{"entity":{"id":"ea1131","kind":"trial","name":"ECOG-ACRIN EA1131","aka":["EA1131"],"tldr":"EA1131 asked whether platinum chemotherapy after surgery beats capecitabine for triple-negative breast cancer that survived pre-operative chemotherapy. It was stopped early because platinum was not going to prove better and was more toxic, so capecitabine stayed the standard.","summary":"ECOG-ACRIN EA1131 (NCT02445391) randomised 415 patients with stage II to III triple-negative breast cancer and residual invasive disease of at least 1 cm after neoadjuvant chemotherapy to four cycles of carboplatin or cisplatin or six cycles of capecitabine; the primary endpoint was three-year invasive disease-free survival in basal-like tumours (77 percent of enrolled patients by PAM50). The trial was closed early after a prespecified futility analysis found platinum unlikely to be superior or non-inferior to capecitabine (JCO 2021; the primary paper is not indexed on Europe PMC, so its hazard ratio is not quoted here). Patient-reported outcomes (Cancer 2024, 296 patients) showed a greater on-treatment symptom burden with capecitabine at cycle 3 despite a similar frequency of clinician-rated adverse events, and a clinically meaningful decline in neurotoxicity scores on platinum. A 2026 post hoc analysis (376 patients, 18 percent Black) found no racial difference in disease-free or overall survival despite worse socioeconomic indices among Black patients. EA1131 keeps capecitabine (CREATE-X) as the non-BRCA post-neoadjuvant standard and is the reason platinum is not offered in that setting.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02445391","url":"https://clinicaltrials.gov/study/NCT02445391"},{"label":"EA1131 patient-reported outcomes (Cancer 2024)","url":"https://doi.org/10.1002/cncr.35187"},{"label":"EA1131: race, socioeconomic status and outcomes (JCO Oncology Advances 2026)","url":"https://doi.org/10.1200/OA-25-00177"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","cisplatin","capecitabine"],"companies":["ecog-acrin"],"institutions":["nci"],"pathways":[],"terms":["rcb","efs","tnbc-residual-disease-decision"],"trials":["create-x","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02445391","phase":"3","setting":"Stage II to III triple-negative breast cancer with residual invasive disease of 1 cm or more after neoadjuvant chemotherapy: adjuvant platinum (carboplatin or cisplatin, four cycles) versus capecitabine (six cycles), United States and South Africa","sponsor":"ECOG-ACRIN Cancer Research Group / National Cancer Institute","result":"Closed for futility: platinum not superior or non-inferior to capecitabine for iDFS in basal-like residual TNBC (primary hazard ratio not indexed).","yearReported":2021,"enrolled":415,"enrolledBasis":"registry","outcomes":[],"replication":"Consistent with CREATE-X's role for capecitabine; no trial has since tested platinum after residual disease."},"route":"/trials/ea1131/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"}],"company":[{"id":"ecog-acrin","kind":"company","name":"ECOG-ACRIN Cancer Research Group","route":"/companies/ecog-acrin/"}],"institution":[{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"rcb","kind":"term","name":"Residual cancer burden (RCB)","route":"/terms/rcb/"},{"id":"tnbc-residual-disease-decision","kind":"term","name":"Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point","route":"/terms/tnbc-residual-disease-decision/"}],"trial":[{"id":"bre12-158","kind":"trial","name":"BRE12-158 (Hoosier Oncology Group)","route":"/trials/bre12-158/"},{"id":"create-x","kind":"trial","name":"CREATE-X","route":"/trials/create-x/"},{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"}]}}