{"analyses":[{"groupDescription":"The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \\> 95% power.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0018","statisticalComment":"Reported p-values are unadjusted and 1-sided","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"54","upperLimit":"66","value":"60"},{"groupId":"OG001","lowerLimit":"40","upperLimit":"53","value":"46"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"212"}],"units":"Participants"}],"description":"Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\\&4) versus not (arms 1\\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.","dispersionType":"95% Confidence Interval","groups":[{"description":"Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \\& 4).","id":"OG000","title":"Factor A: Carboplatin"},{"description":"Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \\& 2).","id":"OG001","title":"Factor A: No Carboplatin"}],"paramType":"NUMBER","populationDescription":"All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).","reportingStatus":"POSTED","timeFrame":"At the time of definitive surgical removal, up to 28 weeks","title":"Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).","type":"PRIMARY","unitOfMeasure":"percentage of participants with pCR"}