{"analyses":[{"ciLowerLimit":"0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.97","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis only","nonInferiorityType":"OTHER","pValue":"0.5992","paramType":"Hazard Ratio (HR)","paramValue":"1.15","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"92.99","upperLimit":"98.28","value":"95.63"},{"groupId":"OG001","lowerLimit":"94.70","upperLimit":"99.17","value":"96.94"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"221"}],"units":"Participants"}],"title":"1 Year"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"88.60","upperLimit":"95.60","value":"92.10"},{"groupId":"OG001","lowerLimit":"85.44","upperLimit":"93.43","value":"89.44"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"202"}],"units":"Participants"}],"title":"2 Years"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"85.37","upperLimit":"93.40","value":"89.39"},{"groupId":"OG001","lowerLimit":"84.40","upperLimit":"92.69","value":"88.54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"title":"3 Years"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.01","upperLimit":"92.53","value":"88.27"},{"groupId":"OG001","lowerLimit":"83.35","upperLimit":"91.93","value":"87.64"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"4 Years"}],"denoms":[{"counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"234"}],"units":"Participants"}],"description":"Invasive disease-free survival (iDFS) including second primary non-breast cancer (SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).","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":"The analysis population included all participants who had undergone surgery. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event.","reportingStatus":"POSTED","timeFrame":"At 1, 2, 3, and 4 years","title":"Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to iDFS (Including SPNBC) Criteria","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}