{"entity":{"id":"geicam-ciboma","kind":"trial","name":"GEICAM/2003-11_CIBOMA/2004-01","aka":["CIBOMA","GEICAM/CIBOMA","GEICAM 2003-11"],"tldr":"This Spanish and Latin American trial gave eight extra cycles of capecitabine after standard chemotherapy for early triple-negative breast cancer and did not significantly reduce relapses. Only tumours without the basal-like pattern seemed to benefit, a finding that still needs confirmation.","summary":"GEICAM/2003-11_CIBOMA/2004-01 (NCT00130533) randomised 876 patients with operable triple-negative breast cancer (node-positive, or node-negative with a tumour of 1 cm or more) who had completed anthracycline or taxane chemotherapy to capecitabine (448) or observation (428), stratified by basal phenotype on cytokeratin 5/6 and EGFR staining (73.9 percent basal). At a median follow-up of 7.3 years disease-free survival was not significantly prolonged (hazard ratio 0.82, 95 percent confidence interval 0.63 to 1.06, p 0.136). In a preplanned subgroup analysis non-basal tumours had a disease-free survival hazard ratio of 0.53 against 0.94 in basal tumours (interaction p 0.069) and an overall survival hazard ratio of 0.42 against 1.23 (interaction p 0.0052); 75.2 percent completed the eight cycles. With CREATE-X (positive in residual disease) and SYSUCC-001 (positive for disease-free survival with a metronomic schedule) it defines where capecitabine helps: after residual disease rather than in unselected early triple-negative disease.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00130533","url":"https://clinicaltrials.gov/study/NCT00130533"},{"label":"Lluch et al., JCO 2020: adjuvant capecitabine after standard neo/adjuvant chemotherapy in early TNBC (GEICAM/CIBOMA)","url":"https://doi.org/10.1200/JCO.19.00904"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":["roche-genentech","geicam"],"institutions":[],"pathways":[],"terms":["efs"],"trials":["create-x","sysucc-001"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00130533","phase":"3","setting":"Operable early triple-negative breast cancer after standard anthracycline or taxane chemotherapy: eight cycles of extended adjuvant capecitabine versus observation, Spain and Latin America","sponsor":"GEICAM Spanish Breast Cancer Group, with CIBOMA and Roche","result":"DFS HR 0.82 (0.63 to 1.06), p 0.136, not significant; non-basal subgroup DFS HR 0.53 vs basal 0.94 (interaction p 0.069).","yearReported":2020,"enrolled":876,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"arms":[{"name":"Extended adjuvant capecitabine","n":448},{"name":"Observation","n":428}],"hr":0.82,"ci":[0.63,1.06],"p":"0.136","source":"https://doi.org/10.1200/JCO.19.00904"}],"replication":"CREATE-X positive in residual disease; SYSUCC-001 positive with a metronomic year."},"route":"/trials/geicam-ciboma/","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/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"}],"company":[{"id":"geicam","kind":"company","name":"GEICAM Spanish Breast Cancer Group","route":"/companies/geicam/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"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":"create-x","kind":"trial","name":"CREATE-X","route":"/trials/create-x/"},{"id":"sysucc-001","kind":"trial","name":"SYSUCC-001","route":"/trials/sysucc-001/"}]}}