An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 35
- 主要终点
- Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression
研究概览
简要总结
This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 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
Arm A, E7389 (Eribulin Mesylate)
The eribulin mesylate dose will be 1.4 mg/m2 administered as an intravenous bolus over 2 to 5 minutes on Days 1 and 8 of each 21-day cycle.
干预措施: E7389 (Eribulin Mesylate) (Drug)
Arm B, Vinorelbine injection
The vinorelbine dose will be 25 mg/m2 administered as an intravenous bolus on Days 1, 8, and 15 of each 21-day treatment cycle.
干预措施: Vinorelbine injection (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression
时间窗: Baseline until date of recorded disease progression or death, or up to 2 years
Time at which the highest drug concentration occurs (tmax) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
Progression-Free Survival (PFS) of Vinorelbine Arm by tumor assessment: Time to disease progression
时间窗: Baseline until date of recorded disease progression or death, or up to 2 years
Maximum observed plasma concentration (Cmax) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
Total clearance (CL) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
Area under the plasma concentration-time curve (AUC) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
Terminal phase rate constant (lambda Z) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
Terminal elimination phase half-life (t1/2) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
Distribution volume at steady-state (Vss) of Eribulin Arm in a minimum of 15 subjects
时间窗: Day 1 and Day 8
次要结局
- Evaluate safety parameters such as electrocardiograms(Baseline until date of recorded disease progression or death)
- Overall Survival (OS)(Baseline until date of death, or up 5 years)
- Duration of Response(Baseline until date of recorded disease progression or death or up to 5 years)
- Evaluate safety parameters such as adverse events (AEs)(Baseline until date of recorded disease progression or death)
- Objective Response Rate (ORR)(Baseline until date of recorded disease progression or death, or up to 5 years)
- Evaluate safety assessments parameters such as vital signs( VS)(Baseline until date of recorded disease progression or death)
- Evaluate safety parameters such as laboratory measurements(Baseline until date of recorded disease progression or death)