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NCT06485089 | RECRUITING | Obesity

Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
Sponsor:

University of Kansas Medical Center

Information provided by (Responsible Party):

Carol Fabian, MD

Brief Summary:

Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.

Condition or disease

Obesity

Breast Cancer Risk

Intervention/treatment

tirzepatide

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 Type : OBSERVATIONAL
Estimated Enrollment : 20 participants
Official Title : Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women With Obesity and Other Risk Factors for Breast Cancer
Actual Study Start Date : 2024-09-14
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 64 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

Location Details

NCT06485089

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Locations

RECRUITING

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

RECRUITING

United States, Kansas

University of Kansas Medical Center Breast Cancer Prevention Center

Westwood, Kansas, United States, 66208