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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
876 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survivalprimary | Extended adjuvant capecitabine | 448 | - | 0.82 (0.63 to 1.06) | 0.136 | link |
| Observation | 428 | - |
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares Capecitabine, Early triple-negative breast cancer, Cytotoxic chemotherapy.
Shares Capecitabine, Early triple-negative breast cancer, Cytotoxic chemotherapy.
Shares Capecitabine, Early triple-negative breast cancer, Cytotoxic chemotherapy.
Shares Capecitabine, Early triple-negative breast cancer, Cytotoxic chemotherapy.