EUCTR2011-005524-17-FR进行中（未招募）1 期
A phase III randomized, double-blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment. - BELLE 2
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
- 842
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
入选标准
- •- Breast cancer that is locally advanced or metastatic
- •- HER2 negative disease, hormone receptor positive status (common breast cancer classification tests)
- •- postmenopausal woman
- •- A tumor sample must be shipped to novartis designed laboratory for identification of biomarkers (PI3K activation status)
- •- Progression recurrence of breast cancer while on after aromatase inhibitor treatment
- •- Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
- •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, AKT inhibitors, mTOR inhibitors, fulvestrant
- •- More than one prior chemotherapy line for metastatic disease
- •- 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
- •- 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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