Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
Recruiting now · Phase 4
Conditions studied: Obesity (Disorder), Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07257484
- Run by
- Weill Medical College of Cornell University
- People needed
- 30
- Starts
- 2026-06-08
- Expected to finish
- 2028-02-25
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Biologically female
- Age ≥ 18
- Obesity as defined by current BMI ≥ 30 kg/m² or ≥ 27.5 kg/m² for individuals of Asian ancestry
- 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
You may not qualify if…
- 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
Where it is running
- Weill Cornell Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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