PER-084-10已完成未知
A RANDOMIZED ,3 ARM, MULTICENTRE, PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF T-DM1 COMBINED WITH PERTUZUMAD OR T-DM1 COMBINED WITH PERTUZUMAB-PLACEBO (BLINDED FOR PERTUZUMAB) VERSUS THE COMBINATION OF TRANSTUZUMAB PLUS TAXANE, AS FIRST LINE TREATMENT IN HER2-POSITIVE PROGRESSIVE OR RECURRENT LOCALLY ADVANCED OR METASTATIC BREAST CANCER (MBC)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
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
- 18 至 90（—）
入选标准
- •Adult participants >/=18 years of age
- •HER2-positive breast cancer
- •Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
- •Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Eastern Cooperative Oncology Group (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 or recurrent locally advanced disease
- •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 and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
- •Prior trastuzumab emtansine or pertuzumab therapy
研究者
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