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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Drug
  • Drug: Tirzepatide
    Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.

Recruiting Locations

Weill Cornell Medicine
New York, New York 10021
Contact:
Sarah Schmitz, MD
646-962-2111
hls9007@med.cornell.edu

More Details

Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

Lynelle Weis
646-962-2423
ljw4002@med.cornell.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.