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NCT Number: NCT07257484

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

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.

Recruiting

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Key information

Conditions

Obesity (Disorder) Body Weight Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine

New York, 10021, United States

Location status: Recruiting

Location contact

Sarah Schmitz, MD

CONTACT

[email protected]

646-962-2111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

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

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  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

    As assessed by SECA scan

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

    Time frame: Baseline, 24 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Henry Cheng

CONTACT

[email protected]

646-962-6026

Lynelle Weis

CONTACT

[email protected]

646-962-2423

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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