Conditions: Breast Cancer
Keywords: Breast cancer Hormone receptor positive HER2-negative Metastatic Locally advanced PI3K Fulvestrant Refractory Aromatase inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1147
Healthy volunteers: no

Brief summary:
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

Detailed description:
Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors \[RECIST\] version 1.1).

Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).

Arms:
arm 1: BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol. arm 2: BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.

Interventions: intervention 1: Fulvestrant intervention 2: BKM120 intervention 3: BKM120 matching placebo
Intervention descriptions: intervention 1: Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter) intervention 2: BKM120 100 mg once daily intervention 3: BKM120 matching placebo, once daily

Protocol document: