Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors (NCT07257484) | Clinical Trial Compass
RecruitingPhase 4
Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
United States30 participantsStarted 2026-06-08
Plain-language summary
This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.
Who can participate
Age range
18 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:
* Biologically female
* Age ≥ 18
* Obesity as defined by current BMI ≥ 30 kg/m²
* Postmenopausal as defined by one or more of the following
* Age ≥60 years
* Age \<60 years with amenorrhea for ≥ 1 year
* Documented bilateral surgical oophorectomy
* Chemical menopause with the addition of LHRH agonists at least 12 weeks prior to enrolment, and plan to remain on LHRH agonists throughout the trial
* HR+ (ER and/or PR) stage 0-III breast cancer
* Completed curative treatment (surgery, chemotherapy, radiotherapy) at least 12 weeks prior to enrolment
* Insurance approval for tirzepatide or willing to pay out of pocket
* Willing to provide informed consent and comply with study procedures
Exclusion Criteria:
* Stage IV breast cancer
* Concomitant use of CDK inhibitors
* Concomitant use of antiHER2 therapy
* The PI may be consulted regarding enrollment of females receiving other endocrine therapy medications
* Other active malignancy requiring treatment
* Enrollment in another investigational clinical trial
* Contraindication to tirzepatide
* Treatment with a GLP-1 receptor agonist within the last 3 months
* Diabetes requiring insulin
* Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
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 testing tirzepatide, a diabetes and weight-loss drug, in postmenopausal breast cancer survivors with obesity — given my personal history and current health status, is this the kind of study worth discussing as a next step for me?
2The primary thing this trial is measuring is whether participants can actually complete all the required assessments through week 24 — what does that tell us about how much is already known about tirzepatide's safety and effects specifically in breast cancer survivors, and does that change how you'd think about the risk-benefit balance for me?
3What are the specific visit and assessment requirements over those 24 weeks, and realistically, how demanding would that be to fit around my ongoing cancer follow-up care and daily life?
4Since this is a Phase 4 trial in HR-positive breast cancer survivors, is there any concern about how tirzepatide might interact with hormone receptor pathways or any hormone-blocking treatments I'm currently on or might need?
5Before considering a trial like this, would you recommend addressing my weight through standard approved options first, or is there a reason this study might actually be a better path for someone in my situation?
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.
What they're measuring
1
Percentage of participants completing week 24 visit with all required assessments
Timeframe: 24 weeks
Trial details
NCT IDNCT07257484
SponsorWeill Medical College of Cornell University