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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)
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreCROWN 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
13,703 Previous Clinical Trials
40,931,660 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,876 Patients Enrolled for Breast Cancer
Wake Forest University Health SciencesLead Sponsor
1,247 Previous Clinical Trials
1,005,012 Total Patients Enrolled
34 Trials studying Breast Cancer
4,997 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to gadolinium or other contrast agents.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am starting or have started breast cancer treatment with hormone therapy after menopause induction.I am experiencing heart symptoms that need urgent investigation.I am being treated with SERD instead of an aromatase inhibitor.I had COVID-19 but have recovered, except for possible loss of taste/smell or mild fatigue.I have had heart artery treatment in the last 6 months or have severe heart artery disease that can't be treated with surgery.I have other cancers, but they're not expected to affect my heart.I am currently or have been treated with specific targeted therapies for cancer.I have long-term kidney problems or abnormal blood salt levels.I am a man diagnosed with breast cancer.You have certain metal devices in your body that make it unsafe for you to have an MRI.I am able to care for myself and perform daily activities.I have asthma or COPD and need medication for it.You have had allergic reactions to drugs that are similar to adenosine.I am a woman 55 or younger and was premenopausal when diagnosed with breast cancer.I have been diagnosed with early to locally advanced breast cancer.My breast cancer is either HER2 positive or negative.
Research Study Groups:
This trial has the following groups:- Group 1: Near-Complete Estrogen Deprivation Therapy Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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