A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tesetaxel every 3 weeks
Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle
干预措施: Tesetaxel (Drug)
Tesetaxel weekly
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 in a 28-day cycle
干预措施: Tesetaxel (Drug)
Capecitabine
Capecitabine 1250 mg/m2 orally twice daily (equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 in a 21-day cycle
干预措施: Capecitabine (Drug)
结局指标
主要结局
Response rate
时间窗: 4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized
the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST \[Version 1.1\])
次要结局
- Clinical benefit rate(12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized)
- Progression-free survival(12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized)
- Progression-free survival rate(6 and 12 months after patients' date of randomization)
- Adverse events(up to 30 days after patients' last dose of study medication)