Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2009
INTERVENTION: FEC‐DOC Group: 5‐FU 500mg/m2 iv day1 Epirubicin 100mg/ m2/day 1 Cyclophosphamide 500mg/m2 iv day1 Every 21 days for 3 cycles, then Docetaxel 100 mg/m2 iv day1 Every 21 days for 3 cycles After completing treatment, surgical operation is performed. Cyclophosphamide 600mg/m2 iv day1 Docetaxel 75mg/m2 iv day1 Every 21 days for 6 cycles. After completing treatment, surgical operation is performed. CONDITION: Breast cancer PRIMARY OUTCOME: histological effect SECONDARY OUTCOME: Safety; Breast conservation rate ; Recurrence‐free survival; Overall survival INCLUSION CRITERIA: 1) Invasive breast cancer proven histologically 2) Hormone receptor‐negative and without distant metastasis 3)No history of surgery, radiotherapy, hormonal therapy against breast cancer 4)ECOG Performance Status(P.S.) 0‐2 5)measurable lesion 6)Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) laboratory parameters WBC >=4,000, <12,000/mm3 or Neutrophil >=2,000 Platelet >=100,000/mm3 Hemoglobin >=9.5g/dl AST and ALT <=1.5x upper limit of normal Total bilirubin <=1.25x upper limit of normal Serum creatinine <=1.5x upper limit of normal 7)Age >=20 to <80 years 8)Written informed consent
Epistemonikos ID: 115bc2352d7a2a88d9c9d1b2049385a268124986
First added on: Aug 22, 2024