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Recruiting NCT07257484

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

Phase IV Interventional Obesity (Disorder) Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide.
Who it may be relevant to
Registry conditions: Obesity (Disorder), Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Percentage of participants completing week 24 visit with all required assessments [Time frame: 24 weeks]
Secondary outcome measures (12)
  • Percent change in body weight from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Absolute change in visceral fat mass from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Percent change in visceral fat mass from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Absolute change in fasting glucose from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Percent change in fasting glucose from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Absolute change in fasting insulin from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Percent change in fasting insulin from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Absolute change in hemoglobin A1c from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Percent change in hemoglobin A1c from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Absolute change in IGF-1 from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Percent change in IGF-1 from baseline to week 24 [Time frame: Baseline, 24 weeks]
  • Absolute change in leptin from baseline to week 24 [Time frame: Baseline, 24 weeks]

Eligibility criteria

Inclusion criteria

  • Biologically female
  • Age ≥ 18
  • Obesity as defined by current BMI ≥ 30 kg/m² or ≥ 27.5 kg/m² for individuals of Asian ancestry
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT07257484 · 25-06029016 · KL2TR002385

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗