EUCTR2012-002571-34-GB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 AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatmen - BELLE 3
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
- 432
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
- •Postmenopausal women breast cancer that is locally advanced or metastatic HER2 negative disease, and a known positive 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 prior treatment with AIs
- •Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
- •Adequate bone marrow and organ function
- •Other protocol defined 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •More than 1 prior chemotherapy given for locally advanced or metastatic disease
- •Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
- •Symptomatic CNS 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 or a history of cardiac dysfunction as defined in the protocol
- •Hypersensitivity to fulvestrant excipients
- •Certain scores on an anxiety and depression mood questionnaire given at screening
- •Other protocol defined criteria may apply
研究者
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