{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.5"},{"groupId":"OG001","value":"39.3"},{"groupId":"OG002","value":"11.2"},{"groupId":"OG003","value":"17.7"}]}],"title":"pCR achieved and Negative Lymph Nodes at Surgery"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"6.5"},{"groupId":"OG002","value":"5.6"},{"groupId":"OG003","value":"6.3"}]}],"title":"pCR achieved and Positive Lymph Nodes at Surgery"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"107"},{"groupId":"OG002","value":"107"},{"groupId":"OG003","value":"96"}],"units":"Participants"}],"description":"pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.","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.","reportingStatus":"POSTED","timeFrame":"Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)","title":"Percentage of Participants Achieving pCR by Lymph Node Status","type":"PRIMARY","unitOfMeasure":"percentage of participants"}