Actively Recruiting
Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN) Study in Premenopausal Women With Breast Cancer
Led by Duke University · Updated on 2026-03-16
90
Participants Needed
3
Research Sites
30 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
This research aims to understand how near-complete estrogen deprivation (NCED) therapy affects heart function in premenopausal women with breast cancer. The study compares heart changes in women receiving NCED therapy for high-risk hormone receptor-positive breast cancer to those in women with hormone receptor-negative breast cancer not receiving NCED. The main focus is on measuring changes in myocardial blood flow and heart stiffness over 24 months. Participants will undergo adenosine stress cardiac magnetic resonance imaging (CMR) tests, including myocardial blood flow measurements, at the start of the study and annually for two years. Additional tests include electrocardiograms at the beginning and after two years, coronary CT angiograms to assess artery plaque, blood draws for laboratory analysis, and quality of life surveys. The study monitors heart changes and breast cancer outcomes, with follow-up extending up to five years from baseline imaging. Throughout the study, participants will receive cardiac imaging stress tests and laboratory tests to track heart changes. Assessments include stress CMR myocardial blood flow, aortic stiffness, myocardial perfusion reserve, and coronary plaque burden. Researchers also develop models to predict heart blood flow deficits and monitor breast cancer survival and treatment changes. Safety and disease outcomes are followed annually after the two-year imaging period, with total participation lasting up to five years.
CONDITIONS
Brief 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
- Planned treatment with NCED therapy including aromatase inhibitor or SERD with induced menopause within 3 months of starting NCED (for HR-positive tumors)
- For non-NCED groups, planned chemotherapy, surgery, or radiation within 3 months (for HR-negative tumors)
- Diagnosed with Stage I to III breast cancer
- HER2 positive or negative breast cancer
- ECOG performance status 0 to 2
- Concurrent malignancies allowed if unlikely to affect heart function
- Prior COVID-19 infection allowed if recovered and free of symptoms except mild fatigue or loss of taste/smell
- Ability to understand and sign informed consent
- Up to 30% with MRI non-compatible breast expanders allowed with approval
You will not qualify if you...
- History of allergic reactions to adenosine or similar compounds
- Active wheezing
- Contraindications to MRI such as certain implants or devices
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Pregnant or not using reliable birth control unless surgically sterile
- Recent coronary revascularization within 6 months or severe coronary artery disease not treatable mechanically
- Ongoing symptoms requiring immediate cardiac catheterization
- Allergy to gadolinium or contrast agents
- Male breast cancer patients
- Known chronic kidney problems or electrolyte abnormalities as judged by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants undergo near-complete estrogen deprivation therapy and receive cardiac imaging stress tests and laboratory tests to monitor heart changes.
3 stress tests with adenosine stress cardiac magnetic resonance imaging at baseline, 12 months, and 24 months; 3 associated laboratory testing visits with blood draws; 2 electrocardiogram visits at baseline and 24 months; 2 computed tomography angiogram assessments at baseline and 24 months; 3 quality of life surveys at each imaging visit
Duration - Up to 5 years
Participants are followed annually for up to 5 years from baseline imaging to monitor overall survival and disease outcomes.
Annual follow-up visits
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
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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