{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.2"},{"groupId":"OG001","value":"30.7"},{"groupId":"OG002","value":"16.7"},{"groupId":"OG003","value":"20.9"}]}],"title":"CR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"56.6"},{"groupId":"OG001","value":"57.4"},{"groupId":"OG002","value":"51.0"},{"groupId":"OG003","value":"50.5"}]}],"title":"PR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.2"},{"groupId":"OG001","value":"11.9"},{"groupId":"OG002","value":"30.4"},{"groupId":"OG003","value":"28.6"}]}],"title":"SD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"2.0"},{"groupId":"OG003","value":"0.0"}]}],"title":"PD"}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"101"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"91"}],"units":"Participants"}],"description":"Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is \\>0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.","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":"NUMBER","populationDescription":"ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.","reportingStatus":"POSTED","timeFrame":"Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months","title":"Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination","type":"SECONDARY","unitOfMeasure":"percentage of participants"}