Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Obesity (Disorder)
• Intervention / Treatment: Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lynelle Weis; Phone Number: 646-962-2423; Email: ljw4002@med.cornell.edu
• Study Contact Backup: Name: Henry Cheng; Phone Number: 646-962-6026; Email: hec4011@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
      • Contact: Sarah Schmitz, MD; Phone Number: 646-962-2111; Email: hls9007@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug	Drug: Tirzepatide; Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants completing week 24 visit with all required assessments	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in body weight from baseline to week 24		Baseline, 24 weeks
Absolute change in visceral fat mass from baseline to week 24	As assessed by SECA scan	Baseline, 24 weeks
Percent change in visceral fat mass from baseline to week 24	As assessed by SECA scan	Baseline, 24 weeks
Absolute change in fasting glucose from baseline to week 24		Baseline, 24 weeks
Percent change in fasting glucose from baseline to week 24		Baseline, 24 weeks
Absolute change in fasting insulin from baseline to week 24		Baseline, 24 weeks
Percent change in fasting insulin from baseline to week 24		Baseline, 24 weeks
Absolute change in hemoglobin A1c from baseline to week 24		Baseline, 24 weeks
Percent change in hemoglobin A1c from baseline to week 24		Baseline, 24 weeks
Absolute change in IGF-1 from baseline to week 24		Baseline, 24 weeks
Percent change in IGF-1 from baseline to week 24		Baseline, 24 weeks
Absolute change in leptin from baseline to week 24		Baseline, 24 weeks
Percent change in leptin from baseline to week 24		Baseline, 24 weeks
Absolute change in adiponectin from baseline to week 24		Baseline, 24 weeks
Percent change in adiponectin from baseline to week 24		Baseline, 24 weeks
Absolute change in hs-CRP from baseline to week 24		Baseline, 24 weeks
Percent change in hs-CRP from baseline to week 24		Baseline, 24 weeks
Absolute change in ghrelin from baseline to week 24		Baseline, 24 weeks
Percent change in ghrelin from baseline to week 24		Baseline, 24 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Sarah Schmitz, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2026
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hormone receptor positive; HR+; postmenopausal; tirzepatide
• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms by Site; Neoplasms; Overnutrition; Body Weight; Skin Diseases; Breast Diseases; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Obesity; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 25-06029016; KL2TR002385 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No