NCT01644890已完成3 期
A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.
详细描述
This study is a randomized, open-label, multi-national phase III study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of the patient signed by herself.
- •Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
- •Aged 20 to 74 at the time of informed consent.
排除标准
- •Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
研究组 & 干预措施
NK105
Experimental
干预措施: NK105 (Drug)
Paclitaxel
Active Comparator
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Baseline, every 6 weeks of study treatment period, and end of study,
PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1. Assessment period was from the day of randomisation until the first observation of lesion progression or death
次要结局
- Overall Survival(Baseline, every 6 weeks of study treatment period, and end of study.)
- Overall Response Rate(Baseline, every 6 weeks of study treatment period, and end of study.)
研究者
研究点 (1)
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