NCT00426530已完成1 期
A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)
研究概览
简要总结
This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
RAD001 Daily Schedule
Experimental
5mg or 10mg
干预措施: everolimus (RAD001) (Drug)
RAD001 Weekly Schedule
Experimental
30mg
干预措施: everolimus (RAD001) (Drug)
结局指标
主要结局
To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)
时间窗: after ever DLT within the first cycle, at least 21 days on treatment, every 2 months from first date of enrollment in a particular regimen
次要结局
- To assess the ability to deliver the trastuzumab and vinorelbine therapy(After LPLV)
- To evaluate the overall tumor response(every 9 weeks/minus 1 week)
- To assess everolimus, trastuzumab and vinorelbine blood levels in this combination(After LPLV)
研究者
研究点 (1)
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