NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Breast caner
Date of first enrollment	07/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : UFT(tegafur + uracil) INN of investigational material : UFT:tegafur, uracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years control material(s) Generic name etc : CMF(cyclophophamide + methotrexate + fluorouracil) INN of investigational material : CMF:cyclophophamide, methotrexate, fluorouracil Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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(s)

Primary Outcome	Efficacy and safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Female
Include criteria	Patients with Stage I, II or IIIA high-risk breast cancer negative for lymph node metastasis.
Exclude criteria