{"groups":[{"description":"Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \\[mg\\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \\[mg/kg\\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.","id":"FG000","title":"Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab"},{"description":"Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\\^2 intravenously (IV) q3w, epirubicin 100mg/m\\^2 IV q3w, and cyclophosphamide 600mg/m\\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\\^2 in Cycle 5, then 100mg/m\\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.","id":"FG001","title":"Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"13"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"4"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrew Prior to Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Reason Unspecified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"199"},{"comment":"1 participant enrolled in Cohort B received Cohort A treatment (and was counted as part of Cohort B for efficacy).","groupId":"FG001","numSubjects":"201"}],"comment":"ITT Population","type":"STARTED"},{"achievements":[{"comment":"1 participant withdrew prior to receiving any study drug.","groupId":"FG000","numSubjects":"198"},{"comment":"1 participant enrolled in Cohort B received Cohort A treatment (and was counted as part of Cohort A for safety).","groupId":"FG001","numSubjects":"1"}],"comment":"Safety Population for Cohort A","type":"Received Any Cohort A Study Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"2 participants withdrew prior to receiving any study drug.","groupId":"FG001","numSubjects":"198"}],"comment":"Safety Population for Cohort B","type":"Received Any Cohort B Study Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"187"},{"groupId":"FG001","numSubjects":"194"}],"type":"Underwent Surgery"},{"achievements":[{"groupId":"FG000","numSubjects":"182"},{"groupId":"FG001","numSubjects":"189"}],"type":"Completed Neoadjuvant Treatment (25 Weeks)"},{"achievements":[{"groupId":"FG000","numSubjects":"181"},{"comment":"1 participant did not complete neoadjuvant treatment but started adjuvant treatment.","groupId":"FG001","numSubjects":"190"}],"type":"Started Adjuvant Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"163"},{"groupId":"FG001","numSubjects":"176"}],"type":"Completed Adjuvant Treatment (Up to 39 Weeks)"},{"achievements":[{"groupId":"FG000","numSubjects":"195"},{"groupId":"FG001","numSubjects":"195"}],"comment":"Includes participants who completed or discontinued neoadjuvant/adjuvant treatment.","type":"Started Treatment-Free Follow-Up (Up to 5 Years)"},{"achievements":[{"groupId":"FG000","numSubjects":"158"},{"groupId":"FG001","numSubjects":"173"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"28"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 401 participants were enrolled, 199 in Cohort A and 202 in Cohort B. One participant in Cohort B who was human epidermal growth factor receptor 2 (HER2) negative and was enrolled by error, was excluded. Hence, 199 participants were included in Cohort A and 201 participants in Cohort B."}