{"analyses":[{"ciLowerLimit":"0.94","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.24","groupDescription":"This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.","groupIds":["OG001","OG002"],"nonInferiorityComment":"Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.","nonInferiorityType":"SUPERIORITY","pValue":"0.13","pValueComment":"One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.","paramType":"Hazard Ratio (HR)","paramValue":"1.08","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"92.6","upperLimit":"95.1","value":"94.0"},{"groupId":"OG001","lowerLimit":"91.8","upperLimit":"93.6","value":"92.8"},{"groupId":"OG002","lowerLimit":"92.1","upperLimit":"93.9","value":"93.1"},{"groupId":"OG003","lowerLimit":"85.5","upperLimit":"89.4","value":"87.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1619"},{"groupId":"OG001","value":"3399"},{"groupId":"OG002","value":"3312"},{"groupId":"OG003","value":"1389"}],"units":"Participants"}],"description":"Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method, and compared between the two randomized arms (arm B vs. arm C) using stratified log rank test and stratified Cox proportional hazard model.","dispersionType":"95% Confidence Interval","groups":[{"description":"Group 1 (Oncotype DX recurrence score =\\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.\n\nAnastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO","id":"OG000","title":"Arm A"},{"description":"Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.\n\nAnastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO","id":"OG001","title":"Arm B"},{"description":"Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.\n\nAnastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO\n\nCombination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials","id":"OG002","title":"Arm C"},{"description":"Group 3 (Oncotype DX recurrence score \\>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment.\n\nAnastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO\n\nCombination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials","id":"OG003","title":"Arm D"}],"paramType":"NUMBER","populationDescription":"All eligible patients who had on-study data and follow-up data were included in the analysis","reportingStatus":"POSTED","timeFrame":"Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years","title":"5-year Disease-free Survival","type":"PRIMARY","unitOfMeasure":"percentage of participants"}