Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

Recruiting

• Conditions: Obesity; Breast Cancer Risk
• Interventions: Drug: tirzepatide

• Registration Number: NCT06485089
• Lead Sponsor: University of Kansas Medical Center

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 periareolar fine needle aspiration (RPFNA) for acquisition of benign breast tissue.

Study Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-09-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women using tirzepatide for weight loss	tirzepatide	Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic

Primary Outcome Measures

Name	Time	Method
Completion rate of 70% or more	6 months	Completion of procedures for biomarker assessment after 3-6 months of tirzeptide
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months	12 months	Accrual defined as signed consent and ompleting baseline proceedures

Secondary Outcome Measures

Name	Time	Method
Change in benign breast tissue estrogen response and ELF5 gene expression	3-6 months	Difference in baseline and off study mRNA
Change in benign breast tissue proliferation	3-6 months	Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher
Assessment of GIP-R expression in breast tissue	3-6 months	GIP- R mRNA and protein
Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho	3-6 months	change in blood levels with assays primarily by ELISA
Change in mammographic fibroglandular volume	6 months	as measured by Volpara software baseline and 6 months

Trial Locations

Locations (2)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

University of Kansas Medical Center Breast Cancer Prevention Center; 🇺🇸 Westwood, Kansas, United States