{"groups":[{"description":"Subjects treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"FG000","title":"Alpelisib + Fulvestrant"},{"description":"Subjects treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"FG001","title":"Placebo + Fulvestrant"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"207"},{"groupId":"FG001","numSubjects":"240"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"11"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"22"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Sponsor decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"284"},{"groupId":"FG001","numSubjects":"288"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"284"},{"groupId":"FG001","numSubjects":"287"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"169"},{"groupId":"FG001","numSubjects":"172"}],"comment":"Subjects with advanced breast cancer with a PIK3CA mutation based on central testing of hotspot-mutations in tumor tissue","type":"PIK3CA Mutant Cohort by Tumor Tissue"},{"achievements":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"116"}],"comment":"Subjects with advanced breast cancer without a PIK3CA mutation based on central testing of hotspot-mutations in tumor tissue","type":"PIK3CA Non-mutant Cohort by Tumor Tissue"},{"achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"94"}],"comment":"Subjects with advanced breast cancer with a PIK3CA mutation measured in ctDNA","type":"PIK3CA Mutant Cohort by ctDNA"},{"achievements":[{"groupId":"FG000","numSubjects":"181"},{"groupId":"FG001","numSubjects":"182"}],"comment":"Subjects with advanced breast cancer without a PIK3CA mutation measured in ctDNA","type":"PIK3CA Non-mutant Cohort by ctDNA"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"284"},{"groupId":"FG001","numSubjects":"288"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"One subject in the PIK3CA mutant cohort, who was randomized to the placebo + fulvestrant arm, did not receive study treatment due to a protocol deviation.","recruitmentDetails":"Participants were enrolled in 198 centers across 31 countries"}