Genetics and Heart Health After Cancer Therapy

Breast Cancer Clinical Trial

— Gene-HEART  

Official title:

Genetics and Heart Health After Cancer Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510689
• Other study ID #: UPCC 13117
• Status: Completed
• Start date: December 5, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Breast Cancer
• Cardiomyopathies
• Drug-Induced Cardiomyopathy
• Heart Diseases
• Hereditary Breast/Ovarian Cancer (brca1, brca2)

Intervention

Diagnostic Test:
• echocardiography
Resting echocardiograms (Vivid E9 or E95, GE Healthcare) with conventional measures of systolic and diastolic function, in conjunction with posthoc quantitation of novel measures of strain and strain rate will be obtained at each study time point.

Other:
• Cardiopulmonary Exercise Testing
A cardiopulmonary exercise test (CPET, also called V02 test) will be completed at each study time point utilizing a standard clinical protocol, on either a stationary bike or treadmill. The purpose of this test is to estimate maximal oxygen consumption (V02 max) as in index of cardiopulmonary fitness. Resting ECG, heart rate, and BP will be obtained prior to beginning the test, during each stage of the test and for 5 minutes after the test is stopped.
• Blood Collection
We will obtain blood samples (approximately 16mL) at baseline and (approximately 12mL) at each follow-up visit. Typically these will be drawn via peripheral venipuncture, however if patients have a port-a-cath in place, blood may be drawn from the port instead.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction		6 years