A PHASE III, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR-POSITIVE AND HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE DISEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY
This international, multicentre, 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 tumours via central
testing. The anticipated duration of the study is approximately 3.5 years.
View this trial on ClinicalTrials.gov
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