{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"95.00","upperLimit":"99.92","value":"97.46"},{"groupId":"OG001","lowerLimit":"90.10","upperLimit":"99.77","value":"94.94"},{"groupId":"OG002","lowerLimit":"100.00","upperLimit":"100.00","value":"100.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"78"}],"units":"Participants"}],"title":"12 Months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"91.40","upperLimit":"98.33","value":"94.87"},{"groupId":"OG001","lowerLimit":"86.50","upperLimit":"98.24","value":"92.37"},{"groupId":"OG002","lowerLimit":"93.80","upperLimit":"100.00","value":"97.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"72"}],"units":"Participants"}],"title":"24 Months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"89.65","upperLimit":"97.41","value":"93.53"},{"groupId":"OG001","lowerLimit":"84.72","upperLimit":"97.38","value":"91.05"},{"groupId":"OG002","lowerLimit":"91.63","upperLimit":"100.00","value":"96.03"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"46"}],"units":"Participants"}],"title":"36 Months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"80"}],"units":"Participants"}],"description":"Invasive Disease-Free Survival is defined as the time from randomization to the first occurrence of one of the following events: ipsilateral invasive breast tumour recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, and death from any cause. Second primary non-breast invasive cancer (with the exception of non-melanoma skin cancers and in situ carcinoma of any site) was included as an event. Participants who had not experienced invasive disease at the time of analysis were censored: i) at the time of the last clinical breast examination if they had post-baseline clinical breast examination; ii) on the date of randomization +1 day if no post-baseline clinical breast examination. Kaplan-Meier methodology was used to estimate the percentage of participants who were event-free at 12, 24, and 36 months.","dispersionType":"95% Confidence Interval","groups":[{"description":"In the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) 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); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV 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":"OG000","title":"All Participants"},{"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":"OG001","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":"OG002","title":"B: PH FDC SC Followed by P+H IV"}],"paramType":"NUMBER","populationDescription":"ITT Population; the number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an invasive-disease free survival (including second primary non-breast cancer) event.","reportingStatus":"POSTED","timeFrame":"At 12, 24, and 36 months","title":"Kaplan-Meier Estimate of the Percentage of Participants Who Were Event-Free for Invasive Disease-Free Survival Including Second Primary Non-Breast Cancer, Overall and by Treatment Sequence","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}