RecruitingPhase 4NCT07257484

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors


Sponsor

Weill Medical College of Cornell University

Enrollment

30 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

  • 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 Criteria9

  • 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

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Interventions

DRUGTirzepatide

Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.


Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT07257484


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