Evaluation of the Effects of Endocrine Therapies on Immune Cell Repertoire and Function in Early Stage Estrogen Receptor Positive Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Changes in estrogen levels in response to adjuvant endocrine therapy.
研究概览
简要总结
The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.
详细描述
The study will enroll mainly subjects with estrogen receptor positive breast cancer that have completed surgery and radiation therapy to remove the tumor(s) and have not yet started standard treatment endocrine therapy. There is one group of subjects who have not been diagnosed with cancer. The information learned from this study will help doctors understand more about how the immune system responds to endocrine therapy for early stage breast cancer in people who are estrogen receptor positive with the goal of developing improved therapies that harness the immune system.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in estrogen levels in response to adjuvant endocrine therapy.
时间窗: 2 years
Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.
次要结局
- Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.(Through study completion, approximately 1 year.)
- Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.(Through study completion, approximately 1 year.)
- Changes in physical manifestations with the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue survey to measure response to adjuvant endocrine therapy.(Through study completion, approximately 1 year.)
- Changes in inflammatory markers with Patient-Reported Arthralgia Inventory (PRAI) to measure response to adjuvant endocrine therapy.(Through study completion, approximately 1 year.)
- Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.(Through study completion, approximately 1 year.)
- Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.(Through study completion, approximately 1 year.)
- Assess changes in RNA express in response to endocrine therapy.(Through study completion, approximately 1 year.)