Breast Cancer Clinical Trial
Official title:
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).
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