PATHFINDER

THIS IS A PROSPECTIVE, OPEN-LABEL, NON-COMPARATIVE 3-ARM CLINICAL TRIAL. THE STUDY WILL BE DIVIDED INTO TWO STAGES: A SAFETY RUN-IN PART FOLLOWED BY A NON-RANDOMIZED PHASE IIA STAGE AS AN EXPANSION STUDY. PRIMARY GOAL WANTS TO EVALUATE THE SAFETY AND TOLERABILITY OF IPATASERTIB (GDC-0068) IN COMBINATION WITH CAPECITABINE, ERIBULIN, OR CARBOPLATIN PLUS GEMCITABINE IN THE INTENTION-TO-TREAT (ITT) POPULATION OF PATIENTS WITH TAXANE-PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER (TNBC). THE SECONDARY GOAL WANTS TO DETERMINE THE EFFICACY OF IPATASERTIB (GDC-0068) IN COMBINATION WITH CAPECITABINE, ERIBULIN, OR CARBOPLATIN PLUS GEMCITABINE IN THE ITT POPULATION AND IN EACH TREATMENT ARM.