NCT07257484 Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
| NCT ID | NCT07257484 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Obesity (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2027-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-06-08 with a primary completion date of 2027-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Sarah Schmitz, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT07257484 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Obesity (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07257484 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07257484 currently recruiting?
Yes, NCT07257484 is actively recruiting participants. Contact the research team at ljw4002@med.cornell.edu for enrollment information.
Where is the NCT07257484 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07257484 clinical trial?
NCT07257484 is sponsored by Weill Medical College of Cornell University. The principal investigator is Sarah Schmitz, MD at Weill Medical College of Cornell University. The trial plans to enroll 30 participants.
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