{"analyses":[{"ciLowerLimit":"-8.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.97","estimateComment":"Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.","nonInferiorityType":"OTHER","paramType":"Difference in tpCR Rate","paramValue":"0.15"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.2","upperLimit":"65.6","value":"59.5"},{"groupId":"OG001","lowerLimit":"53.3","upperLimit":"65.8","value":"59.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"248"}],"units":"Participants"}],"description":"Total pCR (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. The lower bound of the CI will reliably reflect the largest tpCR difference that can be considered unlikely.","dispersionType":"95% Confidence Interval","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 cycles.","id":"OG000","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 cycles.","id":"OG001","title":"Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy"}],"paramType":"NUMBER","populationDescription":"ITT Population: includes all enrolled participants.","reportingStatus":"POSTED","timeFrame":"Following completion of surgery (up to 33 weeks)","title":"Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}