{"groups":[{"description":"Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \\[G-CSF\\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 (neo)adjuvant anti-HER2 treatment cycles.","id":"FG000","title":"Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy"},{"description":"Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 (neo)adjuvant anti-HER2 treatment cycles.","id":"FG001","title":"Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"This includes all randomized participants.","groupId":"FG000","numSubjects":"252"},{"comment":"This includes all randomized participants.","groupId":"FG001","numSubjects":"248"}],"comment":"Intent-to-Treat (ITT) Population","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"252"},{"groupId":"FG001","numSubjects":"248"}],"comment":"Safety Population","type":"Received at Least One Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"242"},{"groupId":"FG001","numSubjects":"234"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Neoadjuvant Treatment Phase (24 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Disease Relapse"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"242"},{"groupId":"FG001","numSubjects":"234"}],"comment":"Completed Neoadjuvant Treatment Phase","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"239"},{"groupId":"FG001","numSubjects":"234"}],"type":"Completed Surgery"},{"achievements":[{"groupId":"FG000","numSubjects":"209"},{"groupId":"FG001","numSubjects":"217"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Surgery & Adjuvant Treatment (42 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"comment":"In addition to participants who completed the previous periods, those who prematurely withdrew from (neo)adjuvant treatment entered the follow-up phase.","groupId":"FG000","numSubjects":"247"},{"comment":"In addition to participants who completed the previous periods, those who prematurely withdrew from (neo)adjuvant treatment entered the follow-up phase.","groupId":"FG001","numSubjects":"241"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"223"},{"groupId":"FG001","numSubjects":"219"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"22"}],"type":"NOT COMPLETED"}],"title":"Treatment-Free Follow-Up (up to 3 Years)"}],"preAssignmentDetails":"A total of 607 patients were screened, 500 of whom were randomized."}