{"analyses":[{"ciLowerLimit":"3.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"30.1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0094","pValueComment":"Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).","paramType":"Difference in Response rates","paramValue":"16.82","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0141","pValueComment":"P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-23.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.5","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0198","pValueComment":"Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).","paramType":"Difference in Response rates","paramValue":"-12.15","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0198","pValueComment":"P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-35.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-8.5","groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0010","pValueComment":"Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).","paramType":"Difference in Response rates","paramValue":"-21.84","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciNumSides":"TWO_SIDED","groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0030","pValueComment":"P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.6","upperLimit":"38.5","value":"29.0"},{"groupId":"OG001","lowerLimit":"36.1","upperLimit":"55.7","value":"45.8"},{"groupId":"OG002","lowerLimit":"10.3","upperLimit":"25.3","value":"16.8"},{"groupId":"OG003","lowerLimit":"15.8","upperLimit":"33.7","value":"24.0"}]}]}],"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. Participants with invalid/missing pCR assessments were defined as non-responders","dispersionType":"95% 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":"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 Pathological Complete Response (pCR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}