Clinical trial · Interventional
A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
NCT01655992CI-TRIAL-00031323terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor decided to stop the study.
Summary
Brief summary (as posted)
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| S1 generic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S1 generic
- description
- 40mg／m2 bid four weeks on two weeks off
- interventionNames
- Drug: S1 generic
- type
- ACTIVE_COMPARATOR
- label
- capecitabine
- description
- 2500mg／m2／day divided into twice two weeks on one week off
- interventionNames
- Drug: capecitabine
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed breast cancer * Pretreated metastatic breast cancer not more than 2 lines chemotherapy * Have not been previously treated with capecitabine,oral fluracil * ECOG performance status of ≤ 1 * Be female and ≥ 18 and ≤ 75 years of age * Have at least one target lesion according to the RECIST criteria 1.1 Exclusion Criteria: * Pregnant or lactating women * ECOG ≥ 2 * Have been treated with capecitabine * Evidence of CNS metastasis * History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer * Abnormal laboratory values: hemoglobin \< 10.0 g/dl, absolute neutrophil count \< 1.5×10\^9/L, platelet count \< 100×10\^9/L, serum creatinine \> upper limit of normal (ULN), serum bilirubin \> ULN, ALT and AST \> 5×ULN, AKP \> 5×ULN * Serious uncontrolled intercurrent infection * Life expectancy of less than 3 months
References
Publications (0)
Data not yet available
No reference posted for this study.