NCT00152178

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	UFT (uracil, tegafur) and tamoxifen	UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.
DRUG	CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen	CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.

Timeline

• Start date: 1996-07-01
• Primary completion: 2008-04-01
• Completion: 2008-08-01
• First posted: 2005-09-09
• Last updated: 2011-07-07

Locations

1 site across 1 country: Japan