Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called tirzepatide on women with obesity and their risk of developing breast cancer. The researchers want to see how tirzepatide, which is used for weight loss, impacts certain markers in the blood, imaging tests, and breast tissue that could indicate a higher risk for breast cancer. The trial is currently recruiting women aged 18 to 75 who have a body mass index (BMI) between 30 and 45 and have additional risk factors for breast cancer, such as a family history of the disease or specific findings on mammograms.

Eligible participants should be women who either have insurance that covers tirzepatide or are likely to get approval for it. During the trial, participants will receive tirzepatide and undergo tests to monitor the impact on their health. It's important to note that women with certain conditions, such as previous breast cancer or specific breast implant types, may not qualify for the study. If you are interested in learning more about your eligibility or what participating involves, please reach out to the trial coordinators.

Gender

FEMALE

Eligibility 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.