Breast Cancer, Obesity (Disorder)
Conditions
Keywords
tirzepatide, hormone receptor positive, HR+, postmenopausal
Brief 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.
Interventions
DRUGTirzepatide
Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.
Sponsors
Weill Medical College of Cornell University
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants completing week 24 visit with all required assessments | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in visceral fat mass from baseline to week 24 | Baseline, 24 weeks | As assessed by SECA scan |
| Percent change in visceral fat mass from baseline to week 24 | Baseline, 24 weeks | As assessed by SECA scan |
| Absolute change in fasting glucose from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in fasting glucose from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in fasting insulin from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in fasting insulin from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in hemoglobin A1c from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in hemoglobin A1c from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in IGF-1 from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in IGF-1 from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in leptin from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in leptin from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in adiponectin from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in adiponectin from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in hs-CRP from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in hs-CRP from baseline to week 24 | Baseline, 24 weeks | — |
| Absolute change in ghrelin from baseline to week 24 | Baseline, 24 weeks | — |
| Percent change in ghrelin from baseline to week 24 | Baseline, 24 weeks | — |
Countries
United States
Contacts
CONTACTLynelle Weis
CONTACTHenry Cheng
PRINCIPAL_INVESTIGATORSarah Schmitz, MD
Weill Medical College of Cornell University
Outcome results
None listed