KCT0001143招募中未知
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •Aged =18 years at signing of informed consent.
- •- Histologically confirmed metastatic breast cancer(MBC), current stage IV.
- •- Documented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+).
- •- Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
- •Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.
排除标准
- •Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
- •Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
研究者
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