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Hormone Therapy

Hormone Therapy for Cardiovascular Health in Breast Cancer Patients (CROWN Trial)

Phase < 1

Recruiting

Led By Alexandra Thomas, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-2

Women age ≤55 who were premenopausal at the time of breast cancer diagnosis (Premenopausal is defined as per NCCN criteria)

Must not have

Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization

Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease previously determined to be not amendable to mechanical intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether breast cancer patients' hearts change when they go on a specific type of hormone therapy.

Who is the study for?

This trial is for women ≤55 years old, premenopausal at breast cancer diagnosis, with Stage I-III HER2 negative or positive breast cancer. They must be starting NCED therapy soon and have an ECOG performance status of 0-2. Patients on certain other non-chemotherapy treatments are eligible. Exclusions include men, those with renal insufficiency, severe heart conditions, metal implants incompatible with MRI, pregnancy, asthma/COPD requiring medication, or allergies to study substances.

What is being tested?

The study aims to assess the impact of near-complete estrogen deprivation (NCED) therapy on heart function in breast cancer patients using various diagnostic tools like electrocardiograms (ECGs), stress cardiac MRIs, CT angiograms and lab tests alongside quality of life surveys.

What are the potential side effects?

While this trial focuses on monitoring heart health rather than drug side effects per se, potential risks may include reactions to contrast agents used in imaging (like gadolinium), discomfort from medical procedures involved in testing such as ECGs and MRIs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am a woman 55 or younger and was premenopausal when diagnosed with breast cancer.

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I have been diagnosed with early to locally advanced breast cancer.

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My breast cancer is either HER2 positive or negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing heart symptoms that need urgent investigation.

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I have had heart artery treatment in the last 6 months or have severe heart artery disease that can't be treated with surgery.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have long-term kidney problems or abnormal blood salt levels.

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I am a man diagnosed with breast cancer.

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I have asthma or COPD and need medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Myocardial Blood Flow - 24 months

Secondary study objectives

Change in Myocardial Blood Flow - 12 months

Myocardial Perfusion Imaging

Change in Stiffness - Thoracic Pulse Wave Velocity

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Near-Complete Estrogen Deprivation Therapy ParticipantsExperimental Treatment5 Interventions

Participants will receive cardiac imaging stress tests as well as study laboratory tests to monitor for changes in heart as well 30-day at the end of the study along with annual long-term follow up to 5 years from baseline imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electrocardiogram

2014

Completed Phase 2

~3060

0 / 10Eligibility criteria met