Status:
COMPLETED
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Lead Sponsor:
Japan Breast Cancer Research Network
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
25-74 years
Phase:
PHASE2
Brief 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.
Detailed Description
The incidence of breast cancer is increasing in Japan: 33,676 women were diagnosed with breast cancer in 2001, making it the leading cause of cancer among women since 1995. Statistical database in Exe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00438100
Start Date
April 1 2008
End Date
May 1 2013
Last Update
May 29 2015
Active Locations (8)
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1
Seiko Hospital
Neyagawa, Osaka, Japan, 572-0831
2
Kyushu Central Hospital
Fukuoka, Japan, 815-8588
3
Kansai Medical University Hirakata Hospital
Hirakata, Japan, 573-1191
4
Hirosaki University Hospital
Hirosaki, Japan, 036-8563