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Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients

Phase 2
25 Years
74 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients

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 Exel format/outline of health welfare statistics from the Ministry
of Labor, Health, and Welfare show that the number of deaths from breast cancer was 9,806 in
2003. Because the ten-year survival rate is about ninety percent in Stages 0 and I breast
cancer patients, detection and treatment at an earlier stage can lead to higher survival
rates. However, the recurrence rate increases as the disease progresses. In addition, about
thirty percent of all breast cancer patients are believed to have recurrent disease. Thus,
developing treatments against recurrence may be an important task.

The Guideline for Breast Cancer Treatment, 2004 version, recommends chemotherapy, including
anthracyclines or taxanes as a first-line chemotherapy for metastatic or recurrent (grade B
recommendation) breast cancer. In a second-line therapy recommended for metastatic or
recurrent diseases, the Guideline reports that a combination of capecitabine, a 5Fu
derivative (an oral chemotherapy of pyrimidine fluorides approved in 2003) with docetaxel is
superior to docetaxel alone for improving survival. This regimen is recommended for patients
with cardiac malfunction who cannot be treated with anthracyclines (grade B recommendation).
However, data are lacking to support capecitabine as a standard regimen as a second-line
therapy; its efficacy needs verification and further study. Accordingly, this study is
designed to investigate the efficacy and safety of S-1 alone, an oral pyrimidine fluoride,
to which an indication of "inoperable or recurrent breast cancer" was added, as a first-line
therapy in patients with inoperable or recurrent breast cancer by comparing it with
Capecitabine alone, which is already approved of the same indication.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

The follow up period will be two years after the last dose has been administered.

Safety Issue:


Principal Investigator

Daigo Yamamoto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Kansai Medical University Hirakata Hospital


Japan: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

April 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Drug Therapy
  • Breast Neoplasms
  • Neoplasms