NOT_YET_RECRUITING
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.
Conditions:
🦠 Obesity 🦠 Breast Cancer Risk
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 20
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Kansas City, Kansas, United States
📍 Westwood, Kansas, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 40 Years to 64 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 June 2024
  • First Submitted that Met QC Criteria 26 June 2024
  • First Posted 3 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 3 July 2024
  • Last Verified June 2024