Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

Weill Cornell Medicine (WCM)

Status and phase: Not yet enrolling; Phase 4

Conditions: Breast Cancer; Obesity (Disorder)

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07257484

KL2TR002385 (U.S. NIH Grant/Contract)

25-06029016

Details and patient eligibility

About

This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal women 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• On adjuvant hormonal therapy (aromatase inhibitor or tamoxifen)

• 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 women 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Drug

Experimental group

Treatment:

Drug: Tirzepatide