Date: 2015-01-13
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Roche (Switzerland)
Product: taselisib
Action
mechanism: phosphoinositide 3-kinase (PI3K) inhibitor. Taselisib is an investigational PI3K inhibitor. Preclinical data have shown that taselisib induced growth inhibition in PI3K?-mutant cell lines.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Bosnia and Herzegovina, Bulgaria, Canada, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Republic of Korea, Mexico, The Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, Thailand, Turkey, USA
Trial
details: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years. (NCT02340221)
Latest
news: * On January 13, 2015, a Phase 3 trial sponsored by Roche was published on the NIH website ClinicalTrials.gov for taselisib and is currently recruiting participants.
