Cardiac Outcomes With Near-Complete Estrogen Deprivation
United States90 participantsStarted 2022-09-02
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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 reasonab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically looking at how near-complete estrogen deprivation affects blood flow to the heart over 24 months — given my breast cancer diagnosis, is my heart health something we should be monitoring closely regardless of whether I participate in a study like this?
2Since this trial is 'active but not recruiting,' it's no longer enrolling new patients — are there similar studies currently open that are looking at the cardiovascular effects of the hormone-lowering treatments I might need?
3The trial is listed as Phase NA, which can sometimes mean it's more of an observational or measurement study rather than a treatment trial — can you explain what that means for what participants actually go through versus receiving standard care?
4If estrogen deprivation is part of my treatment plan, what do we already know about its effects on myocardial blood flow, and should I be getting any baseline heart imaging before starting?
5Are there patients with my specific diagnosis — particularly if triple negative breast cancer applies to me — for whom the cardiovascular risks of estrogen deprivation are higher, and how would that affect the treatment options you'd recommend?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.