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

UMIN ID: UMIN000000609

Registered date:01/09/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Inoperable or recurrent breast cancer
• Date of first enrollment: 2008/04/01
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Capecitabine (arm A): (1) One course is 1600 mg/m2 orally BID for days 1 through 21, followed by a 7-day washout period, and the course is repeated. (2) When the regimen is determined to meet initial dose standards shown in the appropriate standards, and to have no safety issue, administration will be continued with additional courses, as long as the disease has not progressed.
S-1 (arm B): (1) One course is 80 mg/m2 orally BID for days 1 through 28, followed by a 14-day washout period, and the course is repeated. (2) If no abnormal laboratory test results (blood test, liver and kidney function tests) or gastrointestinal symptoms that may be caused by TS-1 have been reported, and if no safety issues arise (grade 0 for all), the washout period can be shortened, although to not less than seven days. (3) When the regimen is determined to meet initial dose standards shown in the appropriate standards, and to have no safety issues, the administration will be continued with additional courses, as long as the disease has not progressed.

Outcome(s)

• Primary Outcome: Progression Free Survival
• Secondary Outcome: - Adverse events - Antitumor effects - Time to treatment failure - Survival rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: (1) Patients with synchronous multiple cancers (2) Complicated with infection (3) Fever from suspected infection (4) Metastasis to the central nerve system (5) A history of ischemic cardiac diseases (6) Active gastrointestinal ulcer (7) Severe nerve disorder (8) Women who are potentially pregnant, pregnant, or breast-feeding (9) Severe drug allergy (10) Severe suppression of the bone marrow (11) Severe renal disorder (12) Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy) (13) Being treated with flucytosine (14) Complicated with the infection onset which a study doctor assesses to be inappropriate for this study

Related Information

• Primary Sponsor: Japan Breast Cancer Research Network
• Source(s) of Monetary Support: None
• Secondary ID(s): NCT00438100