CTRI/2009/091/000817已完成2 期
Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer - None
Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc0 个研究点目标入组 137 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
- •2.Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
- •3.Over-expression of HER2
- •4.Tumor tissue available and adequate for analysis at screening
- •5.At least one measurable lesion
- •Note: There is no upper age limit criteria mentioned in the protocol
排除标准
- •1.Prior treatment with Herceptin (Arm B only)
- •2.More than 4 prior cytotoxic chemotherapy regimens
- •3.Subjects with bone or skin as the only site of measurable disease
- •4.Inadequate cardiac function
- •5.Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
- •6.Active central nervous system metastases
- •7.Pregnant or breastfeeding women
- •8.Inability to swallow the HKI-272 capsules
研究者
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