The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
Phase 3
Completed
- Conditions
- Breast Cancer
- Interventions
- Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
- Registration Number
- NCT00152178
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 680
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 UFT (uracil, tegafur) and tamoxifen UFT (uracil, tegafur) and tamoxifen 2 CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
- Primary Outcome Measures
Name Time Method Relapse-free survival recurrence and survival will be collected for 5 years after surgery
- Secondary Outcome Measures
Name Time Method Overall survival, adverse events, and the quality of life adverse events will be collected during treatment
Trial Locations
- Locations (1)
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵1-1-3, Nakamichi, Higashinari-ku, Osaka, Osaka, Japan