Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
Phase 2
- Conditions
- Inoperable or recurrent breast cancer
- Registration Number
- JPRN-UMIN000000609
- Lead Sponsor
- Japan Breast Cancer Research Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method - Adverse events - Antitumor effects - Time to treatment failure - Survival rate