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

Japan Breast Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: Capecitabine

Drug: S-1

Study type

Interventional

Funder types

Other

Identifiers

NCT00438100

UMIN000000609 (Registry Identifier)

JBCRN-05

Details and patient eligibility

About

To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.

Full 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 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.

Enrollment

142 patients

Sex

Female

Ages

25 to 74 years old

Volunteers

No Healthy Volunteers

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