EUCTR2011-005932-24-DE进行中（未招募）不适用
A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 524
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
- •- Breast cancer that is locally advanced or metastatic
- •- HER2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
- •- A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
- •- Adequate bone marrow and organ function
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior chemotherapy for locally advanced or metastatic disease
- •- Previous treatment with PI3K inhibitors
- •- Symptomatic brain metastases
- •- Concurrent malignancy or malignancy within 3 years prior to start of study treatment
- •- Certain drugs or radiation within 2-4 weeks of enrollment
- •- Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
- •- Active heart (cardiac) disease as defined in the protocol
- •- Sensitivity to paclitaxel treatment or inability to use the paclitaxel standard pre-treatment such as corticosteroids
- •- Pregnant or nursing (lactating) woman
- •- Certain scores on an anxiety and depression mood questionaire given at screening
- •Other protocol defined criteria may apply
研究者
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