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CREATE-X showed that giving the tablet chemotherapy capecitabine for six months after surgery, to women whose breast cancer had not fully disappeared with pre-operative chemotherapy, cut deaths; the gain was largest in triple-negative disease, where five-year survival rose from 70 to 79 percent.
CREATE-X (UMIN000000843) randomised 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy containing an anthracycline, a taxane or both to standard post-surgical treatment with or without capecitabine 1,250 mg/m2 twice daily on days 1 to 14 of 21 for six to eight cycles. The trial stopped early when a prespecified interim analysis met the primary endpoint. Five-year disease-free survival was 74.1 versus 67.6 percent (hazard ratio 0.70, 95 percent confidence interval 0.53 to 0.92, p 0.01) and five-year overall survival 89.2 versus 83.6 percent (hazard ratio 0.59, 0.39 to 0.90, p 0.01). In the triple-negative subgroup disease-free survival was 69.8 versus 56.1 percent (hazard ratio 0.58, 0.39 to 0.87) and overall survival 78.8 versus 70.3 percent (hazard ratio 0.52, 0.30 to 0.90). Hand-foot syndrome occurred in 73.4 percent of the capecitabine group.
CREATE-X predates immunotherapy: none of its patients had pembrolizumab, and whether capecitabine adds to adjuvant pembrolizumab after residual disease on the KEYNOTE-522 regimen has never been tested directly; it is the physician's-choice control in ASCENT-05/OptimICE-RD and TROPION-Breast03. The Spanish GEICAM/CIBOMA trial of extended adjuvant capecitabine in unselected early triple-negative disease was negative and SYSUCC-001 (metronomic capecitabine for a year) positive for disease-free survival, so the evidence for capecitabine is strongest in the CREATE-X population, residual disease after neoadjuvant chemotherapy. The trial has no ClinicalTrials.gov record; it is registered with the UMIN Clinical Trials Registry.
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.
910 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 5 yearsprimary | Capecitabine | - | 74.1% | 0.7 (0.53 to 0.92) | 0.01 | link |
| Control | - | 67.6% | ||||
| Overall survival at 5 years | Capecitabine | - | 89.2% | 0.59 (0.39 to 0.9) | 0.01 | link |
| Control | - | 83.6% | ||||
| Disease-free survival at 5 years, triple-negative subgroup | Capecitabine | - | 69.8% | 0.58 (0.39 to 0.87) | - | link |
| Control | - | 56.1% | ||||
| Overall survival at 5 years, triple-negative subgroup | Capecitabine | - | 78.8% | 0.52 (0.3 to 0.9) | - | link |
| Control | - | 70.3% |
Shares Cytotoxic chemotherapy and the tag registry:umin.
Shares BRE12-158 (Hoosier Oncology Group), Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Early triple-negative breast cancer.
Shares TROPION-Breast03, ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63), Residual cancer burden (RCB), Triple-negative breast cancer (TNBC).
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer.
Shares BRE12-158 (Hoosier Oncology Group), Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Early triple-negative breast cancer, Triple-negative breast cancer (TNBC).
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer, Triple-negative breast cancer (TNBC).
Shares TROPION-Breast03, ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63), Residual cancer burden (RCB), Triple-negative breast cancer (TNBC).
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer, Triple-negative breast cancer (TNBC).