ACTIVE_NOT_RECRUITING

Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

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Conditions

ObesityBreast Cancer Risk

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-09-14
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06485089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 64 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * • BMI 30-45 kg/m2
  2. * Female
  3. * Insurance approved or likely approved for tirzepatide clinical use \*
  4. * 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 .
  1. * • 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)
  2. * Clinical contra-indication to incretin mimetics
  3. * Insurance/third party has denied coverage and participant does not wish to do self-pay.
  4. * Child-bearing potential and not on contraceptives
  5. * Prior invasive breast cancer
  6. * Currently taking any of the following medications: insulin, tamoxifen, raloxifene, letrozole, arimidex, exemestane, incretin mimetics.

Contacts and Locations

Principal Investigator

Carol J Fabian, MD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Kansas Medical Center Breast Cancer Prevention Center
Westwood, Kansas, 66208
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Carol J Fabian, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

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

Study Start Date2024-09-14
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-09-14
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Breast Cancer Risk