Tirzepatide for weight and health in postmenopausal women with HR+ breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 trial examines the practicality, safety, and potential health benefits of weekly tirzepatide for postmenopausal women with HR+ breast cancer and obesity. Participants will take tirzepatide for 6 months with monthly safety and progress checks, plus body composition, blood tests, a stool sample, and surveys at the start and end. The study will assess willingness and ability to adhere to treatment while monitoring for effects on weight and general health. Eligible participants have end-stage treatments completed, are postmenopausal, and meet BMI criteria, with insurance or out-of-pocket access arranged. The trial is led by Weill Medical College of Cornell University and collaborates with NCATS at a single site in New York.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sarah Schmitz, MD — Weill Medical College of Cornell University
• Study coordinator: Lynelle Weis
• Email: ljw4002@med.cornell.edu
• Phone: 646-962-2423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.