Breast Cancer
Conditions
Interventions
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/
Sponsors
Department of Breast and Thyroid Surgery, Kawasaki Medical School
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed breast cancer patients 2) Brest cancer patients not performed curative resection 3) Breast cancer patients receiving with TXT therapy and are diagnosed as SD by diagnostic image 4) More than 20 years old and less 75 years old 5) Performance status(ECOG) shows from 0 to one 6) Expected survival time more than 3 months at least 7) Measurable region can be diagnosed by RECIST 8) Not received by 5-FU derivatives 9) Adequate organ functions 10) Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Adverse events Phase II: Disease free survival time, all survival time and adverse events | — |
Primary
| Measure | Time frame |
|---|---|
| Phase I: Decide most tolerable dose and recommend dose of medicine Phase II: Response rate | — |
Countries
Japan
Contacts
Public ContactKatsuhiro Tanaka
Kawasaki Medical School Breast and Thyroid Surgery
Outcome results
None listed