# SYSUCC-001

Source: https://onco.cc/trials/sysucc-001/  
OnCo record `sysucc-001` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Registry id: NCT01112826
- Phase: 3
- Setting: Operable early triple-negative breast cancer (T1b to T3, N0 to N3c) after standard adjuvant chemotherapy: one year of low-dose metronomic capecitabine 650 mg/m2 twice daily versus observation, 13 Chinese centres
- Sponsor: Sun Yat-sen University Cancer Center
- Enrolled: 443
- Result: 5-year DFS 82.8% vs 73.0% (HR 0.64, p 0.03); 10-year DFS 78.1% vs 66.6% (HR 0.61); 10-year OS 82.4% vs 73.7% (HR 0.67, p 0.058).
- Outcomes: Disease-free survival at 5 years: Metronomic capecitabine 82.8% vs Observation 73%, HR 0.64; Disease-free survival at 10 years: Metronomic capecitabine 78.1% vs Observation 66.6%, HR 0.61; Overall survival at 10 years: Metronomic capecitabine 82.4% vs Observation 73.7%, HR 0.67
- Replication: CREATE-X (residual disease) was positive for survival; GEICAM/CIBOMA (extended capecitabine, unselected early TNBC) was negative.

## Sources

- ClinicalTrials.gov NCT01112826: https://clinicaltrials.gov/study/NCT01112826
- Wang et al., JAMA 2021: SYSUCC-001 primary results: https://doi.org/10.1001/jama.2020.23370
- SYSUCC-001 ten-year outcomes and FOXC1 analysis (Lancet Oncology 2025): https://doi.org/10.1016/S1470-2045(25)00545-5

## 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/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Hand-foot syndrome and hand-foot skin reaction](https://onco.cc/terms/hand-foot-syndrome/), [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/), [GEICAM/2003-11_CIBOMA/2004-01](https://onco.cc/trials/geicam-ciboma/)

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