{"groups":[{"description":"Trastuzumab deruxtecan (5.4 mg/kg Q3W for 8 cycles)","id":"FG000","title":"Arm A"},{"description":"Trastuzumab deruxtecan (5.4 mg/kg Q3W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles","id":"FG001","title":"Arm B"},{"description":"Doxorubicin (60 mg/m2 Q2W) and cyclophosphamide (600 mg/m2 Q2W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles","id":"FG002","title":"Arm C"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"9"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"21"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}],"type":"As recorded on the Case Report Form (CRF)."},{"reasons":[{"groupId":"FG000","numSubjects":"266"},{"groupId":"FG001","numSubjects":"313"},{"groupId":"FG002","numSubjects":"288"}],"type":"Ongoing at the time of primary analysis for pCR"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"286"},{"groupId":"FG001","numSubjects":"321"},{"groupId":"FG002","numSubjects":"320"}],"comment":"927","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"0","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"286"},{"groupId":"FG001","numSubjects":"321"},{"groupId":"FG002","numSubjects":"320"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Eligible patients had histologically documented human epidermal growth factor receptor 2 (HER2) - positive early stage breast cancer. Eligible patients were randomized in a 1:1:1 ratio using an interactive response technology (IRT) to receive either Arm A: Trastuzumab deruxtecan (T-DXd), Arm B: Trastuzumab deruxtecan followed by Paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) or Arm C: Doxorubicin + cyclophosphamide followed by Paclitaxel + trastuzumab + pertuzumab (ddAC-THP).","recruitmentDetails":"The study is active, not recruiting and conducted in 18 countries worldwide across 147 centres, with 927 patients who were randomized up until 24th April 2024. Results are reported for the study at the data cut-off for the primary analysis for pathologic complete response (pCR) on 12th March 2025."}