JPRN-jRCT2080221448未知3 期
A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2- positive progressive or recurrent locally advanced or metastatic breast cancer (MBC)
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 1,092
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •HER2-positive breast cancer
- •- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent
- •- Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1
- •- ECOG Performance Status 0 or 1
- •- Adequate organ function as determined by laboratory results
排除标准
- •- History of prior (or any) chemotherapy for metastatic breast cancer
- •- An interval of < 6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
- •- Hormone therapy < 7 days prior to randomization
- •- Trastuzumab therapy < 21 days prior to randomization
- •- Prior trastuzumab-DM1 or pertuzumab therapy
研究者
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