{"analyses":[{"ciLowerLimit":"-4.0","ciNumSides":"ONE_SIDED","ciPctValue":"97.5","estimateComment":"The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.","groupDescription":"Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.","nonInferiorityType":"NON_INFERIORITY","paramType":"Difference in response rates","paramValue":"4.70"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"34.7","upperLimit":"46.9","value":"40.7"},{"groupId":"OG001","lowerLimit":"39.2","upperLimit":"51.7","value":"45.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"description":"Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.","id":"OG000","title":"Herceptin IV + Chemotherapy"},{"description":"Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.","id":"OG001","title":"Herceptin SC + Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.","reportingStatus":"POSTED","timeFrame":"After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)","title":"Percentage of Participants With Pathological Complete Response (pCR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}