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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-10-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

UFT (uracil, tegafur)

Group Type EXPERIMENTAL

UFT (uracil, tegafur)

Intervention Type DRUG

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

2

CMF(cyclophosphamide, methotrexate, and fluorouracil)

Group Type ACTIVE_COMPARATOR

cyclophosphamide, methotrexate, and fluorouracil

Intervention Type DRUG

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

Interventions

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UFT (uracil, tegafur)

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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