NCT04164615Unknown3 期
A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Progression-free survival, PFS
研究概览
简要总结
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GB221+ Capecitabine tablets
Experimental
test drug+capecitabine
干预措施: GB221 (Drug)
Placebo control + capecitabine tablets
Placebo Comparator
placebo+capecitabine
干预措施: Placebo control (Drug)
结局指标
主要结局
Progression-free survival, PFS
时间窗: through study completion, an average of 2 year
To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
次要结局
- Objective Response Rate, ORR(through study completion, an average of 2 year)
- Antidrug antibody, ADA(through study completion, an average of 2 year)
- Overall survival, OS(through study completion, an average of 2 year)
- PFS in the extended treatment phase(through study completion, an average of 2 year)
研究者
研究点 (1)
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