{"groups":[{"description":"Fulvestrant Day 1 \\& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.\n\nFulvestrant: Fulvestrant 500 mg Day 1 \\& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).\n\nIf no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.\n\nEverolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.\n\nIf no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.","id":"FG000","title":"Fulvestrant & Everolimus"},{"description":"Fulvestrant Day 1 \\& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.\n\nFulvestrant: Fulvestrant 500 mg Day 1 \\& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).\n\nIf no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.\n\nPlacebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.","id":"FG001","title":"Fulvestrant & Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"49"}],"type":"Disesae progression"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Symptomatic progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"still on treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"never start protocol therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"65"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"65"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"A total of 131 patients were enrolled from 23 institutions between May 2013 and November 2015."}