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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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