{"analyses":[{"ciLowerLimit":"-20.84","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-5.41","estimateComment":"A difference in rates \\> 0 favours T-DXd to be associated with a higher rate of pCR than ddAC-THP.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","paramType":"M&N estimate of difference in rates","paramValue":"-13.18","statisticalComment":"Stratified by HR status and HER2 status, with strata weighting by sample size (i.e. Mantel-Haenszel weights).","statisticalMethod":"Miettinen and Nurminen's (M&N) method"},{"ciLowerLimit":"3.95","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.28","estimateComment":"A difference in rates \\> 0 favours T-DXd-THP to be associated with a higher rate of pCR than ddAC-THP.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.003","paramType":"M&N estimate of difference in rates","paramValue":"11.17","statisticalComment":"Stratified by HR status and HER2 status, with strata weighting by sample size (i.e. Mantel-Haenszel weights).","statisticalMethod":"Miettinen and Nurminen's (M&N) method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43.01"},{"groupId":"OG001","value":"67.29"},{"groupId":"OG002","value":"56.25"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"321"},{"groupId":"OG002","value":"320"}],"units":"Participants"}],"description":"Proportion of participants who have no evidence by Hematoxylin \\& Eosin (H\\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.","groups":[{"description":"Trastuzumab deruxtecan (5.4 mg/kg Q3W for 8 cycles)","id":"OG000","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":"OG001","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":"OG002","title":"Arm C"}],"paramType":"NUMBER","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)","title":"Rate of Pathologic Complete Response (pCR).","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}