NL-OMON39231
已完成
3 期
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. - BKM120+Paclitaxel in HER2- Breast Cancer patients, +/- PI3K Activation
ovartis Pharma BV0 个研究点目标入组 10 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ovartis Pharma BV
- 入组人数
- 10
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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
结局指标
主要结局
未指定
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