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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 40 Years and 64 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
women using tirzepatide for weight loss Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic
  • Drug: tirzepatide
    Women taking tirzepatide as part of standard care in the Weight Managment Clinic

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Cathleen Beaver, MD
913-588-3974
cbeaver@kumc.edu

University of Kansas Medical Center Breast Cancer Prevention Center
Westwood, Kansas 66208
Contact:
Carol J Fabian, MD
913-588-7791
cfabian@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Bruce F Kimler, PhD
913-574-2796
bkimler@kumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.