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
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
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).
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.
Key inclusion criteria
Key exclusion criteria
Mobile, Alabama 36688, United States
Atlanta, Georgia 30322, United States
New Orleans, Louisiana 70121, United States
New Orleans, Louisiana 70122-2822, United States
Pittsburgh, Pennsylvania 15232, United States
CABA, Buenos Aires C1050AAK, Argentina
Rio Negro, Viedma 8500, Argentina
Saint-Brieuc Cédex, 22015, France
Saint-Herblain Cédex, 44805, France
Heraklion Crete, Greece 711 10, Greece
Patra - RIO, GR 265 04, Greece
Thesaloniki, Thessaloniki 54622, Greece
Sittard-Geleen, 6162 BG, Netherlands