NCT00051103已完成2 期
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 31
研究概览
简要总结
The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.
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
- •(The patient must meet the following criteria in order to be eligible for this study.)
- •Signed informed consent
- •No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
- •Refractory Stage IIIb or IV breast cancer
- •HER2/neu tumor overexpression
- •Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
- •Tumor tissue available for testing.
- •2 weeks since treatment with Herceptin (alone or in combination).
- •Able to swallow and retain oral medication
- •Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
- •Adequate kidney and liver function
- •Adequate bone marrow function
排除标准
- •(The patient cannot meet any of the following criteria in order to be eligible for this study.)
- •Prior regimens did not include Herceptin.
- •Pregnant or lactating.
- •Conditions that would affect absorption of an oral drug
- •Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
- •Severe cardiovascular disease or cardiac disease requiring a device.
- •Active infection.
- •Brain metastases.
- •Concurrent cancer therapy or investigational therapy.
- •Use of oral or IV steroids.
- •Unresolved or unstable serious toxicity from prior therapy.
- •Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.
研究者
研究点 (31)
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