{"analyses":[{"ciLowerLimit":"0.34","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.40","estimateComment":"HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.","groupDescription":"PFS","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2983","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.30","estimateComment":"HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.","groupDescription":"PFS","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4722","paramType":"Hazard Ratio (HR)","paramValue":"1.25","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"1.07","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.93","estimateComment":"HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.","groupDescription":"PFS","groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0268","paramType":"Hazard Ratio (HR)","paramValue":"2.05","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.27","estimateComment":"HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.","groupDescription":"DFS","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1805","paramType":"Hazard Ratio (HR)","paramValue":"0.60","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"0.42","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.64","estimateComment":"HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.","groupDescription":"DFS","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5901","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"1.08","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.32","estimateComment":"HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.","groupDescription":"DFS","groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0250","paramType":"Hazard Ratio (HR)","paramValue":"2.16","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"71.0","upperLimit":"76.0","value":"71.0"},{"comment":"Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"PFS"},{"categories":[{"measurements":[{"comment":"Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"67.0","upperLimit":"72.0","value":"67.2"},{"comment":"Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"DFS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"107"},{"groupId":"OG002","value":"107"},{"groupId":"OG003","value":"96"}],"units":"Participants"}],"description":"DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.","dispersionType":"80% Confidence Interval","groups":[{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\\^2 on Day 1 of Cycle 1 followed by 100 mg/m\\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.","id":"OG000","title":"Trastuzumab+Docetaxel"},{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\\^2 on Day 1 of Cycle 1 followed by 100 mg/m\\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.","id":"OG001","title":"Trastuzumab+Pertuzumab+Docetaxel"},{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.","id":"OG002","title":"Trastuzumab+Pertuzumab"},{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\\^2 on Day 1 of Cycle 1 followed by 100 mg/m\\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.","id":"OG003","title":"Pertuzumab+Docetaxel"}],"paramType":"MEDIAN","populationDescription":"ITT Population; Analysis was performed according to initial randomization.","reportingStatus":"POSTED","timeFrame":"Randomization up to a maximum of 329 weeks","title":"Progression Free and Disease Free Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}