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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
研究者
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