Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.
Interventions
DRUGUFT (uracil, tegafur) and tamoxifen
UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.
DRUGCMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 65 * Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 11.0 g/dL * Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL * Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | recurrence and survival will be collected for 5 years after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, adverse events, and the quality of life | adverse events will be collected during treatment |
Countries
Japan
Outcome results
None listed