Breast Cancer Clinical Trial
Genetics and Heart Health After Cancer Therapy
Summary
The overall objective of this study is to use patient-centered in vitro and in vivo models to answer the fundamental question of whether or not pathogenic mutations in BRCA1/2 result in an increased risk of CV disease
Eligibility Criteria
Inclusion Criteria
≥18 years of age
Initial diagnosis of Breast Cancer in 2005 or later
Documented BRCA testing (results from a local laboratory are acceptable) showing
confirmation of a germline mutation in BRCA1 or BRCA2 that is predicted or suspected to be deleterious OR
confirmation that no mutation was detected in BRCA1 or BRCA2
Non-carriers will have been treated with an anthracycline-based chemotherapy regimen; carriers may or may not have been treated with an anthracycline-based chemotherapy regimen.
Approximately at least 12 months from initiation of adjuvant treatment or neo-adjuvant chemotherapy
Able to provide informed consent
Exclusion Criteria
Stage IV Breast Cancer
Genetic testing confirming a variant of unknown significance (VUS) or benign polymorphism in BRCA1 or BRCA2
V02 Testing contraindicated for any reason, including:
Myocardial infarction (within past 3 months)
High-risk unstable angina;
High-risk or uncontrolled cardiac arrhythmias;
Symptomatic severe aortic stenosis;
Uncontrolled symptomatic heart failure;
Acute pulmonary embolus or pulmonary infarction;
Acute myocarditis or pericarditis;
Acute aortic dissection;
Coronary revascularization procedure within the past three months;
Uncontrolled hypertension, defined as systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg;
Clinically significant valvular heart disease (severe stenosis or regurgitation);
Known aortic aneurysm; or
Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the V02 test
Women who are pregnant
Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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