An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections
研究概览
简要总结
The goal of this pilot observational study is to learn about the feasibility of collecting patient-reported data and stool and blood samples from patients age 65 and older treated with aromatase inhibitor therapy for breast cancer. Participants will be treated with standard of care aromatase inhibitor therapy and will undergo serial phlebotomy, complete patient-reported questionnaires, and submit serial stool samples.
The main exploratory translational questions it aims to obtain preliminary data for are:
- What are the effects of aromatase inhibitor therapy on biomarkers of aging?
- What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender.
- •Cohort 1: Age 65 or greater. Cohort 2: Age younger than 65 years
- •Cohort 1 Participants (starting AI therapy): Histologically proven stage 0-III carcinoma of the breast or at high risk for development of breast cancer who are planning to undergo treatment with neoadjuvant or adjuvant aromatase inhibitor therapy (anastrozole, letrozole, or exemestane).
- •Cohort 1 Controls (no endocrine therapy): Histologically proven stage 0-III carcinoma of the breast or high risk for development of breast cancer and who are not planning to undergo treatment with any endocrine therapy (AI or tamoxifen).
- •Participants Cohort 2 (starting AI therapy): Histologically proven stage 0-III carcinoma of the breast or at high risk for development of breast cancer who are planning to undergo treatment with neoadjuvant or adjuvant aromatase inhibitor therapy (anastrozole, letrozole, or exemestane).
- •Concurrent treatment with GnRHa therapy, radiation therapy, CDK4/6 inhibitor, bisphosphonate, PARP inhibitor, and/or anti-HER2 therapy is permitted. Prior tamoxifen is permitted.
- •The patient is aware of the nature of her diagnosis, understands the study requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
- •Able to read and understand English.
排除标准
- •Distant metastatic disease
- •Prior aromatase inhibitor therapy except in the context of fertility treatment.
- •Use of exogenous estrogen supplementation other than vaginal estrogen preparations.
研究组 & 干预措施
Age 65+, AI therapy
Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy
干预措施: Aromatase inhibitor (Drug)
Age under 65, AI therapy
Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy
干预措施: Aromatase inhibitor (Drug)
Age 65+, no endocrine therapy
Postmenopausal women age 65 and older who are not starting treatment with any endocrine therapy
结局指标
主要结局
Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections
时间窗: 1 year
To assess feasibility of enrolling patients 65 and older in a study that collects serial blood samples and electronic patient-reported outcomes
次要结局
- Percentage of participants who submit at least 2 out of 3 requested serial stool samples(12 weeks)
研究者
N. Lynn Henry
Professor
University of Michigan