Clinical trial · Interventional
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
NCT00438100CI-TRIAL-00018081completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent 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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine arm
- description
- Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- S-1 arm
- description
- S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- The follow up period will be two years after the last dose has been administered.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-diagnosed breast cancer with metastasis in multiple organs * Performance Status (World Health Organization :WHO) 0-2 * Functions below are maintained in major organs: * Leukocyte count: 4,000/mm3 to 12,000/mm3 * Neutrophil count: \>2,000/mm3 or more * Platelet count: \<100,000/mm3 or more * Hemoglobin: \>9.5 g/dL * Total bilirubin: \>1.5 mg/dL * AST(GOT): within twice a normal upper value in an institution * AST(GPT): within twice a normal upper value in an institution * BUN: \< 25 mg/dL * Creatinine: within a normal upper value in the institution * 24 hours creatinine clearance: \>50 mL/min (using the Cockcroft-Gault formula) * Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85 * Written informed consent will be obtained for patients for entering this study Exclusion Criteria: * Patients with synchronous multiple cancers * Complicated with infection * Fever from suspected infection * Metastasis to the central nerve system * A history of ischemic cardiac diseases * Active gastrointestinal ulcer * Severe nerve disorder * Women who are potentially pregnant, pregnant, or breast-feeding * Severe drug allergy * Severe suppression of the bone marrow * Severe renal disorder * Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy) * Being treated with flucytosine * Complicated with the infection onset which a study doctor assesses to be inappropriate for this study
References
Publications (0)
Data not yet available
No reference posted for this study.