A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2010
INTERVENTION: Follow up with no treatment until the metastasis or the relapse are confirmed after neo‐adjvant chemotherapy or adjvant chemotherapy by standard regimen with evidence UFT (250mg/m2/day) is administered orally on days 1‐5 of every week for 2 year after neo adjvant chemotherapy or adjvant chemotherapy by standard regimen with evidence CONDITION: Breast cancer PRIMARY OUTCOME: 5‐year Disease free survival SECONDARY OUTCOME: Overall survival, Incidence of adverse events, Feasibility INCLUSION CRITERIA: 1. Intermediate and high risk for recurrence according to the classification proposed by St.Gallen, 2007 2. Histologically confirmed Breast Cancer . 3. Receive neo‐adjvant chemotherapy or adjvant chemotherapy by standerd regimen with evidence. 4. Within 12 weeks after standard regimen chemotherapy. 5. The patient has been confirmed to be HER2 negative. 6. Age >=20 to <70 years 7. ECOG Performance status 0‐1 8. Oral intake is possible 9. Sufficient organ function. WBC >=3,500, <12,000/mm3 or Neutrophil >=1,500 Platelet >=100,000/mm3 Hemoglobin >=9.0g/dl Total bilirubin <1.5 mg/dL AST and ALT <100 IU/L Serum creatinine <1.5 mg/dL 10. Written informed consent
Epistemonikos ID: 99500f618b6bce33088cb1dbb0fb8b37b5665d69
First added on: Aug 22, 2024