Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Breast Cancer Research Network
• Treatments: Capecitabine

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: <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