JPRN-jRCT2080220775已完成3 期
A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in previously untreated HER2-positive metastatic breast cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 808
研究概览
简要总结
The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •adult patients, >=18 years of age;
- •-cancer of the breast, with locally recurrent or metastatic disease
- •-HER2 positive (FISH-positive or IHC 3+);
- •-candidate for chemotherapy;
- •-ECOG performance status 0 or 1.
排除标准
- •-anticancer therapy for metastatic breast cancer (except for one prior hormonal regimen);
- •-tyrosine kinase/HER inhibitors for breast cancer, except Herceptin used in the neoadjuvant or adjuvant
- •-systemic breast cancer treatment in neoadjuvant or adjuvant setting, with a disease-free interval from
- •completion of systemic treatment to metastatic diagnosis of <12 months;
- •-CNS metastases;
- •-clinically relevant cardiovascular disease.
研究者
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