Randomized trial of sequential epirubicin and docetaxel against docetaxel in patients with early operable breast cancer.

INTERVENTION: Product Name: Farmorubicin Pharmaceutical Form: Solution for injection INN or Proposed INN: epirubicin Concentration unit: mg/m2 milligram(s)/square meter Concentration type: up to Concentration number: 90‐ Trade Name: Taxotere Product Name: Taxotere Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: docetaxel Concentration unit: mg/m2 milligram(s)/square meter Concentration type: up to Concentration number: 100‐ Trade Name: Sendoxan Product Name: Sendoxan Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: cyclophosphamide Concentration unit: mg/m2 milligram(s)/square meter Concentration type: up to Concentration number: 600‐ CONDITION: Women with operable breast cancer and increased risk of recurrence PRIMARY OUTCOME: Main Objective: To compare invasive disease‐free survival after after chemotherapy with sequential DC (docetaxel plus cyclophosphamide) followed by EC (epirubicin plus cyclophosphamide) against DC. Primary end point(s): Invasive disease‐free survival Secondary Objective: To compare overall survival and survival without distant recurrence and the frequence og serious adverse events after sequential DC and EC against DC. INCLUSION CRITERIA: · Radical surgery for early breast cancer according to DBCG guidelines · Histological confirmation of invasive breast cancer · TOP2A negative tumor · Age 18 to 34 years · Hormone receptor negative tumor and age 35 or older · Hormone receptor positive tumor, age 35 to 59 years, and either node positive disease, tumor size > 2 cm, grade II or III or HER2 positive · Verbal and written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range