NL-OMON44929已完成3 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 treatment - BELLE 3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 22
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
- •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);Patient has adequate tumor tissue for the analysis of PI3K related biomarkers.
- •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
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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