Status:
COMPLETED
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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 withi...
Eligibility Criteria
Inclusion
- 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
- Prior anticancer treatment
Key Trial Info
Start Date :
October 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT00152191
Start Date
October 1 1996
End Date
January 1 2008
Last Update
July 7 2011
Active Locations (1)
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1
National Cancer Center
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan