A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel

UMIN ID: UMIN000002064

Registered date:11/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2009/08/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Phase I TS-1 is administered orally on days 1-14 and stop on days 15-28. This schedule is one course. Taxotere is injected by vein on day1 and 15. The dose level is below. Level 0 30mg/m2 Level 1 40mg/m2 Level 2 50mg/m2 Level 3 60mg/m2 3-6 patients will be enrolled at each level
Phase II Recommended dose of TS-1/Taxotere is used with 25 breast cancer patients involving who recommended level patients in phase I.

Outcome(s)

• Primary Outcome: Phase I: Decide most tolerable dose and recommend dose of medicine Phase II: Response rate
• Secondary Outcome: Phase I: Adverse events Phase II: Disease free survival time, all survival time and adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1) Concomitant malignancy 2) Patient with contraindicate TS-1 and TXT 3) Complications including severe heart disease 4) Patient with cardiac infarction within 6 months 5) Serious renal function disturbance 6) Patient with cirrhosis 7) Patient with dyspnea by pheumonitis and lung fibrosis 8) Patient with uncontrolled diabetia 9) Patient with infectious 10)Gravida and having will of pregnancy 11) Patient with chemical allergy 12) Unsuitable patients by doctors diagnosis

Related Information

• Primary Sponsor: Department of Breast and Thyroid Surgery, Kawasaki Medical School
• Source(s) of Monetary Support: Kawasaki Medical School