{"groups":[{"description":"Patients undergo observation, and receive no active treatment.","id":"FG000","title":"Arm A (Observation) (Closed to Accrual 05/16/2016)"},{"description":"Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV","id":"FG001","title":"Arm B (Cisplatin or Carboplatin)"},{"description":"Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCapecitabine: Given PO","id":"FG002","title":"Arm C (Capecitabine) (Open to Accrual 6/22/2016)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"No active protocol treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Alternative therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"22"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Complicating disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Financial issue"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"16"}],"type":"Still on treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"9"}],"type":"Not start protocol therapy"}],"milestones":[{"achievements":[{"comment":"Patients on arm A were under observation, and there was no specified active protocol therapy.","groupId":"FG000","numSubjects":"3"},{"comment":"2 patients were assigned to arm B before 6/22/2106 (activation date of amendment #3), 197 patients were assigned to arm B after 6/22/2016. Arm A was permanently closed to accrual by 6/22/2016 and arm C was open to accrual after 6/22/2016.","groupId":"FG001","numSubjects":"199"},{"groupId":"FG002","numSubjects":"213"}],"comment":"All patients who were randomized to one of the three arms in the trial throughout the accrual period between April 2015 and March 2021.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"197"},{"groupId":"FG002","numSubjects":"213"}],"type":"Concurrently randomized to arms B and C"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Concurrently randomized to arms A and B"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"187"},{"groupId":"FG002","numSubjects":"204"}],"type":"Started protocol therapy"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"185"},{"groupId":"FG002","numSubjects":"199"}],"type":"Reported treatment data"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"186"},{"groupId":"FG002","numSubjects":"201"}],"comment":"This is the analysis population for adverse event outcomes","type":"Reported adverse event data"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"199"},{"groupId":"FG002","numSubjects":"213"}],"type":"Reported mortality data"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"comment":"2 patients with basal-subtype disease were assigned to arm B before 6/22/2016; 148 patients with basal-subtype disease were assigned to arm B after 6/22/2016.","groupId":"FG001","numSubjects":"150"},{"groupId":"FG002","numSubjects":"160"}],"type":"Basal-subtype disease"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"148"},{"groupId":"FG002","numSubjects":"160"}],"comment":"This is the primary analysis population for IDFS (primary endpoint) and OS and RFS (secondary endpoints).","type":"Basal-subtype disease randomized after 6/22/2016"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"46"}],"comment":"Intrinsic subtype was added as a stratification factor in amendment #3 (activated on 6/22/2016), all eligible patients regardless of intrinsic subtype were randomized to arms B and C","type":"Non basal-subtype disease"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"7"}],"comment":"In amendment #7 (activated in Nov 2020), intrinsic subtype was removed as a stratification factor, all patients were randomized to arms B and C as long as they submitted tumor specimen for PAM50 test. Intrinsic subtype was not known at randomization. At the time of the final analysis, intrinsic subtype was still pending for these patients.","type":"Intrinsic subtype unknown"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"84"}],"type":"Reported health-related quality of life data at 6 months assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"54"}],"type":"Reported health-related quality of life data at 15 months assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"146"},{"groupId":"FG002","numSubjects":"141"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"53"},{"groupId":"FG002","numSubjects":"72"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Before randomization patients were tested about their intrinsic subtype using PAM50 assay at step 0. Before amendment #3, only basal subtype was eligible and was randomized. After amendment #3, all patients were eligible regardless of intrinsic subtype, and intrinsic subtype was added as a stratification factor. After amendment #7 (activated in November 2020), intrinsic subtype was no longer a stratification factor, patients were randomized as long as tumor specimen was submitted for PAM50 test.","recruitmentDetails":"This study was activated on April 29, 2015, with the first accrual on October 20, 2015. Accrual was temporarily suspended on December 28, 2015. The study was reactivated on June 22, 2016 to continue enrollment of patients to arms B and C (capecitabine), and accrual to arm A was permanently closed. Patient accrual was closed on March 30, 2021 with final accrual of 560 patients to step 0 and 415 patients randomized to step 1. Only 415 patients enrolled at Step 1 are included in the analysis."}