NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Breast cancer
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), TAM(tamoxifen) INN of investigational material : UFT:tegafur, uracil , TAM:tamoxifen Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years. control material(s) Generic name etc : CMF(cyclophosphamide + methotrexate + fluorouracil), TAM(tamoxifen) INN of investigational material : CMF:cyclophosphamide, methotrexate, fluorouracil ,TAM:tamoxifen Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.

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 breast cancer positive for axillary lymph node metastasis
Exclude criteria