A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)

Sponsor

Taiho Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00152191

Collaborator

(none)

1,300

Enrollment

Location

Arms

135

Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: UFT (uracil, tegafur) Drug: cyclophosphamide, methotrexate, and fluorouracil	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)

Study Start Date :

Oct 1, 1996

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 UFT (uracil, tegafur)	Drug: UFT (uracil, tegafur) uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
Active Comparator: 2 CMF(cyclophosphamide, methotrexate, and fluorouracil)	Drug: cyclophosphamide, methotrexate, and fluorouracil cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8

Arm

Intervention/Treatment

Experimental: 1

UFT (uracil, tegafur)

Drug: UFT (uracil, tegafur)

uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years

Active Comparator: 2

CMF(cyclophosphamide, methotrexate, and fluorouracil)

Drug: cyclophosphamide, methotrexate, and fluorouracil

cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8

Outcome Measures

Primary Outcome Measures

Relapse-free survival [every course for first three courses, then every other course]

Secondary Outcome Measures

Overall survival, adverse events, and the quality of life [any time]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 75
Performance status 0 or 1 (ECOG)
Hematopoietic WBC ≥ 4,000/mm^{3 Platelet ≥ 100,000/mm}3
Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
Renal Creatinine ≤ ULN