Phase 2
Completed N=142
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Source: ClinicalTrials.gov NCT00438100 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Progression Free Survival — 1.2; 1.3 years
Summary
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
1.2; 1.3 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Antitumor Effects |
— | — |
| SECONDARY Time to Treatment Failure |
— | — |
| SECONDARY Survival Rate |
— | — |
Eligibility Criteria
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: 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: 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
Data sourced from ClinicalTrials.gov (NCT00438100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.