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

ovartis Pharma Services AG0 个研究点目标入组 1,200 人开始时间: 2015年8月27日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- 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 hile on after aromatase inhibitor treatment
•- Measurable disease or non measurable disease bone lesions lytic or mixed 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

•- 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

发起方