{"groups":[{"description":"In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"FG000","title":"A: P+H IV Followed by PH FDC SC"},{"description":"In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"FG001","title":"B: PH FDC SC Followed by P+H IV"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"80"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"80"}],"comment":"Received all 6 cycles of cross-over treatment","type":"Completed Cross-Over Treatment"},{"achievements":[{"comment":"One participant discontinued the cross-over period after completing cross-over treatment (after receiving Cycle 6) and did not start treatment continuation. They entered directly into the follow-up period.","groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"80"}],"comment":"Completed the Treatment Cross-Over Period","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Treatment Cross-Over (Cycles 1 to 6)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Reason Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease Relapse"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"80"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"70"},{"groupId":"FG001","numSubjects":"68"}],"type":"Received PH FDC SC for Treatment Continuation"},{"achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"12"}],"type":"Received P+H IV for Treatment Continuation"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"comment":"One participant withdrew from the study during the continuation period (withdrawal by subject) and did not enter follow-up.","groupId":"FG001","numSubjects":"77"}],"comment":"Received all cycles of continuation treatment (from Cycle 7 up to 18 total cycles of neo/adjuvant treatment)","type":"Completed Continuation Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"77"}],"comment":"Completed the Treatment Continuation Period","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Treatment Continuation (Cycles 7 to ≤18)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Reason Not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"79"}],"comment":"Participants who discontinued previous treatment periods but remained in the study continued into the follow-up period.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"75"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Follow-Up Period (≥3 Years)"}],"recruitmentDetails":"A total of 183 patients were screened and 160 participants were enrolled."}