{"analyses":[{"groupDescription":"Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \\<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \\>25) in patients randomized to arms B and C","groupIds":["OG001","OG002"],"nonInferiorityComment":"Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis","nonInferiorityType":"OTHER","pValue":"0.004","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"92.4","upperLimit":"96.8","value":"95.1"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 0-10 & Age<=50"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"93.0","upperLimit":"96.1","value":"94.7"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 0-10 & Age 51-65"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"86.5","upperLimit":"93.3","value":"90.5"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of 0-10 were assigned to arm A","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 0-10 & Age 66-75"},{"categories":[{"measurements":[{"comment":"Patients with RS of 11-15 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"92.5","upperLimit":"96.8","value":"95.1"},{"groupId":"OG002","lowerLimit":"91.1","upperLimit":"96.3","value":"94.3"},{"comment":"Patients with RS of 11-15 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 11-15 & Age <=50"},{"categories":[{"measurements":[{"comment":"Patients with RS of 11-15 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"93.4","upperLimit":"96.9","value":"95.5"},{"groupId":"OG002","lowerLimit":"91.7","upperLimit":"95.6","value":"93.9"},{"comment":"Patients with RS of 11-15 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 11-15 & Age 51-65"},{"categories":[{"measurements":[{"comment":"Patients with RS of 11-15 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"80.9","upperLimit":"91.4","value":"87.1"},{"groupId":"OG002","lowerLimit":"85.3","upperLimit":"95.0","value":"91.4"},{"comment":"Patients with RS of 11-15 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 11-15 & Age 66-75"},{"categories":[{"measurements":[{"comment":"Patients with RS of 16-20 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"89.0","upperLimit":"94.2","value":"92.0"},{"groupId":"OG002","lowerLimit":"92.1","upperLimit":"96.4","value":"94.7"},{"comment":"Patients with RS of 16-20 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 16-20 & Age <=50"},{"categories":[{"measurements":[{"comment":"Patients with RS of 16-20 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"92.3","upperLimit":"95.8","value":"94.3"},{"groupId":"OG002","lowerLimit":"89.9","upperLimit":"94.0","value":"92.2"},{"comment":"Patients with RS of 16-20 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 16-20 & Age 51-65"},{"categories":[{"measurements":[{"comment":"Patients with RS of 16-20 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"84.6","upperLimit":"93.8","value":"90.1"},{"groupId":"OG002","lowerLimit":"84.8","upperLimit":"93.8","value":"90.2"},{"comment":"Patients with RS of 16-20 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 16-20 & Age 66-75"},{"categories":[{"measurements":[{"comment":"Patients with RS of 21-25 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"81.1","upperLimit":"90.2","value":"86.3"},{"groupId":"OG002","lowerLimit":"87.7","upperLimit":"95.0","value":"92.1"},{"comment":"Patients with RS of 21-25 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 21-25 & Age <=50"},{"categories":[{"measurements":[{"comment":"Patients with RS of 21-25 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"88.4","upperLimit":"93.9","value":"91.6"},{"groupId":"OG002","lowerLimit":"90.5","upperLimit":"95.4","value":"93.4"},{"comment":"Patients with RS of 21-25 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 21-25 & Age 51-65"},{"categories":[{"measurements":[{"comment":"Patients with RS of 21-25 were randomized to arm B or arm C","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"87.9","upperLimit":"96.8","value":"93.8"},{"groupId":"OG002","lowerLimit":"84.2","upperLimit":"94.9","value":"90.9"},{"comment":"Patients with RS of 21-25 were randomized to arm B or arm C","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"RS 21-25 & Age 66-75"},{"categories":[{"measurements":[{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"82.1","upperLimit":"89.7","value":"86.4"}]}],"title":"RS >25 & Age <=50"},{"categories":[{"measurements":[{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"84.7","upperLimit":"89.9","value":"87.5"}]}],"title":"RS >25 & Age 51-65"},{"categories":[{"measurements":[{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Patients with RS of \\>25 were assigned to arm D","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"84.4","upperLimit":"93.4","value":"89.8"}]}],"title":"RS >25 & Age 66-75"}],"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. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. \\>25) and age groups (\\<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method.","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 by Age and Recurrence Score Groups","type":"SECONDARY","unitOfMeasure":"percentage of participants"}