Current partner codePEPTIDESDE
NCT07257484·Phase 4·INTERVENTIONAL

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

Status

Recruiting

Phase

Phase 4

Enrollment

30

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Tirzepatide

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

Timeline

From registration to results.

  1. First posted

    Dec 2, 2025

  2. Study start

    Jun 8, 2026

  3. Primary completion

    Dec 3, 2027

  4. Study completion

    Feb 25, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 22, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage of participants completing week 24 visit with all required assessments

Time frame · 24 weeks

Secondary outcomes

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

As assessed by SECA scan

Percent change in visceral fat mass from baseline to week 24

Time frame · Baseline, 24 weeks

As assessed by SECA scan

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
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: * 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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Weill Cornell Medicine

New York, New York, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.