A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Reduction in Ki-67 compared to baseline Ki-67
研究概览
简要总结
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.
详细描述
OBJECTIVES:
- To evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression in women with ductal carcinoma in situ of the breast.
OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat.
Blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6 protein expression, and histone H4 and α-tubulin acetylation.
After completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older 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
研究组 & 干预措施
Vorinostat
干预措施: vorinostat (Drug)
Vorinostat
干预措施: protein expression analysis (Genetic)
Vorinostat
干预措施: immunohistochemistry staining method (Other)
Vorinostat
干预措施: laboratory biomarker analysis (Other)
Vorinostat
干预措施: neoadjuvant therapy (Procedure)
Vorinostat
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Reduction in Ki-67 compared to baseline Ki-67
时间窗: 3 days prior to surgery
次要结局
- Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples(3 days prior to surgery)