Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women With Obesity and Other Risk Factors for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Completion rate of 70% or more
研究概览
简要总结
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• BMI 30-45 kg/m2
- •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
排除标准
- •• 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.
研究组 & 干预措施
women using tirzepatide for weight loss
Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic
干预措施: tirzepatide (Drug)
结局指标
主要结局
Completion rate of 70% or more
时间窗: 6 months
Completion of procedures for biomarker assessment after 3-6 months of tirzeptide
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months
时间窗: 12 months
Accrual defined as signed consent and ompleting baseline proceedures
次要结局
- Change in benign breast tissue estrogen response and ELF5 gene expression(3-6 months)
- Change in benign breast tissue proliferation(3-6 months)
- Assessment of GIP-R expression in breast tissue(3-6 months)
- Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho(3-6 months)
- Change in mammographic fibroglandular volume(6 months)
研究者
Carol Fabian, MD
Professor
University of Kansas Medical Center