EUCTR2005-003926-24-IT进行中（未招募）不适用
A Randomized, Multicenter Open-Label Phase III Study of Lapatinib in Combination with Trastuzumab versus Lapatinib Monotherapy in Subjects with Metastatic Breast Cancer whose disease has progressed on Trastuzumab-Containing Regimens - A Study of GW572016 (lapatinib) in Advanced Breast Cancer
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 270 人开始时间: 2006年2月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Signed informed consent. 2. Female >18 years. 3. Metastatic breast cancer, histologically/cytologically confirmed. 4. Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited toTaxane and Anthracycline. 5. Subjects must have received and progressed following treatment with at least TWO trastuzumab plus cytotoxic chemotherapy regimens in the metastatic settingSubjects must have archived tumor tissue available for testing. 6. Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or lactating females. 2. Prior therapy with an ErbB1 and/or ErbB2 inhibitor other than trastuzumab. 5. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject`s safety. 10. Known history or clinical evidence of leptomeningeal carcinomatosis. 11. Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy).15. Current active hepatic or biliary disease.
研究者
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