Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

University of Kansas

Status

Enrolling

Conditions

Obesity

Breast Cancer Risk

Treatments

Drug: tirzepatide

Study type

Observational

Funder types

Other

Identifiers

NCT06485089

STUDY00160627

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

40 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.