NCT05309655Active, not recruiting
Cardiac Outcomes With Near-Complete Estrogen Deprivation
The Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN) Study
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 25 Mar 2022
- Start date
- 2 Sept 2022
- Primary completion date
- 1 May 2028
- Lead sponsor
- Duke University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05309655
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 2 Sept 2022 to the primary completion date, 1 May 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease previously determined to be not amendable to mechanical intervention.
- Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine
- 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.
- Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization
- Men with breast cancer.
- Known chronic renal insufficiency or chronic electrolyte abnormalities as determined by the treating physician.
Other
- 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.
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Virginia Commonwealth University/Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Wake Forest Baptist Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.