Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women with Obesity and Other Risk Factors for Breast Cancer

Status: closed to accrual

This clinical trial studies the effects of tirzepatide on blood, imaging, and breast tissue biomarkers in women with obesity and other risk factors for breast cancer. The use of drugs to suppress appetite and assist in weight loss, like tirzepatide, is becoming increasingly common. While there are reasons to think that this type of drug may alter processes that are linked to the development of cancer, nothing definite is known at this time. This trial utilizes several research tests to examine changes that occur when a woman is taking tirzepatide prescribed for purposes of weight loss. Dual energy X-ray absorptiometry (DXA) is an imaging test that measures bone density (the amount of bone mineral contained in a certain volume of bone) by passing x-rays with two different energy levels through the bone. DXA scans can estimate the amount of fat and muscle in the body. Random periareolar fine needle aspiration (RPFNA) is a procedure that is used to assess risk for development of breast cancer and to acquire breast tissue for evaluation of changes over the course of the study. The RPFNA procedure involves withdrawing cells and breast fluid from two different areas in each of the breasts after the skin has been numbed with local anesthetic. A mammography uses film or a computer to create a picture of the breast. This trial may help researchers conduct future studies to examine the effect of tirzepatide in women that have an above average risk for development of breast cancer.

Inclusion Criteria

Age 40-64
Body mass index (BMI) 30 – 45 kg/m^2
Female
Insurance approved or likely approved for tirzepatide clinical use * Note that for women approved for tirzepatide who have signed consent but who are unable to start this drug because of supply issues and begin semaglutide instead are still eligible to continue on study
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 lobular carcinoma in situ (LCIS) * Prior treated ductal carcinoma in situ (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 ( Breast Cancer Risk Assessment Tool [BCRAT], Breast Cancer Surveillance Consortium [BCSC], IBIS)
Lower age limit of 40 stems from women 40 and over will be likely to have completed childbearing. Age to begin screening mammography even for average risk women is now 40. Upper limitation of age 64 is to avoid a poorly cellular RPFNA specimen. BMI of 30 kg/m^2 general lower limit for insurance to approve tirzepatide and is required for entrance into the University of Kansas Medical Center (KUMC) Weight Management clinic. BMI upper limit is based on likelihood of diabetes, general poor health, and difficulty accessing glandular breast tissue. Male breast cancer uncommon and more difficult to perform RPFNA on men. Requiring additional risk factors besides obesity likely to produce more information on change in risk biomarkers in women at elevated risk and women may be more motivated to complete the 6- month study period

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 principal investigator [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

PRIMARY OBJECTIVES:

I. To assess feasibility in terms of:

Ia. Accrual rate (≥ 1/month) defined as both signing a consent and completing the baseline procedures for biomarker assessments;

Ib. Completion rate (≥ 70%) where completion is defined as a minimum of 12 weeks of tirzepatide and at minimum completion of at least the end of study blood draw and breast fine needle aspiration.

SECONDARY OBJECTIVES:

I. To provide preliminary estimates of baseline values and direction and magnitude of change for risk biomarkers including:

Ia. Gastric inhibitory polypeptide receptor (GIPR) (proportion of specimens with positive immunohistochemistry [IHC] stain);

Ib. Ki-67 (change for those with 1% or higher at baseline);

Ic. Estrogen response gene index;

Id. ElF-5;

Ie. Deoxyribonucleic acid (DNA) damage and aromatase (if sufficient cells);

If. Mammographic Fibroglandular volume (FGV);

Ig. Blood hormones, IGF-1, Klotho and circulating micro ribonucleic acid (miRNA);

Ih. Selected adipocytokines.

TERTIARY OBJECTIVE:

I. To correlate change in biomarker with change in total fat mass, visceral fat mass, and change in mammary adipocyte diameter.

OUTLINE:

Patients undergo DXA scan over 20 minutes, mammography over 15 minutes, and RPFNA over 30 minutes at baseline and at 6 months on study. Patients also undergo collection of blood samples throughout the trial.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women with Obesity and Other Risk Factors for Breast Cancer

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help