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

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: cyclophosphamide, methotrexate, and fluorouracil; Drug: UFT (uracil, tegafur)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152191

01023001

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Exclusion criteria

• Prior anticancer treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

1

Experimental group

Description:

UFT (uracil, tegafur)

Treatment:

Drug: UFT (uracil, tegafur)

2

Active Comparator group

Description:

CMF(cyclophosphamide, methotrexate, and fluorouracil)

Treatment:

Drug: cyclophosphamide, methotrexate, and fluorouracil