NCT07257484 · Weill Medical College of Cornell University
Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Biologically female
- 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
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations