NIPH Clinical Trials Search

UMIN ID: C000000416

Registered date:01/06/2006

Randomized study of Taxane vs TS-1 in metastatic or recurrent breast cancer patients

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMetastatic or recurrent breast cancer
Date of first enrollment2006/06/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Taxane arm is given one administration chosen from below three pattern of administration by doctor. We repeat it 6 cycles or till cancer becomes worse. (1) Dosetaxel 60-75mg/m2 (one cycle: 3 or 4 weeks interval adoministration) (2) Paclitaxel 175mg/m2 (one cycle: 3 or 4 weeks interval adoministration) (3) Paclitaxel 175mg/m2 (one cycle: every 3 week administration continuously followed by 1 week rest period) TS-1 arm is given 40-60mg/m2 (adjusted to body surface) TS-1 administration 2 times/day (morning and evening) for 28 days continuously followed by 14 days rest period. Total 6 weeks is regarded as one cycle. We repeated it 4 cycles or till cancer becomes worse.


Primary OutcomeOverall Survival
Secondary OutcomeProgression-Free Survival Time To Treatment Failure Adverse Events Hearth-Related QOL Efficacy of medical economy

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteria1)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

Related Information


public contact
Name Shizuhiro Yamada
Address 1-1-7, Nishiwaseda, Shinjyuku-ku Tokyo, 169-0051 JAPAN Japan
Telephone 03-5287-2633
Affiliation Public Health research Foundation Comprehensive Support Project for Clinical Research
scientific contact
Name Hirofumi Mukai
Address 6-5-1, Kasiwanoha, Kashiwa-shi, Chiba-ken, 227-8577, Japan Japan
Telephone 04-7133-1111
E-mail no@nomail
Affiliation National Cancer Center East Hospital Department of Chemotherapy