drugset / Trial / NCT00152178
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |