Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.
Interventions
uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
DRUGcyclophosphamide, methotrexate, and fluorouracil
cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 * Performance status 0 or 1 (ECOG) * Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 * Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN * Renal Creatinine ≤ ULN
Exclusion criteria
* Prior anticancer treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | every course for first three courses, then every other course |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, adverse events, and the quality of life | any time |
Countries
Japan
Outcome results
None listed