Randomized study of Taxane vs TS-1 in metastatic or recurrent breast cancer patients
- Conditions
- Metastatic or recurrent breast cancer
- Registration Number
- JPRN-C000000416
- Lead Sponsor
- SELECT BC executive committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 600
Not provided
1)During pregnancy or lactation, or planning to get pregnant 2)HER2(Her2/neu, Erb B2) IHC (3+) or FISH(fluorescence in situ hybridization) (+) at primary or metastatic lesion 3)Anaphylaxis against medicine or solvent of this protocol treatment 4)Active double cancers 5)Brain metastasis which needs treatment for hyperfunction of intracranial pressure or urgent irradiation 6)Extended liver metastasis or lymphatic lung metastasis with dyspnea 7)Only one assessable lesion having past radiation therapy 8)Retention of pleural fluid, ascites and pericardial fluid which need urgent treatment 9)Active infectious disease 10)Interstitial pneumonia or idiopathic interstitial pneumonia 11)HBs(+) 12)Diabetes mellitus in bad control or during insulin treatment 13)Mental disease with difficulty of taking part in this study 14)Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Progression-Free Survival Time To Treatment Failure Adverse Events Hearth-Related QOL Efficacy of medical economy