The Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN) Study
Duke University
Summary
The purpose of this research study is to understand what effect near complete estrogen deprivation (NCED) therapy has on the heart in breast cancer patients. Investigators want to understand if NCED changes how the heart works.
Description
Primary Objective: To determine the 24-month difference in stress myocardial blood flow during adenosine stress cardiovascular magnetic resonance imaging (CMR) in premenopausal women treated with near complete estrogen deprivation for high-risk hormone receptor-positive breast cancer and in premenopausal women treated without near complete estrogen deprivation for hormone receptor-negative breast cancer. Secondary Objectives: * To determine the 12-month difference in stress myocardial blood flow during adenosine stress cardiovascular magnetic resonance imaging (CMR) in premenopausal women tr…
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria * Women age ≤55 who were premenopausal at the time of breast cancer diagnosis; (Premenopausal is defined as per NCCN criteria). * Planned breast cancer treatment with NCED (near-complete estrogen deprivation) therapy that includes aromatase inhibitor therapy (or SERD) with medically or surgically induced menopause within three (3) months of initiating NCED (HR-positive tumor) or, for the cohorts not receiving NCED therapy, within three (3) months of planned chemotherapy, surgery or radiation. Index date for three months is defined as final date of treatment with chemotherap…
Interventions
- DrugAdenosine Stress Cardiac Magnetic Resonance Imaging
Adenosine stress CMR test with contrast to include cardiovascular structural and functional measures including myocardial blood flow through quantitative perfusion mapping. Participants will have 3 stress tests as a part of this research. These tests will happen when at the beginning of the study, and then every year for 2 years.
- Diagnostic TestElectrocardiogram
A 12-lead electrocardiogram will be done when at the start of the study and at the participant's 2 year stress test to look at the electrical signals of your heart.
- Diagnostic TestComputed Tomography Angiogram
Contrasted coronary CT angiography will be performed for visual and quantitative analysis of coronary artery plaque burdens.
- OtherLaboratory Testing
10 teaspoons of blood will be withdrawn at every visit that participants receive a stress test. Participants may have up to six blood draws associated with each imaging visit.
- BehavioralQuality of Life Survey
A general health status survey with 10 questions and should take about 5-10 minutes to finish. This survey is related to research.
Locations (3)
- Duke Cancer CenterDurham, North Carolina
- Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina
- Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia