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OpenTrials
Completed

NCT Number: NCT06485089

Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

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

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Key information

Age range

40 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Women taking tirzepatide as part of standard care in the Weight Managment Clinic

Primary outcomes

  1. Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months

    Time frame: 12 months

    Accrual defined as signed consent and ompleting baseline proceedures

  2. Completion rate of 70% or more

    Time frame: 6 months

    Completion of procedures for biomarker assessment after 3-6 months of tirzeptide

Secondary outcomes

  1. Change in mammographic fibroglandular volume

    Time frame: 6 months

    as measured by Volpara software baseline and 6 months

  2. Change in benign breast tissue proliferation

    Time frame: 3-6 months

    Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher

  3. Change in benign breast tissue estrogen response and ELF5 gene expression

    Time frame: 3-6 months

    Difference in baseline and off study mRNA

  4. Assessment of GIP-R expression in breast tissue

    Time frame: 3-6 months

    GIP- R mRNA and protein

  5. Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho

    Time frame: 3-6 months

    change in blood levels with assays primarily by ELISA

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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