Genetics and Heart Health After Cancer Therapy

Plain-language summary

This study examines how BRCA1 and BRCA2 gene status relates to heart health in people who have had breast cancer treatment, using echocardiography, exercise testing, and blood samples. It enrolled patients over 18 diagnosed with breast cancer in 2005 or later who had documented BRCA testing. This was a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Abramson Cancer Center at Penn Medicine

Intervention

echocardiography, Cardiopulmonary Exercise Testing, Blood Collection

Start date

12/5/2017

Estimated completion

5/31/2022

Countries

United States

Related genes

Locations

• Philadelphia, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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