A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- PFS of two regimen
研究概览
简要总结
What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.
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
2/3dose strategy
HER2 negative advanced breast cancer patient
干预措施: nab-paclitaxel regimen1 (Drug)
3/4dose strategy
HER2 negative advanced breast cancer patient
干预措施: nab-paclitaxel regimen2 (Drug)
结局指标
主要结局
PFS of two regimen
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen
次要结局
- Side effect of two regimen(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Li Huiping
Head of the department of breast oncology
Peking University Cancer Hospital & Institute