Surrogate Endpoints in Prevention Studies and Ductal Lavage
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Diagnostic procedures, such as ductal lavage, may improve the ability to assess the effectiveness of chemopreventive drugs, such as tamoxifen, on breast cells and may help doctors plan more effective treatment.
PURPOSE: This phase II trial is studying how well ductal lavage works in assessing changes in breast cells in women with early breast cancer or in those at high risk of developing breast cancer who are eligible for tamoxifen therapy.
详细描述
OBJECTIVES:
- Evaluate cell morphology and protein expression of breast epithelial cells in ductal lavage samples as a marker of tamoxifen effect from women with breast cancer or from women at high risk for developing breast cancer.
- Evaluate methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples from these participants.
- Evaluate the protein profile of nipple aspiration fluid from these participants before and after treatment with tamoxifen.
OUTLINE: This is a multicenter study.
Participants who are eligible for tamoxifen chemoprevention therapy undergo ductal lavage. Participants are informed of cytological findings and choose to receive oral tamoxifen once daily for 5 years vs observation only. All participants undergo repeat ductal lavage at 6 months. Participants with atypical cytology undergo a third ductal lavage at 12 months.
Mammographic density is measured at study entry and at 12 months.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect
时间窗: Before and after tamoxifen treatment
Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples
时间窗: At time of each ductal lavage.
Protein profile of nipple aspiration fluid before and after tamoxifen treatment
时间窗: Before and after tamoxifen treatment.
次要结局
未报告次要终点