Conditions: Metastatic Breast Cancer
Keywords: BKM120 fulvestrant breast cancer metastatic locally advanced AI treated mTOR inhibitor PI3K PIK3CA PTEN HER2- HR+
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 432
Healthy volunteers: no

Brief summary:
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

Detailed description:
Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.

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: