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Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women using tirzepatide for weight loss | Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tirzepatide | Drug | Women taking tirzepatide as part of standard care in the Weight Managment Clinic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months | Accrual defined as signed consent and ompleting baseline proceedures | 12 months |
| Completion rate of 70% or more | Completion of procedures for biomarker assessment after 3-6 months of tirzeptide | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mammographic fibroglandular volume | as measured by Volpara software baseline and 6 months | 6 months |
| Change in benign breast tissue proliferation | Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher |
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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)
Must be biologically female
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.
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| Name | Affiliation | Role |
|---|---|---|
| Carol J Fabian, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| University of Kansas Medical Center Breast Cancer Prevention Center |
Limited number of participants increases risk of identification of individuals
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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Blood, stool, benign breast tissue
| 3-6 months |
| Change in benign breast tissue estrogen response and ELF5 gene expression | Difference in baseline and off study mRNA | 3-6 months |
| Assessment of GIP-R expression in breast tissue | GIP- R mRNA and protein | 3-6 months |
| Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho | change in blood levels with assays primarily by ELISA | 3-6 months |
| Westwood |
| Kansas |
| 66208 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |