{"analyses":[{"ciLowerLimit":"-9.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.9","groupDescription":"The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".7","paramType":"difference in percentages between arms","paramValue":"2.3","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.8","upperLimit":"64.9","value":"56.5"},{"groupId":"OG001","lowerLimit":"45.7","upperLimit":"62.6","value":"54.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"142"}],"units":"Participants"}],"description":"Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies","id":"OG000","title":"FEC-75 Then Paclitaxel/Trastuzumab"},{"description":"Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies","id":"OG001","title":"Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75"}],"paramType":"NUMBER","populationDescription":"All patients who started study treatment are included in the analysis of the primary endpoint.","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy","type":"PRIMARY","unitOfMeasure":"percentage of participants"}