{"groups":[{"description":"Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)","id":"FG000","title":"Everolimus + Vinorelbine + Trastuzumab"},{"description":"Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)","id":"FG001","title":"Placebo + Vinorelbine + Trastuzumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"14"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Abnormal test procedure"},{"reasons":[{"groupId":"FG000","numSubjects":"217"},{"groupId":"FG001","numSubjects":"242"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}],"type":"New cancer therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"14"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}],"type":"Patients untreated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"284"},{"groupId":"FG001","numSubjects":"285"}],"type":"STARTED"},{"achievements":[{"comment":"Pts completed= on treatment at time of DCO. Not Completed = ended treatment as per protocol.","groupId":"FG000","numSubjects":"3"},{"comment":"Pts completed= on treatment at time of DCO. Not Completed = ended treatment as per protocol.","groupId":"FG001","numSubjects":"7"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"281"},{"groupId":"FG001","numSubjects":"278"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"284 patients randomized to the Everolimus + trastuzumab + vinorelbine arm, 280 took drug. 285 patients randomized to the placebo + trastuzumab + vinorelbine arm, 282 too drug. A total of 569 were comprised to randomized total and 562 to safety.","recruitmentDetails":"DCO ( Data cut-off) for patient disposition is 1-Apr-2015. Each Cycle = 21 days"}