# GEICAM/2003-11_CIBOMA/2004-01

Source: https://onco.cc/trials/geicam-ciboma/  
OnCo record `geicam-ciboma` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: CIBOMA; GEICAM/CIBOMA; GEICAM 2003-11
- Registry id: 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
- Enrolled: 876
- 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).
- Outcomes: Disease-free survival: Extended adjuvant capecitabine vs Observation, HR 0.82
- Replication: CREATE-X positive in residual disease; SYSUCC-001 positive with a metronomic year.

## Sources

- ClinicalTrials.gov NCT00130533: https://clinicaltrials.gov/study/NCT00130533
- Lluch et al., JCO 2020: adjuvant capecitabine after standard neo/adjuvant chemotherapy in early TNBC (GEICAM/CIBOMA): https://doi.org/10.1200/JCO.19.00904

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/)
- companies: [GEICAM Spanish Breast Cancer Group](https://onco.cc/companies/geicam/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/)
- trials: [CREATE-X](https://onco.cc/trials/create-x/), [SYSUCC-001](https://onco.cc/trials/sysucc-001/)

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