Trial | NCT00152178  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    680
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.
Study Started
Jul 31
1996
Primary Completion
Apr 30
2008
Study Completion
Aug 31
2008
Last Update
Jul 07
2011
Estimate

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.

1 Experimental

UFT (uracil, tegafur) and tamoxifen

2 Active Comparator

CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Criteria 

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
No Results Posted