Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
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 periareolar fine needle aspiration (RPFNA) for acquisition of benign breast tissue.
Study Type
OBSERVATIONAL
Enrollment
25
Women taking tirzepatide as part of standard care in the Weight Managment Clinic
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kansas Medical Center Breast Cancer Prevention Center
Westwood, Kansas, United States
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months
Accrual defined as signed consent and ompleting baseline proceedures
Time frame: 12 months
Completion rate of 70% or more
Completion of procedures for biomarker assessment after 3-6 months of tirzeptide
Time frame: 6 months
Change in mammographic fibroglandular volume
as measured by Volpara software baseline and 6 months
Time frame: 6 months
Change in benign breast tissue proliferation
Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher
Time frame: 3-6 months
Change in benign breast tissue estrogen response and ELF5 gene expression
Difference in baseline and off study mRNA
Time frame: 3-6 months
Assessment of GIP-R expression in breast tissue
GIP- R mRNA and protein
Time frame: 3-6 months
Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho
change in blood levels with assays primarily by ELISA
Time frame: 3-6 months
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