NCT00637026已完成2 期
A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 65
- 主要终点
- Molecular alterations occuring in breast cancer tissue following Iressa treatment
研究概览
简要总结
A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis
排除标准
- •Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa
结局指标
主要结局
Molecular alterations occuring in breast cancer tissue following Iressa treatment
时间窗: At time of diagnosis and time of patient surgery
次要结局
- Molecular alterations occurring in normal skin tissue following Iressa treatment(At time of diagnosis and time of patient surgery)
- To correlate molecular changes with pharmacokinetic parameters(At time of diagnosis and time of patient surgery)
- To evaluate tolerability of short term Iressa treatment
研究者
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