EUCTR2006-001596-37-BE进行中（未招募）1 期
A phase Ib/II study investigating the combination of RAD001 withtrastuzumab and paclitaxel in patients with HER2-overexpressingmetastatic breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Female or male patients = 18 years old with WHO performance status
- •HER-2 over-expressing metastatic breast cancer cells confirmed by
- •Progressive disease on prior trastuzumab alone/or in combination with
- •other anticancer agents, or relapsed any time after completion of this
- •therapy (phase l)
- •Patient resistance to trastuzumab and taxanes (Phase ll)
- •Measurable disease according to RECIST (Phase ll)
- •Patients neurologically stable with adequate bone marrow, liver and
- •renal function
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •Patients receiving endocrine therapy for breast cancer = 2 weeks prior
- •to study treatment start
- •Patients currently receiving chemotherapy, immunotherapy or
- •radiotherapy or who have received these = 4 weeks prior to study
- •treatment start or patients who have received lapatinib = 2 weeks prior
- •to study treatment start
- •Patients who have previously received mTOR inhibitors
- •Other protocol-defined exclusion criteria may apply
研究者
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