NCT00386685已完成2 期
Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Response rate (best overall response under treatment)
研究概览
简要总结
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.
The secondary objectives are safety and pharmacokinetic interaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic breast cancer (MBC)
- •HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
- •Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
- •Adequate organs functions
排除标准
- •More than one previous chemotherapy regimen for metastatic disease
- •Cardiac dysfunction
结局指标
主要结局
Response rate (best overall response under treatment)
时间窗: study period
次要结局
- Incidence of grade 3-4 toxicities, pharmacokinetic interaction(study period)
研究者
研究点 (4)
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