drugset / Trial / NCT00152178

The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

NCT00152178

Phase 3 Completed 680 enrolled Taiho Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
1996-07
Primary completion
2008-04
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 65 mg/m2 Oral
Comparator Methotrexate Small molecule 40 mg/m2 Intravenous
Comparator fluorouracil Small molecule 500 mg/m2 Intravenous
Subject uracil-tegafur Unknown 270 mg/m2 Oral
Background Tamoxifen Small molecule 20 mg Oral

Indications