A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects should meet all of the following criteria to participate in the trial.
- •Subjects who aged 18 years or older.
- •Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
- •Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
- •If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
- •Subjects who have measurable disease in accordance with the RECIST criteria
排除标准
- 未提供
研究组 & 干预措施
Genexol®-PM
This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
干预措施: Genexol-PM® (Drug)
Genexol®
This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
干预措施: Genexol® (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 6 months
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
次要结局
- Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response(Event driven)
- Safety and toxicity(Throughout study)