{"groups":[{"description":"Participants received inavolisib, 9 milligrams (mg), orally, once daily (QD) on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, intramuscular (IM) injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.","id":"FG000","title":"Inavo+Palbo+Fulv"},{"description":"Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.","id":"FG001","title":"Pbo+Palbo+Fulv"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"55"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Symptomatic Deterioration"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"11"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"97"}],"type":"Ongoing in the study"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"164"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"164"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 325 participants with phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit, alpha isoform (PIK3CA) mutation, hormone receptor-positive, human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer were randomized in 1:1 ratio to Inavolisib+ Palbociclib + Fulvestrant (Inavo+Palbo+Fulv) arm or Placebo + Palbociclib + Fulvestrant (Pbo+Palbo+Fulv) arm in this study.","recruitmentDetails":"Participants took part in the study across 123 investigative centers in 28 countries. This study is still ongoing."}