Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

NCT07257484 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 25-06029016KL2TR002385
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity (Disorder); Breast Cancer

Keywords

tirzepatide; hormone receptor positive; HR+; postmenopausal

Outcome Measures

Primary Outcomes (1)

• Percentage of participants completing week 24 visit with all required assessments

  24 weeks

Secondary Outcomes (19)

• Percent change in body weight from baseline to week 24

  Baseline, 24 weeks

• Absolute change in visceral fat mass from baseline to week 24

  Baseline, 24 weeks

• Percent change in visceral fat mass from baseline to week 24

  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

Study Arms (1)

Drug

EXPERIMENTAL

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

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

Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Obesity; Breast Neoplasms

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Sarah Schmitz, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynelle Weis

CONTACT

646-962-2423; ljw4002@med.cornell.edu

Henry Cheng

CONTACT

646-962-6026; hec4011@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)