NCT00754312终止1 期
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
研究概览
简要总结
The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
ER positive
干预措施: SNDX-275 (Drug)
2
Experimental
ER negative and/or PR negative histology
干预措施: SNDX-275 (Drug)
3
Experimental
triple negative histology (for ER, PR, HER-2)
干预措施: SNDX-275 (Drug)
结局指标
主要结局
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
时间窗: 14 days
次要结局
- Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters(14 days)
- Evaluate changes in gene and/or protein expression of exploratory biomarkers in invasive breast cancer tissue before and after SNDX-275 administration, as tissue sample permits.(14 days)
研究者
研究点 (1)
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