NCT01051609已完成不适用
Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
研究概览
简要总结
The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.
研究设计
- 研究类型
- Observational
- 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
- •Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent.
- •Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.
排除标准
- •History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
- •Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
- •Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
- •Active or ongoing infection
- •Known metastatic disease
- •Known history of HIV or hepatitis infections
- •Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI)
- •Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)
- •Pregnant or lactating
- •Unable to speak, read, and write in English
结局指标
主要结局
Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
时间窗: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor
次要结局
未报告次要终点
研究者
研究点 (1)
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