{"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":"0.0089","statisticalComment":"Reported p-values are unadjusted and 1-sided","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52","upperLimit":"65","value":"59"},{"groupId":"OG001","lowerLimit":"41","upperLimit":"54","value":"48"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"218"}],"units":"Participants"}],"description":"Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2\\&4) versus not (arms 1\\&3) 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 B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 \\& 4).","id":"OG000","title":"Factor B: Bevacizumab"},{"description":"Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 \\& 3)","id":"OG001","title":"Factor B: No Bevacizumab"}],"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"}