Genetics and Heart Health After Cancer Therapy (NCT03510689) | Clinical Trial Compass
CompletedNot Applicable
Genetics and Heart Health After Cancer Therapy
United States79 participantsStarted 2017-12-05
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…