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

UMIN ID: C000000416

Registered date:01/06/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Metastatic or recurrent breast cancer
• Date of first enrollment: 2006/06/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: Progression-Free Survival Time To Treatment Failure Adverse Events Hearth-Related QOL Efficacy of medical economy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: SELECT BC executive committee
• Source(s) of Monetary Support: Public Health Research Foundation