A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
Phase 3
Completed
- Conditions
- Breast Cancer
- Interventions
- Drug: cyclophosphamide, methotrexate, and fluorouracil
- Registration Number
- NCT00152191
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 UFT (uracil, tegafur) UFT (uracil, tegafur) 2 cyclophosphamide, methotrexate, and fluorouracil CMF(cyclophosphamide, methotrexate, and fluorouracil)
- Primary Outcome Measures
Name Time Method Relapse-free survival every course for first three courses, then every other course
- Secondary Outcome Measures
Name Time Method Overall survival, adverse events, and the quality of life any time
Trial Locations
- Locations (1)
National Cancer Center
🇯🇵5-1-1, Tsukiji, chuo-ku, Tokyo, Japan