Effects of Therapeutic Agents on Estrogens in the Breast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Comparison of estrogen compounds in urine
研究概览
简要总结
RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens.
PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.
详细描述
OBJECTIVES:
- Learn the effects of selected chemotherapy agents on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.
- Determine whether tamoxifen citrate or aromatase inhibitor alters the metabolism of estrogens.
OUTLINE: Patients are stratified according to planned therapy (tamoxifen citrate vs aromatase inhibitor).
Patients receive tamoxifen citrate or an aromatase inhibitor as planned. Urine samples (and nipple aspirate fluid, if possible) are collected before beginning treatment and after 2-6 months of treatment. Samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultraperformance liquid chromatography with tandem mass spectrometric detection.
Patients' information, including race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy, and disease type, is collected through medical record review.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed ductal carcinoma in situ or invasive breast cancer
- •Scheduled to receive tamoxifen citrate or an aromatase inhibitor
- •Estrogen receptor or progesterone receptor positive
- •ECOG performance status 0, 1, or 2
排除标准
- •Not pregnant or nursing
- •No prior antiestrogen drug such as tamoxifen citrate or raloxifene
- •No concurrent estrogens
结局指标
主要结局
Comparison of estrogen compounds in urine
时间窗: before and after treatment for two-to-six months
Comparison of estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months
次要结局
未报告次要终点