CClinicalTrials.gg
Sign In
RecruitingNCT07257484Updated Jul 22, 2026

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

A Phase 4 interventional study of Tirzepatide in Obesity (Disorder) and Breast Cancer, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Obesity (Disorder)
  • Breast Cancer

Keywords

  • tirzepatide
  • hormone receptor positive
  • HR+
  • postmenopausal
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 30 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Drug

    Drug: Tirzepatide

Interventions

  • DrugTirzepatide

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

06

What researchers measure

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

    As assessed by SECA scan

    Time frame: Baseline, 24 weeks

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

    As assessed by SECA scan

    Time frame: Baseline, 24 weeks

  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

07

Study locations

1 of 1 sites recruiting
  • Weill Cornell Medicine
    New York, New York 10021, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07257484
Lead sponsor
Weill Medical College of Cornell University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Responsible party
Sponsor
First posted
Dec 2, 2025
Start date
Jun 8, 2026
Primary completion
Dec 3, 2027 (estimated)
Completion
Feb 25, 2028 (estimated)
Last update
Jul 22, 2026

Study contacts

Lynelle Weis
Contact
ljw4002@med.cornell.edu
646-962-2423
Henry Cheng
Contact
hec4011@med.cornell.edu
646-962-6026
Sarah Schmitz, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Obesity→

Other studies from this sponsor

Weill Medical College of Cornell University

Start the discussion