Status:
ACTIVE_NOT_RECRUITING
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Obesity
Breast Cancer Risk
Eligibility:
FEMALE
40-64 years
Brief Summary
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
Detailed Description
Women who are scheduled to take tirzepatide for weight loss will be assessed before and after taking drug for change in risk biomarkers. These include mammography, DXA scan, blood draw, and random per...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
September 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06485089
Start Date
September 14 2024
End Date
April 1 2026
Last Update
October 29 2025
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
University of Kansas Medical Center Breast Cancer Prevention Center
Westwood, Kansas, United States, 66208