Conditions: Breast Neoplasms
Keywords: Breast Neoplasms Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

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 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.

Arms:
arm 1: Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. arm 2: S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.

Interventions: intervention 1: Capecitabine intervention 2: S-1
Intervention descriptions: intervention 1: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. intervention 2: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.

Protocol document: