Actively Recruiting
Cardiac Outcomes With Near-Complete Estrogen Deprivation
Led by Duke University · Updated on 2026-03-16
90
Participants Needed
3
Research Sites
326 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardiac Outcomes With Near-Complete Estrogen Deprivation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 55 or younger, premenopausal at breast cancer diagnosis as defined by NCCN criteria
- Planned treatment with near-complete estrogen deprivation therapy including aromatase inhibitors or selective estrogen receptor degraders with induced menopause within 3 months of starting therapy for hormone receptor-positive tumors
- For hormone receptor-negative tumors, treatment planned with chemotherapy, surgery, or radiation within 3 months prior to study start
- Women with HER2 negative or positive breast cancer
- Allowed treatment with CDK-inhibitors, PARP inhibitors, immunotherapy, or biologic non-chemotherapy agents
- Diagnosed with Stage I to III breast cancer
- ECOG performance status between 0 and 2
- Patients with certain concurrent malignancies not expected to affect heart function
- Recovered from prior COVID-19 with no active symptoms except loss of taste or smell and/or mild fatigue
- Able and willing to provide informed consent
- Up to 30% of patients with MRI non-compatible breast expanders allowed with study PI approval
You will not qualify if you...
- History of allergic reactions to adenosine or similar compounds
- Active wheezing
- Contraindications for MRI including certain metal implants, pacemakers, defibrillators, neurostimulators, or some breast expanders
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Pregnancy or unwillingness to undergo pregnancy testing unless surgically sterilized
- Coronary revascularization within the past 6 months or severe multi-vessel coronary artery disease not amenable to intervention
- Ongoing symptoms of cardiac ischemia requiring immediate catheterization
- Allergy or sensitivity to gadolinium or other contrast agents
- Male breast cancer patients
- Known chronic kidney failure or chronic electrolyte imbalances as determined by physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
S
Sarah Hatcher, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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