Breast Cancer Risk, Obesity
Conditions
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.
Interventions
DRUGtirzepatide
Women taking tirzepatide as part of standard care in the Weight Managment Clinic
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Completion rate of 70% or more | 6 months | Completion of procedures for biomarker assessment after 3-6 months of tirzeptide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mammographic fibroglandular volume | 6 months | as measured by Volpara software baseline and 6 months |
| 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 |
| Change in benign breast tissue estrogen response and ELF5 gene expression | 3-6 months | Difference in baseline and off study mRNA |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarol J Fabian, MD
University of Kansas Medical Center
Outcome results
None listed