Genetics and Heart Health After Cancer Therapy



Status:Recruiting
Conditions:Breast Cancer, Breast Cancer, Ovarian Cancer, Cancer, Cancer, Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/4/2018
Start Date:December 5, 2017
End Date:June 5, 2024
Contact:Bonnie Ky, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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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


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Bonnie Ky, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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from
Philadelphia, PA
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