Clinical trial · Interventional
Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity (Disorder) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tirzepatide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug
- interventionNames
- Drug: Tirzepatide
Primary outcomes (1)
- measure
- Percentage of participants completing week 24 visit with all required assessments
- timeFrame
- 24 weeks
Secondary outcomes (19)
- measure
- Percent change in body weight from baseline to week 24
- timeFrame
- Baseline, 24 weeks
- measure
- Absolute change in visceral fat mass from baseline to week 24
- timeFrame
- Baseline, 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available