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Cardiac Outcomes With Estrogen Deprivation for Breast Cancer

This study is looking at how near-complete estrogen deprivation (NCED) therapy, which includes aromatase inhibitor therapy or SERD, affects the heart in women with breast cancer. Researchers want to see if this treatment changes how well your heart works. You may be able to join if you are a woman aged 18-55, were premenopausal (before menopause) at your breast cancer diagnosis, and are planning to receive NCED therapy for hormone receptor-positive breast cancer. The study will measure changes in your heart's blood flow over 24 months to see if the treatment has an impact.

Study design
This interventional study plans to enroll 90 participants. It compares women receiving near-complete estrogen deprivation for hormone receptor-positive breast cancer with women not receiving this treatment for hormone receptor-negative breast cancer.
What's involved
You would undergo three Adenosine Stress Cardiac Magnetic Resonance Imaging (CMR) tests, electrocardiograms, and Computed Tomography Angiograms. You would also have blood draws at each stress test visit and complete a 10-question quality of life survey.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in myocardial blood flow at 24 months, indicating follow-up for at least two years.

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NCT05309655

Cardiac Outcomes With Near-Complete Estrogen Deprivation

Active, Not Recruiting
NAAges 18–55InterventionalTreatment
Duke University
~90 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Adenosine Stress Cardiac Magnetic Resonance ImagingElectrocardiogramComputed Tomography AngiogramLaboratory TestingQuality of Life Survey

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Myocardial Blood Flow - 24 months
Measured over At baseline and at 24 months

Conditions

Breast Cancer
Triple Negative Breast Cancer
Cardiovascular Complications

Explore related trials

Breast Carcinoma

Where it's being run

3 sites across 2 states
North Carolina2
Virginia1

Study leadership

  • Alexandra Thomas, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 chemotherapy, surgery or radiation which ever happens last (HR-negative tumor). Treatment with a Gonadotropin Releasing Hormone (GnRH) agonist for fertility preservation during chemotherapy is allowed and is not considered part of the NCED antineoplastic therapy.
Women with human epidermal growth factor-2 (HER2) negative and women with human epidermal growth factor-2 (HER2) positive breast cancer are eligible.
Treatment with CDK-inhibitor, PARP inhibitor immunotherapy or biologic (non-chemotherapy) agent as part of anti-neoplastic treatment plan is allowed. These agents are not considered chemotherapy.
Treatment with selective-estrogen receptor degrader (SERD) rather than aromatase inhibitor is allowed.
Diagnosed with Stage I-III breast cancer.
ECOG performance status of 0-2
Patients with concurrent malignancies are eligible as long as therapies and disease course for these are reasonably expected to not impact cardiovascular function. (Examples of eligible malignancies include: papillary/follicular thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ and early stage cervical cancers, etc.).
Patients with prior COVID-19 are eligible if they have recovered from the illness and are free of COVID-related symptoms other than allowable persistent symptoms: loss of taste and smell and/or grade 1 fatigue.
Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
The study will allow up to 30% of patients with MRI non-compatible breast expanders recognizing that baseline CMR will be outside of imaging window. Note: Registration of these participants will require study PI approval (Dr. Jordan or Dr. Thomas).

Exclusion

History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine
Active wheezing.
Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices, or some breast expanders.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study. Because some methods of birth control are not 100% reliable, a pregnancy test is required, unless the patient has undergone either a bilateral oophorectomy, hysterectomy or both.
Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease previously determined to be not amendable to mechanical intervention.
Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization
Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients.
Men with breast cancer.
Known chronic renal insufficiency or chronic electrolyte abnormalities as determined by the treating physician.

What this trial measures

  • Change in Myocardial Blood Flow - 24 monthsAt baseline and at 24 months

    Change in myocardial blood flow will be measured by adenosine CMR imaging. Comparisons will be made using longitudinal mixed models to examine within- and between- group effects on outcomes measured. These mixed models will include fixed effects for group (NCED/TNBC), baseline assessment of the outcome of interest (i.e. MPR) to adjust for potential risk-factor profile differences between groups and the time point at which the measurements are made relative to the baseline assessment.