RecruitingNot ApplicableNCT05309655

Cardiac Outcomes With Near-Complete Estrogen Deprivation

The Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN) Study


Sponsor

Duke University

Enrollment

90 participants

Start Date

Sep 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a very strong estrogen-lowering treatment (used in breast cancer) affects heart health in younger women. Some breast cancer treatments dramatically reduce estrogen, which may increase the risk of heart problems over time. **You may be eligible if...** - You are a woman aged 55 or younger who was premenopausal when diagnosed with breast cancer - You are receiving or planned to receive a treatment that involves very low estrogen levels (such as an aromatase inhibitor combined with medically or surgically induced menopause) - You had a hormone receptor-positive or hormone receptor-negative breast cancer diagnosis **You may NOT be eligible if...** - You already have significant pre-existing heart disease or certain heart rhythm problems - You have conditions that make cardiac monitoring unfeasible - You do not meet the specific treatment timeline requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Durham, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05309655


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