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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01610284.
Locations matching your search criteria
United States
California
Los Angeles
Translational Research In Oncology - US Inc (TRIO-US)Status: Active
Name Not Available
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).
Lead OrganizationNovartis Pharmaceuticals Corporation
