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
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
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.
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).
Key Inclusion Criteria:
Key Exclusion Criteria:
Mobile, Alabama 36688, United States
Fullerton, California 92835, United States
La Jolla, California 92093-0658, United States
Los Angeles, California 90017, United States
Los Angeles, California 90053, United States
Multiple Locations, Illinois, United States
Baltimore, Maryland 21231, United States
Tupelo, Mississippi 38801, United States
Nashville, Tennessee 37232, United States
San Antonio, Texas 78229, United States
Roanoke, Virginia 24014, United States
Kennewick, Washington 99336, United States
Morgantown, West Virginia 26506, United States
Madison, Wisconsin 53792-6164, United States
CABA, Buenos Aires C1050AAK, Argentina
Rio Negro, Viedma 8500, Argentina
Woollongong, New South Wales 2500, Australia
Shengyang, Liaoning 110042, China
Saint Priest En Jarez, Pays de la Loire Region 42270, France
Saint-Herblain Cédex, 44805, France
Heraklion Crete, Greece 711 10, Greece
Sakyo Ku, Kyoto 606 8507, Japan
Koto Ku, Tokyo 135 8550, Japan
Las Palmas de Gran Canarias, Las Palmas de Gran Canaria 35016, Spain