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

NCT00152178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2011-07-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hiroki Koyama, MD · Osaka Medical Center for Cancer and Cardiovascular Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-07-31
Primary Completion
2008-04-30
Completion
2008-08-31

Countries

  • Japan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152178 on ClinicalTrials.gov