Evaluating the effects of tirzepatide on breast cancer risk biomarkers in women with obesity
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women With Obesity and Other Risk Factors for Breast Cancer
This study is testing if the weight loss medication tirzepatide can change breast cancer risk factors in women who are overweight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 64 Years |
| Sex | Female |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 2 sites (Kansas City, Kansas and 1 other locations) |
| Trial ID | NCT06485089 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the impact of tirzepatide, a medication used for weight loss, on biomarkers associated with breast cancer risk in women with obesity. Participants will undergo assessments before and after treatment, including mammography, DXA scans, blood draws, and fine needle aspirations to collect breast tissue samples. The goal is to determine how weight loss through tirzepatide influences these risk biomarkers, potentially providing insights into breast cancer prevention strategies.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a BMI between 30-45 kg/m2 and additional breast cancer risk factors.
Not a fit: Patients with subglandular breast implants or those who are not on contraceptives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify effective strategies for reducing breast cancer risk in women with obesity.
How similar studies have performed: While there have been studies on weight loss and breast cancer risk, the specific use of tirzepatide in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • BMI 30-45 kg/m2
* Female
* Insurance approved or likely approved for tirzepatide clinical use \*
* Additional risk factors for breast cancer other than obesity (any one or more) First or second degree with breast cancer Known high density on mammogram (heterogenous or extremely dense) Prior biopsy showing atypical hyperplasia or LCIS Prior treated DCIS Known carrier breast cancer predisposition gene mutation or known mutation in family member .
2- fold or higher estimated 10 year or lifetime risk compared to population by standard risk model (BCRAT, BCSC, IBIS
Exclusion Criteria:
* • Subglandular breast implants (women with subpectoral implants are eligible if C cup or greater; breast can easily be pulled off the chest wall; and with approval of PI)
* Clinical contra-indication to incretin mimetics
* Insurance/third party has denied coverage and participant does not wish to do self-pay.
* Child-bearing potential and not on contraceptives
* Prior invasive breast cancer
* Currently taking any of the following medications: insulin, tamoxifen, raloxifene, letrozole, arimidex, exemestane, incretin mimetics.
Where this trial is running
Kansas City, Kansas and 1 other locations
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- University of Kansas Medical Center Breast Cancer Prevention Center — Westwood, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Carol J Fabian, MD — University of Kansas Medical Center
- Study coordinator: Bruce F Kimler, PhD
- Email: bkimler@kumc.edu
- Phone: 913-574-2796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.