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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
Planned breast cancer treatment with NCED 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
Treatment with selective-estrogen receptor degrader (SERD) rather than aromatase inhibitor is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

CROWN Trial 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.Check my eligibility
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.See study design
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.

CROWN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am starting or have started breast cancer treatment with hormone therapy after menopause induction.
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I am being treated with SERD instead of an aromatase inhibitor.
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I had COVID-19 but have recovered, except for possible loss of taste/smell or mild fatigue.
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I have other cancers, but they're not expected to affect my heart.
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I am currently or have been treated with specific targeted therapies for cancer.
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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.

CROWN Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Myocardial Blood Flow - 24 months
Secondary outcome measures
Change in Myocardial Blood Flow - 12 months
Myocardial Perfusion Imaging
Change in Stiffness - Thoracic Pulse Wave Velocity
+3 more

CROWN 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,257 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,253 Patients Enrolled for Breast Cancer
Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,906 Total Patients Enrolled
31 Trials studying Breast Cancer
4,930 Patients Enrolled for Breast Cancer
Alexandra Thomas, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
2 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Breast Cancer
25 Patients Enrolled for Breast Cancer

Media Library

Near-Complete Estrogen Deprivation Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05309655 — Phase < 1
Breast Cancer Research Study Groups: Near-Complete Estrogen Deprivation Therapy Participants
Breast Cancer Clinical Trial 2023: Near-Complete Estrogen Deprivation Therapy Highlights & Side Effects. Trial Name: NCT05309655 — Phase < 1
Near-Complete Estrogen Deprivation Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309655 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participants in this research endeavor?

"Affirmative. Records from clinicaltrials.gov verify that this research study, which was posted on September 2nd 2022, is currently recruiting participants. Approximately 90 individuals need to be enrolled at 3 different medical centres."

Answered by AI

Is recruitment for this research endeavor still open?

"Affirmative. According to the information on clinicaltrials.gov, this medical trial is currently recruiting candidates and was first posted on September 2nd 2022 before being updated most recently on October 7th 2022. 90 individuals from 3 sites are needed for full participation in the experiment."

Answered by AI

Is it possible to take part in this research project?

"This medical trial seeks to recruit 90 individuals aged between 18 and 55 who were diagnosed with breast cancer. To partake, they must adhere the following conditions: NCED treatment plan complete with aromatase inhibitor or SERD therapy post-chemotherapy/surgery/radiation; no higher than ECOG 2; serum potassium level of 3.5 – 5.2 mmol/L and eGFR >30ml per min per 1.73m2; age ≤55 at diagnosis time (premenopausal); HER2 positive tumour admissible; concurrent malignancies permissible if not impacting cardiovascular activity; prior COVID-19"

Answered by AI

Are adults aged 30 or older allowed to participate in this experiment?

"Prospective participants must be aged 18-55. There are 75 trials for minors and 2576 studies open to seniors."

Answered by AI
~28 spots leftby Dec 2024