A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 821
- 试验地点
- 14
- 主要终点
- Objective response rates
研究概览
简要总结
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.
详细描述
Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.
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
- •Patients with histologic diagnosis of breast carcinoma
- •Stage IV (M1) disease
- •Adult (18 years of age or older) patients
排除标准
- •Patients treated with a taxane within the past year
- •Patients whose tumor tissue is known to show over expression of HER2/neu
研究组 & 干预措施
Taxol
Taxol 80mg/m2/week
干预措施: Taxol (Drug)
TOCOSOL
TOCOSOL Paclitaxel
干预措施: TOCOSOL Paclitaxel (Drug)
结局指标
主要结局
Objective response rates
时间窗: Based on enrollment
Toxicities
时间窗: Based on enrollment
次要结局
- Median overall survival(Based on enrollment)
- Progression-free survival(Based on enrollment)
- Time-to-disease progression(Based on enrollment)