6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients

Inclusion Criteria: * Histological proven primary breast cancer * Tumour size \>0.5 cm and \<5 cm (pT1b-pT2, pN0, M0) * Axillary lymph nodes tumour free (node-negative disease) * Adequate surgical procedure: R0-resection and axillary dissection with more than 10 lymph nodes examined or adequate sentinel procedure in a qualified centre * Frozen tumour tissue available (for analysis of biological markers and microarrays, centres with biological risk assessment only). The material has to be stored in liquid nitrogen immediately after excision. * Paraffin blocks or (at least) pathology slides of primary tumour (stained and unstained) and axillary nodes (stained) available for central review. * HER-2/neu determination by immunohistochemistry. Patients will be stratified to be HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+ and FISH positive). * No distant metastasis * Age \>18 years, \<70 years * Performance status ECOG \<2 (WHO Performance Status 0-1) * Adequate cardiac function (echocardiographically measured left ventricular ejection fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%) * Adequate bone function (neutrophil count \>1.5 x109 /l and platelet count \>100 x109 /l) * Adequate renal function (serum creatinine \<120 µmol/l or 1.35 mg/dl) and hepatic function (serum bilirubin \<1 x UNL, ASAT or ALAT (SGOT or SGPT) \<2,5 x UNL) * Before patient registration/randomization, written informed consent must be obtained according to ICH/EU GCP, and national/local regulations Exclusion Criteria: * Chemotherapy contraindicated * Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the sentinel node. * Other concomitant pathology compromising survival (at entry), or preventing the administration of chemotherapy with either FEC or Docetaxel * Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study * Estimated life-expectancy \<10 years (irrespective of breast cancer diagnosis) * Patient not accessible for treatment and follow up * Endocrine treatment not according to the latest standard recommendations of the AGO Kommission "Mamma" * Pregnancy, lactation (sufficient non-hormonal contraception in fertile women required) * Surgery more than six weeks ago at the start of chemotherapy * Pre-existing polyneuropathy * Previous or concomitant other malignancy (including contralateral breast cancer) except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix * Prior chemotherapy or radiotherapy or endocrine therapy