100.00%)', ' Herpetic eruption 0/33 (0.00%)', ' Dry skin 15/33 (45.45%)', ' Alopecia 57/57 (100.00%)', 'Adverse Events 2:', ' Total: 23/23 (100.00%)', ' Dry eyes 2/11 (18.18%)', ' Heartburn 2/11 (18.18%)', ' Nausea after the CT (before day 7) 23/23 (100.00%)', ' Herpetic eruption 3/11 (27.27%)', ' Dry skin 9/11 (81.82%)', ' Alopecia 23/23 (100.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
714c540c-1fa1-47c7-ac13-1e8f056d1e31
|
|
Comparison
|
Adverse Events
|
NCT00688740
|
NCT00191815
|
The most common adverse events in the primary trial and the secondary trial is Neutropenia with a total of 3 cases across all cohorts.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT00688740', 'Intervention': ['INTERVENTION 1: ', ' TAC (Docetaxel)', ' docetaxel in combination with doxorubicin and cyclophosphamide', 'INTERVENTION 2: ', ' FAC (5-fluorouracil)', ' 5-fluorouracil in combination with doxorubicin and cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).', ' Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.', 'Exclusion criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease-Free Survival Events', ' Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.', ' Time frame: up to 10 year follow-up', 'Results 1: ', ' Arm/Group Title: TAC (Docetaxel)', ' Arm/Group Description: docetaxel in combination with doxorubicin and cyclophosphamide', ' Overall Number of Participants Analyzed: 745', ' Measure Type: Number', ' Unit of Measure: Participants 287', 'Results 2: ', ' Arm/Group Title: FAC (5-fluorouracil)', ' Arm/Group Description: 5-fluorouracil in combination with doxorubicin and cyclophosphamide', ' Overall Number of Participants Analyzed: 746', ' Measure Type: Number', ' Unit of Measure: Participants 333'], 'Adverse Events': ['Adverse Events 1:', ' Total: 267/744 (35.89%)', ' Neutropenia *2/744 (0.27%)', ' Anaemia *1/744 (0.13%)', ' Leukopenia *1/744 (0.13%)', ' Thrombocytopenia *1/744 (0.13%)', ' Thrombotic thrombocytopenic purpura *1/744 (0.13%)', ' Atrial flutter *1/744 (0.13%)', ' Cardiac arrest *1/744 (0.13%)', ' Myocardial ischaemia *1/744 (0.13%)', ' Arrhythmia *0/744 (0.00%)', ' Cardiac failure congestive *0/744 (0.00%)', 'Adverse Events 2:', ' Total: 67/736 (9.10%)', ' Neutropenia *1/736 (0.14%)', ' Anaemia *0/736 (0.00%)', ' Leukopenia *0/736 (0.00%)', ' Thrombocytopenia *0/736 (0.00%)', ' Thrombotic thrombocytopenic purpura *0/736 (0.00%)', ' Atrial flutter *0/736 (0.00%)', ' Cardiac arrest *0/736 (0.00%)', ' Myocardial ischaemia *0/736 (0.00%)', ' Arrhythmia *2/736 (0.27%)', ' Cardiac failure congestive *1/736 (0.14%)']}
|
{'Clinical Trial ID': 'NCT00191815', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Cisplatin', ' Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).'], 'Eligibility': ['Inclusion Criteria:', ' You are female in the age of 18 to 75 years old.', ' You have been diagnosed with the metastatic breast cancer.', ' You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.', ' You must sign this informed consent form', 'Exclusion Criteria:', ' You are pregnant or breastfeeding.', ' Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.', ' You have been diagnosed with serious concomitant or acute infectious disease.', ' You have used experimental medications within the last month.'], 'Results': ['Outcome Measurement: ', ' Objective Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Cisplatin', ' Arm/Group Description: Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 7', ' Partial Response: 19', ' Stable Disease: 19', ' Progressive Disease: 5', 'Not Assessable: 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Atrial fibrillation 1/67 (1.49%)', ' Ventricular fibrillation 1/67 (1.49%)', ' Gastrointestinal perforation 1/67 (1.49%)', ' Periproctitis 1/67 (1.49%)', ' General physical health deterioration 1/67 (1.49%)', ' Escherichia sepsis 1/67 (1.49%)', ' Pneumonia 1/67 (1.49%)', ' Tumour pain 1/67 (1.49%)', ' Renal failure acute 1/67 (1.49%)', ' Pleurisy 1/67 (1.49%)']}
|
3948b30d-934d-485c-b324-b3571e2957a3
|
Single
|
Adverse Events
|
NCT01166763
|
the primary trial recorded 4 life-threatening adverse events.
|
Contradiction
|
[
0,
1,
2,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT01166763', 'Intervention': ['INTERVENTION 1: ', ' High Dose Vitamin D3 (10,000 IU Weekly)', ' Group/Cohort Label vitamin D3', ' vitamin D3: oral capsules, 10,000 IU per week for 6 months'], 'Eligibility': ['Inclusion Criteria:', ' Subjects must be premenopausal women age 55 or younger, and actively menstruating with 4 or more periods per year.', ' Subjects may be using barrier contraceptive, an intrauterine device, a Nuvaring, or similar non-oral contraceptive; or oral contraceptives.', ' Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:', ' five-year Gail risk of 3X the average risk of the age group;', ' a first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer;', ' prior biopsy exhibiting atypical hyperplasia (AH), LCIS, DCIS, RPFNA evidence of hyperplasia with atypia within the last three years;', ' Chest or neck radiation before age 30;', ' Breast density equals or exceeds 50 percent.', ' If previously on a chemoprevention agent or prevention trial, subjects must have completed study participation at least 6 months prior to baseline biomarker assessment.', ' If subject has a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and is either not eligible or is not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy).', ' Subject must have had a mammogram performed at the University of Kansas Breast Imaging Center with estimated visual breast density of greater than 10 percent.', ' Subject must have had within six months prior to entering the study, an RPFNA during the follicular portion (day 1-10) of the menstrual cycle with material for cytomorphology, Ki-67 and qRT-PCR; in addition to serum obtained and banked.', ' Subjects must have 25(OH)D level < 30 ng/ml as measured within 8 weeks of starting intervention. Subjects may have been identified as having low vitamin D levels through participation in HSC 11313, Osteopenia/Osteoporosis in Pre-menopausal Women at High Risk for Development of Breast Cancer, but low level must be confirmed within 8 weeks prior to starting study agent Subject must be willing to continue the same hormonal milieu present at baseline throughout trial.', ' Subjects must be willing to undergo measurement of height, weight, and BMI at initiation of intervention.', ' Subjects must have participated in HSC 11313, and have had a DEXA scan for bone density and body fat analysis on the GE Lunar Prodigy Advance research unit in the Breast Cancer Survivorship Center.', ' Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA.', 'Exclusion Criteria:', ' Women that have had a metastatic malignancy of any kind.', ' Women that have had prior invasive breast cancer If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by FNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied.', ' Women who are pregnant or nursing.', ' Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA.', ' Women who have used fertility drugs within six months prior to baseline aspiration.', ' Women with a history of sarcoidosis, hypercalcemia, hyperparathyroidism, or renal stones.', ' Women who are receiving treatment for rheumatoid arthritis or other connective tissue diseases.', ' Women who have an elevated blood calcium level at baseline; defined as any elevation above the institutional normal range.'], 'Results': ['Outcome Measurement: ', ' Change in Mammographic Breast Density Over Course of Study', ' Change in the percent of the breast area that is considered to be at higher density on mammogram.', ' Time frame: baseline and 6 months', 'Results 1: ', ' Arm/Group Title: High Dose Vitamin D3 (10,000 IU Weekly)', ' Arm/Group Description: Group/Cohort Label vitamin D3', ' vitamin D3: oral capsules, 10,000 IU per week for 6 months', ' Overall Number of Participants Analyzed: 27', ' Mean (Standard Deviation)', ' Unit of Measure: Change in percent dense breast area -0.5 (5.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/30 (10.00%)', ' Cholecystitis * [1]1/30 (3.33%)', ' Increase in diarrhea * [2]1/30 (3.33%)', ' Flank pain * [3]1/30 (3.33%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
45cf29ce-25f5-4719-8468-69d94893c9e7
|
|
Single
|
Eligibility
|
NCT01823991
|
Patients with metallic vascular clips placed to prevent bleeding from conditions such as intracranial aneurysms, are elligible for the primary trial.
|
Contradiction
|
[
9,
19
] |
[] |
{'Clinical Trial ID': 'NCT01823991', 'Intervention': ['INTERVENTION 1: ', ' A - Cognutrin #1', ' Cognutrin Treatment Time 1', 'INTERVENTION 2: ', ' B - Cognutrin #2', 'Cognutrin Time 2.'], 'Eligibility': ['Inclusion Criteria:', ' Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)', ' Able to understand and sign the informed consent', ' Fluent in reading, comprehension and communication in the English language', ' No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence of cognitive impairment', ' Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score >60%)', ' Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)', ' Must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice', 'Exclusion Criteria:', ' Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months', ' Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)', ' Patients with advanced or Stage IIIIB or IV breast cancer or other cancers', ' Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial', ' History of known allergy to components of the study supplements', ' Renal or liver disease', ' Concurrent participation in another chemoprevention trial', ' Evidence of bleeding diathesis or coagulopathy', ' Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.)', ' Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging', ' Medical history of concussions', ' Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the potential participant inappropriate for entry into this study'], 'Results': ['Outcome Measurement: ', ' Change in Cognitive Function Scores With Intervention - HVLT and COWA', ' Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The HVLT test assesses verbal learning and memory. Subjects are given a list of words and asked to repeat as many words as they can recall at 3 times. There is no absolute low & high, as scores are age adjusted. Reported scores are T-scores- average score should be 50, with a standard deviation of 10. Any score below 50 indicates performance below population averages and any score above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be -3.0 and 3.0. A lower Z score is indicative of poor fluency.', ' Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)', 'Results 1: ', ' Arm/Group Title: A - Cognutrin #1', ' Arm/Group Description: Cognutrin Treatment Time 1', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Error)', ' Unit of Measure: score HVLT-total recall: 49.04 (6.41)', ' HVLT-delayed recall: 44.82 (5.33)', ' COWA-z score: -.341 (.686)', 'Results 2: ', ' Arm/Group Title: B - Cognutrin #2', ' Arm/Group Description: Cognutrin Time 2.', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Error)', ' Unit of Measure: score HVLT-total recall: 44.93 (7.55)', ' HVLT-delayed recall: 41.59 (7.02)', ' COWA-z score: -.452 (.577)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/18 (5.56%)', ' Psychosis * [1]1/18 (5.56%)', 'Adverse Events 2:', ' Total: 0/18 (0.00%)', ' Psychosis * [1]0/18 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7502090d-1bcb-4be9-9358-81afb9440a17
|
|
Comparison
|
Eligibility
|
NCT01840163
|
NCT02005549
|
the primary trial and the secondary trial do not exclude patients with concurrent systemic antitumor therapy.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT01840163', 'Intervention': ['INTERVENTION 1: ', ' CanSORT Online Tool (Intervention)', ' Comprehensive (interactive) version of decision tool', ' CanSORT Online Tool', 'INTERVENTION 2: ', ' Static Version of CanSORT Tool (Control)', ' Static version (non-interactive) version of CanSORT decision tool', ' Static version of CanSORT tool'], 'Eligibility': ['Inclusion Criteria:', ' Stage 1-2 invasive breast cancer diagnosis,', ' DCIS', ' Ability to read English', 'Exclusion Criteria:', 'Male'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.', ' Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.', ' Time frame: 4-5 weeks from date of enrollment', 'Results 1: ', ' Arm/Group Title: CanSORT Online Tool (Intervention)', ' Arm/Group Description: Comprehensive (interactive) version of decision tool', ' CanSORT Online Tool', ' Overall Number of Participants Analyzed: 251', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 148 59.0%', 'Results 2: ', ' Arm/Group Title: Static Version of CanSORT Tool (Control)', ' Arm/Group Description: Static version (non-interactive) version of CanSORT decision tool', ' Static version of CanSORT tool', ' Overall Number of Participants Analyzed: 245', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 105 42.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/267 (0.00%)', 'Adverse Events 2:', ' Total: 0/270 (0.00%)']}
|
{'Clinical Trial ID': 'NCT02005549', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab+Docetaxel+Capecitabine', ' Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, 18-70years of age;', ' histologically-proven invasive breast cancer;', ' no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;', ' no distant disease/secondary cancer.', 'Exclusion Criteria:', ' pregnant or lactating women;', ' pre-operative local treatment for breast cancer;', ' prior or concurrent systemic antitumor therapy;', ' clinically significant cardiac disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR)', ' pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.', ' Time frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])', 'Results 1: ', ' Arm/Group Title: Bevacizumab+Docetaxel+Capecitabine', ' Arm/Group Description: Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 22.22 (6.41 to 47.64)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/18 (27.78%)', ' Intestinal perforation * 1/18 (5.56%)', ' General physical health deterioration * 1/18 (5.56%)', ' Impaired healing * 1/18 (5.56%)', ' Neutropenic infection * 1/18 (5.56%)', ' Contralateral breast cancer * 1/18 (5.56%)', ' Menorrhagia * 1/18 (5.56%)', ' Deep vein thrombosis * 2/18 (11.11%)']}
|
89f84928-82a9-413e-ab25-400657002c55
|
Single
|
Adverse Events
|
NCT00930930
|
The most frequent adverse event in cohort 1 of the primary trial was lymphopenia.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29
] |
[] |
{'Clinical Trial ID': 'NCT00930930', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin and Paclitaxel + RAD001', ' Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks', ' cisplatin: Given IV', ' everolimus: Given orally', ' paclitaxel: Given IV', ' Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment', 'INTERVENTION 2: ', ' Cisplatin and Paclitaxel + Placebo', ' Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks', ' cisplatin: Given IV', ' paclitaxel: Given IV', ' placebo: Given orally', ' Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment'], 'Eligibility': ['Eligibility criteria', ' -Maximum number of patients will include two-thirds of the patients in Arm 1 and one-third of the patients for Arm 2 (total of 145 patients). Estimated time for accrual with ~ 3 patients/month would be ~ 3.5 years.', 'Inclusion criteria:', ' Patients must provide informed written consent.', ' Patient must be 18 years of age.', ' ECOG performance status 0-1.', ' Clinical stage II or stage III triple-negative (ER and/or PR no staining or weak staining in less than or equal to 10% cells by immunohistochemistry [IHC] and HER2-negative by Herceptest [0, 1+] or FISH) invasive mammary carcinoma, confirmed by histological analysis.', ' Patients who have measurable* residual tumor at the primary site', ' *Measurable disease: any mass that can be reproducibly measured by physical examination, mammogram, and/or ultrasound and can be accurately measured in at least one dimension (longest diameter to be recorded) as 10 mm (1 cm), either in the breast or axillary lymph nodes.', ' Available core biopsies from the time of diagnosis. Fresh tissue must be obtainable at baseline or fresh tissue biopsy prior to treatment initiation.', ' Patients who will undergo surgical treatment with either segmental resection or total mastectomy.', ' Patients must have adequate hematologic, hepatic, and renal function. All tests must be obtained less than 4 weeks from study entry. This includes:', ' ANC >/=1500/mm3', ' Platelet count >/=100,000/mm3', ' Creatinine </=1.5X upper limits of normal', ' Bilirubin, SGOT, SGPT </=1.5X upper limits of normal*', ' * for patients with Gilbert"s syndrome, direct bilirubin will be measured instead of total bilirubin.', ' The patient must have not had anyprior chemotherapy for primary breast cancer.', ' Patients with a prior history of contra-lateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer within the last 5 years.', ' Able to swallow and retain oral medication.', ' Four days prior to biopsy procedures patients must be off medications that could increase risk of bleeding (i.e. ASA, NSAIDS, Coumadin, heparin products)', ' Potential subjects must complete all screening assessments as outlined in the protocol.', ' The pre-menopausal patient of childbearing potential must have had a negative pregnancy test and agreed to use birth control methods while participating in the study. Note: Women of childbearing potential and their male counterparts should use a barrier method of contraception during and for 3 months following protocol therapy.', ' Ineligibility Criteria', 'Exclusion Criteria:', ' Locally recurrent breast cancer.', ' Pregnant or lactating women.', ' Evidence of distant metastatic disease (i.e. lung, liver, bone, brain, etc.)', ' Use of CYP3A4 modifiers (Appendix A)', ' Serious medical illness that in the judgment of the treating physician places the patient at high risk of operative mortality.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.', ' History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinomas are eligible.', ' History of hepatitis B or hepatitis C. If patient is judged to be at risk for having had exposure to viral B or C hepatitis (i.e. illicit IV drug use, blood transfusion prior to 1990, body piercing, tattoos, etc.), appropriate testing should be performed (i.e. Hepatitis B surface antigen antibody, and Hepatitis C antibody)', ' Active or uncontrolled infection requiring parenteral antibiotics.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Symptomatic neuropathy ( grade 2).', ' Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, or any other biologic therapy) other than the ones specified in the protocol.', ' Concurrent treatment with an investigational agent.', ' Used an investigational drug within 15 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response', ' Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.', ' Time frame: at time of surgery, week 15-18', 'Results 1: ', ' Arm/Group Title: Cisplatin and Paclitaxel + RAD001', ' Arm/Group Description: Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks', ' cisplatin: Given IV', ' everolimus: Given orally', ' paclitaxel: Given IV', ' Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment', ' Overall Number of Participants Analyzed: 88', ' Measure Type: Number', ' Unit of Measure: participants 34', 'Results 2: ', ' Arm/Group Title: Cisplatin and Paclitaxel + Placebo', ' Arm/Group Description: Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks', ' cisplatin: Given IV', ' paclitaxel: Given IV', ' placebo: Given orally', ' Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: participants 17'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/96 (22.92%)', ' Anemia 1/96 (1.04%)', ' lymphopenia 1/96 (1.04%)', ' cardiac ischemia/infarction 1/96 (1.04%)', ' sinus tachycardia 2/96 (2.08%)', ' Dehydration 5/96 (5.21%)', ' colitis 1/96 (1.04%)', ' diarrhea 5/96 (5.21%)', ' ileus 1/96 (1.04%)', ' nausea 2/96 (2.08%)', ' vomiting 1/96 (1.04%)', ' distal small bowel obstruction 1/96 (1.04%)', ' edema 1/96 (1.04%)', ' fatigue 2/96 (2.08%)', 'Adverse Events 2:', ' Total: 6/49 (12.24%)', ' Anemia 0/49 (0.00%)', ' lymphopenia 0/49 (0.00%)', ' cardiac ischemia/infarction 0/49 (0.00%)', ' sinus tachycardia 0/49 (0.00%)', ' Dehydration 1/49 (2.04%)', ' colitis 0/49 (0.00%)', ' diarrhea 0/49 (0.00%)', ' ileus 0/49 (0.00%)', ' nausea 1/49 (2.04%)', ' vomiting 1/49 (2.04%)', ' distal small bowel obstruction 0/49 (0.00%)', ' edema 0/49 (0.00%)', ' fatigue 0/49 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
79dbf7bf-e08d-4eae-a804-0daeb83d6f01
|
|
Single
|
Results
|
NCT01381874
|
The Exemestane group in the primary trial had a better median Progression-Free Survival than the Abiraterone Acetate + Prednisone group, however the patient with the maximum PFS was in the Abiraterone Acetate + Prednisone group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01381874', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).', 'INTERVENTION 2: ', ' Abiraterone Acetate + Prednisone', ' Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).'], 'Eligibility': ['Inclusion Criteria:', ' Female patients must be postmenopausal', ' ER+, Human epidermal growth factor receptor 2 (Her2) negative metastatic breast cancer', ' Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression', ' No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy', ' Eastern Cooperative Oncology Group (ECOG) performance status score of <=1', ' Patients with disease confined only to bone may be included, but patients with purely sclerotic lesions may not participate in the study', 'Exclusion Criteria:', ' Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor. Prior treatment with ketoconazole for <= 7 days is permitted and topical formulations of ketoconazole are permitted', ' Potential patients must not have taken anastrozole, letrozole, fulvestrant, or any chemotherapy for at least 2 weeks (bevacizumab for at least 3 weeks) before randomization', ' Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization', ' Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection', ' Clinical or biochemical evidence of hyperaldosteronism or hypopituitarism', ' Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system.', ' Time frame: Approximately 2 years', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).', ' Overall Number of Participants Analyzed: 102', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 3.68 (1.94 to 5.26)', 'Results 2: ', ' Arm/Group Title: Abiraterone Acetate + Prednisone', ' Arm/Group Description: Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).', ' Overall Number of Participants Analyzed: 89', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 3.65 (2.73 to 5.59)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/102 (11.76%)', ' Anaemia * 0/102 (0.00%)', ' Febrile Neutropenia * 0/102 (0.00%)', ' Atrial Fibrillation * 0/102 (0.00%)', ' Cardiac Failure Congestive * 0/102 (0.00%)', ' Vertigo * 1/102 (0.98%)', ' Hypoaldosteronism * 0/102 (0.00%)', ' Abdominal Pain * 0/102 (0.00%)', ' Anorectal Varices * 0/102 (0.00%)', ' Ascites * 0/102 (0.00%)', " Crohn's Disease * 0/102 (0.00%)", 'Adverse Events 2:', ' Total: 18/87 (20.69%)', ' Anaemia * 0/87 (0.00%)', ' Febrile Neutropenia * 0/87 (0.00%)', ' Atrial Fibrillation * 1/87 (1.15%)', ' Cardiac Failure Congestive * 0/87 (0.00%)', ' Vertigo * 0/87 (0.00%)', ' Hypoaldosteronism * 0/87 (0.00%)', ' Abdominal Pain * 0/87 (0.00%)', ' Anorectal Varices * 0/87 (0.00%)', ' Ascites * 0/87 (0.00%)', " Crohn's Disease * 1/87 (1.15%)", ' Faecal Incontinence * 1/87 (1.15%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c9ff5b91-cec7-4da7-b1cd-f08f3874e8ed
|
|
Comparison
|
Adverse Events
|
NCT00777101
|
NCT00559845
|
There were no depressed patients in either the primary trial or the secondary trial, however there was one suicide attempt in cohort 2 of the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
{'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%)']}
|
{'Clinical Trial ID': 'NCT00559845', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab', ' FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.', ' FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over 15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.', ' Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.', ' Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female participants, >=18 years of age;', ' stage III, or inflammatory breast cancer;', ' estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;', ' normal left ventricular ejection fraction (LVEF).', 'Exclusion Criteria:', ' previous chemotherapy/endocrine therapy;', ' evidence of distant metastatic disease;', ' other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);', ' chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response Following Principle Investigator Review', ' Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.', ' Time frame: Up to 7.5 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab', ' Arm/Group Description: FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.', ' FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over 15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.', ' Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.', ' Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles.', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: percentage of participants 23.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/54 (14.81%)', ' Anaemia 1/54 (1.85%)', ' Febrile Neutropenia 1/54 (1.85%)', ' Retinopathy Hypertensive 1/54 (1.85%)', ' Febrile Infection 1/54 (1.85%)', ' Postoperative Wound Complication 1/54 (1.85%)', ' Cardiac Imaging Procedure Abnormal 1/54 (1.85%)', ' Malignant Melanoma In Situ 1/54 (1.85%)', ' Suicide Attempt 1/54 (1.85%)', ' Dyspnoea 1/54 (1.85%)']}
|
23040754-d1ad-4660-aacf-3298aefa5dae
|
Single
|
Adverse Events
|
NCT01033032
|
The only adverse event recorded in the primary trial was one single case of pleural effusion.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT01033032', 'Intervention': ['INTERVENTION 1: ', ' Amrubicin', ' Systemic therapy with amrubicin'], 'Eligibility': ['Inclusion Criteria:', ' Females >=18 years of age.', ' Histologic diagnosis of HER2-negative breast cancer. HER-2 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)', ' Evidence of metastatic or locally advanced, inoperable breast cancer.', ' Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens.', ' Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was 6 months prior to study entry.', ' Measurable disease per RECIST criteria version 1.1', ' Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).', ' Patients must have QTc interval of <=450 msec.', ' No intercurrent significant medical conditions or cardiac illness.', ' Patients must be >=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.', ' Adequate organ function including the following:', ' ANC >=1500 cells/mL', ' Platelet count >=100,000 cells/mL', ' Hemoglobin >=9 g/dL', ' Total bilirubin <=1.5 x ULN; AST/ALT <=2.5 x ULN, (except if due to hepatic metastases, then <=5 x ULN)', ' Serum creatinine <1.5 x ULN', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed <=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.', ' Patients must be accessible for treatment and follow-up.', ' Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.', " Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable. Additionally, the patient's INR must be adequate if the patient is receiving treatment with coumadin.", " Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient's enrollment in this study.", 'Exclusion Criteria:', ' Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy.', " Prior treatment with >=3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study).", ' Major surgery or systemic therapy <=3 weeks of study treatment.', ' Prior high-dose chemotherapy requiring hematopoietic stem cell support.', ' Prior radiation therapy to >25% of the bone marrow.', ' Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at >=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.', ' Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.', ' Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]).', ' Any of the following <=12 months prior to starting study treatment:', ' myocardial infarction;', ' severe unstable angina;', ' congestive heart failure;', ' ongoing cardiac dysrhythmia.', ' Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.', ' Patients with previous allergy or hypersensitivity to anthracyclines.', ' Patients who have had a 10% drop in LVEF on previous anthracycline therapy.', ' Palliative radiotherapy to areas of metastatic breast cancer must have been completed >7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).', ' Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.', ' History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) of MTD/Phase II Patients', ' Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.', ' Time frame: every 6 weeks until progressive disease', 'Results 1: ', ' Arm/Group Title: Amrubicin', ' Arm/Group Description: Systemic therapy with amrubicin', ' Overall Number of Participants Analyzed: 66', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.0 (2.5 to 5.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' FEBRILE NEUTROPENIA 0/3 (0.00%)', ' LYMPH NODE PAIN 0/3 (0.00%)', ' NEUTROPHIL COUNT DECREASED 0/3 (0.00%)', ' THROMBOCYTOPENIA 0/3 (0.00%)', ' CHEST PAIN 0/3 (0.00%)', ' DEHYDRATION 0/3 (0.00%)', ' PLEURAL EFFUSION 1/3 (33.33%)', ' PNEUMONITIS 0/3 (0.00%)', ' PULMONARY INFILTERATES 0/3 (0.00%)', ' ALOPECIA 0/3 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e3be834c-c311-4132-8529-d354b9e620b9
|
|
Single
|
Eligibility
|
NCT01326481
|
Patients with Myocardial Infarction,percutaneous transluminal coronary angioplasty or Deep vein thrombosis within the last 2 - 6 months are eligible for the primary trial.
|
Contradiction
|
[
10,
18
] |
[] |
{'Clinical Trial ID': 'NCT01326481', 'Intervention': ['INTERVENTION 1: ', ' Carotuximab (TRC105) Plus Capecitabine', ' All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)', ' Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)', ' Measurable disease by RECIST 1.1 criteria (Part 2 only)', ' Willing and able to consent for self to participate in study', ' Progressive or recurrent disease after prior systemic chemotherapy regimen', ' Age 18 years', ' ECOG performance status of 0 or 1', ' Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade 1 or baseline (except alopecia)', ' Adequate organ function', 'Exclusion Criteria:', ' Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.', ' Prior treatment with TRC105', ' History of hypersensitivity reaction to antimetabolite therapy', ' Receipt of an investigational agent within 28 days of starting study treatment', ' Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment', ' Minor surgical procedures within 14 days prior to first dose of TRC105', ' History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease', ' Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months', ' Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy', ' Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia', ' Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105', ' Cardiac dysrhythmias of NCI CTCAE Grade 2 within the last month', ' Hemorrhage within 28 days of starting study treatment', ' Unhealed wounds within 28 days of starting study treatment', ' History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment', ' Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness', ' Known active viral or nonviral hepatitis', ' History of hypersensitivity reaction to human or mouse antibody products', ' Lung cancer with central chest lesions', ' Pregnancy or breastfeeding'], 'Results': ['Outcome Measurement: ', ' Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine', ' Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.', ' Time frame: 1.5 years', 'Results 1: ', ' Arm/Group Title: Carotuximab (TRC105) Plus Capecitabine', ' Arm/Group Description: All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Patients with DLT at 7.5 mg/kg: 0 0.0%', ' Patients without DLT at 7.5 mg/kg: 3 50.0%', ' Patients with DLT at 10 mg/kg: 0 0.0%', ' Patients without DLT at 10 mg/kg: 3 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/19 (31.58%)', ' Febrile neutropenia [1]1/19 (5.26%)', ' Fatigue [1]1/19 (5.26%)', ' Pyrexia [1]1/19 (5.26%)', ' Fracture [1]1/19 (5.26%)', ' Hip Fracture [1]1/19 (5.26%)', ' Headache [2]1/19 (5.26%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
8115b5e3-e178-433b-b114-09d97daaa8d7
|
|
Comparison
|
Adverse Events
|
NCT00333775
|
NCT00201864
|
There are several cardiac adverse events recorded in the primary trial, but not a single one in the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] |
[
0,
1,
2,
3,
4,
5,
6
] |
{'Clinical Trial ID': 'NCT00333775', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel 100 mg/m^2 Plus Placebo', ' Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.', 'INTERVENTION 2: ', ' Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg', ' Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.'], 'Eligibility': ['Inclusion criteria:', ' Female patients 18 years of age.', ' Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy.', ' No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.', 'Exclusion criteria:', ' Previous chemotherapy for metastatic or locally recurrent breast cancer.', ' Radiotherapy for treatment of metastatic disease.', ' Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix.', ' Spinal cord compression or brain metastases.', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization.', ' Inadequate bone marrow, liver, or renal function.', ' Uncontrolled hypertension.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).', ' Time frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)', 'Results 1: ', ' Arm/Group Title: Docetaxel 100 mg/m^2 Plus Placebo', ' Arm/Group Description: Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 241', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 8.0 (7.2 to 8.3)', 'Results 2: ', ' Arm/Group Title: Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg', ' Arm/Group Description: Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 248', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 8.7 (8.2 to 9.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 82/217 (37.79%)', ' Febrile neutropenia 21/217 (9.68%)', ' Neutropenia 4/217 (1.84%)', ' Leukopenia 0/217 (0.00%)', ' Anaemia 1/217 (0.46%)', ' Thrombocytopenia 0/217 (0.00%)', ' Atrial fibrillation 0/217 (0.00%)', ' Arrhythmia 1/217 (0.46%)', ' Arteriospasm coronary 0/217 (0.00%)', ' Atrioventricular block first degree 0/217 (0.00%)', ' Cardiac failure 0/217 (0.00%)', 'Adverse Events 2:', ' Total: 106/252 (42.06%)', ' Febrile neutropenia 29/252 (11.51%)', ' Neutropenia 13/252 (5.16%)', ' Leukopenia 3/252 (1.19%)', ' Anaemia 0/252 (0.00%)', ' Thrombocytopenia 1/252 (0.40%)', ' Atrial fibrillation 1/252 (0.40%)', ' Arrhythmia 0/252 (0.00%)', ' Arteriospasm coronary 1/252 (0.40%)', ' Atrioventricular block first degree 1/252 (0.40%)', ' Cardiac failure 1/252 (0.40%)']}
|
{'Clinical Trial ID': 'NCT00201864', 'Intervention': ['INTERVENTION 1: ', ' Exemestane and Fulvestrant', ' Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Proven breast cancer', ' Metastatic or locally advanced breast cancer', ' Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)', ' Postmenopausal status', ' No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed', ' ECOG (Eastern Cooperative Oncology Group) performance status 0-2', ' Adequate organ function', 'Exclusion Criteria:', ' No prior Exemestane or Fulvestrant', ' Uncontrolled intercurrent illness including but not limited to:', ' ongoing or active infection', ' symptomatic congestive heart failure', ' unstable angina pectoris', ' cardiac arrhythmia', ' myocardial infarction within the last 3 months', ' psychiatric illness/social situations that would limit compliance with study', ' Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.', ' Presence of bleeding diathesis or coagulopathy, patients requiring coumadin'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.', ' TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: Every 2 cycles up to 2 years', 'Results 1: ', ' Arm/Group Title: Exemestane and Fulvestrant', ' Arm/Group Description: Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.9 (3.9 to 13.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/40 (15.00%)', ' Nausea 1/40 (2.50%)', ' Vomiting 1/40 (2.50%)', ' Chest pain 1/40 (2.50%)', ' Hypercalcemia 1/40 (2.50%)', ' Thromboembolism 2/40 (5.00%)']}
|
bbcfc019-2d60-413f-88f9-04cacec55e30
|
Single
|
Eligibility
|
NCT00232479
|
Patients with HER2 positive breast or colon carcinoma are eligible for the primary trial.
|
Contradiction
|
[
0,
1
] |
[] |
{'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%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e7899445-9b80-4429-b4c3-d47bd36a2347
|
|
Single
|
Eligibility
|
NCT00754845
|
Patients who received over 5 years of anastrozole therapy, completed 2 years prior, are eligible for the primary trial.
|
Entailment
|
[
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00754845', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' letrozole: Given orally', 'INTERVENTION 2: ', ' Placebo', ' Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' placebo: Given orally'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Previously diagnosed with primary breast cancer', ' Must have received 4½ - 6 years of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane), either as initial therapy or after prior tamoxifen citrate, including treatment received as part of clinical trial CAN-NCIC-MA17', ' Completed aromatase inhibitor therapy 2 years ago', ' No metastatic or recurrent disease, contralateral breast cancer, or ductal carcinoma in situ in either breast, as determined by the following:', ' Clinical examination of the breast area, axillae, and neck within the past 60 days', ' Mammogram within the past 12 months*', ' Chest x-ray within the past 60 days', ' Bone scan, if alkaline phosphatase > 2 times normal and/or there are symptoms of metastatic disease AND confirmatory x-ray, if bone scan results are questionable, within the past 60 days', ' Abdominal ultrasound, liver scan, or CT scan of the abdomen within the past 60 days, if ALT, AST, or alkaline phosphatase > 2 times normal NOTE: *A baseline mammogram is not required for patients who have undergone bilateral complete mastectomy', ' Hormone-receptor status:', ' Estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) primary tumor at the time of diagnosis, defined as a tumor receptor content of > 10 fmol/mg protein or receptor positive by immunocytochemical assay (for patients not previously enrolled on clinical trial CAN-NCIC-MA17)', ' ER+ and/or PR+ primary tumor OR hormone receptor status of primary tumor unknown (for patients previously enrolled on clinical trial CAN-NCIC-MA17)', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Life expectancy 5 years', ' WBC > 3.0 x 10^9/L OR granulocyte count (polymorphs + bands) 1.5 times 10^9/L', ' Platelet count > 100 x 10^9/L', ' AST and/or ALT < 2 times upper limit of normal (ULN)*', ' Alkaline phosphatase < 2 times ULN*', ' Able (i.e. sufficiently fluent) and willing to complete quality-of-life questionnaires in either English or French (NCIC CTG participating centers)', ' Inability to complete questionnaires due to illiteracy in English or French, loss of sight, or other equivalent reason allowed', ' Accessible for treatment and follow-up', ' No other prior or concurrent malignancy except adequately treated, superficial squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or other cancer treated > 5 years ago that is presumed cured NOTE: *Elevated levels allowed provided imaging examinations have ruled out metastatic disease', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No concurrent selective estrogen receptor modulator (e.g., raloxifene, idoxifene)', ' No other concurrent anticancer therapy'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS)', ' It is defined as the months from the day of randomization to the earliest date when a recurrence of the primary disease (recurrence in the breast, chest wall and nodal sites or the development of metastatic disease) or a contralateral breast cancer was observed. Subjects who died without recurrence of the primary disease or the development of the contralateral breast cancer were censored at their death date. If a patient has not recurred, developed a contralateral breast cancer, or died, disease-free survival was censored on the date of the last day the patient was known to be alive. Probability of disease free survival at 5 years is estimated and reported.', ' Time frame: Unitil the end of study with a median follow up of 75 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' letrozole: Given orally', ' Overall Number of Participants Analyzed: 959', ' Measure Type: Number', ' Unit of Measure: probability of DFS at 5 years 0.95 (0.93 to 0.96)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.', ' placebo: Given orally', ' Overall Number of Participants Analyzed: 959', ' Measure Type: Number', ' Unit of Measure: probability of DFS at 5 years 0.91 (0.89 to 0.93)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/959 (1.56%)', ' CNS hemorrhage/bleeding 20/959 (0.00%)', ' Melena/GI bleeding 21/959 (0.10%)', ' Rectal bleeding/ hematochezia 21/959 (0.10%)', ' Cardiac troponin I (cTnI) 0/959 (0.00%)', ' Thrombosis/embolism 20/959 (0.00%)', ' Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia) 21/959 (0.10%)', ' Edema 21/959 (0.10%)', ' Cardiac left ventricular function 21/959 (0.10%)', 'Adverse Events 2:', ' Total: 19/954 (1.99%)', ' CNS hemorrhage/bleeding 21/954 (0.10%)', ' Melena/GI bleeding 20/954 (0.00%)', ' Rectal bleeding/ hematochezia 20/954 (0.00%)', ' Cardiac troponin I (cTnI) 1/954 (0.10%)', ' Thrombosis/embolism 21/954 (0.10%)', ' Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia) 21/954 (0.10%)', ' Edema 20/954 (0.00%)', ' Cardiac left ventricular function 21/954 (0.10%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2a50cc2a-281b-4bc6-9f18-6bd9686c682d
|
|
Single
|
Results
|
NCT01151046
|
The placebo group in the primary trial had a much lower Median PFS than the MM-121 cohort.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01151046', 'Intervention': ['INTERVENTION 1: ', ' MM-121 + Exemestane', ' MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day', 'INTERVENTION 2: ', ' Placebo + Exemestane', ' Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day'], 'Eligibility': ['Inclusion Criteria:', ' Locally advanced or metastatic breast cancer', ' Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer', ' 18 years of age', 'Exclusion Criteria:', ' Received prior treatment with exemestane', ' Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)', ' Symptomatic CNS disease'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).', ' Time frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks', 'Results 1: ', ' Arm/Group Title: MM-121 + Exemestane', ' Arm/Group Description: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day', ' Overall Number of Participants Analyzed: 56', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 15.9 (9.3 to 30.3)', 'Results 2: ', ' Arm/Group Title: Placebo + Exemestane', ' Arm/Group Description: Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day', ' Overall Number of Participants Analyzed: 59', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 10.7 (8.1 to 16.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/56 (12.50%)', ' Febrile Neutropenia * 1/56 (1.79%)', ' Cardiovascular insufficiency * 1/56 (1.79%)', ' Tacchycardia * 0/56 (0.00%)', ' Abdominal Pain (Upper) * 0/56 (0.00%)', ' Gastritis * 0/56 (0.00%)', ' Nausea * 2/56 (3.57%)', ' Vomiting * 1/56 (1.79%)', ' Chest Pain * 1/56 (1.79%)', ' Disease Progression * 1/56 (1.79%)', ' Pneumonia * 0/56 (0.00%)', ' Hepatic Failure * 2/56 (3.57%)', 'Adverse Events 2:', ' Total: 11/59 (18.64%)', ' Febrile Neutropenia * 0/59 (0.00%)', ' Cardiovascular insufficiency * 0/59 (0.00%)', ' Tacchycardia * 1/59 (1.69%)', ' Abdominal Pain (Upper) * 1/59 (1.69%)', ' Gastritis * 1/59 (1.69%)', ' Nausea * 0/59 (0.00%)', ' Vomiting * 0/59 (0.00%)', ' Chest Pain * 0/59 (0.00%)', ' Disease Progression * 1/59 (1.69%)', ' Pneumonia * 1/59 (1.69%)', ' Hepatic Failure * 0/59 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
26419cec-e256-46a7-9026-94dbe026c63d
|
|
Comparison
|
Results
|
NCT02336737
|
NCT01432886
|
the secondary trial is testing for the DLT of its interventions, whereas the primary trial is evaluating the dose limiting toxicity for SentiMag and SiennaXP.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1
] |
{'Clinical Trial ID': 'NCT02336737', 'Intervention': ['INTERVENTION 1: ', ' SiennaXP Injection', ' Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.', ' Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.', ' SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe', ' Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)', 'Isosulfan blue dye: Injection of a single dose of isosulfan blue dye'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).', ' Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.', ' Subjects aged 18 years or more at the time of consent.', ' Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2.', ' Subject has a clinical negative node status (i.e. T0-3, N0, M0).', 'Exclusion Criteria:', ' The subject is pregnant or lactating.', ' The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.', ' The subject has a known hypersensitivity to Isosulfan Blue Dye.', ' The subject has participated in another investigational drug study within 30 days of scheduled surgery.', " Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.", ' Subject has had preoperative radiation therapy to the affected breast or axilla.', ' Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.', ' Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP.', ' Subject has an iron overload disease.', ' Subject has pacemaker or other implantable device in the chest wall.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Detected Lymph Nodes', ' The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye', ' Time frame: During surgical procedure <1 hour', 'Results 1: ', ' Arm/Group Title: SiennaXP Injection', ' Arm/Group Description: Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.', ' Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.', ' SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe', ' Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)', 'Isosulfan blue dye: Injection of a single dose of isosulfan blue dye', ' Overall Number of Participants Analyzed: 146', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 145 99.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/147 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01432886', 'Intervention': ['INTERVENTION 1: ', ' E7389 With Weekly Trastuzumab', ' Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.', 'INTERVENTION 2: ', ' E7389 With Tri-weekly Trastuzumab', ' Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.'], 'Eligibility': ['Inclusion Criteria', ' Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.', ' Histologically or cytologically confirmed with breast cancer', ' Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method', ' Subjects who meet any of the following criteria:', ' Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane', ' Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane', ' Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer', ' Adequate organ function', ' Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1', ' Subjects who have submitted written informed consent for study entry', ' Exclusion Criteria', ' Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment', ' Subjects with severe active infection requiring active treatment', ' Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.', ' Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives', ' Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.', ' Subjects who are pregnant (positive B-hCG test) or breastfeeding', ' Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT)', ' For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.', ' Time frame: Up to 3 weeks', 'Results 1: ', ' Arm/Group Title: E7389 With Weekly Trastuzumab', ' Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: E7389 With Tri-weekly Trastuzumab', ' Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)']}
|
8ef93fe0-0a12-4a7e-93aa-c40af7154a57
|
Single
|
Results
|
NCT00171340
|
the primary trial results imply that Zoledronic Acid 4 mg Upfront causes a +ve Change in Bone Mineral Density, whereas Zoledronic Acid 4 mg Delayed causes a smaller, but still positive change in Bone Mineral Density (within a certain patient demographic).
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00171340', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid 4 mg Upfront', ' Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', 'INTERVENTION 2: ', ' Zoledronic Acid 4 mg Delayed', ' Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.'], 'Eligibility': ['Inclusion Criteria:', ' Stage I-IIIa breast cancer', ' Postmenopausal or recently postmenopausal', ' Recent surgery for breast cancer', ' Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status', ' No prior treatment with letrozole', ' Other protocol-defined inclusion criteria may apply.', 'Exclusion Criteria:', ' Metastatic disease', ' Invasive bilateral disease', ' Clinical or radiological evidence of existing fracture in spine or hip', ' Prior treatment with IV bisphosphonates in the past 12 months', ' Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)', ' Use of Tibolone within 6 months', ' Prior use of parathyroid hormone for more than 1 week', ' Previous or concomitant malignancy', ' Abnormal renal function', ' History of disease effecting bone metabolism', ' Other protocol-defined exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.', ' Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).', ' Time frame: Baseline, 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid 4 mg Upfront', ' Arm/Group Description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 423', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage change in BMD 2.208 (3.4194)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid 4 mg Delayed', ' Arm/Group Description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.', ' Overall Number of Participants Analyzed: 418', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage change in BMD -3.617 (4.2151)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 133/525 (25.33%)', ' Anaemia 1/525 (0.19%)', ' Febrile neutropenia 1/525 (0.19%)', ' Acute myocardial infarction 2/525 (0.38%)', ' Angina pectoris 3/525 (0.57%)', ' Angina unstable 1/525 (0.19%)', ' Aortic valve incompetence 1/525 (0.19%)', ' Arrhythmia 0/525 (0.00%)', ' Atrial fibrillation 1/525 (0.19%)', ' Atrioventricular block complete 0/525 (0.00%)', ' Cardiac arrest 0/525 (0.00%)', 'Adverse Events 2:', ' Total: 124/535 (23.18%)', ' Anaemia 1/535 (0.19%)', ' Febrile neutropenia 0/535 (0.00%)', ' Acute myocardial infarction 0/535 (0.00%)', ' Angina pectoris 2/535 (0.37%)', ' Angina unstable 0/535 (0.00%)', ' Aortic valve incompetence 1/535 (0.19%)', ' Arrhythmia 1/535 (0.19%)', ' Atrial fibrillation 4/535 (0.75%)', ' Atrioventricular block complete 1/535 (0.19%)', ' Cardiac arrest 2/535 (0.37%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f5d50d87-b419-4537-87ec-7c9d23b765db
|
|
Single
|
Intervention
|
NCT01797120
|
Cohort 2 of the primary trial is only receiving placebo tablets, and no other medications.
|
Entailment
|
[
7,
8,
9,
3,
4,
12
] |
[] |
{'Clinical Trial ID': 'NCT01797120', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant & Everolimus', ' Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Fulvestrant & Placebo', ' Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent.', ' 18 years.', ' ECOG Performance Status 0 or 1.', ' Histologically or cytologically confirmed adenocarcinoma of the breast.', ' Stage IV disease or inoperable locally advanced disease.', ' ER and/or PR-positive disease. Tumors must be HER-2/neu negative or equivocal.', ' Aromatase Inhibitor (AI) resistant, defined as:', ' relapsed while receiving adjuvant therapy with an AI or,', ' progressive disease while receiving an AI for metastatic disease', ' Received one prior cycle of fulvestrant within 28 days of randomization are eligible.', ' 2 prior doses of fulvestrant are not eligible', ' Must be female and postmenopausal.', ' May have received 1 prior systemic chemotherapy regimen for metastatic disease.', ' Adequate organ function:', ' Whole Blood Cells (WBC) 3.0 x 10⁹/L, Absolute neutrophil count (ANC) 1.5 x 10⁹/L and platelet count 100 x 10⁹/L', ' hemoglobin 9 g/dL', ' serum bilirubin 1.5 X ULN (Upper Limit of Normal)', ' Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) 2.5 X ULN ( 5 x ULN in patients with liver metastases)', ' serum creatinine 1.5 X ULN', ' serum albumin 3 g/dL', ' fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN.', ' Prothrombin time (PT) with international normalized ratio (INR) 1.5', ' May have measurable disease, non-measurable disease, or both.', ' Basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix within the past five years treated with curative intent. History of prior malignancy are eligible if disease-free for >3 years.', 'Exclusion Criteria:', ' Major surgery or significant traumatic injury within 4 weeks of randomization or patients that may require major surgery during the course of the study.', ' Investigational agents within 4 weeks of randomization.', ' Anticancer treatment within 4 weeks of randomization, with the following exceptions:', ' Bisphosphonates or Zometa for bone metastases', ' a GnRH analog is permitted if the patient had progressive disease on a GnRH (Gonadotropin-Releasing Hormone) analog plus a SERM (Selective Estrogen Receptor Modulators) or an AI; the GnRH analog may continue but the SERM or AI must be discontinued.', ' Prior treatment with an mTOR inhibitor.', ' Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent 5 mg prednisone or equivalent daily.', ' Receive immunization with attenuated live vaccines within one week of randomization or during the study period.', ' Current or a prior history of brain metastases or leptomeningeal disease. Must not have rapidly progressive, life-threatening metastases.', ' Known hypersensitivity/history of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or fulvestrant.', ' Congenital or acquired immune deficiency at increased risk of infection.', ' Impairment of gastrointestinal function/disease that may significantly alter the absorption of everolimus.', ' Active, bleeding diathesis.', " History of any condition or uncontrolled intercurrent illness that in the opinion of the local investigator might interfere with or limit the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient.", ' Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:', ' Symptomatic congestive heart failure of New York Heart Association Class III or IV', ' Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease', ' History of symptomatic pulmonary disease or non-malignant pulmonary disease requiring treatment.', ' Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN', ' Active (acute or chronic) or uncontrolled severe infections', ' Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).', ' Note: Detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival documented by Physical Exam, CT Scan or MRI in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone from randomization to documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Every 3 months until progression or up to 3 years', 'Results 1: ', ' Arm/Group Title: Fulvestrant & Everolimus', ' Arm/Group Description: Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 66', ' Median (95% Confidence Interval)', ' Unit of Measure: months 10.3 (7.6 to 13.8)', 'Results 2: ', ' Arm/Group Title: Fulvestrant & Placebo', ' Arm/Group Description: Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.', ' Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).', ' If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.', ' Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.', ' Overall Number of Participants Analyzed: 65', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.1 (3.0 to 8.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/64 (48.44%)', ' Anemia 2/64 (3.13%)', ' Lymphocytopenia 2/64 (3.13%)', ' Hypertension 2/64 (3.13%)', ' Neutropenia 2/64 (3.13%)', ' Thrombocytopenia 1/64 (1.56%)', ' Thromboembolic Event 1/64 (1.56%)', ' Oral mucositis 7/64 (10.94%)', ' Diarrhea 2/64 (3.13%)', ' Fatigue 4/64 (6.25%)', ' Elevated AST 2/64 (3.13%)', ' Elevated ALT 1/64 (1.56%)', ' Esophageal Candidiasis 1/64 (1.56%)', 'Adverse Events 2:', ' Total: 5/65 (7.69%)', ' Anemia 1/65 (1.54%)', ' Lymphocytopenia 0/65 (0.00%)', ' Hypertension 0/65 (0.00%)', ' Neutropenia 0/65 (0.00%)', ' Thrombocytopenia 0/65 (0.00%)', ' Thromboembolic Event 0/65 (0.00%)', ' Oral mucositis 0/65 (0.00%)', ' Diarrhea 1/65 (1.54%)', ' Fatigue 3/65 (4.62%)', ' Elevated AST 1/65 (1.54%)', ' Elevated ALT 0/65 (0.00%)', ' Esophageal Candidiasis 0/65 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f52ab54b-7a78-4449-9dfe-5fc67323e5c2
|
|
Single
|
Adverse Events
|
NCT00426556
|
There were more than 3 cases of Febrile neutropenia, Leukopenia and Neutropenia across all cohorts in the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
14,
15,
16,
17,
18
] |
[] |
{'Clinical Trial ID': 'NCT00426556', 'Intervention': ['INTERVENTION 1: ', ' Phase I - RAD001 5mg + PT, Daily', ' Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', 'INTERVENTION 2: ', ' Phase I - RAD001 10mg + PT, Daily', ' Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patients 18 years old with WHO performance status 1', ' HER-2 over-expressing metastatic breast cancer cells confirmed by histology', ' Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)', ' Patient resistance to trastuzumab and taxanes (Phase ll)', ' Measurable disease according to RECIST (Phase ll)', ' Patients neurologically stable with adequate bone marrow, liver and renal function', 'Exclusion Criteria:', ' Patients receiving endocrine therapy for breast cancer 2 weeks prior to study treatment start', ' Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these 4 weeks prior to study treatment start or patients who have received lapatinib 2 weeks prior to study treatment start', ' Patients who have previously received mTOR inhibitors', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Phase II: Overall Response Rate', ' The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.', ' Time frame: every 8 - 9 weeks until disease progression or a new lesion is identified', 'Results 1: ', ' Arm/Group Title: Phase I - RAD001 5mg + PT, Daily', ' Arm/Group Description: Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants ', 'Results 2: ', ' Arm/Group Title: Phase I - RAD001 10mg + PT, Daily', ' Arm/Group Description: Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/6 (50.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Leukopenia 0/6 (0.00%)', ' Neutropenia 0/6 (0.00%)', ' Thrombocytopenia 0/6 (0.00%)', ' Cardio-respiratory arrest 0/6 (0.00%)', ' Cardiopulmonary failure 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Visual impairment 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Dysphagia 0/6 (0.00%)', ' Gastric ulcer 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 6/17 (35.29%)', ' Febrile neutropenia 0/17 (0.00%)', ' Leukopenia 0/17 (0.00%)', ' Neutropenia 0/17 (0.00%)', ' Thrombocytopenia 0/17 (0.00%)', ' Cardio-respiratory arrest 1/17 (5.88%)', ' Cardiopulmonary failure 0/17 (0.00%)', ' Vertigo 0/17 (0.00%)', ' Visual impairment 0/17 (0.00%)', ' Abdominal pain 0/17 (0.00%)', ' Diarrhoea 1/17 (5.88%)', ' Dysphagia 0/17 (0.00%)', ' Gastric ulcer 1/17 (5.88%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
c0277198-6eef-4cf3-9527-dea5d01a4000
|
|
Single
|
Eligibility
|
NCT01582971
|
In order to participate in the primary trial, participants must have 20/20 vision and a hiistologically confirmed, measurable, invasive breast carcinoma.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14
] |
[] |
{'Clinical Trial ID': 'NCT01582971', 'Intervention': ['INTERVENTION 1: ', ' Week 5 Intervention Group', ' Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.', ' Friend/family member was trained in foot reflexology protocol by certified reflexologist.', ' Friend/family member provides 4 weekly sessions to patient.', 'INTERVENTION 2: ', ' Week 5 Control Group', ' Standard medical care: no reflexology'], 'Eligibility': ['Inclusion Criteria:', ' Age 21', ' Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence', ' Able to perform basic ADLs', ' Undergoing chemotherapy and/or hormonal therapy for breast cancer', ' Able to speak and understand English', ' Have access to a telephone', ' Able to hear normal conversation', ' Cognitively oriented to time, place, and person (determined via nurse recruiter)', 'Exclusion Criteria:', ' Diagnosis of major mental illness on the medical record and verified by the recruiter', ' Residing in a nursing home', ' Bedridden', ' Currently receiving regular reflexology', ' Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval'], 'Results': ['Outcome Measurement: ', ' The M.D. Anderson Symptom Inventory (MDASI)', ' The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived.', ' Higher symptom severity and interference scores represent worse outcome.', ' Time frame: Week 5 and week 11', 'Results 1: ', ' Arm/Group Title: Week 5 Intervention Group', ' Arm/Group Description: Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.', ' Friend/family member was trained in foot reflexology protocol by certified reflexologist.', ' Friend/family member provides 4 weekly sessions to patient.', ' Overall Number of Participants Analyzed: 89', ' Least Squares Mean (Standard Error)', ' Unit of Measure: units on a scale MDASI summed symptom severity: 23.55 (1.52)', ' MDASI summed symptom interference: 11.19 (1.16)', 'Results 2: ', ' Arm/Group Title: Week 5 Control Group', ' Arm/Group Description: Standard medical care: no reflexology', ' Overall Number of Participants Analyzed: 91', ' Least Squares Mean (Standard Error)', ' Unit of Measure: units on a scale MDASI summed symptom severity: 29.69 (1.48)', ' MDASI summed symptom interference: 16.04 (1.12)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/128 (0.00%)', 'Adverse Events 2:', ' Total: 0/128 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
fea87f74-c8ef-4efd-944a-053f5e5a752f
|
|
Single
|
Adverse Events
|
NCT00394251
|
There were more cases of Cardiac failure than Pericardial effusion recorded in cohort 1.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00394251', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 Subset', ' 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.', 'INTERVENTION 2: ', ' AC --> ABI-007', ' Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).'], 'Eligibility': ['Inclusion Criteria:', ' A patient was eligible for inclusion in this study only if all of the following criteria were met:', ' Female, age greater than or equal to 18 to less than or equal to 70 years old.', ' Estrogen receptor (ER) and progesterone receptor (PR) status have been determined.', ' Operable, histologically confirmed adenocarcinoma of the breast', ' Must have met 1 of the following criteria:', ' T1-3, N1-3, M0, regardless of ER or PR status.', ' T > 2 cm, N0, M0 (T2-3N0M0), regardless of ER or PR status.', ' T > 1 cm, N0, M0 (T1cN0M0) and both ER and PR negative', ' T > 1 cm, N0, M0, ER or PR positive and grade 3', ' Patients with one sentinel lymph node metastasis 0.2-2 mm in size were not required to undergo completion axillary dissection unless only 1 sentinel lymph node was examined. This completion axillary dissection was optional if 1 out of 2 or more sentinel lymph nodes was positive for a micrometastasis. Therefore if 1 of 1 sentinel lymph node was positive for micrometastasis(0.2-2 mm), then a completion axillary dissection was required.', ' Patients with more than one sentinel node micrometastasis or 1 node with a micrometastasis > 2 mm and/or T3 disease must have undergone completion, standard axillary dissection. -Note: the following were not eligible-', " T1b,c,N0M0 and ER or PR positive and grade 1 or 2 Tx tumors (regardless of nodal status) T4 disease [i.e., patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes", ' Note: Sentinel lymph node micrometastasis < 0.2 mm in considered N0 disease', ' Negative surgical margins on lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on ductal carcinoma in situ [DCIS]).', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Normal electrocardiogram (ECG, as assessed by the investigator).', ' No pre-existing peripheral neuropathy.', ' It had not been longer than 84 days since the date of definitive surgery (eg, mastectomy or in the case of a breast-sparing procedure, axillary dissection).', ' Laboratory values were to be as follows:', ' White blood cell count: > or equal to 3,000/mm^3', ' Absolute neutrophil count:> or equal to 1,500/mm^3', ' Platelets:> or equal to 100,000/mm^3', ' Hemoglobin: > or equal to 8g/dL', " Bilirubin:< or equal to the institution's ULN", ' Creatinine: < or equal to 1.7 mg/dL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase could be up to 2.5 times the institutional ULN.', " All staging studies including physical exam, chest x-ray, and bone scan had to show no evidence of metastatic disease, including suspicious lymphadenopathy or skin nodules on physical exam. A chest x-ray and bone scan were mandatory; however, all other staging studies were at the treating physician's discretion. Any other staging test (eg, Computed Tomography [CT] scans, magnetic resonance imaging [MRI] studies, ultrasound of abdomen, Positron Emission Tomography [PET] scans must have been negative for metastatic disease. An abdominal CT scan or PET scan was mandatory for patients with liver function tests elevated above the upper limit of normal (ULN) to rule out metastatic disease. If the patient had a staging PET scan then a bone scan was not necessary, but a chest x-ray was required.", ' Patient had a negative serum pregnancy test < or equal to 14 days of the first dose of study drug (patients of childbearing potential).', ' If fertile, patient had agreed to us an acceptable method of birth control to avoid pregnancy [Note: oral contraceptives were not allowed] for the duration of chemotherapy and hormonal therapy and for 6 months thereafter.', ' If obese, a patient must have been treated with doses calculated using his/her actual body surface area (BSA) (the physician must have been comfortable treating at the full BSA dose regardless of BSA).', ' Patient had signed a Patient Informed Consent Form.', 'Exclusion Criteria:', ' A patient was not eligible for inclusion in this study if any of the following criteria applied:', ' Patients with HER-2 positive breast cancer (IHC 3+ or FISH +) who were eligible for adjuvant Herceptin therapy.', ' Stage IV breast cancer (M1 disease on TNM staging system).', ' Prior anthracycline, anthracenedione (mitoxantrone), or taxane therapy', ' Neoadjuvant therapy for this breast cancer.', ' Previous invasive cancers if treated < 5 years prior to entering this study, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; the latter were not required to have occurred more than 5 years prior to study entry.', ' Prior invasive breast cancer if diagnosed < 5 years prior to entering study. Patients must have finished adjuvant hormonal therapy prior to registration. Patients with prior DCIS are eligible. Patients with DCIS who were treated with tamoxifen must have finished tamoxifen prior to registration.', ' Serious medical illness, other than that treated by this study, which would limit survival to < 4 years, or psychiatric condition that would prevent informed consent and compliance with study treatment.', ' Uncontrolled or severe cardiovascular disease including recent (< or equal to 12 months) myocardial infarction or unstable angina.', ' Active uncontrolled bacterial, viral (including clinically defined Acquired Immune Deficiency Syndrome [AIDS]), or fungal infection.', ' Patients with active or chronic hepatitis with abnormal liver function tests (LFTs) or patients who were known to be HIV positive.', ' Uncontrolled disease such as uncontrolled diabetes.', ' Any prior history of hypertensive crisis or hypertensive encephalopathy.', ' Any known central nervous system (CNS) disease.', ' Known hypersensitivity to any component of bevacizumab.', ' No history of cerebrovascular accident or transient ischemic attack at any time.', ' Active symptomatic vascular disease, e.g., aortic aneurysm or aortic dissection, and no peripheral vascular disease, e.g., claudication, within six months of study entry.', ' No major surgical procedure, open biopsy, or significant traumatic injury within 28 days and no core biopsy or minor surgical procedure (excluding placement of a vascular access device) within seven days of study entry. No anticipated need for major surgical procedure during the course of study.', ' No history of abdominal fistula, gastrointestinal perforation, or intra- abdominal process within six months of study entry.', ' No serious non-healing wound, ulcer, or bone fracture.', ' No proteinuria at screening as demonstrated by urine protein: urine creatinine (UPC) ratio of > or equal to 1.0 or urine dipstick for proteinuria > or equal to 2+ (patients discovered to have > or equal to 2+ proteinuria on dipstick urinalysis at baseline should have undergone a 24 hour urine collection and must have demonstrated < or equal to 1g of protein in 24 hours to be eligible).', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and /or diastolic blood pressure> 100 mmHg on antihypertensive medications) or New York Heart Association (NYHA) Grade 2 or greater congestive heart failure.', ' History or coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic acetyl salicylic acid (ASA)> or equal to 325 mg. per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH) for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.', ' Left Ventricular Ejection Fraction (LVEF) on cardiac echocardiography (ECHO) < 50% (or institutional lower limit of normal [LLN]) and > or equal to 74%. LVEF of greater than 75% at baseline should have been re- reviewed and/or the test repeated as it could be falsely elevated.', ' Patients who were receiving concurrent immunotherapy.', " A history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of breast cancer recurrence or which could shorten a patient's survival.", ' Patient had had an organ allograft.', ' Patient was pregnant or breastfeeding.', ' Patient was unable to comply with requirements of study.', ' Patient was receiving any other investigational drugs.'], 'Results': ['Outcome Measurement: ', ' Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy', ' Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.', ' Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7).', ' Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7).', ' Time frame: Month 7', 'Results 1: ', ' Arm/Group Title: ABI-007 Subset', ' Arm/Group Description: 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.', ' Overall Number of Participants Analyzed: 74', ' Measure Type: Number', ' Unit of Measure: participants At least 1 AE at 3 Months: 65', ' Neurology: Neuropathy: Sensory: 36', ' Constitutional Symptoms: Fatigue: 16', ' Dermatology/Skin: Hair Loss/Alopecia (Scalp+Body): 2', ' Endocrine: Hot Flashes/Flushes: 12', ' Cardiac General: Hypertension: 4', ' Pain: Arthralgia: 7', ' Hemorrhage/Bleeding: Nasal: 11', ' Pain: Other - Extremity: 4', ' Pain: Myalgia: 10', ' Dermatology/Skin: Nail Changes: 14', ' Constitutional Symptoms: Insomnia: 3', 'Results 2: ', ' Arm/Group Title: AC --> ABI-007', ' Arm/Group Description: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).', ' Overall Number of Participants Analyzed: 74', ' Measure Type: Number', ' Unit of Measure: participants At least 1 AE at 3 Months: 74', ' Neurology: Neuropathy: Sensory: 50', ' Constitutional Symptoms: Fatigue: 46', ' Dermatology/Skin: Hair Loss/Alopecia (Scalp+Body): 33', ' Endocrine: Hot Flashes/Flushes: 28', ' Cardiac General: Hypertension: 18', ' Pain: Arthralgia: 22', ' Hemorrhage/Bleeding: Nasal: 19', ' Pain: Other - Extremity: 15', ' Pain: Myalgia: 20', ' Dermatology/Skin: Nail Changes: 22', ' Constitutional Symptoms: Insomnia: 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/98 (30.61%)', ' Coagulopathy 1/98 (1.02%)', ' Febrile neutropenia 7/98 (7.14%)', ' Pancytopenia 2/98 (2.04%)', ' Cardiac failure 0/98 (0.00%)', ' Cardiac failure congestive 0/98 (0.00%)', ' Pericardial effusion 0/98 (0.00%)', ' Appendicitis perforated 1/98 (1.02%)', ' Colitis 1/98 (1.02%)', ' Ileus 1/98 (1.02%)', ' Abdominal pain upper 1/98 (1.02%)', ' Gastrointestinal haemorrhage 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 21/99 (21.21%)', ' Coagulopathy 0/99 (0.00%)', ' Febrile neutropenia 5/99 (5.05%)', ' Pancytopenia 0/99 (0.00%)', ' Cardiac failure 1/99 (1.01%)', ' Cardiac failure congestive 4/99 (4.04%)', ' Pericardial effusion 1/99 (1.01%)', ' Appendicitis perforated 0/99 (0.00%)', ' Colitis 0/99 (0.00%)', ' Ileus 0/99 (0.00%)', ' Abdominal pain upper 0/99 (0.00%)', ' Gastrointestinal haemorrhage 1/99 (1.01%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
43560d8e-0767-40ce-b2fb-1b8dda231bdf
|
|
Single
|
Adverse Events
|
NCT01998906
|
The same number of cases of Neutropenia, Febrile neutropenia and Pancytopenia are observed in patients from cohort 1 of the primary trial.
|
Contradiction
|
[
0,
2,
3,
4
] |
[] |
{'Clinical Trial ID': 'NCT01998906', 'Intervention': ['INTERVENTION 1: ', ' HER2+ TC', ' Participants with HER2+ breast cancer received treatment as follows:', ' Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.', ' Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.', ' Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.', ' Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.', 'INTERVENTION 2: ', ' HER2+ C', ' Participants with HER2+ breast cancer received treatment as follows:', ' Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.', ' Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.', ' Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age, with locally advanced breast cancer.', 'Exclusion Criteria:', ' previous therapy for any invasive malignancy.'], 'Results': ['Outcome Measurement: ', ' Event-Free Survival (EFS) - Percentage of Participants With an Event', ' EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.', ' Time frame: Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'Results 1: ', ' Arm/Group Title: HER2+ TC', ' Arm/Group Description: Participants with HER2+ breast cancer received treatment as follows:', ' Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.', ' Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.', ' Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.', ' Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.', ' Overall Number of Participants Analyzed: 115', ' Measure Type: Number', ' Unit of Measure: percentage of participants 40.0', 'Results 2: ', ' Arm/Group Title: HER2+ C', ' Arm/Group Description: Participants with HER2+ breast cancer received treatment as follows:', ' Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.', ' Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.', ' Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off.', ' Overall Number of Participants Analyzed: 116', ' Measure Type: Number', ' Unit of Measure: percentage of participants 50.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/115 (15.65%)', ' Febrile neutropenia * 7/115 (6.09%)', ' Neutropenia * 1/115 (0.87%)', ' Pancytopenia * 1/115 (0.87%)', ' Diarrhoea * 0/115 (0.00%)', ' Nausea * 0/115 (0.00%)', ' Stomatitis * 0/115 (0.00%)', ' Vomiting * 1/115 (0.87%)', ' Asthenia * 1/115 (0.87%)', ' Mucosal inflammation * 0/115 (0.00%)', ' Pyrexia * 3/115 (2.61%)', ' Gastrointestinal infection * 1/115 (0.87%)', 'Adverse Events 2:', ' Total: 8/112 (7.14%)', ' Febrile neutropenia * 3/112 (2.68%)', ' Neutropenia * 2/112 (1.79%)', ' Pancytopenia * 0/112 (0.00%)', ' Diarrhoea * 2/112 (1.79%)', ' Nausea * 2/112 (1.79%)', ' Stomatitis * 1/112 (0.89%)', ' Vomiting * 1/112 (0.89%)', ' Asthenia * 0/112 (0.00%)', ' Mucosal inflammation * 1/112 (0.89%)', ' Pyrexia * 0/112 (0.00%)', ' Gastrointestinal infection * 0/112 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
2417fea2-7c8e-4f03-a918-c3cfcbe97425
|
|
Comparison
|
Eligibility
|
NCT01904903
|
NCT01663727
|
Patients must have LVEF < 50% to be eligible for the primary trial.
|
Entailment
|
[
3
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18
] |
{'Clinical Trial ID': 'NCT01904903', 'Intervention': ['INTERVENTION 1: ', ' HER2 Therapies, Cardiac Medications', ' Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses', ' Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:', ' Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.', ' Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.', ' Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.', ' Trastuzumab: HER2 therapy', ' Pertuzumab: HER2 therapy', ' Ado Trastuzumab Emtansine: HER2 therapy'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patient diagnosed with stage I-IV breast cancer', ' HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) 2.0 on breast specimen or biopsy of a metastatic site', ' LVEF < 50% and 40% documented in echocardiogram done within the last 30 days', ' HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy', ' Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation', ' Age 18 years', ' Patient is willing and able to comply with protocol required assessments and procedures', 'Exclusion Criteria:', ' Previous hospitalization due to documented heart failure in the last 12 months', ' Current signs or symptoms of heart failure or ischemia', ' History of arrhythmia requiring pharmacological or electrical treatment', ' Concomitant use of anthracyclines or use of anthracyclines in the last 50 days', ' Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.', ' History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function.', ' Cardiac events are defined as any of the following:', ' Presence of symptoms attributable to heart failure as confirmed by a cardiologist', ' Cardiac arrhythmia requiring pharmacological or electrical treatment', ' Myocardial infarction', ' Sudden cardiac death or death due to myocardial infarct, arrhythmia or heart failure', ' Asymptomatic worsening of cardiac function defined as:', ' - Asymptomatic decline in LVEF > 10% points from baseline and/or EF < 35% corroborated by a confirmatory echocardiogram in 2-4 weeks', ' Planned oncologic therapy is defined as:', ' In the adjuvant setting: completion of 1 year total of HER2 targeted therapy. If a patient already received part of the planned HER2 targeted therapy prior to enrollment in this trial, planned oncologic therapy will be achieved when a total of 1 year is completed.', ' In the metastatic setting: cessation of treating regimen due to progressive disease or non-cardiac toxicity or non-cardiac death.', ' Time frame: Up to 18 months.', 'Results 1: ', ' Arm/Group Title: HER2 Therapies, Cardiac Medications', ' Arm/Group Description: Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses', ' Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:', ' Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.', ' Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.', ' Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.', ' Trastuzumab: HER2 therapy', ' Pertuzumab: HER2 therapy', ' Ado Trastuzumab Emtansine: HER2 therapy', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 27 90.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/30 (10.00%)', ' Cardiac event 3/30 (10.00%)']}
|
{'Clinical Trial ID': 'NCT01663727', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel+Placebo', ' Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', 'INTERVENTION 2: ', ' Paclitaxel+ Bevacizumab', ' Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' ECOG performance status of 0 or 1', ' For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception', ' For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization', 'Exclusion Criteria:', ' Disease-Specific Exclusions:', ' HER2-positive status', ' Prior chemotherapy for locally recurrent or metastatic disease', ' Prior hormonal therapy < 2 weeks prior to randomization', ' Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization', ' Investigational therapy within 28 days of randomization', ' General Medical Exclusions:', ' Life expectancy of < 12 weeks', ' Inadequate organ function', ' Uncontrolled serious medical or psychiatric illness', ' Active infection requiring intravenous (IV) antibiotics at screening', ' Pregnancy or lactation', ' History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population', ' Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.', ' Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)', 'Results 1: ', ' Arm/Group Title: Paclitaxel+Placebo', ' Arm/Group Description: Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', ' Overall Number of Participants Analyzed: 242', ' Measure Type: Number', ' Unit of Measure: percentage of participants 69.4', 'Results 2: ', ' Arm/Group Title: Paclitaxel+ Bevacizumab', ' Arm/Group Description: Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', ' Overall Number of Participants Analyzed: 239', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 45/233 (19.31%)', ' Anaemia * 2/233 (0.86%)', ' Febrile neutropenia * 0/233 (0.00%)', ' Leukopenia * 1/233 (0.43%)', ' Neutropenia * 1/233 (0.43%)', ' Atrial fibrillation * 1/233 (0.43%)', ' Left ventricular dysfunction * 0/233 (0.00%)', ' ACUTE CORONARY SYNDROME * 0/233 (0.00%)', ' CARDIAC FAILURE CONGESTIVE * 1/233 (0.43%)', ' Optic nerve disorder * 1/233 (0.43%)', 'Adverse Events 2:', ' Total: 66/238 (27.73%)', ' Anaemia * 1/238 (0.42%)', ' Febrile neutropenia * 4/238 (1.68%)', ' Leukopenia * 1/238 (0.42%)', ' Neutropenia * 0/238 (0.00%)', ' Atrial fibrillation * 0/238 (0.00%)', ' Left ventricular dysfunction * 1/238 (0.42%)', ' ACUTE CORONARY SYNDROME * 1/238 (0.42%)', ' CARDIAC FAILURE CONGESTIVE * 0/238 (0.00%)', ' Optic nerve disorder * 0/238 (0.00%)']}
|
55391bc6-41a8-4686-82d6-6814166d32b8
|
Single
|
Results
|
NCT00091832
|
cohort 1 of the primary trial had a negative (median) Percent Change From Baseline of urea-adjusted Urinary N-telopeptide (uNTx/Ur).
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00091832', 'Intervention': ['INTERVENTION 1: ', ' Bisphosphonate IV Q4W', ' Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion', 'INTERVENTION 2: ', ' Denosumab 30 mg Q4W', ' Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'], 'Eligibility': ['Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma', ' At least one bone metastasis'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)', ' Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.', ' Time frame: Baseline and Week 13', 'Results 1: ', ' Arm/Group Title: Bisphosphonate IV Q4W', ' Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion', ' Overall Number of Participants Analyzed: 38', ' Mean (Standard Deviation)', ' Unit of Measure: Percent change -10.19 (208.84)', 'Results 2: ', ' Arm/Group Title: Denosumab 30 mg Q4W', ' Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: Percent change -52.87 (95.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/43 (34.88%)', ' Anaemia 0/43 (0.00%)', ' Febrile bone marrow aplasia 0/43 (0.00%)', ' Febrile neutropenia 1/43 (2.33%)', ' Leukopenia 0/43 (0.00%)', ' Neutropenia 1/43 (2.33%)', ' Thrombocytopenia 0/43 (0.00%)', ' Angina pectoris 0/43 (0.00%)', ' Cardiac tamponade 0/43 (0.00%)', ' Cardio-respiratory arrest 0/43 (0.00%)', ' Cardiopulmonary failure 1/43 (2.33%)', ' Pericardial effusion 0/43 (0.00%)', 'Adverse Events 2:', ' Total: 11/42 (26.19%)', ' Anaemia 1/42 (2.38%)', ' Febrile bone marrow aplasia 1/42 (2.38%)', ' Febrile neutropenia 0/42 (0.00%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 0/42 (0.00%)', ' Thrombocytopenia 0/42 (0.00%)', ' Angina pectoris 1/42 (2.38%)', ' Cardiac tamponade 0/42 (0.00%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Cardiopulmonary failure 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
06d25b0a-ef0d-4b6e-a8ed-c91689bfa82b
|
|
Comparison
|
Intervention
|
NCT02122796
|
NCT01575522
|
The intervention section for the primary trial does not detail the type, dosage or duration of the intervention, unlike the secondary trial.
|
Contradiction
|
[
0,
1,
2
] |
[
0,
1,
2,
3,
4
] |
{'Clinical Trial ID': 'NCT02122796', 'Intervention': ['INTERVENTION 1: ', ' Patients Undergoing Mastectomy Surgery', ' Number of individuals having mastectomy surgery who were approached for participation in the trial'], 'Eligibility': ['Inclusion Criteria:', ' Women', ' 18 years or older', ' Undergoing mastectomy surgery', 'Exclusion Criteria:', ' Non-English speaking', ' Pregnant', ' Also undergoing an oophorectomy, TRAM or Latissimus flap surgery'], 'Results': ['Outcome Measurement: ', ' Number of Patients Eligible Compared to the Number Approached and Enrolled', ' Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.', ' Time frame: One year', 'Results 1: ', ' Arm/Group Title: Patients Undergoing Mastectomy Surgery', ' Arm/Group Description: Number of individuals having mastectomy surgery who were approached for participation in the trial', ' Overall Number of Participants Analyzed: 252', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Elligible: 61 24.2%', ' Approached: 252 100.0%', ' Consented: 30 11.9%', ' Declined: 31 12.3%', ' Final Sample with complete data: 26 10.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01575522', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Tivantinib)', ' Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically or cytologically confirmed invasive breast cancer, with recurrent or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation', ' Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' Participants must have recent evidence of progressive disease', ' Participants must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days before enrollment in the study', ' Participants must have discontinued all biologic therapy (including vaccines) at least 14 days before enrollment in the study', ' Participants must have discontinued any investigational therapy at least 14 days before enrollment in the study', ' Participants may have received prior radiation therapy in either the metastatic or early-stage setting', ' Radiation therapy must be completed at least 14 days before enrollment in the study', ' Participant must not have received radiation to > 25% of his or her bone marrow within 30 days of starting study treatment', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Hemoglobin >= 9.0 g/dL', ' Absolute neutrophil count >= 1,500/mcL', ' Platelets >= 100,000/mcL', ' Total bilirubin =< 1.5 times upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN; for participants with documented liver metastases, AST/ALT =< 5.0 times ULN', ' Serum creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal', ' Either the primary tumor and/or the metastasis must be triple-negative; the invasive tumor must be hormone-receptor poor, defined as estrogen-receptor negative (ER-) and progesterone-receptor negative (PR-), or staining < 10% by immunohistochemistry (IHC)', ' Human epidermal growth factor receptor 2 (HER2) status: the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC, or FISH < 2.0', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the study and for 90 days after the last investigational drug dose received', ' Female subjects of childbearing potential must have a negative serum pregnancy test within 21 days of cycle 1 day 1', ' Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment; bisphosphonate therapy may also be initiated on study treatment if needed', ' Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Participants who have received chemotherapy, biologic, investigational, or radiotherapy within 14 days prior to entering the study', ' Participants who are receiving any other investigational agents', ' Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms', ' Participants with a history of treated central nervous system (CNS) metastases are eligible', ' Treated brain metastases are defined as those having no evidence of progression or hemorrhage for >= 2 months after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) during the screening period', ' Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician', ' Participants may be taking anti-convulsant medications, which must be non-enzyme-inducing anti-epileptic drugs', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197', ' History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study', ' Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible'], 'Results': ['Outcome Measurement: ', ' PFS Status', ' Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Time from start of treatment to time of progression or death, assessed up to 6 months', 'Results 1: ', ' Arm/Group Title: Treatment (Tivantinib)', ' Arm/Group Description: Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO', ' Overall Number of Participants Analyzed: 22', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.2 (1.0 to 1.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/22 (59.09%)', ' Constipation 1/22 (4.55%)', ' Death [1]3/22 (13.64%)', ' Neutropenia 1/22 (4.55%)', ' Anxiety 1/22 (4.55%)', ' Pleural effusion 1/22 (4.55%)', ' Cough 1/22 (4.55%)', ' Dyspnea 3/22 (13.64%)', ' Cellulitis 1/22 (4.55%)', ' Thromboembolic event 1/22 (4.55%)']}
|
15553950-e26b-4fbb-a576-8455e6bb7b23
|
Comparison
|
Intervention
|
NCT02606708
|
NCT02504424
|
Only patients in the primary trial receive 40.5 Gy of Accelerated Intensity Modulated Radiation Therapy, patients in the secondary trial receive no radiotherapy whatsoever.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT02606708', 'Intervention': ['INTERVENTION 1: ', ' Accelerated Intensity Modulated Radiation Therapy (AIMRT)', ' All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.', ' Accelerated intensity modulated radiation therapy (AIMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Pre- or post-menopausal women with Stage I and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy. and after sentinel node biopsy and/or axillary node dissection', ' At least 2 weeks from last chemotherapy', ' Tumors < 5 mm do not require nodal assessment', '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 > 5 years.', ' Pregnant or lactating women.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Local Recurrence in Breast', ' Defined by the discovery of invasive disease or DCIS in the same region of the breast after segmental mastectomy and radiation, by clinical or radiographic means.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Accelerated Intensity Modulated Radiation Therapy (AIMRT)', ' Arm/Group Description: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.', ' Accelerated intensity modulated radiation therapy (AIMRT)', ' Overall Number of Participants Analyzed: 314', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 1.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/314 (0.00%)']}
|
{'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%)']}
|
58838d25-bf87-44e7-a604-23468d67a1e3
|
Single
|
Results
|
NCT01959490
|
In total only 20% of participants in the primary trial did not achieve Pathological Complete Response.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT01959490', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1P (HER2 Positive)', ' Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Cohort 1T (HER2 Positive)', ' Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast, with sufficient tissue available for estrogen receptor (ER), progesterone receptor (PR), and HER 2 testing', ' HER2 must be positive by IHC or ISH testing by laboratory standard.', ' Needle biopsy or incisional biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1', ' Resectable disease-clinical stage I (T/0/N0miT1N0-N0mi), IIA-IIIA (T2 N0/T3N0 or T1-3 N1-N2a) or unresectable disease - clinical stage IIIB/IIIC (T4 or T1-3 N2b-3); no evidence of metastatic disease', ' No prior chemotherapy, hormonal therapy, or radiation therapy for this cancer', ' Absolute neutrophil count (ANC) 1000/ul', ' Platelet count 100,000/ul', ' Hemoglobin 9 g/dl', ' Serum creatinine 1.5 mg/dl or measured creatinine clearance of > 30 ml/min', ' Total bilirubin upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) 2.5 x ULN', " Patients with multiple foci of invasive cancer in the same breast are eligible if any single lesion meets the above size criteria and all sampled lesions are histologically similar (whether radiographically detected lesions separate from the target lesion are sampled for histologic evaluation is left to the discretion of the treating physicians); the presence of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) in either breast will not render a patient ineligible; patients with a small focus of invasive cancer detected the contralateral breast (clinical T1N0) are eligible, however only the histologic response in the breast containing the target lesions will be considered in determining the patient's pathologic response", ' Measurable disease in the breast or axilla that measures at least 1 cm by either clinical or radiographic measurement', 'Exclusion Criteria:', ' Excisional biopsy', ' Pregnant and lactating women are not eligible; all participants of reproductive age must have a negative serum pregnancy test at baseline and agree to use an effective barrier method of contraception during the entire period of treatment on the study', " Patients with New York Heart Association (NYHA) grade 2 or higher congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, or arterial thrombotic event with the past 12 months, uncontrolled hypertension (systolic blood pressure > 150 and/or diastolic blood pressure > 100 on antihypertensive medications; patients not on medication for high blood pressure who are found to have systolic blood pressure [SBP] > 150 and/or diastolic blood pressure [DBP] > 100 should have 3 documented episodes of elevated blood pressure before being considered 'uncontrolled', if they have 3 documented episodes of elevated blood pressure, then can be started on antihypertensive medications; patients currently on antihypertensive medications with elevated blood pressures as defined above may have their medications adjusted; if patients have persistent [3 episodes] of high blood pressure despite medication adjustment they will be considered ineligible for study participation; each measured episode should be 24 hours apart), prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled or clinically significant arrhythmia, grade II or greater peripheral vascular disease or prior history of stroke or transient ischemic attack (TIA); patient must have a pretreatment multi gated acquisition scan (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) above lower limit of normal", ' No non-breast malignancy within the past 5 years other than treated squamous or basal cell carcinoma of the skin or CIS of the cervix', ' Patients known to be human immunodeficiency virus (HIV) positive are not eligible for the study given their potentially compromised immune systems and increased risk of treatment-related toxicity', ' Advanced (T1N1-4/T2-3 N any) invasive cancer in the contralateral breast', ' Any known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage', ' Patients must not have a non-healing wound or fracture', ' Patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months', ' Patients must not have a bleeding diathesis, hereditary of acquired bleeding disorder or coagulopathy', ' Patients on therapeutic doses of Coumadin or Lovenox are ineligible to participate in study', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study; core biopsy or other minor surgical procedure, for example placement of a vascular access device, are excluded from this requirement', ' No known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.', ' Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.', ' Time frame: Up to 30 days after last cycle of treatment', 'Results 1: ', ' Arm/Group Title: Cohort 1P (HER2 Positive)', ' Arm/Group Description: Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 80.0%', 'Results 2: ', ' Arm/Group Title: Cohort 1T (HER2 Positive)', ' Arm/Group Description: Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/5 (20.00%)', ' Anemia * 0/5 (0.00%)', ' Febrile neutropenia * 0/5 (0.00%)', ' Diarrhea * 1/5 (20.00%)', ' Neutrophil count decreased * 0/5 (0.00%)', ' White blood cell decreased * 0/5 (0.00%)', ' Syncope * 1/5 (20.00%)', ' Hypotension * 1/5 (20.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Anemia * 0/6 (0.00%)', ' Febrile neutropenia * 0/6 (0.00%)', ' Diarrhea * 0/6 (0.00%)', ' Neutrophil count decreased * 0/6 (0.00%)', ' White blood cell decreased * 0/6 (0.00%)', ' Syncope * 0/6 (0.00%)', ' Hypotension * 0/6 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
02426c34-ebf9-4bd4-9d55-86fad89baf20
|
|
Comparison
|
Adverse Events
|
NCT00618826
|
NCT02040857
|
the primary trial and the secondary trial only record 4 of the same adverse events.
|
Entailment
|
[
0,
3,
8,
10,
5
] |
[
0,
9,
3,
6,
11
] |
{'Clinical Trial ID': 'NCT00618826', 'Intervention': ['INTERVENTION 1: ', ' Treatment', ' Paclitaxel / Gemcitabine'], 'Eligibility': ['Inclusion Criteria:', ' Patient must be 18 years of age or older with histologically confirmed breast cancer and clinical evidence of metastatic disease.', ' Patients must have measurable or non-measurable disease. X-rays, scans or physical examinations used to assess measurable disease must be performed within 28 days prior to registration. X-rays, scans or physical examinations to assess non-measurable disease must be completed within 42 days prior to registration. Patients with effusions or ascites as the only sites of disease are ineligible.', ' Patients must meet the following requirements regarding prior and concurrent chemotherapy:Patients must not have received prior chemotherapy regimens for metastatic breast cancer. Patients may have received adjuvant/neoadjuvant chemotherapy, for a total of 3 prior regimens.', ' Prior therapy with paclitaxel or docetaxel is allowed in the adjuvant or neoadjuvant setting, if given > 6 months prior to registration.', ' Patients must have >14 days delay between the conclusion of any radiation and the start of gemcitabine, provided the acute effects of radiation treatment have resolved.', ' Patients may have received any number of exogenous hormonal therapies and/or trastuzumab in the adjuvant, neoadjuvant or metastatic setting. Last dose of prior hormonal therapy at least 14 days prior to registration.', ' Patients may receive concomitant bisphosphonate therapy for bone metastasis.', ' Patients must have recovered from any prior surgery. Two weeks must have elapsed from the time of any minor surgery and 4 weeks of any major surgery.', ' Patients must have adequate bone marrow reserve as evidenced by the following: ANC > 1500/mcL, platelets > 100, 000/mcL, and hemoglobin > 9.0 gm/dL. These results must be obtained within 28 days prior to registration.', ' Patients must have serum creatinine < 1.5 mg/dL, obtained within 28 days prior to registration.', ' Urine Protein: creatinine ratio 1.0 at screening.', ' Patients must have adequate liver function.', ' Patients must have a Zubrod performance status of 0-1.', 'Exclusion Criteria:', ' Patients must not have tumors that carry HER-2 gene amplifications as determined by (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein 3+ level assessed by immunohistochemistry; or may have tumors that carry HER=2 gene amplification and have had disease progression while on trastuzumab. Patients who have previously been treated with trastuzumab must be off treatment at least 28 days prior to registration.', ' Patients must not have CNS metastasis, leptomeningeal disease or lymphatic pulmonary metastases.', ' Patients must not have had prior therapy with gemcitabine or bevacizumab.', ' Patient must not have major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of treatment, anticipation of need for major surgical procedure during the course of the study.', ' Patients must not have received radiation to > 50% of the marrow-bearing bone.', ' Patients must not have a history of significant symptomatic cardiac disease or left ventricular ejection fraction (LVEF) < 50% of the institutional lower limit of normal (ILLN). An isotope cardiac scan (MUGA) and ECG must be obtained within 28 days.', ' Patients with uncontrolled hypertension are NOT eligible (BP>150/100).', ' Patients must not have pr-existing clinically significant (Grade 2 or greater per CTCAE Version 3.0 motor or sensory neuropathy except for abnormalities due to cancer.', ' Patients known to be HIV positive.', ' Patients must not be nursing or pregnant. Men and women of reproductive potential must agree to use an effective contraceptive method.', ' No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years.', ' Patients must not have had a Stroke or Myocardial Infarction in the past 6 months. Patients with unstable agina, significant peripheral vascular disease, history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the last 6 months should be excluded.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Time from study entry to disease progression or death', ' Time frame: maximum 50 months', 'Results 1: ', ' Arm/Group Title: Treatment', ' Arm/Group Description: Paclitaxel / Gemcitabine', ' Overall Number of Participants Analyzed: 13', ' Median (95% Confidence Interval)', ' Unit of Measure: months 43 (7 to 45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/14 (71.43%)', ' Hemoglobin 2/14 (14.29%)', ' Lymphopenia 1/14 (7.14%)', ' Cardiac ischemia/infarction 1/14 (7.14%)', ' Hypertension 2/14 (14.29%)', ' Hypotension 1/14 (7.14%)', ' Constipation 1/14 (7.14%)', ' Diarrhea 1/14 (7.14%)', ' Heartburn/dyspepsia 1/14 (7.14%)', ' Fatigue (asthenia, lethargy, malaise) 2/14 (14.29%)', ' Rigors/chills 1/14 (7.14%)']}
|
{'Clinical Trial ID': 'NCT02040857', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib With Adjuvant Endocrine Therapy', ' Palbociclib 125 mg PO qd 21 days on, 7 days off', ' Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.', ' Men and both pre- and postmenopausal women are eligible.', ' Prior Treatment:', ' Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.', ' Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.', ' If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.', ' Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.', ' ECOG performance status 0-1', ' Age 18 years.', ' Normal organ and marrow function', ' Baseline QTc 480 ms', ' The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Concurrent therapy with other investigational agents.', ' Prior therapy with any CDK4/6 inhibitor.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.', ' Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.', ' Current use of drugs that are known to prolong the QT interval', ' Subjects with organ allograft requiring immunosuppression.', ' 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 prior to entry onto the study.', ' Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.', ' No ongoing combination antiretroviral therapy'], 'Results': ['Outcome Measurement: ', ' 2-Year Treatment Discontinuation Rate', ' The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.', ' Time frame: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.', 'Results 1: ', ' Arm/Group Title: Palbociclib With Adjuvant Endocrine Therapy', ' Arm/Group Description: Palbociclib 125 mg PO qd 21 days on, 7 days off', ' Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd', ' Overall Number of Participants Analyzed: 152', ' Measure Type: Number', ' Unit of Measure: percentage of participants 31 (24 to 39)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 96/162 (59.26%)', ' Cardiac disorders - Other, specify 2/162 (1.23%)', ' Diarrhea 1/162 (0.62%)', ' Mucositis oral 2/162 (1.23%)', ' Nausea 1/162 (0.62%)', ' Fatigue 6/162 (3.70%)', ' Breast infection 2/162 (1.23%)', ' Soft tissue infection 1/162 (0.62%)', ' Lymphocyte count decreased 2/162 (1.23%)', ' Neutrophil count decreased 78/162 (48.15%)', ' Hypertension 1/162 (0.62%)']}
|
9e28c807-8d88-4eea-87ee-48a42bd002ab
|
Single
|
Eligibility
|
NCT02600923
|
Patients with Leukemia, Hepatitis or Polycystic Kidney Disease cannot be included in the primary trial.
|
Entailment
|
[
0,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT02600923', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib+Letrozole', ' Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).', ' Women who are not of childbearing potential.', ' ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).', ' HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines).', ' Patients must be appropriate candidates for letrozole therapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Adequate bone marrow function.', ' Adequate liver function', ' Adequate renal function.', 'Exclusion Criteria:', ' Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.', ' Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry.', ' Prior treatment with any CDK inhibitor.', ' Previous participation in a palbociclib clinical study.', ' Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.', ' QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.', ' High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment.', ' Diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. Note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter.', ' Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, brain metastases are permitted.', ' Other severe acute or chronic medical or psychiatric conditions.', ' Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)', ' An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Palbociclib+Letrozole', ' Arm/Group Description: Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.', ' Overall Number of Participants Analyzed: 130', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 1: 0 0.0%', ' Grade 2: 17 13.1%', ' Grade 3: 82 63.1%', ' Grade 4: 23 17.7%', 'Grade 5: 7 5.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/130 (24.62%)', ' Anaemia * 1/130 (0.77%)', ' Febrile neutropenia * 1/130 (0.77%)', ' Neutropenia * 1/130 (0.77%)', ' Pancytopenia * 1/130 (0.77%)', ' Arteriosclerosis coronary artery * 1/130 (0.77%)', ' Ascites * 1/130 (0.77%)', ' Chest pain * 1/130 (0.77%)', ' Disease progression * 2/130 (1.54%)', ' General physical health deterioration * 1/130 (0.77%)', ' Cellulitis * 1/130 (0.77%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
80ac126e-c756-4031-9541-e50d51c18b38
|
|
Single
|
Intervention
|
NCT02953860
|
Patients in the primary trial receive less mg of Enzalutamide than Fulvestrant on a weekly basis.
|
Contradiction
|
[
3
] |
[] |
{'Clinical Trial ID': 'NCT02953860', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant With Enzalutamide', ' 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.', ' Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.'], 'Eligibility': ['Inclusion Criteria:', ' ER+ Her2- breast cancer', ' Metastatic', ' Female, at least 18 years of age', ' Candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant', ' Measurable or evaluable by RECIST 1.1', ' ECOG PS 0-2', ' Able to swallow study drug and comply with study requirements', ' Tumor available for fresh biopsy (two biopsies - pretreatment as regards enzalutamide, and during treatment at 4 weeks). The patient will be also be asked if they would be willing to provide a third biopsy at time of progression.', ' If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression. Patients may have already gotten the loading dose of ovarian suppression. Pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screening.', ' ANC >1000/uL and platelets >75,000/uL at screening visit', " Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)", ' Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or < 5 times ULN if patient has documented liver metastases', ' Creatinine < 1.5 times ULN', ' INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy', ' Willing to donate blood for research at 4 time points', ' Written informed consent obtained prior to biopsies and blood samples', ' Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued.', 'Exclusion Criteria:', ' Current or previously treated brain or leptomeningeal metastases', ' History of seizures', ' Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464)', ' Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant', ' To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.', ' Time frame: 24 Weeks', 'Results 1: ', ' Arm/Group Title: Fulvestrant With Enzalutamide', ' Arm/Group Description: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.', ' Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 21.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/32 (6.25%)', ' myocardial infarction [1]1/32 (3.13%)', ' cholecystitis [2]1/32 (3.13%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1a1d7d1d-ec49-46db-b6bc-dfd94575e46c
|
|
Single
|
Eligibility
|
NCT00717886
|
Prior axillary surgery, axillary radiation, breast cancer and breast radiation are not permitted for entry to the primary trial.
|
Entailment
|
[
3,
4,
5,
6,
7
] |
[] |
{'Clinical Trial ID': 'NCT00717886', 'Intervention': ['INTERVENTION 1: ', ' Upper Extremity Lymphatic Mapping for Breast Cancer Patients', ' Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.'], 'Eligibility': ['Inclusion Criteria:', ' Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.', ' Females > 21 years of age', 'Exclusion Criteria:', ' Prior ipsilateral axillary surgery', ' Prior ipsilateral axillary radiation', ' Prior ipsilateral breast cancer', ' Prior ipsilateral breast radiation', ' Allergy to isosulfan blue dye', ' History of ipsilateral upper extremity lymphedema', ' Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast', ' Prior history of neoadjuvant chemotherapy for current breast cancer', ' Bulky axillary disease at presentation (N2)'], 'Results': ['Outcome Measurement: ', ' Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).', ' [Not Specified]', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Upper Extremity Lymphatic Mapping for Breast Cancer Patients', ' Arm/Group Description: Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/9 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
68a9f2f0-cf11-4cd4-847c-53b8befd6002
|
|
Single
|
Eligibility
|
NCT00756717
|
Patients with cytologically confirmed, non metastatic, early stage invasive breast cancer with an Allred score of 1 are excluded from the primary trial.
|
Entailment
|
[
0,
1
] |
[] |
{'Clinical Trial ID': 'NCT00756717', 'Intervention': ['INTERVENTION 1: ', ' MK-0752', ' Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days', ' MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed early stage, ER-positive (Allred score 3), invasive breast cancer that is not either locally advanced by criteria other than size or inflammatory, and is not metastatic. - Patients must be candidates for surgical removal of the tumor by lumpectomy or mastectomy.', ' Patients must not have bilateral tumors. Tumor must be amenable to core biopsy in midstudy.', ' Patients must be >18 years of age.', ' Patients must have a performance status 1 by Zubrod criteria.', ' Patients must have a life expectancy of greater than three months.', ' Patients must have normal organ and marrow function within 28 days of registration as defined below:', ' absolute neutrophil count >1,500/μL', ' platelets >100,000/μL', ' total bilirubin 1.5 x the institutional upper limit of normal', ' AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal', ' creatinine within normal institutional limits OR', ' creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal', ' Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A negative serum pregnancy test must be obtained within 72 hours of receiving the first dose of the hormonal therapy as well as within 72 hours of the first dose of the MK-0752 GSI medication for women of child-bearing potential. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', 'Exclusion Criteria:', ' Patients may not have received any prior chemotherapy or endocrine therapy (tamoxifen, raloxifene, or an aromatase inhibitor) and may not have received prior therapy with a gamma-secretase inhibitor or other investigational agents. - Patients may not have received previous radiation therapy.', ' Patients may not be currently participating or have participated in a study with an investigational compound or device within 30 days.', ' Patients must not have known brain or CNS disease, evidence of brain or CNS metastases, or carcinomatous meningitis.', ' Patients must not have an 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.', ' Patients may not have known hypersensitivity to the components of MK-0752 or it analogs.', ' Patients will be excluded if there is a known history of human immunodeficiency (HIV) virus infection, or a known history of hepatitis B or C infection.', ' Patients must not have a previous history of inflammatory bowel disease or uncontrolled irritable bowel syndrome.', ' Patients must not have a history of greater than one basal cell carcinoma of the skin within the past five years or a history of Gorlin syndrome.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing at Least One Adverse Event', ' The number of participants experiencing at least one adverse event during the 24-day observation period and initial post-operative visit.', ' Time frame: 30 days', 'Results 1: ', ' Arm/Group Title: MK-0752', ' Arm/Group Description: Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days', ' MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants At least one adverse event: 15 75.0%', ' No Adverse Events: 5 25.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
9bcd40cf-8221-4383-8891-76a4bcc5c766
|
|
Single
|
Results
|
NCT00291577
|
It is not possible for a participant of the primary trial to have a Time to Reach Maximum Plasma Concentration of 6, 24 or 12 hours.
|
Contradiction
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT00291577', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib in Combination With Docetaxel', ' Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer with evidence of unresectable, locally recurrent or metastatic disease', ' Candidate for treatment with docetaxel', 'Exclusion Criteria:', ' Prior chemotherapy in the advanced disease setting', ' Inflammatory breast cancer', ' HER2 positive disease'], 'Results': ['Outcome Measurement: ', ' Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters', ' Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.', ' Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose', 'Results 1: ', ' Arm/Group Title: Sunitinib in Combination With Docetaxel', ' Arm/Group Description: Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.', ' Overall Number of Participants Analyzed: 11', ' Median (Full Range)', ' Unit of Measure: hours SU011248 C1D2: 6.0 (4.0 to 24.0)', ' SU011248 C2D3: 6.0 (2.0 to 8.0)', ' SU012662 C1D2: 6.0 (2.0 to 24.0)', ' SU012662 C2D3: 6.0 (4.0 to 24.0)', ' Total drug C1D2: 6.0 (2.0 to 24.0)', ' Total drug C2D3: 6.0 (2.0 to 8.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/22 (50.00%)', ' Febrile neutropenia 4/22 (18.18%)', ' Leukopenia 1/22 (4.55%)', ' Neutropenia 2/22 (9.09%)', ' Stomatitis 1/22 (4.55%)', ' Fatigue 1/22 (4.55%)', ' Oedema peripheral 1/22 (4.55%)', ' Pyrexia 1/22 (4.55%)', ' Jaundice 1/22 (4.55%)', ' Back pain 1/22 (4.55%)', ' Musculoskeletal pain 1/22 (4.55%)', ' Cerebral haemorrhage 1/22 (4.55%)', ' Headache 1/22 (4.55%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
341156fc-9cbd-492f-8e9e-8fbf98191625
|
|
Single
|
Adverse Events
|
NCT00201851
|
There were no cases of Oesophageal spasming observed in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00201851', 'Intervention': ['INTERVENTION 1: ', ' A - Scheduled Surgery', ' Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'INTERVENTION 2: ', ' B - Immediate Surgery', ' Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'], 'Eligibility': ['Inclusion Criteria:', ' Open for accrual in Asia only', ' Female age 18-50,', ' premenopausal with regular cycles (>25-35 in length)', ' fine-needle aspiration diagnosis', ' Stage II-IIIA hormone receptor positive invasive breast cancer', ' No prior radiation or chemotherapy', ' Must be surgical candidate for bilateral oophorectomy'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' 5-year disease-free survival', ' Time frame: two- to three-year accrual and initial two or more years of follow-up period', 'Results 1: ', ' Arm/Group Title: A - Scheduled Surgery', ' Arm/Group Description: Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 244', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64', 'Results 2: ', ' Arm/Group Title: B - Immediate Surgery', ' Arm/Group Description: Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 255', ' Measure Type: Number', ' Unit of Measure: percentage of participants 71'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/244 (0.00%)', ' Pregnancy *0/244 (0.00%)', ' Endocervical cancer *0/244 (0.00%)', ' Nosocomial pneumonia *0/244 (0.00%)', ' Venous thrombosis *0/244 (0.00%)', 'Adverse Events 2:', ' Total: 5/255 (1.96%)', ' Pregnancy *1/255 (0.39%)', ' Endocervical cancer *1/255 (0.39%)', ' Nosocomial pneumonia *2/255 (0.78%)', ' Venous thrombosis *1/255 (0.39%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
44ae021e-241b-4dbf-b88f-0b9d41eab555
|
|
Single
|
Adverse Events
|
NCT00080301
|
There were 5 more cases of THROMBOCYTOPENIA in cohort 2 of the primary trial, than in cohort 1.
|
Entailment
|
[
0,
7,
13,
20
] |
[] |
{'Clinical Trial ID': 'NCT00080301', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone + Capecitabine', ' Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine 1250 mg/m2 BID x 14 days'], 'Eligibility': ['Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.', ' Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).', ' Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.', ' Patients must be resistant to taxane therapy.', ' Patients may not have any history of brain and/or leptomeningeal metastases.', ' Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).', ' Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)', " PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.", ' Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity', 'Results 1: ', ' Arm/Group Title: Ixabepilone + Capecitabine', ' Arm/Group Description: Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days', ' Overall Number of Participants Analyzed: 375', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.85 (5.45 to 6.97)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine 1250 mg/m2 BID x 14 days', ' Overall Number of Participants Analyzed: 377', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 4.17 (3.81 to 4.50)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 127/368 (34.51%)', ' ANAEMIA 3/368 (0.82%)', ' LEUKOPENIA 0/368 (0.00%)', ' NEUTROPENIA 0/368 (0.00%)', ' COAGULOPATHY 3/368 (0.82%)', ' LYMPHADENOPATHY 0/368 (0.00%)', ' THROMBOCYTOPENIA 2/368 (0.54%)', ' BONE MARROW FAILURE 0/368 (0.00%)', ' FEBRILE NEUTROPENIA 4/368 (1.09%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/368 (0.00%)', ' ATRIAL FLUTTER 0/368 (0.00%)', ' CARDIAC ARREST 0/368 (0.00%)', 'Adverse Events 2:', ' Total: 151/369 (40.92%)', ' ANAEMIA 11/369 (2.98%)', ' LEUKOPENIA 6/369 (1.63%)', ' NEUTROPENIA 18/369 (4.88%)', ' COAGULOPATHY 0/369 (0.00%)', ' LYMPHADENOPATHY 1/369 (0.27%)', ' THROMBOCYTOPENIA 7/369 (1.90%)', ' BONE MARROW FAILURE 1/369 (0.27%)', ' FEBRILE NEUTROPENIA 15/369 (4.07%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/369 (0.27%)', ' ATRIAL FLUTTER 1/369 (0.27%)', ' CARDIAC ARREST 1/369 (0.27%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
523a44a3-6b90-4be7-ab46-6b6addd7b5b9
|
|
Comparison
|
Intervention
|
NCT03475992
|
NCT03106077
|
Participants in the primary trial receive different interventions depending on their cancer hormone status, so Triple-Negative patients are seperated from HER2+ patients for example, whereas all patients in the secondary trial took the same intervention.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[
0,
1,
2
] |
{'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%)']}
|
258a51ca-e1f0-4d9a-88a6-8749f4822034
|
Comparison
|
Results
|
NCT00057941
|
NCT01806259
|
Recurrence-free Survival, used as the outcome measurement in the secondary trial and Clinical Benefit Rate, used in the primary trial are not synonymous, and represent entirely different patient characteristics.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT00057941', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole and ZD1839', '[Not Specified]', 'INTERVENTION 2: ', ' Fulvestrant and ZD1839', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have estrogen and/or progesterone receptor positive histologically confirmed adenocarcinoma of the breast with measurable recurrent or metastatic carcinoma of the breast', ' Baseline measurements and evaluations of involved sites should be performed as close as possible to study entry, but must be within 4 weeks prior to randomization', ' Patients with available tissue blocks from either the primary or metastatic site must submit the tissue for EGFR analysis', ' All patients must be postmenopausal females defined by:', ' Prior bilateral oophorectomy or bilateral ovarian irradiation', ' No menstrual period for 12 months or longer. If age 55 years or less and on tamoxifen within the prior 6 months, must have an estradiol level in the postmenopausal range', ' Patients must not have had more than 2 prior chemotherapy regimens for metastatic disease and no chemotherapy within 3 weeks prior to randomization; no concurrent chemotherapy is allowed while on protocol therapy', ' Patients must not have prior hormonal therapy for metastatic disease; no prior therapy in the adjuvant setting with an estrogen receptor down-regulator (e.g. fulvestrant) or an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane, aminoglutethamide); non-protocol concurrent hormonal therapy is not allowed', ' Patients must not have had prior therapy with agents that target EGFR', ' Previous, but not concomitant, therapy with trastuzumab (Herceptin) is allowed; patients must not receive trastuzumab (Herceptin) within 3 weeks prior to randomization', ' Patients must have ECOG performance status of 0, 1, or 2', ' Neutrophils >= 1500/mm^3', ' Platelets >= 100,000/mm^3', ' Bilirubin =< 1.25 x upper limit of normal', ' SGPT (ALT) and SGOT (AST) =< 2.5 x upper limit of normal if no demonstrable liver metastases or =< 5 times upper limit of normal in the presence of liver metastases', ' Calculated creatinine clearance >= 30ml/min', ' INR, PT and PTT within normal range', ' Patients must not be receiving therapy with anticoagulants or have other contraindication to i.m. injections', ' Patients must not have a history of central nervous system metastasis', ' Patients may receive concurrent radiation therapy to painful sites of boney disease or areas of impending fracture as long as the radiation therapy is initiated prior to study entry and sites of measurable disease outside the radiation therapy port are available to follow; patient who have received prior radiation therapy must have recovered from toxicity of the prior radiation therapy', " Patients must not take the following medications that may alter ZD1839 pharmacokinetics while enrolled in this trial: phenytoin, carbamazapine, phenobarbitol, rifampicin, and St. John's Wort, oxcarbazepine, rifapentine, modafinil, and griseofulvin", ' Patients age =< 55 years must not be receiving LHRH agonists or antagonists within 3 months prior to randomization', ' Patients who have an ocular inflammation or infection should be fully treated before entry into the trial; patients with a neuropathic keratopathy or diabetes or those with anterior basement membrane disease must be advised of the need for frequent opthalmalogic exams', " Patients who continue to wear contact lenses must be advised that they have an increased risk of ocular events; the decision to wear contact lenses should be discussed with the patient's treating oncologist and ophthalmologist", ' Patients must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities', ' Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate', ' Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.', ' Time frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years', 'Results 1: ', ' Arm/Group Title: Anastrozole and ZD1839', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 72', ' Measure Type: Number', ' Unit of Measure: percentage of participants 44 (33 to 57)', 'Results 2: ', ' Arm/Group Title: Fulvestrant and ZD1839', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Number', ' Unit of Measure: percentage of participants 41 (29 to 53)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/74 (36.49%)', ' Anemia 1/74 (1.35%)', ' Sinus bradycardia 0/74 (0.00%)', ' Dyspepsia 0/74 (0.00%)', ' Dysphagia 1/74 (1.35%)', ' Gastritis 1/74 (1.35%)', ' Nausea 3/74 (4.05%)', ' Vomiting 2/74 (2.70%)', ' Diarrhea w/o prior colostomy 4/74 (5.41%)', ' Fatigue 2/74 (2.70%)', ' AST increased 5/74 (6.76%)', ' ALT increased 3/74 (4.05%)', ' Infection w/o neutropenia 1/74 (1.35%)', 'Adverse Events 2:', ' Total: 28/74 (37.84%)', ' Anemia 1/74 (1.35%)', ' Sinus bradycardia 1/74 (1.35%)', ' Dyspepsia 1/74 (1.35%)', ' Dysphagia 0/74 (0.00%)', ' Gastritis 0/74 (0.00%)', ' Nausea 3/74 (4.05%)', ' Vomiting 2/74 (2.70%)', ' Diarrhea w/o prior colostomy 10/74 (13.51%)', ' Fatigue 2/74 (2.70%)', ' AST increased 6/74 (8.11%)', ' ALT increased 3/74 (4.05%)', ' Infection w/o neutropenia 3/74 (4.05%)']}
|
{'Clinical Trial ID': 'NCT01806259', 'Intervention': ['INTERVENTION 1: ', ' Ketorolac 30 mg', ' Active drug to be compared with placebo', 'Ketorolac 30 mg IV', 'INTERVENTION 2: ', ' NaCl 0.9% 3mL', 'Ketorolac 30 mg IV'], 'Eligibility': ['Inclusion Criteria:', ' Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes', 'Exclusion Criteria:', ' Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )'], 'Results': ['Outcome Measurement: ', ' Recurrence-free Survival', ' 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Ketorolac 30 mg', ' Arm/Group Description: Active drug to be compared with placebo', ' Ketorolac 30 mg IV', ' Overall Number of Participants Analyzed: 96', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 80 83.3%', 'Results 2: ', ' Arm/Group Title: NaCl 0.9% 3mL', ' Arm/Group Description: Ketorolac 30 mg IV', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 96 89.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/96 (8.33%)', ' Hematoma requiring surgery 1/96 (1.04%)', ' Any type (not bleeding related) 7/96 (7.29%)', 'Adverse Events 2:', ' Total: 7/107 (6.54%)', ' Hematoma requiring surgery 0/107 (0.00%)', ' Any type (not bleeding related) 7/107 (6.54%)']}
|
83bacd68-871a-4777-ba23-1f9a3df9227d
|
Comparison
|
Results
|
NCT00369655
|
NCT00091832
|
One patient in the primary trial had a Confirmed tumor partial response, in contrast thirty patients in the secondary trial had partial tumor response.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] |
[
0,
1,
2,
3
] |
{'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%)']}
|
fedc0601-fd6b-4f9b-9ce7-6d9ee2e591e9
|
Single
|
Adverse Events
|
NCT00391092
|
In total there were 32 cases of Febrile neutropenia in the primary trial, and only one case of anemia.
|
Contradiction
|
[
0,
2,
4,
12,
14,
16
] |
[] |
{'Clinical Trial ID': 'NCT00391092', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Docetaxel', " Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.", 'INTERVENTION 2: ', ' Trastuzumab + Bevacizumab + Docetaxel', " Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' HER2 positive breast cancer with locally recurrent or metastatic lesions;', ' eligible for chemotherapy;', ' baseline LVEF >=50%.', 'Exclusion Criteria:', ' previous chemotherapy for metastatic or locally recurrent breast cancer;', ' previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);', ' other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;', ' clinically significant cardiovascular disease;', ' chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', " PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.", ' Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Docetaxel', " Arm/Group Description: Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.", ' Overall Number of Participants Analyzed: 208', ' Median (95% Confidence Interval)', ' Unit of Measure: months 13.7 (11.4 to 16.3)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Bevacizumab + Docetaxel', " Arm/Group Description: Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.", ' Overall Number of Participants Analyzed: 216', ' Median (95% Confidence Interval)', ' Unit of Measure: months 16.5 (14.1 to 19.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 63/206 (30.58%)', ' Febrile neutropenia * 14/206 (6.80%)', ' Neutropenia * 9/206 (4.37%)', ' Anaemia * 1/206 (0.49%)', ' Leukopenia * 0/206 (0.00%)', ' Thrombocytopenia * 1/206 (0.49%)', ' Cardiac failure * 0/206 (0.00%)', ' Cardiac failure congestive * 1/206 (0.49%)', ' Cardiomyopathy * 0/206 (0.00%)', ' Coronary artery occlusion * 1/206 (0.49%)', ' Coronary artery thrombosis * 0/206 (0.00%)', 'Adverse Events 2:', ' Total: 72/215 (33.49%)', ' Febrile neutropenia * 18/215 (8.37%)', ' Neutropenia * 6/215 (2.79%)', ' Anaemia * 1/215 (0.47%)', ' Leukopenia * 1/215 (0.47%)', ' Thrombocytopenia * 0/215 (0.00%)', ' Cardiac failure * 1/215 (0.47%)', ' Cardiac failure congestive * 0/215 (0.00%)', ' Cardiomyopathy * 1/215 (0.47%)', ' Coronary artery occlusion * 0/215 (0.00%)', ' Coronary artery thrombosis * 1/215 (0.47%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1a451f2e-0818-4a86-8808-0e4cce700aef
|
|
Comparison
|
Adverse Events
|
NCT01325207
|
NCT02429427
|
Patients participating in the primary trial and the secondary trial experienced a variety of cardiac problems.
|
Entailment
|
[
2
] |
[
6,
7,
8,
9,
10,
11
] |
{'Clinical Trial ID': 'NCT01325207', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1 - Trastuzumab 10mg IT 2/Week', ' Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', '1 cycle = 28 days.', 'INTERVENTION 2: ', ' Cohort 2 - Trastuzumab 20mg IT 2/Week', ' Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', '1 cycle = 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' ELIGIBILITY CRITERIA', ' HER2 positive (IHC 3+ and/or FISH positive) breast cancer patients with leptomeningeal metastases by MRI or CSF (if MRI is negative).', ' o Review will be performed for cases not reviewed at Northwestern for confirmation, but will not preclude patients from entering the trial (pathology report is sufficient for registration).', ' Patients can have concomitant brain metastases as long as they do not require active treatment or have been treated.', ' Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma will be eligible for phase I', ' Life expectancy > 8 weeks', ' Normal renal (creatinine < 1.5 ULN), liver (bilirubin < 1.5 x ULN, transaminases < 3.0 x ULN, except in known hepatic metastasis, wherein may be < 5 x ULN) and blood counts (WBC > 3.0, Neutrophils > 1500, platelets >100 000, Hemoglobin > 10).', ' LVEF > 50%', ' KPS > 50', ' Age > 18 years', ' Cannot be on systemic agents (chemotherapy) that have CNS penetration unless they develop leptomeningeal metastases while on these agent(s) and have controlled systemic disease. May continue on IV trastuzumab, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy. Patients requiring systemic chemotherapy are eligible but will not be able to start treatment until after the first assessment by imaging and cytology.', ' Patients may need a CSF flow study at the discretion of the treating principal investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed.', ' Patients should be > 2 weeks from RT treatment and all effects of treatment should have resolved', ' No limit on prior systemic or IT therapies.', ' CSF sampling to document LM if not documented on MRI.', ' Must be willing to have an Ommaya reservoir placed.', ' NO history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 3 years.', ' Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.', ' Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.', ' Women may not be pregnant or breast-feeding.', ' Ability to sign an informed consent; can be signed by family member or health care proxy. Informed consent must be done prior to registration on study.', ' All patients must have given signed, informed consent prior to registration on study.', ' No known hypersensitivity to trial medications Note: The eligibility criteria listed above are interpreted literally and cannot be waived.', 'Exclusion Criteria:', ' - Any deviations from the inclusion criteria'], 'Results': ['Outcome Measurement: ', ' Number of Dose Limiting Toxicities (DLT) of IT Trastuzumab in Sequential Cohorts of Escalating Doses for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.', ' Patients will be treated using a standard 3+3 dose-escalation design for cohorts 1 and 2. This will be followed by an accelerated phase I for cohorts 3 and 4, and then a standard 3 + 3 for the 5th cohort. In the accelerated phase (cohorts 3 and 4), 1 patient will be enrolled per cohort; if a toxicity is seen in that patient then the cohort would be expanded to 6 patients to allow for 1/6 patients per cohort to have a dose limiting toxicity (DLT) before dose escalation. Cohort 5 will enroll a total of 6 patients regardless of the toxicity experienced in patient one. However, if 2 or more DLTs are observed in cohort 5, cohort 4 will be reopened to enroll of a total of 6 patients. Whatever dose is ultimately declared the MTD should have 6 patients total. If 1/6 DLTs are seen in cohort 5 that will be considered the MTD.', ' Dosing is as follows:', ' Cohort 1-10 mg IT Cohort 2-20 mg IT Cohort 3-40 mg IT Cohort 4-60 mg IT Cohort 5-80 mg IT', ' Time frame: From treatment initiation through the first 4 weeks of treatment.', 'Results 1: ', ' Arm/Group Title: Cohort 1 - Trastuzumab 10mg IT 2/Week', ' Arm/Group Description: Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', ' 1 cycle = 28 days.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: DLTs 0', 'Results 2: ', ' Arm/Group Title: Cohort 2 - Trastuzumab 20mg IT 2/Week', ' Arm/Group Description: Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.', ' Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.', ' 1 cycle = 28 days.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: DLTs 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Pericardial effusion [1]0/3 (0.00%)', ' Abdominal muscle wall hemorrhage [2]0/3 (0.00%)', ' Dehydration [3]0/3 (0.00%)', ' Gastroenteritis 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Vomiting [4]0/3 (0.00%)', ' Colonic perforation [5]0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Chemical meningitis 0/3 (0.00%)', ' Lung infection 0/3 (0.00%)', ' Wound infection 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 2/3 (66.67%)', ' Pericardial effusion [1]0/3 (0.00%)', ' Abdominal muscle wall hemorrhage [2]0/3 (0.00%)', ' Dehydration [3]0/3 (0.00%)', ' Gastroenteritis 0/3 (0.00%)', ' Dehydration 0/3 (0.00%)', ' Vomiting [4]0/3 (0.00%)', ' Colonic perforation [5]0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Chemical meningitis 0/3 (0.00%)', ' Lung infection 0/3 (0.00%)', ' Wound infection 1/3 (33.33%)']}
|
{'Clinical Trial ID': 'NCT02429427', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.', 'INTERVENTION 2: ', ' Placebo', ' Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Placebo: Two capsules once daily with food'], 'Eligibility': ['Inclusion Criteria:', ' Completely resected (greater or equal 1mm), histologically or cytologically proven unilateral breast cancer', ' Female greater or equal 18 years of age', ' If (neo) adjuvant chemotherapy received, patient must have received at least 4 cycles. Chemotherapy must be completed prior to study entry', ' Hormone Receptor negatives must have received prior chemotherapy', ' Study entry must be within any of the following timelines: 3 months of the end of definitive breast surgery OR between 3 weeks and 4 months after day 1 of the last cycle of adjuvant chemotherapy OR 6 weeks of the end of radiotherapy.', ' WHO performance status 0 or 1', ' Pre-treatment haematology and biochemistry values within acceptable local limits: Haemoglobin, white blood cell greater or equal to 3.0 x 109/l or absolute neutrophil count greater or equal to 1.51 x 109/l, Platelets greater or equal to 100 x 109/l, Serum bilirubin less than 1.5 x upper normal limit , Alkaline phosphatase less or equal to 1.5 x upper normal limit , Serum creatinine less than 1.5 x upper normal limit', ' Negative pregnancy test for patients with child-bearing potential', ' Normal baseline ECG and clinical cardiovascular assessment after completion of all (neo) adjuvant chemotherapy', ' No previous or current evidence for metastatic disease', ' Be accessible for and consent to long term follow-up', ' Written informed consent prior to commencement of specific protocol procedures must be obtained and documented according to the local regulatory requirements', ' Exclusion Criteria', ' Patients with node negative, T1, Grade 1 breast cancer', ' Unresectable, metastatic or bilateral breast cancer', ' Active or previous peptic ulceration or gastrointestinal bleeding in the last year', ' Active or previous history of inflammatory bowel disease', ' A past history of adverse reaction/hypersensitivity to NSAIDs, including celecoxib and salicylates, or sulphonamides', ' On current or planned chronic NSAIDs therapy (except low dose aspirin 100 mg four times per day or 325mg once daily).', ' Current or long-term use of oral corticosteroids', ' Known or suspected congestive heart failure (greater than New York Heart Association I) and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension (ie BP greater than 160/90mmHg) under treatment with two anti-hypertensive drugs, rhythm abnormalities requiring permanent treatment.', ' Patients with diabetes controlled by diet and oral medication are eligible for the study however patients with insulin dependent diabetes are excluded', ' Past history of stroke/Transient ischaemic attack, symptomatic peripheral vascular disease or carotid disease', ' Previously entered into an adjuvant chemotherapy trial for which approval for entry into REACT has not been granted', ' ER receptor status unknown, Human epidermal growth factor receptor 2 or FISH positive, or Human epidermal growth factor receptor 2 status unknown', ' 14. Hormone Receptor negative and not received (neo)adjuvant chemotherapy 15. Use of hormone replacement therapy within the last 6 weeks 16. Pregnant or lactating women or women of childbearing potential unwilling/unable to use non-hormonal contraception 17. No previous or concomitant malignancies except adequately treated squamous cell / basal cell carcinoma of the skin, in situ carcinoma of the cervix or ductal carcinoma in situ/lobular carcinoma in situ of the breast, unless there has been a disease-free interval of 10 years or more 18. Psychiatric or addictive disorders which could preclude obtaining informed consent 19. Clinical evidence of severe osteoporosis and/or history of osteoporotic fracture'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients.', ' From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death)', ' Time frame: Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.', ' Overall Number of Participants Analyzed: 1763', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 2 Year DFS rate: 91 (90 to 93)', ' 5 Year DFS rate: 84 (82 to 86)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.', ' Placebo: Two capsules once daily with food', ' Overall Number of Participants Analyzed: 876', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 2 Year DFS rate: 90 (87 to 92)', ' 5 Year DFS rate: 83 (81 to 86)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 148/1755 (8.43%)', ' Anaemia * 1/1755 (0.06%)', ' Neutropenia * 0/1755 (0.00%)', ' Thrombocytopenia * 0/1755 (0.00%)', ' Thrombocytopenic purpura * 1/1755 (0.06%)', ' Acute cardiac event * 1/1755 (0.06%)', ' Aortic valve incompetence * 1/1755 (0.06%)', ' Arrhythmia * 1/1755 (0.06%)', ' Atrial fibrillation * 1/1755 (0.06%)', ' Cardiac failure * 0/1755 (0.00%)', ' Cardiac tamponade * 0/1755 (0.00%)', 'Adverse Events 2:', ' Total: 64/868 (7.37%)', ' Anaemia * 2/868 (0.23%)', ' Neutropenia * 2/868 (0.23%)', ' Thrombocytopenia * 1/868 (0.12%)', ' Thrombocytopenic purpura * 0/868 (0.00%)', ' Acute cardiac event * 0/868 (0.00%)', ' Aortic valve incompetence * 0/868 (0.00%)', ' Arrhythmia * 1/868 (0.12%)', ' Atrial fibrillation * 0/868 (0.00%)', ' Cardiac failure * 1/868 (0.12%)', ' Cardiac tamponade * 1/868 (0.12%)']}
|
52333afb-0e7a-4823-ae9b-746e0ce57c8c
|
Single
|
Adverse Events
|
NCT00005908
|
There was only one patient cohort in the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[] |
{'Clinical Trial ID': 'NCT00005908', 'Intervention': ['INTERVENTION 1: ', ' Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine', ' Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.', 'INTERVENTION 2: ', ' Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine', ' Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15'], 'Eligibility': ['INCLUSION CRITERIA:', ' Stage II or III breast cancer with a tumor size of greater than 2 cm. Patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.', ' At least 18 years of age.', ' Adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^3 and platelet count greater than 100,000/mm^3.', ' Adequate renal function as defined by creatinine less than 1.6 mg/dL.', ' Adequate hepatic function as defined by total (T.) bilirubin less than 1.4 mg/dL and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal', ' Zubrod Performance status 0-2.', 'EXCLUSION CRITERIA:', ' Medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude chemotherapy administration. Patients may be evaluated by psychiatry or medical subspecialties as appropriate.', ' Pregnant or lactating women', ' Known bleeding disorders', ' Hypersensitivity to Tween 80 (Polysorbate)', ' Cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.', ' Prior chemotherapy or hormonal therapy for breast cancer. Patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.', ' Active malignancy diagnosed within the last 5 years. (Cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.', ' Time frame: 6 years', 'Results 1: ', ' Arm/Group Title: Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine', ' Arm/Group Description: Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: Participants 9', 'Results 2: ', ' Arm/Group Title: Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine', ' Arm/Group Description: Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: Participants 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/30 (96.67%)', ' Febrile neutropenia [1]3/30 (10.00%)', ' Lymphatics 1/30 (3.33%)', ' Diarrhea (without colostomy) 5/30 (16.67%)', ' Abdominal pain or cramping 2/30 (6.67%)', ' Colitis 1/30 (3.33%)', ' Dehydration 1/30 (3.33%)', ' Nausea 1/30 (3.33%)', ' Stomatitis/pharyngitis (oral/pharyngeal/mucositis) 1/30 (3.33%)', ' Vomiting 1/30 (3.33%)', 'Adverse Events 2:', ' ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4216b27f-4d3e-4029-9637-2e6dade15b73
|
|
Comparison
|
Adverse Events
|
NCT00246090
|
NCT00266799
|
Cohort 1 of the primary trial 0.0015% less total adverse events than cohort 2 of the secondary trial.
|
Contradiction
|
[
0,
1
] |
[
15,
16
] |
{'Clinical Trial ID': 'NCT00246090', 'Intervention': ['INTERVENTION 1: ', ' E7389 1.4 mg/m^2', ' E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.', ' Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.', ' Prior therapy must be documented by the following criteria prior to entry onto study:', ' Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.', ' One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.', ' Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.', ' Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.', ' Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.', ' Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.', ' Progression on or within six months of the last regimen for advanced disease, documented by the following:', ' The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.', ' Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.', " Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.", ' Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter [LD] by spiral computer tomography [CT] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.', ' Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy Grade 2 and alopecia.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.', ' Life expectancy of 3 months.', ' Adequate renal function as evidenced by serum creatinine 2.0 mg/dL or calculated creatinine clearance 40 mL/minute (min) per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x 10^9/L hemoglobin 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count 100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.', ' Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).', ' Willing and able to comply with the study protocol for the duration of the study.', ' Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.', 'Exclusion Criteria:', ' Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.', ' Patients must not have received radiation therapy encompassing > 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).', ' Patients must not have pre-existing neuropathy > Grade 2.', ' Patients must not have participated in a prior E7389 clinical trial.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).', ' Time frame: Every two cycles', 'Results 1: ', ' Arm/Group Title: E7389 1.4 mg/m^2', ' Arm/Group Description: E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 269', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 14.1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 88/291 (30.24%)', ' Anemia3/291 (1.03%)', ' Febrile Neutropenia11/291 (3.78%)', ' Leukopenia1/291 (0.34%)', ' Neutropenia7/291 (2.41%)', ' Thrombocytopenia2/291 (0.69%)', ' Cardiac Arrest1/291 (0.34%)', ' Pericardial Effusion1/291 (0.34%)', ' Pericarditis1/291 (0.34%)', ' Tachycardia2/291 (0.69%)', ' Diplopia1/291 (0.34%)', ' Macular Hole1/291 (0.34%)', ' Abdominal Pain3/291 (1.03%)']}
|
{'Clinical Trial ID': 'NCT00266799', 'Intervention': ['INTERVENTION 1: ', ' Pegylated Liposomal Doxorubicin (PLD)', ' PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be female.', ' Patients must have metastatic disease of a cytological or histological confirmed breast cancer.', ' Patients must be 18 years or older.', ' Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable/evaluable disease are not excluded. Also patients with only bone metastasis are not excluded.', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) 0-2.', ' Patients must have a sufficient life expectancy to be treated with chemotherapy.', ' Patients must be willing and able to complete study questionnaires.', ' Patients must have adequate renal function as evidenced by serum creatinine <=1.5 mg/dL, or a creatinine clearance of >=45 mL/min (if serum creatinine is > 1.5 mg/dL but <= 1.8 mg/dL).', ' Patients must have adequate bone marrow function as evidenced by leukocyte count greater than 3.5 g/L, hemoglobin >=9.0 g/dL, and platelet count >=100x10^9/L.', ' Patients must have adequate liver function as evidenced by bilirubin of <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase <=3 times, ULN unless related to liver metastasis.', ' Patients must have Sodium and Potassium values within normal limits.', ' Patients whose clinical condition (co-morbidity) allows a treatment with monotherapy or who expressed their wish to be treated with monotherapy.', ' Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.', 'Exclusion Criteria:', ' History of receiving prior chemotherapy in the metastatic setting (Note: patients may have had', ' hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy).', ' Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded.', ' Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients.', ' Patients with known DPD (dihydro pyrimidine dehydrogenase) deficiency.', ' Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine.', ' Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy, trastuzumab, or biologicals are also not permitted.', ' Patients with Human epidermal growth factor receptor 2 (Her-2/neu) overexpressing tumors with the most recent evaluation as the relevant result', ' immunologically Her2neu 3+ positive', ' Her2neu-2+ positive and ´Fluorescent in-situ hybridization (FISH)´ positive', ' History of treatment with capecitabine', ' History of treatment with anthracyclines in the adjuvant setting exceeding cumulative doses of anthracyclines by more than 360 mg/m^2 doxorubicin (or equivalents, i.e. 600mg/m^2 epirubicine).', ' Patients with anthracycline resistant disease are not permitted. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 12 months after completion of anthracycline therapy.', ' Strong remission pressure that requires polychemotherapy with the exception of patients who are not suitable for a treatment with polychemotherapy or not accepting polychemotherapy.', ' Evidence of primary or metastatic malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater.', ' Patients with reduced liver functions (evidenced by bilirubin of above 1.5 times the upper limits of normal (ULN); alkaline phosphatase above 3 times ULN (except related to liver metastasis, in which case <=5 x ULN).', ' Dyspnea on exertion.', ' History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure or myocardial infarct within less than six months or an left ventricular ejection fraction (LVEF) below 50%.', ' Woman with childbearing potential with insufficient contraception [e.g. intra-uterine device (IUD) are regarded as sufficient] during the study period and the six months following the last study drug application. All methods based on hormonal contraception are not permitted.', ' Existing pregnancy or lactation (note on pregnancy test). A negative pregnancy test for women of childbearing potential has to be in place prior randomization (Note: A pregnancy test has to be done for patients who are not postmenopausal. Postmenopausal is defined as those not having a menstrual period for 12 months in a row).', ' Existing doubts on ability and willingness of the subject for cooperation.', ' Participation of the subject at a clinical study within the last 30 days.', ' Participation of the subject in the same clinical study at an earlier date.', ' Concomitant participation in another study than the one described here.', ' Abuse of drugs, alcohol, or pharmaceuticals.', ' Any condition, whether medical or non-medical, that may interfere, in the opinion of the investigator, with aim of this study.'], 'Results': ['Outcome Measurement: ', ' Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.', ' Time frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death', 'Results 1: ', ' Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD)', ' Arm/Group Description: PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: Months By Investigator Assessment (ITT): 6.02 (5.10 to 8.19)', ' By RECIST Criteria (ITT): 6.58 (5.29 to 8.19)', ' By Investigator Assessment (TTP N = 63, N = 59): 5.85 (4.37 to 7.86)', ' By RECIST Criteria (TTP N = 63, N = 59): 6.02 (4.37 to 7.86)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 102', ' Median (95% Confidence Interval)', ' Unit of Measure: Months By Investigator Assessment (ITT): 6.05 (4.27 to 9.07)', ' By RECIST Criteria (ITT): 7.10 (4.77 to 9.53)', ' By Investigator Assessment (TTP N = 63, N = 59): 5.88 (2.99 to 8.98)', ' By RECIST Criteria (TTP N = 63, N = 59): 6.05 (4.08 to 9.27)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/98 (30.61%)', ' NEUTROPENIA 1/98 (1.02%)', ' ATRIAL FIBRILLATION 1/98 (1.02%)', ' CARDIAC FAILURE 1/98 (1.02%)', ' TACHYCARDIA 0/98 (0.00%)', ' ACUTE VESTIBULAR SYNDROME 1/98 (1.02%)', ' VERTIGO 0/98 (0.00%)', ' ABDOMINAL PAIN 0/98 (0.00%)', ' COLITIS 0/98 (0.00%)', ' DIARRHOEA 2/98 (2.04%)', ' FEMORAL HERNIA 0/98 (0.00%)', ' HAEMATEMESIS 0/98 (0.00%)', ' ILEUS 0/98 (0.00%)', ' NAUSEA 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 46/102 (45.10%)', ' NEUTROPENIA 0/102 (0.00%)', ' ATRIAL FIBRILLATION 0/102 (0.00%)', ' CARDIAC FAILURE 0/102 (0.00%)', ' TACHYCARDIA 2/102 (1.96%)', ' ACUTE VESTIBULAR SYNDROME 0/102 (0.00%)', ' VERTIGO 1/102 (0.98%)', ' ABDOMINAL PAIN 2/102 (1.96%)', ' COLITIS 1/102 (0.98%)', ' DIARRHOEA 8/102 (7.84%)', ' FEMORAL HERNIA 1/102 (0.98%)', ' HAEMATEMESIS 1/102 (0.98%)', ' ILEUS 1/102 (0.98%)']}
|
14a32a42-424b-4b97-bae9-05f4bb2b415b
|
Single
|
Eligibility
|
NCT00030823
|
Patients with stage I, II, III or IV breast cancer may be eliglbe for the primary trial.
|
Entailment
|
[
4,
2,
11
] |
[] |
{'Clinical Trial ID': 'NCT00030823', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', ' Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:', ' Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy', ' May or may not have elevated CA 15-3 or CEA levels', ' Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels', ' Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart', ' For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart', ' Stage III and completed adjuvant therapy no more than 24 months ago', ' Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy', ' Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection', ' Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago', ' Stage IV that is stable on hormonal therapy', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 and over', ' Sex:', ' Male or female', ' Menopausal status:', ' Not specified', 'Performance status:', ' Karnofsky 80-100%', ' Life expectancy:', ' Not specified', ' Hematopoietic:', ' Lymphocyte count at least 500/mm^3', ' WBC at least 3,000/mm^3', ' Hepatic:', ' AST no greater than 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase no greater than 1.5 times ULN', ' Renal:', ' Creatinine no greater than 1.5 times ULN', ' Cardiovascular:', ' No clinically significant New York Heart Association class III or IV cardiac disease', ' Other:', ' Not pregnant', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No prior seafood allergy', ' No known prior immunodeficiency or autoimmune disease', ' No other active cancer except basal cell or squamous cell skin cancer', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' At least 6 weeks since prior immunotherapy', ' No prior vaccine with any of the antigens in this study', ' Chemotherapy:', ' See Disease Characteristics', ' At least 4 weeks since prior chemotherapy', ' No concurrent chemotherapy', ' Endocrine therapy:', ' See Disease Characteristics', ' Radiotherapy:', ' See Disease Characteristics', ' At least 4 weeks since prior radiotherapy', ' No concurrent radiotherapy', ' Surgery:', ' See Disease Characteristics', ' At least 4 weeks since prior surgery', ' Concurrent surgery for local recurrence allowed if patient remains disease free'], 'Results': ['Outcome Measurement: ', ' Safety', ' By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/13 (7.69%)', ' SGPT (ALT) 1/13 (7.69%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4d83c630-d767-40cf-9aec-c871c6fc7f38
|
|
Single
|
Eligibility
|
NCT03371732
|
Any patients with Karnofsky Index < 80 are eligible for the primary trial.
|
Contradiction
|
[
0,
1,
2,
3
] |
[] |
{'Clinical Trial ID': 'NCT03371732', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Arm 1: Motivational Intervention group', ' Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.', 'INTERVENTION 2: ', ' Arm 2', ' Arm 2: Educational advises group', ' Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.'], 'Eligibility': ['Inclusion Criteria :', ' women with primary breast cancer, without ongoing support for substance use.', ' An AUDIT-C score >1 or more than one cigarette smoked per day.', ' Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).', ' Exclusion Criteria :', ' Patients who currently use substances for which a second-line care is already committed.', ' Patients with a Karnofsky index <70.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months', ' Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months', ' AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Arm 1: Motivational Intervention group', ' Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Success: 23 47.9%', ' Success not maintained: 18 37.5%', 'Missing: 7 14.6%', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Arm 2: Educational advises group', ' Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Success: 19 35.8%', ' Success not maintained: 29 54.7%', 'Missing: 5 9.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4fd230f2-caf1-44d6-81f2-4f51dda6da3a
|
|
Single
|
Results
|
NCT00764322
|
The Ultra-rapid Metabolizers group of the primary trial had average increase of Endoxifen Concentration over 6 ng/mL over 4 months.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12
] |
[] |
{'Clinical Trial ID': 'NCT00764322', 'Intervention': ['INTERVENTION 1: ', ' Ultra-rapid Metabolizers', ' Those with the highest transformation of the CYP2D6 genotype to allelic activity', 'INTERVENTION 2: ', ' Extensive Metabolizers', ' Those with the most normal transformation of the CYP2D6 genotype to allelic activity'], 'Eligibility': ['Inclusion:', ' Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention', ' Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy 6 months Absolute Neutrophil Count (ANC) 1.0 x 10^9/L Platelet count 100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2.5 times Upper Limit of Normal (ULN) Total bilirubin 2.5 times ULN Creatinine clearance 50 mL/min Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' No limitations to number of prior therapies', ' No limitations for prior radiotherapy', ' More than 14 days since prior and no other concurrent investigational agent', ' Exclusion:', ' Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin', ' No concurrent medications known to inhibit CYP2D6, including any of the following:', ' Amiodarone', ' Haloperidol', ' Indinavir', ' Ritonavir', ' Quinidine', ' No concurrent selective serotonin reuptake inhibitors, except the following:', ' Venlafaxine', 'Citalopram'], 'Results': ['Outcome Measurement: ', ' Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes', ' Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Ultra-rapid Metabolizers', ' Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants', ' 8.4 (4.59)', ' 4-Month endoxifen concentration: 4 participants', ' 15.35 (5.48)', 'Results 2: ', ' Arm/Group Title: Extensive Metabolizers', ' Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 119', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants', ' 10.00 (6.00)', ' 4-Month endoxifen concentration: 106 participants', ' 9.30 (5.03)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/161 (0.00%)', ' headache * 20/161 (0.00%)', ' Mood alteration 2 [1]0/161 (0.00%)', ' Hemorrhage, GU 0/161 (0.00%)', ' thrombosis * 2 [2]0/161 (0.00%)', 'Adverse Events 2:', ' Total: 3/290 (1.03%)', ' headache * 21/290 (0.34%)', ' Mood alteration 2 [1]1/290 (0.34%)', ' Hemorrhage, GU 1/290 (0.34%)', ' thrombosis * 2 [2]1/290 (0.34%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
7a3d1ca7-8776-4ace-bbc0-107635b93583
|
|
Single
|
Eligibility
|
NCT02040857
|
Only men and postmenopausal women are eligible for the primary trial.
|
Contradiction
|
[
2
] |
[] |
{'Clinical Trial ID': 'NCT02040857', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib With Adjuvant Endocrine Therapy', ' Palbociclib 125 mg PO qd 21 days on, 7 days off', ' Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.', ' Men and both pre- and postmenopausal women are eligible.', ' Prior Treatment:', ' Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.', ' Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.', ' If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.', ' Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.', ' ECOG performance status 0-1', ' Age 18 years.', ' Normal organ and marrow function', ' Baseline QTc 480 ms', ' The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Concurrent therapy with other investigational agents.', ' Prior therapy with any CDK4/6 inhibitor.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.', ' Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.', ' Current use of drugs that are known to prolong the QT interval', ' Subjects with organ allograft requiring immunosuppression.', ' 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 prior to entry onto the study.', ' Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.', ' No ongoing combination antiretroviral therapy'], 'Results': ['Outcome Measurement: ', ' 2-Year Treatment Discontinuation Rate', ' The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.', ' Time frame: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.', 'Results 1: ', ' Arm/Group Title: Palbociclib With Adjuvant Endocrine Therapy', ' Arm/Group Description: Palbociclib 125 mg PO qd 21 days on, 7 days off', ' Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd', ' Overall Number of Participants Analyzed: 152', ' Measure Type: Number', ' Unit of Measure: percentage of participants 31 (24 to 39)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 96/162 (59.26%)', ' Cardiac disorders - Other, specify 2/162 (1.23%)', ' Diarrhea 1/162 (0.62%)', ' Mucositis oral 2/162 (1.23%)', ' Nausea 1/162 (0.62%)', ' Fatigue 6/162 (3.70%)', ' Breast infection 2/162 (1.23%)', ' Soft tissue infection 1/162 (0.62%)', ' Lymphocyte count decreased 2/162 (1.23%)', ' Neutrophil count decreased 78/162 (48.15%)', ' Hypertension 1/162 (0.62%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e95902f1-bf4f-4bb5-8f48-4fa5ba6425d0
|
|
Comparison
|
Eligibility
|
NCT01966471
|
NCT00981812
|
A patient who had a breast-conserving surgery in the year prior to study entry would be excluded from both the primary trial and the secondary trial.
|
Contradiction
|
[
0,
4,
5
] |
[
5,
12
] |
{'Clinical Trial ID': 'NCT01966471', 'Intervention': ['INTERVENTION 1: ', ' Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane', ' Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.', 'INTERVENTION 2: ', ' Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab', ' Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1', ' Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable', ' HER2-positive breast cancer', ' Known hormone receptor status of the primary tumor', 'Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy', ' Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:', ' Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory', ' Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive', ' No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization', ' Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans', ' Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required', ' Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment', 'Exclusion Criteria:', ' History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma', ' History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin', ' Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer', ' For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)', ' Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy', ' History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study', ' Participants with contraindication to RT while adjuvant RT is clinically indicated', ' Concurrent anti-cancer treatment in another investigational trial', ' Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy', ' Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV', ' Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines', ' Inadequate hematologic, renal or liver function', ' Pregnant or lactating women', ' Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol', ' Chronic immunosuppressive therapies, including systemic corticosteroids'], 'Results': ['Outcome Measurement: ', ' Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation', ' IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.', ' Time frame: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.', 'Results 1: ', ' Arm/Group Title: Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane', ' Arm/Group Description: Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.', ' Overall Number of Participants Analyzed: 826', ' Measure Type: Number', ' Unit of Measure: Percent Probability 94.10 (92.46 to 95.73)', 'Results 2: ', ' Arm/Group Title: Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab', ' Arm/Group Description: Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.', ' Overall Number of Participants Analyzed: 832', ' Measure Type: Number', ' Unit of Measure: Percent Probability 92.75 (90.95 to 94.54)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 216/926 (23.33%)', ' Anaemia 2/926 (0.22%)', ' Febrile neutropenia 51/926 (5.51%)', ' Leukopenia 2/926 (0.22%)', ' Neutropenia 16/926 (1.73%)', ' Thrombocytopenia 0/926 (0.00%)', ' Arrhythmia 1/926 (0.11%)', ' Cardiac failure 5/926 (0.54%)', ' Cardiac failure congestive 3/926 (0.32%)', ' Cardiomyopathy 0/926 (0.00%)', ' Congestive cardiomyopathy 2/926 (0.22%)', 'Adverse Events 2:', ' Total: 195/912 (21.38%)', ' Anaemia 3/912 (0.33%)', ' Febrile neutropenia 31/912 (3.40%)', ' Leukopenia 0/912 (0.00%)', ' Neutropenia 10/912 (1.10%)', ' Thrombocytopenia 1/912 (0.11%)', ' Arrhythmia 0/912 (0.00%)', ' Cardiac failure 2/912 (0.22%)', ' Cardiac failure congestive 1/912 (0.11%)', ' Cardiomyopathy 1/912 (0.11%)', ' Congestive cardiomyopathy 0/912 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00981812', 'Intervention': ['INTERVENTION 1: ', ' Lesions Visualized Using Positron Emission Mammography (PEM)', ' Total lesions visualized using positron emission mammography.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' subject is 25-100 years of age', ' subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy', ' subject is able to provide informed consent', 'Exclusion Criteria:', ' subject is pregnant', ' subject is actively lactating or discontinued breastfeeding less than 2 months ago', ' subject has breast implants', ' subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study', ' subject has contraindications for core biopsy and other invasive procedures', ' subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus', ' subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months', ' subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging'], 'Results': ['Outcome Measurement: ', ' Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.', ' [Not Specified]', ' Time frame: At time of biopsy', 'Results 1: ', ' Arm/Group Title: Lesions Visualized Using Positron Emission Mammography (PEM)', ' Arm/Group Description: Total lesions visualized using positron emission mammography.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: Breast Lesions Index Lesioins: 22', ' Index Lesions Visualized at PEM: 21', ' Additional Lesions seen only at PEM: 6', ' Lesions technically adequate for targeting: 26', ' Number of Lesions Biopsied: 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}
|
1196db61-0846-4185-afc9-dc4b2fccd059
|
Comparison
|
Intervention
|
NCT02005887
|
NCT00050011
|
All Participants in the primary trial and the secondary trial are receiving the same daily dose of oral Letrozole for the same duration of time.
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Entailment
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[
0,
1,
2,
3,
4
] |
[
0,
1,
2,
3,
4
] |
{'Clinical Trial ID': 'NCT02005887', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Triptorelin + Letrozol', ' Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles', ' Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', 'INTERVENTION 2: ', ' Arm B: Degarelix + Letrozol', ' Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles', ' Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female gender', ' Premenopausal status measured within 14 days Prior to randomization: Estradiol (E2) must be above 54 pg/mL (or above 198 pmol/L', ' Age 18 years', ' Performance Status - Eastern Cooperative Oncology Group (ECOG) 0-1', ' Histologically confirmed invasive breast cancer: Primary tumor greater than 2 cm Diameter, any nodal stage, no evidence of metastasis (M0)', ' Primary tumor must have ER and PgR >50% of the cells', ' Primary tumor must be HER2-negative (by IHC and/or ISH)', ' Hematopoietic status: Absolute neutrophil count 1.5 × 109/L, platelet count 100 × 109/L, hemoglobin 9 g/dL', ' Hepatic status: Serum total bilirubin 1.5 × upper limit of normal (ULN), AST and ALT 2.5 × ULN, Alkaline phosphatase 2.5 × ULN', ' Renal status: Creatinine 1.5 ×ULN', ' Negative serum pregnancy test, within 2 weeks (preferably 7 days) prior to randomization.', ' The patient must be willing to use effective non-hormonal contraception after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed within 2 months prior to randomization and during the trial.', ' Prior fertility treatment is allowed but must have been stopped at least 12 months before randomization.', ' The patient has completed the baseline patient-reported symptoms questionnaire.', ' Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.', ' The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.', ' The patient accepts blood samples to be taken for the determination of the primary endpoint.', ' The patient agrees to make tumor available for submission for central pathology review and for translational studies as part of this protocol', 'Exclusion Criteria:', ' Postmenopausal', ' Any hormonal treatment (e.g., oral, injectable, implant, or medicated IUD) in the previous 2 months', ' Presence of HER2 overexpression or amplification', ' Received any prior treatment for primary invasive breast cancer', ' Received any GnRH analog or SERM or AI within 12 months prior to randomization', ' A history of malignant neoplasms within the past 10 years, except for curatively treated,Basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the bladder', ' Previous ipsilateral breast cancer (invasive or in situ) at any time', ' Inflammatory breast cancer', ' Bilateral invasive breast cancer', ' 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', ' Active or uncontrolled infection CTCAE v.4 grade 2 or higher', ' Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent', ' Treatment with an investigational agent must have stopped at least 30 days before randomization.', ' Pregnant or lactating women; lactation has to stop before randomization.'], 'Results': ['Outcome Measurement: ', ' Time to Optimal Ovarian Function Suppression', ' Time from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression ( 2.72 pg/mL or 10 pmol/L) during the 6 cycles of neoadjuvant treatments.', ' Time frame: up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Arm A: Triptorelin + Letrozol', ' Arm/Group Description: Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles', ' Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: days 14 (8 to 14)', 'Results 2: ', ' Arm/Group Title: Arm B: Degarelix + Letrozol', ' Arm/Group Description: Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles', ' Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)', ' Letrozole: Letrozole 2.5 mg orally every day for 6 cycles', ' Overall Number of Participants Analyzed: 25', ' Median (95% Confidence Interval)', ' Unit of Measure: days 3 (3 to 3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT00050011', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Upfront', ' Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', 'INTERVENTION 2: ', ' Zoledronic Acid Delayed-start', ' In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Postmenopausal status defined by one of the following :', ' women equal to or greater than 55 years with cessation of menses', ' spontaneous cessation of menses within the past 1 year, but amenorrheic in women less than or equal to 55 years (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved', ' bilateral oophorectomy (prior to the diagnosis of breast cancer).', ' Adequately diagnosed and treated breast cancer defined as:', ' Patients with breast cancer whose tumor can be removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery and who receive appropriate additional local treatments such as radiotherapy according to best practice.', ' Patients must be at the end of their local treatment without evidence of local residual disease.', ' Patients must have no clinical or radiological evidence of distant metastasis.', ' Hormone receptor positive defined as:', ' ER and/or PR greater than or equal to1 0 fmol/mg cytosol protein; or greater than or equal to 10% of the tumor cells positive by', ' immunohistochemical evaluation.', ' Patients with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD are eligible.', ' Patients who will receive adjuvant chemotherapy are eligible for participation. Adjuvant chemotherapy must be completed prior to randomization.', ' The date of randomization must not be more than the following:', ' 12 weeks from completion of surgery;', ' 12 weeks after completion of adjuvant chemotherapy;', " 12 weeks after completion of surgery and radiation therapy; however the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", " 12 weeks after completion of chemotherapy and radiation therapy; however, the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", ' Patients who have undergone neoadjuvant chemotherapy are eligible.', ' No prior treatment with Femara.', 'Exclusion criteria:', ' Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization.', ' Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.', ' Patients with a history of fracture with low-intensity or no associated trauma.', ' Patients who have started adjuvant hormonal therapy or who have completed adjuvant hormonal therapy prior to randomization.', ' Patients who have received any endocrine therapy within the past 12 months (other than neoadjuvant tamoxifen or toremifene, insulin and/or oral anti-diabetic medications, and thyroid hormone replacement). Hormone replacement therapy must be discontinued prior to randomization.', ' Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months.', ' Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be discontinued within 3 weeks of baseline evaluations.', ' Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting, is acceptable).', ' Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months.', ' Patients with prior use of Tibolone within the last 6 months.', ' Any prior use of PTH for more than 1 week.', ' Prior use of systemic sodium fluoride for > 3 months during the past 2 years.', ' Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.', ' Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.', ' Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded.', ' Uncontrolled seizure disorders associated with falls.', ' Patients with abnormal renal function as evidenced by a serum creatinine equal to or greater than 3 mg/dL (265.2 mmol/L).', " History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months prior to study entry.", ' Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.', ' Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days.', ' Additional Exclusion Criteria: (for Spine DXA)', ' History of surgery at the lumbosacral spine, with or without implantable devices.', ' Scoliosis with a Cobb angle >15 degree at the lumbar spine.', ' Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan.', ' Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.', ' Additional protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)', ' Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.', ' Time frame: Baseline, 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Upfront', ' Arm/Group Description: Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 253', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD 1.955 (3.3658)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Delayed-start', ' Arm/Group Description: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 256', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD -2.325 (3.9542)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 83/300 (27.67%)', ' Anaemia 2/300 (0.67%)', ' Granulocytopenia 1/300 (0.33%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 0/300 (0.00%)', ' Acute coronary syndrome 1/300 (0.33%)', ' Acute myocardial infarction 2/300 (0.67%)', ' Angina pectoris 2/300 (0.67%)', ' Aortic valve stenosis 1/300 (0.33%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 0/300 (0.00%)', 'Adverse Events 2:', ' Total: 71/300 (23.67%)', ' Anaemia 0/300 (0.00%)', ' Granulocytopenia 0/300 (0.00%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 1/300 (0.33%)', ' Acute coronary syndrome 0/300 (0.00%)', ' Acute myocardial infarction 1/300 (0.33%)', ' Angina pectoris 1/300 (0.33%)', ' Aortic valve stenosis 0/300 (0.00%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 1/300 (0.33%)']}
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567ec6e3-87aa-4a4a-94b8-ebdf2e0cbf64
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Single
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Adverse Events
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NCT00490646
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Cohort 1 of the primary trial had 25% more patients experiencing Cholecystitis than cohort 2.
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Contradiction
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[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27
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{'Clinical Trial ID': 'NCT00490646', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV', ' trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV', ' trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.', ' Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.', ' Measurable disease', ' Left Ventricular Ejection Fraction (LVEF) 50%', 'Exclusion Criteria:', ' Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)', ' Relapse within 1 year after (neo)adjuvant taxane or trastuzumab', ' Neuropathy > Grade 1', ' Significant cardiovascular disease', ' Any brain metastases'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)', ' Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.', ' Time frame: Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)', 'Results 1: ', ' Arm/Group Title: Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV', ' Arm/Group Description: trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60.0 (38.7 to 78.9)', 'Results 2: ', ' Arm/Group Title: Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV', ' Arm/Group Description: trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 52.0 (31.3 to 72.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/24 (54.17%)', ' FEBRILE NEUTROPENIA 5/24 (20.83%)', ' HAEMATOTOXICITY 0/24 (0.00%)', ' NEUTROPENIA 3/24 (12.50%)', ' LYMPHADENOPATHY 0/24 (0.00%)', ' PERICARDIAL EFFUSION 1/24 (4.17%)', ' ATRIAL FIBRILLATION 1/24 (4.17%)', ' APLASIA 0/24 (0.00%)', ' NAUSEA 0/24 (0.00%)', ' PYREXIA 1/24 (4.17%)', ' EXTRAVASATION 0/24 (0.00%)', ' CHOLECYSTITIS 1/24 (4.17%)', ' PATHOLOGICAL FRACTURE 1/24 (4.17%)', 'Adverse Events 2:', ' Total: 6/24 (25.00%)', ' FEBRILE NEUTROPENIA 0/24 (0.00%)', ' HAEMATOTOXICITY 1/24 (4.17%)', ' NEUTROPENIA 0/24 (0.00%)', ' LYMPHADENOPATHY 1/24 (4.17%)', ' PERICARDIAL EFFUSION 0/24 (0.00%)', ' ATRIAL FIBRILLATION 0/24 (0.00%)', ' APLASIA 1/24 (4.17%)', ' NAUSEA 1/24 (4.17%)', ' PYREXIA 0/24 (0.00%)', ' EXTRAVASATION 1/24 (4.17%)', ' CHOLECYSTITIS 0/24 (0.00%)', ' PATHOLOGICAL FRACTURE 0/24 (0.00%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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7e629f62-2981-4462-a4c1-f0cc9c24777a
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Single
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Intervention
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NCT00600340
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Cohorts 1 of the primary trial recieves Bevacizumab at a higher frequency than cohort 2.
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Entailment
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[
0,
1,
2,
3,
4,
5
] |
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{'Clinical Trial ID': 'NCT00600340', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab Plus Paclitaxel', ' Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', 'INTERVENTION 2: ', ' Bevacizumab Plus Capecitabine', ' Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks'], 'Eligibility': ['Inclusion Criteria', ' Written informed consent obtained prior to any study-specific procedure.', ' Age 18 years.', ' Able to comply with the protocol.', ' Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.', ' Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.', ' Life expectancy more than 12 weeks.', ' Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:', ' Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.', ' Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin.', ' Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that:', ' no more than 30% of marrow-bearing bone was irradiated', ' the last fraction of radiotherapy was administered 3 weeks prior to randomization.', ' Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF 50% by either echocardiogram or multigated acquisition scan (MUGA).', ' Adequate hematological function', ' Absolute neutrophil count (ANC) 1.5 x 109/L', ' Platelet count 100 x 109/L', ' Hemoglobin 9 g/dL (may be transfused to maintain or exceed this level).', ' Adequate liver function', ' Total bilirubin 1.25 x upper normal limit (ULN)', ' Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5.0 x ULN in patients with liver metastases.', ' Adequate renal function', ' Serum creatinine 1.25 x ULN or calculated creatinine clearance 50 mL/min.', ' Urine dipstick for proteinuria < +2. Patients discovered to have +2 proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate 1g of protein in 24 hours', ' The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization', ' Patients on heparin treatment should have a baseline activated partial thromboplastin time (aPTT) between 1.5 - 2.5 times ULN or patients value before starting heparin treatment', ' Patients on low molecular weight heparins (LMWH) should receive daily dose of 1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent anticoagulant, according to package insert', ' Patients on coumarin derivatives should have an international normalized ratio (INR) between 2.0 and 3.0 assessed at baseline in two consecutive measurements 1-4 days apart', ' Patients not receiving anticoagulant medication must have an INR 1.5 and aPTT 1.5 times ULN within 7 days prior to randomization', ' Exclusion Criteria', ' Previous chemotherapy for metastatic or locally recurrent breast cancer.', ' Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization.', ' Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above).', ' Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.', ' Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization.', ' Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases.', ' History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).', ' Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.', ' Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization.', ' Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).', ' Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).', ' History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.', ' Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg).', ' Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.', ' Non-healing wound, active peptic ulcer or bone fracture.', ' History of abdominal fistula, or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization.', ' Active infection requiring i.v. antibiotics at randomization.', ' Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.', ' Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug.', ' Men who do not agree to use effective contraception during the study and for a period of 6 months following the last administration of study drug.', ' Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study', ' Clinically significant malabsorption syndrome or inability to take oral medication.', ' Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake.', ' Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.', ' Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications.', ' Known Dihydropyrimidine Dehydrogenase (DPD) deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency)', ' Known hypersensitivity to any of the study drugs (including 5-FU) or excipients. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. History of hypersensitivity reactions with drugs formulated in Cremophor® EL (polyoxyethylated castor oil), or previous therapy with bevacizumab.'], 'Results': ['Outcome Measurement: ', ' Overall Survival (PP Population)', " Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.", ' Time frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab Plus Paclitaxel', ' Arm/Group Description: Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks', ' Overall Number of Participants Analyzed: 266', ' Median (95% Confidence Interval)', ' Unit of Measure: months 30.2 (25.6 to 32.6)', 'Results 2: ', ' Arm/Group Title: Bevacizumab Plus Capecitabine', ' Arm/Group Description: Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m twice-daily, days 1-14, every 3 weeks', ' Overall Number of Participants Analyzed: 265', ' Median (95% Confidence Interval)', ' Unit of Measure: months 26.1 (22.3 to 29.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 65/284 (22.89%)', ' Anaemia 0/284 (0.00%)', ' Febrile neutropenia 2/284 (0.70%)', ' Leukopenia 1/284 (0.35%)', ' Neutropenia 1/284 (0.35%)', ' Acute coronary syndrome 0/284 (0.00%)', ' Acute myocardial infarction 1/284 (0.35%)', ' Atrial fibrillation 1/284 (0.35%)', ' Atrioventricular block 1/284 (0.35%)', ' Atrioventricular block complete 0/284 (0.00%)', ' Cardio-respiratory arrest 0/284 (0.00%)', 'Adverse Events 2:', ' Total: 68/277 (24.55%)', ' Anaemia 4/277 (1.44%)', ' Febrile neutropenia 1/277 (0.36%)', ' Leukopenia 1/277 (0.36%)', ' Neutropenia 1/277 (0.36%)', ' Acute coronary syndrome 1/277 (0.36%)', ' Acute myocardial infarction 0/277 (0.00%)', ' Atrial fibrillation 0/277 (0.00%)', ' Atrioventricular block 0/277 (0.00%)', ' Atrioventricular block complete 1/277 (0.36%)', ' Cardio-respiratory arrest 1/277 (0.36%)']}
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{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
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c660faec-58d8-4ba9-8e18-1775b1135819
|
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Single
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Adverse Events
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NCT03078751
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Cohort 2 of the primary trial reported one case of AML.
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Contradiction
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[
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'Clinical Trial ID': 'NCT03078751', 'Intervention': ['INTERVENTION 1: ', ' Ribociclib + Adjuvant Endocrine Therapy (ET)', ' Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)', 'INTERVENTION 2: ', ' Placebo + Adjuvant Endocrine Therapy (ET)', ' Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen'], 'Eligibility': ['Key Inclusion Criteria:', ' Histologically confirmed unilateral primary invasive adenocarcinoma of the breast', ' Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer', ' Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen', ' Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue', ' Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of 4 cycles or 12 weeks which included taxanes prior to screening', ' Patient has completed adjuvant radiotherapy (if indicated) prior to screening', ' Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET', ' ECOG Performance Status 0 or 1', ' Adequate bone marrow and organ function', ' Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits', ' QTcF interval < 450 msec and mean resting heart rate 50-90 bpm', ' Key Exclusion Criteria:', ' Prior treatment with CDK4/6 inhibitor', ' Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years', ' Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin', ' Distant metastases of breast cancer beyond regional lymph nodes', ' Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery', ' Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias', ' Uncontrolled hypertension with systolic blood pressure >160 mmHg', ' Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.', ' Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the study', ' Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events and Serious Adverse Events', ' These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not', ' Time frame: Up to 26 months', 'Results 1: ', ' Arm/Group Title: Ribociclib + Adjuvant Endocrine Therapy (ET)', ' Arm/Group Description: Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Participants Adverse Events: 25', ' Serious Adverse Events: 4', 'Results 2: ', ' Arm/Group Title: Placebo + Adjuvant Endocrine Therapy (ET)', ' Arm/Group Description: Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: Participants Adverse Events: 21', ' Serious Adverse Events: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/26 (15.38%)', ' Disseminated intravascular coagulation 1/26 (3.85%)', ' Cardiac failure congestive 1/26 (3.85%)', ' Breast cellulitis 1/26 (3.85%)', ' Cellulitis 1/26 (3.85%)', ' Acute myeloid leukaemia 1/26 (3.85%)', ' Seizure 0/26 (0.00%)', ' Pulmonary embolism 1/26 (3.85%)', 'Adverse Events 2:', ' Total: 2/24 (8.33%)', ' Disseminated intravascular coagulation 0/24 (0.00%)', ' Cardiac failure congestive 0/24 (0.00%)', ' Breast cellulitis 0/24 (0.00%)', ' Cellulitis 1/24 (4.17%)', ' Acute myeloid leukaemia 0/24 (0.00%)', ' Seizure 1/24 (4.17%)', ' Pulmonary embolism 0/24 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
a6fcfea0-eacd-4a04-92a8-55a0c3c8bfb2
|
|
Comparison
|
Intervention
|
NCT01830933
|
NCT01224678
|
Patients in the primary trial do not receive any extra medication for the study, whereas in the secondary trial they are given an oral medication.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
5
] |
{'Clinical Trial ID': 'NCT01830933', 'Intervention': ['INTERVENTION 1: ', ' Usual Care', ' Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.', 'INTERVENTION 2: ', ' BreastCARE Intervention', ' Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.', ' Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.', ' BreastCARE : The physician will receive a physician report that contains information similar to the patient report.'], 'Eligibility': ['Inclusion Criteria:', ' Patient component:', ' Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period', ' Between the ages of 40 and 74', ' Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White', ' Have no history of breast cancer are eligible to participate.', ' Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF', 'Exclusion Criteria:', ' Patient component: Women whose physicians object to their participation in the study', ' Physician component: No exclusion criteria for physicians'], 'Results': ['Outcome Measurement: ', ' Knowledge of Breast Cancer Risk Factors', ' Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O', ' Time frame: one week post-initial visit (approximately one week)', 'Results 1: ', ' Arm/Group Title: Usual Care', ' Arm/Group Description: Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.', ' Overall Number of Participants Analyzed: 655', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 48.9 (24.3)', 'Results 2: ', ' Arm/Group Title: BreastCARE Intervention', ' Arm/Group Description: Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.', ' Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.', ' BreastCARE : The physician will receive a physician report that contains information similar to the patient report.', ' Overall Number of Participants Analyzed: 580', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 56.4 (24.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/655 (0.00%)', 'Adverse Events 2:', ' Total: 0/580 (0.00%)']}
|
{'Clinical Trial ID': 'NCT01224678', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Patients receive oral placebo once daily for 12 months.', 'INTERVENTION 2: ', ' Vitamin D', ' Patients receive oral vitamin D (2000 IU) once daily for 12 months.'], 'Eligibility': ['Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.', ' Women with breast density 25% (scattered fibroglandular densities or greater) are eligible.', ' Prior Treatment', ' Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.', ' Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.', ' Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.', ' Vitamin D Use', ' Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.', ' Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.', ' Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.', ' Patients with a history of breast implants or breast reduction are not eligible.', ' Patients with two or more bone fractures in the past five years are not eligible.', ' Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.', ' Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.', ' Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.', ' Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.', ' Required initial laboratory values - Calcium < 10.5 mg/dL'], 'Results': ['Outcome Measurement: ', ' Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms', ' To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients receive oral placebo once daily for 12 months.', ' Overall Number of Participants Analyzed: 46', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -3.4 (7.1)', 'Results 2: ', ' Arm/Group Title: Vitamin D', ' Arm/Group Description: Patients receive oral vitamin D (2000 IU) once daily for 12 months.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -1.4 (11.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/150 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
3ee5742b-6bc3-400f-92eb-641384a75201
|
Single
|
Eligibility
|
NCT01823991
|
Patients with irrational fear of confined spaces are not elligible for the primary trial.
|
Entailment
|
[
9,
19
] |
[] |
{'Clinical Trial ID': 'NCT01823991', 'Intervention': ['INTERVENTION 1: ', ' A - Cognutrin #1', ' Cognutrin Treatment Time 1', 'INTERVENTION 2: ', ' B - Cognutrin #2', 'Cognutrin Time 2.'], 'Eligibility': ['Inclusion Criteria:', ' Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)', ' Able to understand and sign the informed consent', ' Fluent in reading, comprehension and communication in the English language', ' No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence of cognitive impairment', ' Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score >60%)', ' Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)', ' Must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice', 'Exclusion Criteria:', ' Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months', ' Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)', ' Patients with advanced or Stage IIIIB or IV breast cancer or other cancers', ' Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial', ' History of known allergy to components of the study supplements', ' Renal or liver disease', ' Concurrent participation in another chemoprevention trial', ' Evidence of bleeding diathesis or coagulopathy', ' Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.)', ' Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging', ' Medical history of concussions', ' Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the potential participant inappropriate for entry into this study'], 'Results': ['Outcome Measurement: ', ' Change in Cognitive Function Scores With Intervention - HVLT and COWA', ' Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The HVLT test assesses verbal learning and memory. Subjects are given a list of words and asked to repeat as many words as they can recall at 3 times. There is no absolute low & high, as scores are age adjusted. Reported scores are T-scores- average score should be 50, with a standard deviation of 10. Any score below 50 indicates performance below population averages and any score above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be -3.0 and 3.0. A lower Z score is indicative of poor fluency.', ' Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)', 'Results 1: ', ' Arm/Group Title: A - Cognutrin #1', ' Arm/Group Description: Cognutrin Treatment Time 1', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Error)', ' Unit of Measure: score HVLT-total recall: 49.04 (6.41)', ' HVLT-delayed recall: 44.82 (5.33)', ' COWA-z score: -.341 (.686)', 'Results 2: ', ' Arm/Group Title: B - Cognutrin #2', ' Arm/Group Description: Cognutrin Time 2.', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Error)', ' Unit of Measure: score HVLT-total recall: 44.93 (7.55)', ' HVLT-delayed recall: 41.59 (7.02)', ' COWA-z score: -.452 (.577)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/18 (5.56%)', ' Psychosis * [1]1/18 (5.56%)', 'Adverse Events 2:', ' Total: 0/18 (0.00%)', ' Psychosis * [1]0/18 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
f6af788f-ee96-4308-8dec-12d0c46e957a
|
|
Comparison
|
Results
|
NCT00118157
|
NCT01401959
|
Participants in the primary trial had a higher likelihood of achieving 2 Year Disease-Free Survival than those in either cohort of the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
{'Clinical Trial ID': 'NCT00118157', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.', ' lapatinib ditosylate: Given orally', ' tamoxifen citrate: Given orally'], 'Eligibility': ['Inclusion Criteria:', ' Primary adenocarcinoma of the breast confirmed by histology or cytology', ' Locally advanced or metastatic disease not amenable to surgery or radiation therapy with curative intent', ' Estrogen and/or progesterone receptor positive cancer', ' Patients have failed hormonal manipulation with tamoxifen, either showing no response (primary resistance) to initial therapy or relapse/progression after showing initial response (secondary failure)', ' At least 1 measurable (target) lesion (i.e. any malignant tumor mass that can be accurately measured in at least 1 dimension, >= 20 mm with conventional radiographic techniques or >= 10 mm with magnetic resonance imaging [MRI] or spiral computerized tomography [CT] scans), in a previously un-irradiated area', ' No more than 450 mg/m^2 of prior doxorubicin', ' Life expectancy >= 3 months', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Absolute neutrophil count (ANC) >= 1500/mm^3', ' Platelets >= 100,000/mm^3', ' Hemoglobin >= 9.0 g/dL', ' Creatinine (Cr) =< upper limit of normal (ULN) or Cr clearance > 60 mL/min/m^2', ' Total bilirubin =< 1.5 x ULN', ' Alanine aminotransferase (ALT) =< 1.5 x ULN or =< 3 x ULN with liver metastases', ' Aspartate aminotransferase (AST) =< 5 x ULN or =< 3 x ULN with liver metastases', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multi gated acquisition scan (MUGA) scan; (note that baseline and on-treatment scans should be performed using the same modality and preferably at the same institution)', ' Patients on oral anticoagulants (Coumadin, warfarin) should either be switched to low molecular weight heparin or have a very close monitoring of international normalized ratio (INR), if continued on Coumadin', ' Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and women within 6 months of menopause; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; both men and women should be counseled in contraceptive use due to unknown effects of the drug on the fetus and breast feeding should be avoided', ' Ability to understand and the willingness to sign a written informed consent document', ' Ability to swallow and retain oral medication', 'Exclusion Criteria:', ' Patients who have had prior treatment with EGFR and or Her-2 targeting therapies (prior trastuzumab combined with chemotherapy in the adjuvant setting only is allowed, but the combination of trastuzumab with hormonal therapy is not allowed)', ' Current treatment with any other anti-neoplastic agent, including trastuzumab; patients may continue to receive zoledronic acid for bone metastases or hypercalcemia', ' Radiation therapy within 2 weeks of enrollment or surgery within 4 weeks', ' Rapidly progressive disease in major organs (i.e. lymphangitic spread, bulky liver metastasis) or known brain/leptomeningeal metastatic disease requiring active therapy; (patients with asymptomatic, stable previously treated metastases to the central nervous system and surrounding tissues are eligible; however patients must not have a requirement for corticosteroids due to central nervous system metastases at the time of study entry)', ' Any of the following conditions within 6 months of enrollment: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, coronary/peripheral artery bypass grafting; patients who have experienced a pulmonary embolus, deep venous thrombosis or other clinically significant thromboembolic event within 6 months of enrollment are eligible if they are clinically stable on anticoagulation therapy', ' Pregnancy or breast feeding; breastfeeding should be discontinued if the mother is treated with GW572016; female patients must agree to use effective contraception during the study period, be surgically sterile, or be post-menopausal; in addition, male patients will be required to use effective contraception during the study period or be surgically sterile; the definition of effective contraception will be based on the judgment of the investigator', ' Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016', " Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)", ' Treatment with any agents that interact with cytochrome P450 3A should be avoided and used with caution, if necessary; when possible, patients should be switched to alternative medications; patients requiring anticoagulation should either be switched to a low molecular weight heparin injection or have a very close monitoring of INR, if continued on Coumadin', ' Previous (within 5 years of enrollment) or current malignancies at other sites, except adequately treated basal cell or squamous cell skin cancers and carcinoma in situ of the cervix', ' Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for study entry'], 'Results': ['Outcome Measurement: ', ' Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)', ' [Not Specified]', ' Time frame: 4 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.', ' lapatinib ditosylate: Given orally', ' tamoxifen citrate: Given orally', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 1 (1 to 27)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/19 (100.00%)', ' Hemolysis 3/19 (15.79%)', ' Pericardial effusion 1/19 (5.26%)', ' Supraventricular tachycardia 1/19 (5.26%)', ' Cardiac disorders - Other, specify 4/19 (21.05%)', ' Chest pain - cardiac 1/19 (5.26%)', ' Diarrhea 19/19 (100.00%)', ' Death NOS 10/19 (52.63%)', ' Fatigue 13/19 (68.42%)', ' White blood cell decreased 3/19 (15.79%)', ' Dehydration 1/19 (5.26%)']}
|
{'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%)']}
|
2e09a2ec-149e-46b4-b60a-ed421fdbc9b3
|
Single
|
Results
|
NCT01231659
|
Less than 20 the primary trial participants achieved partial response (PR).
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] |
[] |
{'Clinical Trial ID': 'NCT01231659', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Letrozole', ' All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.', ' Refractory disease to hormonal therapy is defined as:', ' Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.', ' Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.', ' Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.', 'Exclusion Criteria:', ' Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.', ' Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Response Rate (ORR)', ' Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.', ' Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Letrozole', ' Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 37.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/72 (36.11%)', ' Anaemia 5/72 (6.94%)', ' Cardiac arrest 1/72 (1.39%)', ' Cardiac failure congestive 1/72 (1.39%)', ' Hypercalcaemia 1/72 (1.39%)', ' Nausea 1/72 (1.39%)', ' Vomiting 3/72 (4.17%)', ' Death 1/72 (1.39%)', ' Disease progression 2/72 (2.78%)', ' Infusion related reaction 1/72 (1.39%)', ' Pyrexia 3/72 (4.17%)', ' Cholecystitis 1/72 (1.39%)', ' Cellulitis 2/72 (2.78%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
e0b7a120-8735-413d-9a47-8508b2feffb3
|
|
Single
|
Eligibility
|
NCT00981812
|
Women who have undergone a breast enlargement procedure, and have since had the implants removed, are excluded from the primary trial.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] |
[] |
{'Clinical Trial ID': 'NCT00981812', 'Intervention': ['INTERVENTION 1: ', ' Lesions Visualized Using Positron Emission Mammography (PEM)', ' Total lesions visualized using positron emission mammography.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' subject is 25-100 years of age', ' subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy', ' subject is able to provide informed consent', 'Exclusion Criteria:', ' subject is pregnant', ' subject is actively lactating or discontinued breastfeeding less than 2 months ago', ' subject has breast implants', ' subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study', ' subject has contraindications for core biopsy and other invasive procedures', ' subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus', ' subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months', ' subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging'], 'Results': ['Outcome Measurement: ', ' Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.', ' [Not Specified]', ' Time frame: At time of biopsy', 'Results 1: ', ' Arm/Group Title: Lesions Visualized Using Positron Emission Mammography (PEM)', ' Arm/Group Description: Total lesions visualized using positron emission mammography.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: Breast Lesions Index Lesioins: 22', ' Index Lesions Visualized at PEM: 21', ' Additional Lesions seen only at PEM: 6', ' Lesions technically adequate for targeting: 26', ' Number of Lesions Biopsied: 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
1393c5d9-d2be-433b-9abf-9449b46588c4
|
|
Comparison
|
Intervention
|
NCT00195013
|
NCT00620373
|
Cohort 2 of the primary trial is a placebo group, the secondary trial does not have a placebo group.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7
] |
[
0,
1,
2,
3,
4,
5
] |
{'Clinical Trial ID': 'NCT00195013', 'Intervention': ['INTERVENTION 1: ', ' Glutamine', ' 10 grams three times a day (orally) for four days and then stop', ' glutamine: 10 grams three times a day (orally) for four days and then stop', 'INTERVENTION 2: ', ' Placebo', ' 10 grams three times a day (orally) for four days and then stop', ' Placebo: 10 grams three times a day (orally) for four days and then stop'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed breast cancer, Stage I, II, III or IV or other solid tumors.', ' Patients must be receiving weekly paclitaxel or nab-paclitaxel chemotherapy or have recently completed paclitaxel or nab-paclitaxel chemotherapy and have at least a Grade I peripheral neuropathy (see Appendix A) because of therapy.', ' Because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.', ' ECOG performance status <1 (Karnofsky >90%).', ' Life expectancy of greater than 3 months.', ' Patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.', ' The effects of glutamine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Patients who have experienced prior neuropathies not associated with chemotherapy', ' Patients may not be receiving any other investigational agents.', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.', ' There are no known allergies associated with glutamine.', ' Uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.', ' Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glutamine. Breastfeeding should also be discontinued if the mother is treated with glutamine.', ' Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with glutamine. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.', ' Concurrent chemotherapy with another drug known to cause neuropathy (CDDP or CBDCA or oxaliplatin) are excluded.'], 'Results': ['Outcome Measurement: ', ' Change in Peripheral Neuropathy Score', ' Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result).', ' Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity.', ' Time frame: Duration of study, approximately 10 weeks per subject', 'Results 1: ', ' Arm/Group Title: Glutamine', ' Arm/Group Description: 10 grams three times a day (orally) for four days and then stop', ' glutamine: 10 grams three times a day (orally) for four days and then stop', ' Overall Number of Participants Analyzed: 14', ' Mean (Full Range)', ' Unit of Measure: Change in Total Neuropathy Score 0.3 (-5 to 3)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: 10 grams three times a day (orally) for four days and then stop', ' Placebo: 10 grams three times a day (orally) for four days and then stop', ' Overall Number of Participants Analyzed: 16', ' Mean (Full Range)', ' Unit of Measure: Change in Total Neuropathy Score 0.9 (-6 to 7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00620373', 'Intervention': ['INTERVENTION 1: ', ' Mammography Only', ' For this reporting arm, the interpretation and analysis was done with mammography only.', 'INTERVENTION 2: ', ' Gamma Imaging', ' For this reporting arm, the interpretation and analysis was done with gamma imaging only.'], 'Eligibility': ['Inclusion Criteria:', ' Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).', ' Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).', ' Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.', ' Subjects had to have at least one of the following risk factors:', ' Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)', ' History of chest, mediastinal, or axillary irradiation', ' Personal history of breast cancer', ' History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma', ' Gail or Claus model lifetime risk greater than or equal to 20%', ' Gail model 5 year risk greater or equal to 2.5%', ' Gail model 5 year risk greater or equal to 1.6%', ' One first-degree relative with history of breast cancer', ' Two second-degree relatives with history of breast cancer', 'Exclusion Criteria:', ' They are unable to understand and sign the consent form', ' They are pregnant or lactating', ' They are physically unable to sit upright and still for 40 minutes.', ' They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).', ' They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.', ' They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.'], 'Results': ['Outcome Measurement: ', ' Diagnostic Yield', ' Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).', ' Time frame: 12 months after mammography and gamma imaging', '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: 936', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened 3.2 (1.1 to 9.4)', 'Results 2: ', ' Arm/Group Title: Gamma Imaging', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with gamma imaging only.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened 9.6 (5.1 to 18.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/969 (0.00%)', 'Adverse Events 2:', ' ']}
|
abfa5699-2863-4319-9386-4b359f2062f2
|
Single
|
Eligibility
|
NCT01196052
|
Participants in the primary trial must be willing to undergo anthracycline-based chemotherapy, or have previously received either cyclophosphamide or epirubicin.
|
Entailment
|
[
0,
4
] |
[] |
{'Clinical Trial ID': 'NCT01196052', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Adult patients 18 years of age.', ' Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).', ' Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.', ' Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.', ' Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.', ' Patients may enroll before or after AC/FEC chemotherapy has completed.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate hematologic, biochemistry, and cardiac assessments.', 'Exclusion Criteria:', ' Stage IV breast cancer or bilateral breast cancer.', ' Pregnant or breastfeeding women.', ' History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.', ' Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.', ' Active cardiac history.', ' Current chronic daily treatment with oral corticosteroids or equivalent.', ' Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.', ' Active, unresolved infections at screening.', ' Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.', ' Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.', ' Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.', ' Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.', ' Grade 2 peripheral neuropathy at Baseline.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment', ' A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10% from Baseline to an LVEF of < 50%.', ' Time frame: Baseline to 12 weeks after the start of trastuzumab emtansine treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 0 (0.00 to 2.45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/148 (10.14%)', ' Febrile neutropenia 1/148 (0.68%)', ' Atrial fibrillation 2/148 (1.35%)', ' Abdominal pain 1/148 (0.68%)', ' Diarrhoea 1/148 (0.68%)', ' Pyrexia 2/148 (1.35%)', ' Cellulitis 1/148 (0.68%)', ' Device related infection 2/148 (1.35%)', ' Gastroenteritis viral 1/148 (0.68%)', ' Gastrointestinal infection 1/148 (0.68%)', ' Upper respiratory tract infection 1/148 (0.68%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
4038f7c3-87e2-47d6-811b-fd2b21679577
|
|
Single
|
Eligibility
|
NCT01031446
|
Sarah has been experiencing epileptic seizures from a brain tumor. This excludes her from participating in the primary trial.
|
Entailment
|
[
5
] |
[] |
{'Clinical Trial ID': 'NCT01031446', 'Intervention': ['INTERVENTION 1: ', ' RAD001 and Cisplatin and Paclitazel', ' Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive mammary carcinoma', ' Stage IV disease', ' Basal-like disease (triple-negative, hormone-refractory, HER2-negative)', ' No locally recurrent breast cancer', ' No symptomatic brain metastases', ' Patients with a history of brain metastases are eligible provided they are clinically stable for > 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers', ' Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers', ' PATIENT CHARACTERISTICS:', ' Pre- or post-menopausal', ' European Cooperative Oncology Group (ECOG) performance status 0-1', ' Life expectancy 6 months', ' Absolute neutrophil count (ANC) 1,000/mm^3', ' Platelet count 100,000/mm^3', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)', ' Direct bilirubin will be measured in patients with Gilbert syndrome', ' serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)', ' Alkaline phosphatase 3 times ULN (in the presence of liver metastasis)', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment', ' Able to swallow and retain oral medication', ' No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel', ' No concurrent uncontrolled illness including, but not limited to, any of the following:', ' Ongoing or active infection requiring parenteral antibiotics', ' Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)', ' New York Heart Association class III-IV congestive heart failure', ' Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months', ' Uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support)', ' Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0])', ' Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)', ' Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary', ' No symptomatic neuropathy grade 2', ' No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ', ' No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies', ' No history of hepatitis B or C', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from prior therapy', ' Prior total cumulative life-time dose of doxorubicin 360 mg/m^2 or epirubicin 640 mg/m^2', ' No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy)', ' At least 2 weeks since prior investigational drugs', ' At least 14 days since prior and no concurrent herbal or dietary supplements', ' At least 14 days since prior and no concurrent CYP3A4 inducers', ' At least 7 days since prior and no concurrent CYP3A4 inhibitors', ' Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry', ' No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)'], 'Results': ['Outcome Measurement: ', ' Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer', ' The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.', ' Time frame: at 8 weeks', 'Results 1: ', ' Arm/Group Title: RAD001 and Cisplatin and Paclitazel', ' Arm/Group Description: Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: mg/m2 Cisplatin: 25', 'Paclitaxel: 80'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/55 (16.36%)', ' neutrophils2/55 (3.64%)', ' leukocytes1/55 (1.82%)', ' platelets1/55 (1.82%)', ' febrile neutropenia, ANC < 1.0 x 10e9L, fever 38.5 degrees Celsius1/55 (1.82%)', ' anemia2/55 (3.64%)', ' thrombocytopenia2/55 (3.64%)', ' ventricular tachycardia1/55 (1.82%)', ' pain-abdomen3/55 (5.45%)', ' diarrhea1/55 (1.82%)', ' nausea3/55 (5.45%)', ' vomiting3/55 (5.45%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
5097f4cd-9118-473d-a2a0-72f0cd12c7a5
|
|
Single
|
Intervention
|
NCT00956813
|
All the primary trial subjects are required to take the intervention PO daily.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[] |
{'Clinical Trial ID': 'NCT00956813', 'Intervention': ['INTERVENTION 1: ', ' Flaxseed', ' Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.', 'INTERVENTION 2: ', ' Placebo', ' Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.'], 'Eligibility': ['Bothersome hot flashes, defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention', ' Presence of hot flashes for 1 month', ' Meets 1 of the following criteria:', ' History of breast cancer or other cancer (currently without malignant disease)', ' No history of breast cancer and wishes to avoid estrogen due to a perceived increased risk of breast cancer', ' Hormone receptor status not specified', ' Postmenopausal as defined by 1 of the following*:', ' NOTE: *Women with 1 ovary but without a uterus should be deemed postmenopausal by either age > 55 OR a combination of estrogen within a postmenopausal range (per local lab) and follicle-stimulating hormone > 40 mIU/mL', ' Absence of a period in the past 12 months', ' Bilateral oophorectomy', ' ECOG performance status 0-1', ' Life expectancy 6 months', ' Able to complete questionnaire(s) alone or with assistance', ' No diabetes requiring oral or injectable antihyperglycemics', ' No hypotension', ' No history of allergic or other adverse reaction to flaxseed', ' No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal condition where the patient should not consume and/or has an intolerance/allergies to seeds or nuts', ' At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents', ' Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for 4 weeks and is not expected to stop the medication during study treatment', ' At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind', ' Trastuzumab allowed', ' No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies', ' No concurrent ( 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal)', ' Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is 800 IU/day, it was started > 30 days before study initiation, and is to be continued through study period', ' Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible', ' No concurrent anticoagulants or anti-platelets (1 mg of Coumadin for central line patency allowed)', ' Aspirin allowed ( 81 mg)', ' No concurrent anti-hypertensives', ' No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk)'], 'Results': ['Outcome Measurement: ', ' To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.', ' The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.', ' The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7.', ' The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.', ' Time frame: Baseline and 7 weeks', 'Results 1: ', ' Arm/Group Title: Flaxseed', ' Arm/Group Description: Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.', ' Overall Number of Participants Analyzed: 69', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -4.9 (6.41)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.', ' Overall Number of Participants Analyzed: 77', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale -3.5 (6.47)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/101 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
68e6a088-ab80-4a89-90d4-39308bccb1c2
|
|
Comparison
|
Intervention
|
NCT00446030
|
NCT00975676
|
the primary trial and the secondary trial have no overlap in the drugs they use for their interventions, however they both have placebo groups.
|
Contradiction
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2,
3,
4,
5
] |
{'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']}
|
a4c49b44-91b3-4a3c-bfbf-b3758cc398f1
|
Comparison
|
Eligibility
|
NCT00971737
|
NCT00392392
|
Patients with a positive FISH result are eligible for the secondary trial, but not for the primary trial.
|
Entailment
|
[
0,
1,
2,
3
] |
[
0,
3
] |
{'Clinical Trial ID': 'NCT00971737', 'Intervention': ['INTERVENTION 1: ', ' Cyclophosphamide and Vaccine Only', ' Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.', ' allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally', ' cyclophosphamide: Given IV', 'INTERVENTION 2: ', ' Cyclophosphamide, Vaccine and Trastuzumab', ' Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.', ' allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally', ' trastuzumab: Given IV', ' cyclophosphamide: Given IV'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast', ' Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC', ' Stage IV disease', ' Must not be eligible for therapy of known curative potential for metastatic breast cancer', ' Measurable or evaluable disease', " Stable CNS disease allowed provided that it's adequately treated and not under active treatment", ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-1', ' ANC > 1,000/mm^3', ' Platelets > 100,000/mm^3', ' Serum bilirubin < 2.0 mg/dL (unless due to Gilbert syndrome)', ' AST and ALT < 2 times upper limit of normal (ULN)', ' Alkaline phosphatase < 5 times ULN', ' Serum creatinine < 2.0 mg/dL', ' Ejection fraction normal by MUGA OR 50% by echocardiogram', ' Not pregnant or nursing', ' Fertile patients must use effective contraception', ' HIV negative', ' Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed', ' No prior or concurrent autoimmune disease requiring management with systemic immunosuppression, including any of the following:', ' Inflammatory bowel disease', ' Systemic vasculitis', ' Scleroderma', ' Psoriasis', ' Multiple sclerosis', ' Hemolytic anemia or immune-mediated thrombocytopenia', ' Rheumatoid arthritis', ' Systemic lupus erythematosus', ' Sjogren syndrome', ' Sarcoidosis', ' Other rheumatologic disease', ' No other malignancies within the past 5 years, except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related endometrial cancer that has been adequately treated', ' No active major medical or psychosocial problems that could be complicated by study participation', ' No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest', ' No uncontrolled medical problems', ' No evidence of active acute or chronic infection', ' No known severe hypersensitivity to trastuzumab, except mild to moderate infusion reactions that are easily managed and do not recur', ' No allergy to corn', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' More than 28 days since prior and no other concurrent chemotherapy, radiation therapy, or biologic therapy (except trastuzumab)', ' Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed', ' More than 28 days since prior and no other concurrent participation in an investigational new drug trial', ' More than 28 days since prior and no other concurrent systemic oral steroids', ' Topical, ocular, and nasal steroids allowed', ' No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine'], 'Results': ['Outcome Measurement: ', ' Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events', ' Number of grade 3 or 4 nonhematologic toxicity (except alopecia), or any grade 4 hematologic toxicity as defined by NCI CTCAE v3.0', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Cyclophosphamide and Vaccine Only', ' Arm/Group Description: Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.', ' allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally', ' cyclophosphamide: Given IV', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: adverse events 0', 'Results 2: ', ' Arm/Group Title: Cyclophosphamide, Vaccine and Trastuzumab', ' Arm/Group Description: Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.', ' allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally', ' trastuzumab: Given IV', ' cyclophosphamide: Given IV', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: adverse events 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'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%)']}
|
08917306-11b0-44ad-8f45-9a67d7f6073e
|
Comparison
|
Intervention
|
NCT00073073
|
NCT00054028
|
There are no placebo or control groups in the primary trial or the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5
] |
[
0,
1,
2
] |
{'Clinical Trial ID': 'NCT00073073', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.', ' Exemestane: exemestane 25 mg by mouth (PO) every day for two years', ' Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years', ' Vitamin D: Vitamin D 400 international units PO every day x 2 years'], 'Eligibility': ['INCLUSION CRITERIA:', ' Postmenopausal female.', ' Postmenopausal defined as no menses for at least 12 months or bilateral oophorectomy. In unclear cases, (e.g. 50 year old who has had hysterectomy) chemical confirmation of postmenopausal status may be confirmed with follicle stimulating hormone (FSH) greater than 35 U/L.', ' Elevated risk for developing invasive breast cancer by virtue of one of the following criteria:', ' Gail Model risk of greater than or equal to 1.7% over 5 years from study entry. (This is the same minimum level of risk required for a subject to be eligible for the recently completed NSABP-P1 tamoxifen breast cancer prevention trial).', ' Lobular neoplasia.', ' Atypical ductal hyperplasia.', ' DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation, +/- tamoxifen.', ' Deleterious mutations in BRCA1 or 2 OR A priori risk assessment of 20% chance or greater of carrying BRCA1/2 gene mutation. The BRCAPRO and Couch model will both be used to asses this risk. If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria.', ' Prior stage I or II breast cancer at least 2 years out from treatment for invasive disease and no prior use of aromatase inhibitors.', ' Subjects should be willing to abstain from use of hormonal therapies (e.g. tamoxifen, hormone replacement therapy, oral contraceptive pills, hormone-containing intrauterine devices (IUDs). E-string is acceptable). Venlafaxine will be offered as supportive care for women with menopausal symptoms.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1.', ' Subject has been counseled regarding her options and has signed the informed consent document.', ' Baseline dual-emission x-ray absorptiometry (DEXA) scan with bone mineral density (BMD) T-score greater than or equal to 2.5 at antero posterior (AP) spine.', ' Hemoglobin greater than or equal to 11 g/dl.', ' Creatinine less than 1.5 times the upper limits of normal.', ' Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times upper limit of normal.', ' No investigational agent for the past 30 days.', ' If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceding enrollment.', 'EXCLUSION CRITERIA:', ' Current or recent chronic use (within 3 months) of hormonal medications, e.g. oral contraceptive pills, hormone replacement therapy, tamoxifen, raloxifene, IUD with progestins or corticosteroids. (Subjects on chronic topical or inhaled steroids will be eligible for the study.) Current use of phenytoin, carbamazepine, rifampin due to increased estrogen metabolism.', ' History of clotting or bleeding disorder.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane (e.g. anastrozole, letrozole, formestane).', ' 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.'], 'Results': ['Outcome Measurement: ', ' Percent Change in Mammographic Density at 1 Year on Exemestane', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.', ' Exemestane: exemestane 25 mg by mouth (PO) every day for two years', ' Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years', ' Vitamin D: Vitamin D 400 international units PO every day x 2 years', ' Overall Number of Participants Analyzed: 42', ' Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -2.4 (-5.0 to 0.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/42 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00054028', 'Intervention': ['INTERVENTION 1: ', ' Suramin and Paclitaxel', ' Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed stage IIIB or IV metastatic breast cancer (MBC)', 'Prior chemotherapy:', ' Phase I: patients must have received prior paclitaxel or other taxanes in either the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be completed at least 21 days before study entry; prior treatment with anthracyclines is not required', ' Phase II: up to two prior chemotherapy regimens for stage IIIB or IV MBC; patients must have received prior paclitaxel or other taxanes in either the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be completed at least 21 days before study entry; prior treatment with anthracyclines is not required', ' Measurable disease (phase II)', ' No known brain metastases', ' Hormone receptor status:', ' Not specified', ' Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2', ' White blood cell (WBC) at least 3,000/mm^3', ' Absolute neutrophil count at least 1,000/mm^3', ' Platelet count at least 100,000/mm^3', ' Hemoglobin at least 9.0 g/dL', ' Bilirubin no greater than 1.5 mg/dL', ' Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal', ' Creatinine no greater than 1.5 mg/dL', ' Left ventricular ejection fraction (LVEF) at least lower limit of normal', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of allergic reactions attributable to compounds of similar chemical or biological composition to Cremophor', ' No concurrent uncontrolled illness that would preclude study compliance', ' No ongoing or active infection', ' No uncontrolled diabetes mellitus', ' No psychiatric illness or social situations that would preclude study compliance', ' No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' See Disease Characteristics', ' At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered', ' No more than 2 prior chemotherapy regimens for this malignancy (phase II)', ' No concurrent steroids or hormones except the following:', ' Steroids to prevent hypersensitivity reactions prior to paclitaxel administration', ' Hormones for nondisease-related conditions (e.g., insulin for diabetes)', ' At least 3 weeks since prior radiotherapy and recovered', ' At least 3 weeks since prior surgery and recovered', ' No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients', ' No other concurrent investigational agents', ' Concurrent bisphosphonates (i.e., pamidronate or zoledronate) are allowed for the treatment of hypercalcemia or palliation of skeletal metastases'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients That Achieved Target Suramin Concentrations in Plasma', ' Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Suramin and Paclitaxel', ' Arm/Group Description: Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: percent of patients 88'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/31 (3.23%)', ' Adult respiratory distress syndrome (ARDS) 1/31 (3.23%)']}
|
9702cb6a-bdb1-415f-bb99-3b740728a4ea
|
Comparison
|
Results
|
NCT00706030
|
NCT00171704
|
participants from both cohorts of the primary trial had a drastically lower CNS Objective Response Rate than those in the secondary trial.
|
Contradiction
|
[
0,
1,
2,
3
] |
[
0,
1,
2,
3
] |
{'Clinical Trial ID': 'NCT00706030', 'Intervention': ['INTERVENTION 1: ', ' Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib', ' Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure', 'INTERVENTION 2: ', ' Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib', ' Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).', ' At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).', ' At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).', 'Exclusion Criteria:', " More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).", ' Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.', ' Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate', ' Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.', ' Time frame: From first dose date to progression or last tumor assessment, up to four years and six months.', 'Results 1: ', ' Arm/Group Title: Neratinb 240 mg + Vinorelbine 25 mg/m - No Prior Lapatinib', ' Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: percentage of participants 35.9 (24.3 to 48.9)', 'Results 2: ', ' Arm/Group Title: Neratinib 240 mg + Vinorelbine 25 mg/m - Prior Lapatinib', ' Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.3 (1.7 to 40.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/6 (50.00%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Neutropenia 0/6 (0.00%)', ' Bradycardia 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Pancreatitis 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Disease progression 0/6 (0.00%)', ' Fatigue 0/6 (0.00%)', ' Pyrexia 0/6 (0.00%)', ' Cholelithiasis 0/6 (0.00%)', ' Hepatic pain 0/6 (0.00%)', ' Bacteraemia 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 3/6 (50.00%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Neutropenia 1/6 (16.67%)', ' Bradycardia 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Pancreatitis 0/6 (0.00%)', ' Vomiting 0/6 (0.00%)', ' Disease progression 0/6 (0.00%)', ' Fatigue 1/6 (16.67%)', ' Pyrexia 1/6 (16.67%)', ' Cholelithiasis 0/6 (0.00%)', ' Hepatic pain 1/6 (16.67%)', ' Bacteraemia 0/6 (0.00%)']}
|
{'Clinical Trial ID': 'NCT00171704', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' 2.5 mg once daily (q.d.)orally for 5 years', 'INTERVENTION 2: ', ' Tam-Let', ' 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.'], 'Eligibility': ['Inclusion Criteria', ' Female', ' Post-menopausal hormone status defined as:', ' Patients with menostasis (amenorrhea) > 12 months or history of oophorectomy.', ' Patients 55 years with history of hysterectomy or having continued/renewed menstruation on cyclic hormone treatment.', ' Patients of 50-54 years: Menopausal status was determined on the basis of follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values.', ' Histologically confirmed resected breast cancer and eligible for adjuvant endocrine therapy. As a minimum, patients had to have receptor-positive tumors, which were defined either as estrogen receptor (ER) and/or progesterone receptor (PgR) 10 fmol/mg cytosol protein; or 10% of the tumor cells positive by immunocytochemical evaluation.', ' Adequate bone marrow function (white blood cell count [WBC] > 3.0 x 109 /L, platelets 100.0 x 109 /L, and hemoglobin > 10 g/dL).', ' Documented evidence of adequate renal function (creatinine < 180 µmol/L) and hepatic function (bilirubin < 30 µmol/L, alanine aminotransferase (ALT) < 1.5 x upper normal limit of the laboratory).', ' Life expectancy of at least 24 months at the time of enrollment.', ' Written voluntary informed consent prior to initiation of any study procedure.', ' Willingness to undergo all scheduled tests and examinations for evaluation of bone density and bone metabolism, and lipid profiles in addition to the standard assessments for monitoring their breast cancer status.', ' Exclusion Criteria', ' Patients with distant metastases as defined by the criteria of the Danish Breast Cancer Co-operative Group (DBCCOG).', " Pre-existing bone disease (e.g. osteomalacia, osteogenesis imperfecta, Paget's disease).", ' Patients receiving bisphosphonates for more than 3 months before randomization.', ' Chronic treatment with drugs known to interfere with bone metabolism, e.g.', ' Anti-convulsants within the past year.', ' Corticosteroids at doses greater than the equivalent of 5 mg/day prednisone for more than two weeks in the past 6 months (prior to randomization).', ' Any previous treatment with sodium fluoride at daily doses 5 mg/day for a period exceeding 1 month.', ' Anabolic steroids in the past 12 months.', ' Long term use of coumarin derivatives and heparin at the time of randomization.', " Metabolic diseases known to interfere with bone metabolism (e.g., Hyperparathyroidism, hypoparathyroidism, uncontrolled thyroid disease, Cushing's disease, vitamin D deficiency, malabsorption syndrome, etc.).", ' Treatment with lipid-lowering agents within the 3 months prior to randomization (this exclusion criterion did not apply to patients randomized in the United Kingdom).', ' Patients receiving other anti-cancer treatment.', ' Previous neoadjuvant / adjuvant chemotherapy and /or previous adjuvant endocrine therapy (e.g., anti-estrogens, AIs).', ' History of previous or concomitant malignancy within the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who had a previous other malignancy must have been disease free for five years. Patients with endometrial cancer and/or invasive breast cancer at any time in their medical history were excluded. Patients with invasive bilateral breast cancer were excluded. Patients with vaginal discharge/ vaginal bleeding with evidence of malignancy were excluded.', ' Any other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)', ' Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.', ' Time frame: Baseline, 24 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years', ' Overall Number of Participants Analyzed: 63', ' Median (Full Range)', ' Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)', 'Results 2: ', ' Arm/Group Title: Tam-Let', ' Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.', ' Overall Number of Participants Analyzed: 68', ' Median (Full Range)', ' Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 50/133 (37.59%)', ' Acute myocardial infarction 0/133 (0.00%)', ' Angina pectoris 1/133 (0.75%)', ' Angina unstable 0/133 (0.00%)', ' Arrhythmia 1/133 (0.75%)', ' Atrial fibrillation 2/133 (1.50%)', ' Atrial flutter 0/133 (0.00%)', ' Bundle branch block left 1/133 (0.75%)', ' Myocardial infarction 0/133 (0.00%)', ' Pericarditis 0/133 (0.00%)', ' Sinus bradycardia 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 41/130 (31.54%)', ' Acute myocardial infarction 2/130 (1.54%)', ' Angina pectoris 1/130 (0.77%)', ' Angina unstable 1/130 (0.77%)', ' Arrhythmia 0/130 (0.00%)', ' Atrial fibrillation 2/130 (1.54%)', ' Atrial flutter 1/130 (0.77%)', ' Bundle branch block left 0/130 (0.00%)', ' Myocardial infarction 1/130 (0.77%)', ' Pericarditis 1/130 (0.77%)', ' Sinus bradycardia 1/130 (0.77%)']}
|
7afa2d1f-7922-4b09-b52a-43bd9a4788a9
|
Single
|
Eligibility
|
NCT01299038
|
Joe has had an alcohol addiction for 15 years, resulting in Cirrhosis therefore he is likely to be excluded from the primary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] |
[] |
{'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': ''}
|
dfd5acc2-6824-4b63-93ad-34e6a0a4c621
|
|
Comparison
|
Eligibility
|
NCT03273426
|
NCT01091168
|
Patients with Concurrent serious uncontrolled medical disorder may be eligible for the primary trial, but are always excluded from the secondary trial.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11
] |
[
4
] |
{'Clinical Trial ID': 'NCT03273426', 'Intervention': ['INTERVENTION 1: ', ' Core Needle Biopsy', ' Ultrasound-guided core needle biopsy (14G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', 'INTERVENTION 2: ', ' Vacuum-assisted Biopsy', ' Vacuum-assisted biopsy (10G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.'], 'Eligibility': ['Inclusion Criteria:', ' Patients', ' with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)', ' who received NAC', ' with detectable lesion / clip marker on ultrasound', ' with cT1-T3 tumors', ' clinical and imaging complete or near-complete response on MRI', ' with informed consent', 'Exclusion Criteria:', ' Multifocal cancer', ' Residual microcalcification', ' Contralateral breast cancer'], 'Results': ['Outcome Measurement: ', ' Negative Predictive Value', ' Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR', ' Time frame: 2 weeks', 'Results 1: ', ' Arm/Group Title: Core Needle Biopsy', ' Arm/Group Description: Ultrasound-guided core needle biopsy (14G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.2 (71.94 to 95.64)', 'Results 2: ', ' Arm/Group Title: Vacuum-assisted Biopsy', ' Arm/Group Description: Vacuum-assisted biopsy (10G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: percentage of participants 85.7 (64.37 to 95.22)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: ']}
|
{'Clinical Trial ID': 'NCT01091168', 'Intervention': ['INTERVENTION 1: ', ' Vinflunine', ' Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.', ' vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks', 'INTERVENTION 2: ', ' Alkylating Agent', ' Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.', ' Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin'], 'Eligibility': ['Inclusion Criteria:(main conditions)', ' Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,', ' Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.', 'Exclusion Criteria:', ' Concurrent serious uncontrolled medical disorder,', ' known or clinical evidence of brain metastases or leptomeningeal involvement,', ' pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,', ' history of second primary malignancy,', ' HIV infection, preexisting neuropathy,', ' pregnancy or breast feeding.'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.', ' Time frame: From baseline up to 3 years 1 month', 'Results 1: ', ' Arm/Group Title: Vinflunine', ' Arm/Group Description: Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.', ' vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks', ' Overall Number of Participants Analyzed: 298', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.7 to 10.4)', 'Results 2: ', ' Arm/Group Title: Alkylating Agent', ' Arm/Group Description: Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.', ' Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin', ' Overall Number of Participants Analyzed: 296', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.3 (7.5 to 10.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 82/297 (27.61%)', ' Neutropenia 6/297 (2.02%)', ' Anaemia 6/297 (2.02%)', ' Febrile neutropenia 3/297 (1.01%)', ' Thrombocytopenia 1/297 (0.34%)', ' Endocardititis staphylococcal 1/297 (0.34%)', ' Arteriospasm coronary 1/297 (0.34%)', ' Atrial fibrillation 1/297 (0.34%)', ' Cardiac failure 0/297 (0.00%)', ' Constipation 5/297 (1.68%)', ' Vomiting 6/297 (2.02%)', ' Abdominal pain 4/297 (1.35%)', 'Adverse Events 2:', ' Total: 66/290 (22.76%)', ' Neutropenia 0/290 (0.00%)', ' Anaemia 0/290 (0.00%)', ' Febrile neutropenia 1/290 (0.34%)', ' Thrombocytopenia 2/290 (0.69%)', ' Endocardititis staphylococcal 0/290 (0.00%)', ' Arteriospasm coronary 0/290 (0.00%)', ' Atrial fibrillation 1/290 (0.34%)', ' Cardiac failure 1/290 (0.34%)', ' Constipation 0/290 (0.00%)', ' Vomiting 3/290 (1.03%)', ' Abdominal pain 1/290 (0.34%)']}
|
97e9967e-6525-4082-bd11-8c30e14d23fd
|
Single
|
Results
|
NCT00082433
|
the primary trial results suggest that 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle + Capecitabine, may increase OS, compared to Capecitabine alone.
|
Entailment
|
[
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15
] |
[] |
{'Clinical Trial ID': 'NCT00082433', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone + Capecitabine', ' Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.', 'INTERVENTION 2: ', ' Capecitabine', 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'], 'Eligibility': ['Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).', ' Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.', ' Patients may not have any history of brain and/or leptomeningeal metastases.', ' Patients may not have Grade 2 or worse neuropathy at the time of study entry.', ' Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)'], 'Results': ['Outcome Measurement: ', ' Overall Survival (OS)', ' Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.', ' Time frame: from date of randomization until death', 'Results 1: ', ' Arm/Group Title: Ixabepilone + Capecitabine', ' Arm/Group Description: Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.', ' Overall Number of Participants Analyzed: 609', ' Median (95% Confidence Interval)', ' Unit of Measure: months 16.39 (14.95 to 17.91)', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.', ' Overall Number of Participants Analyzed: 612', ' Median (95% Confidence Interval)', ' Unit of Measure: months 15.64 (13.86 to 17.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 192/603 (31.84%)', ' ANAEMIA 5/603 (0.83%)', ' LEUKOPENIA 1/603 (0.17%)', ' NEUTROPENIA 8/603 (1.33%)', ' LYMPH NODE PAIN 0/603 (0.00%)', ' THROMBOCYTOPENIA 3/603 (0.50%)', ' FEBRILE NEUTROPENIA 5/603 (0.83%)', ' PERICARDITIS 1/603 (0.17%)', ' ANGINA UNSTABLE 0/603 (0.00%)', ' CARDIAC FAILURE 0/603 (0.00%)', ' SINUS TACHYCARDIA 0/603 (0.00%)', ' ATRIAL FIBRILLATION 2/603 (0.33%)', 'Adverse Events 2:', ' Total: 205/595 (34.45%)', ' ANAEMIA 7/595 (1.18%)', ' LEUKOPENIA 8/595 (1.34%)', ' NEUTROPENIA 18/595 (3.03%)', ' LYMPH NODE PAIN 1/595 (0.17%)', ' THROMBOCYTOPENIA 4/595 (0.67%)', ' FEBRILE NEUTROPENIA 34/595 (5.71%)', ' PERICARDITIS 0/595 (0.00%)', ' ANGINA UNSTABLE 1/595 (0.17%)', ' CARDIAC FAILURE 1/595 (0.17%)', ' SINUS TACHYCARDIA 2/595 (0.34%)', ' ATRIAL FIBRILLATION 0/595 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
d11dd4ae-28be-4ad2-a452-4374c48f08d1
|
|
Single
|
Adverse Events
|
NCT02273973
|
Twice as many patients in cohort 1 of the primary trial suffered from Erysipelas than diarrhoea.
|
Contradiction
|
[
0,
3,
11
] |
[] |
{'Clinical Trial ID': 'NCT02273973', 'Intervention': ['INTERVENTION 1: ', ' Experimental: Taselisib + Letrozole', ' Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.', 'INTERVENTION 2: ', ' Placebo Comparator: Placebo + Letrozole', ' Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants', ' Postmenopausal status', ' Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage III breast cancer; (iii) Documented absence of distant metastases (M0)', ' Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer', ' Breast cancer eligible for primary surgery', ' Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)', ' Adequate hematological, renal, and hepatic function', ' Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule', " Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol, in the investigator's judgment", 'Exclusion Criteria:', ' Any prior treatment for primary invasive breast cancer', ' Participants with cT4 or cN3 stage breast tumors', ' Bilateral invasive, multicentric, or metastatic breast cancer', ' Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy', ' Type 1 or 2 diabetes requiring antihyperglycemic medication', ' Inability or unwillingness to swallow pills', ' Malabsorption syndrome or other condition that would interfere with enteric absorption', " History of prior or currently active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis). Any predisposition for gastrointestinal (GI) toxicity requires prior approval from the Medical Monitor.", " Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) >470 milliseconds (msec)", ' Diffusing capacity of the lungs for carbon monoxide (DLCO) <60% of the predicted values', ' Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension, unstable angina, history of myocardial infarction, cardiac failure class II-IV', ' Any contraindication to MRI examination', ' Active infection requiring intravenous antibiotics', ' Participants requiring any daily supplemental oxygen', ' Clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis', ' Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participants at high risk from treatment complications', ' Significant traumatic injury within 3 weeks prior to initiation of study treatment', ' Major surgical procedure within 4 weeks prior to initiation of study treatment', ' Inability to comply with study and follow-up procedures', ' History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1', ' Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.', ' Time frame: From Baseline to 16 weeks', 'Results 1: ', ' Arm/Group Title: Experimental: Taselisib + Letrozole', ' Arm/Group Description: Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.', ' Overall Number of Participants Analyzed: 166', ' Measure Type: Number', ' Unit of Measure: percentage of participants 50.0', 'Results 2: ', ' Arm/Group Title: Placebo Comparator: Placebo + Letrozole', ' Arm/Group Description: Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.', ' Overall Number of Participants Analyzed: 168', ' Measure Type: Number', ' Unit of Measure: percentage of participants 39.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/167 (11.98%)', ' Cardiac failure acute 0/167 (0.00%)', ' Diarrhoea 5/167 (2.99%)', ' Colitis 2/167 (1.20%)', ' Enterocolitis 1/167 (0.60%)', ' Enterocolitis haemorrhagic 1/167 (0.60%)', ' Stomatitis 1/167 (0.60%)', ' Impaired healing 1/167 (0.60%)', ' Sudden death 1/167 (0.60%)', ' Postoperative wound infection 2/167 (1.20%)', ' Erysipelas 2/167 (1.20%)', ' Bacterial diarrhoea 1/167 (0.60%)', 'Adverse Events 2:', ' Total: 4/167 (2.40%)', ' Cardiac failure acute 1/167 (0.60%)', ' Diarrhoea 0/167 (0.00%)', ' Colitis 0/167 (0.00%)', ' Enterocolitis 0/167 (0.00%)', ' Enterocolitis haemorrhagic 0/167 (0.00%)', ' Stomatitis 0/167 (0.00%)', ' Impaired healing 0/167 (0.00%)', ' Sudden death 0/167 (0.00%)', ' Postoperative wound infection 1/167 (0.60%)', ' Erysipelas 0/167 (0.00%)', ' Bacterial diarrhoea 0/167 (0.00%)']}
|
{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}
|
3b6229a9-00a1-4d26-9285-6d9f6a25fd77
|
|
Comparison
|
Eligibility
|
NCT00322348
|
NCT00429572
|
the primary trial and the secondary trial use different metrics to evaluate potential candidates' performance status.
|
Entailment
|
[
2
] |
[
2
] |
{'Clinical Trial ID': 'NCT00322348', 'Intervention': ['INTERVENTION 1: ', ' ZOLADEX 10.8 mg', ' ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks', 'INTERVENTION 2: ', ' ZOLADEX 3.6 mg', ' ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer', ' World Health Organization (WHO) performance status of 0, 1, or 2', ' Provided written informed consent', 'Exclusion Criteria:', ' Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks', ' Received radiotherapy within the past 4 weeks', ' History of systemic malignancy other than breast cancer within the previous 3 years', ' Estimated survival less than 24 weeks'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Progression Free Survival (PFS) at Week 24', ' The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.', ' Time frame: Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).', 'Results 1: ', ' Arm/Group Title: ZOLADEX 10.8 mg', ' Arm/Group Description: ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 69.4', 'Results 2: ', ' Arm/Group Title: ZOLADEX 3.6 mg', ' Arm/Group Description: ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 73.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/50 (4.00%)', ' Peritonsillar Abscess 0/50 (0.00%)', ' Humerus Fracture 1/50 (2.00%)', ' Endometrial Hyperplasia 1/50 (2.00%)', ' Haematoma 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 3/48 (6.25%)', ' Peritonsillar Abscess 1/48 (2.08%)', ' Humerus Fracture 0/48 (0.00%)', ' Endometrial Hyperplasia 1/48 (2.08%)', ' Haematoma 1/48 (2.08%)']}
|
{'Clinical Trial ID': 'NCT00429572', 'Intervention': ['INTERVENTION 1: ', ' Allogeneic Transplantation', ' Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.'], 'Eligibility': ['Inclusion Criteria:', ' Recurrent or residual metastatic breast carcinoma', ' Zubrod performance status less than 2', ' 18-60 years old', ' Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.', ' No major organ dysfunction or active infection', 'Exclusion Criteria: None'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Tumor Response', ' Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.', ' Time frame: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.', 'Results 1: ', ' Arm/Group Title: Allogeneic Transplantation', ' Arm/Group Description: Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 5', ' Stable Disease: 9', ' Partial Response: 1', ' Progressive Disease: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/19 (0.00%)']}
|
9eab20ad-ffc6-473f-8087-c6c3f06f356f
|
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