Clinical trial NCT06485089: Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
Official title: Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women With Obesity and Other Risk Factors for Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Breast Cancer Risk
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending the KUMC Weight Management Clinic and approved or likely to be approved to start a clinical standard of care regimen of tirzepatide for weight loss.

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months
timeFrame: 12 months
measure: Completion rate of 70% or more
timeFrame: 6 months
Secondary outcomes:
measure: Change in mammographic fibroglandular volume
timeFrame: 6 months
measure: Change in benign breast tissue proliferation
timeFrame: 3-6 months
measure: Change in benign breast tissue estrogen response and ELF5 gene expression
timeFrame: 3-6 months
measure: Assessment of GIP-R expression in breast tissue
timeFrame: 3-6 months
measure: Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Medical Center Breast Cancer Prevention Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References: