This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Progression-free survival rate after 16 weeks of treatment
Time frame: 16 weeks after the first BEZ235 administration
determine the efficacy of BEZ235 (objective response rate)
Time frame: about 6 months
evaluate the clinical benefit rate of BEZ235
Time frame: about 6 months
evaluate the time to response
Time frame: about 6 months
evaluate the Progression Free Survival Rate at 16-week & 24-week using the Kaplan-Meier method
Time frame: 16-week & 24-week after the first BEZ235 administration
evaluate safety of BEZ235 (frequency and severity of Adverse Events, abnormal laboratory values, other safety data as appropriate)
Time frame: 30-35 days after treatment discontinuation
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