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SYSUCC-001 gave a year of low-dose daily capecitabine after standard chemotherapy for early triple-negative breast cancer in China. Fewer women relapsed at five years (83 versus 73 percent) and at ten years (78 versus 67 percent), but the improvement in survival itself did not reach statistical significance.
SYSUCC-001 (NCT01112826) randomised 443 women with early triple-negative breast cancer who had completed standard adjuvant chemotherapy at 13 Chinese centres between 2010 and 2016 to capecitabine 650 mg/m2 twice daily for one year without interruption or observation; 434 were analysed. At a median follow-up of 61 months (JAMA 2021) five-year disease-free survival was 82.8 versus 73.0 percent (hazard ratio 0.64, 95 percent confidence interval 0.42 to 0.95, p 0.03), distant disease-free survival 85.8 versus 75.8 percent (0.60) and overall survival 85.5 versus 81.3 percent (0.75, 0.47 to 1.19, p 0.22); hand-foot syndrome occurred in 45.2 percent (7.7 percent grade 3). The ten-year update (Lancet Oncology 2025, median 116 months) gave disease-free survival 78.1 versus 66.6 percent (hazard ratio 0.61, p 0.0074) and overall survival 82.4 versus 73.7 percent (0.67, 0.45 to 1.01, p 0.058); in an exploratory analysis FOXC1-high tumours (149 patients) had disease-free (0.33) and overall survival (0.25) benefit while FOXC1-low tumours had none. The population (93 percent T1 to T2, 62 percent node-negative, no neoadjuvant therapy or immunotherapy) is not the CREATE-X residual-disease population, and the regimen has not been adopted in Western guidelines.
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.
443 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 5 yearsprimary | Metronomic capecitabine | 221 | 82.8% | 0.64 (0.42 to 0.95) | 0.03 | link |
| Observation | 213 | 73% | ||||
| Disease-free survival at 10 years | Metronomic capecitabine | - | 78.1% | 0.61 (0.43 to 0.88) | 0.0074 | link |
| Observation | - | 66.6% | ||||
| Overall survival at 10 years | Metronomic capecitabine | - | 82.4% | 0.67 (0.45 to 1.01) | 0.058 | link |
| Observation | - | 73.7% |
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.