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Trial · Interventional

RecruitingPhase 4Registry data

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

NCTNCT07257484 (opens ClinicalTrials.gov in a new tab)Other id25-06029016Other idKL2TR002385
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
8 Jun 2026
Primary completion
3 Dec 2027 (estimated)
Completion
25 Feb 2028 (estimated)
First posted
2 Dec 2025
Last update posted
22 Jul 2026
Conditions
Obesity (Disorder) · Breast Cancer

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 4

    Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

    NCT07257484

    8 Jun 2026 to est. 25 Feb 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • TirzepatideDrug

Arms1

  • Experimental

    Drug

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of participants completing week 24 visit with all required assessments

    Time frame · 24 weeks

Secondary outcomes(19)

  1. Percent change in body weight from baseline to week 24

    Time frame · Baseline, 24 weeks

  2. Absolute change in visceral fat mass from baseline to week 24

    Time frame · Baseline, 24 weeks

    Registry description

    As assessed by SECA scan

  3. Percent change in visceral fat mass from baseline to week 24

    Time frame · Baseline, 24 weeks

    Registry description

    As assessed by SECA scan

  4. Absolute change in fasting glucose from baseline to week 24

    Time frame · Baseline, 24 weeks

  5. Percent change in fasting glucose from baseline to week 24

    Time frame · Baseline, 24 weeks

  6. Absolute change in fasting insulin from baseline to week 24

    Time frame · Baseline, 24 weeks

  7. Percent change in fasting insulin from baseline to week 24

    Time frame · Baseline, 24 weeks

  8. Absolute change in hemoglobin A1c from baseline to week 24

    Time frame · Baseline, 24 weeks

  9. Percent change in hemoglobin A1c from baseline to week 24

    Time frame · Baseline, 24 weeks

  10. Absolute change in IGF-1 from baseline to week 24

    Time frame · Baseline, 24 weeks

  11. Percent change in IGF-1 from baseline to week 24

    Time frame · Baseline, 24 weeks

  12. Absolute change in leptin from baseline to week 24

    Time frame · Baseline, 24 weeks

  13. Percent change in leptin from baseline to week 24

    Time frame · Baseline, 24 weeks

  14. Absolute change in adiponectin from baseline to week 24

    Time frame · Baseline, 24 weeks

  15. Percent change in adiponectin from baseline to week 24

    Time frame · Baseline, 24 weeks

  16. Absolute change in hs-CRP from baseline to week 24

    Time frame · Baseline, 24 weeks

  17. Percent change in hs-CRP from baseline to week 24

    Time frame · Baseline, 24 weeks

  18. Absolute change in ghrelin from baseline to week 24

    Time frame · Baseline, 24 weeks

  19. Percent change in ghrelin from baseline to week 24

    Time frame · Baseline, 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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