Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer

Inclusion Criteria:

* Histologically proven early breast cancer requiring adjuvant chemotherapy (lymph node positive or other features of high risk according to St-Gallen criteria)
* Margins of resection histologically free of invasive carcinoma and ductal carcinoma in situ.
* Radiotherapy performed according to center's policy and always follows completion of adjuvant chemotherapy
* Performance status 0 to 1 on the ECOG scale (Appendix A)
* The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as \> 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH
* Age \> 18 years and age \<70 years (upper age limit based on the lack of safety data for this population).
* Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution).
* Adequate organ function (as defined by neutrophils \> 1.5 x109/L, Platelets \> 100 x 109/L, Hemoglobin \> 10 g/dl, total bilirubin \> 1 UNL, ASAT (SGOT) and ALAT (SGPT) \> 1.5 UNL, alkaline phosphatase \> 2.5 UNL, creatinine \> 1.5 mg/dl (150 µmol/L)
* Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated.
* Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during study treatment (chemotherapy, radiotherapy and endocrine therapy). No pregnant or lactating patients are allowed.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria:

* Metastatic disease (M1) or inoperable residual axillary disease
* Prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy)
* Prior radiation therapy for breast cancer.
* Pre-existing motor or sensory neurotoxicity of a severity \> grade 2 by NCI criteria.
* Pregnant or lactating patients
* Other serious illness or medical condition:
* Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias.
* History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
* Active uncontrolled infection
* Active peptic ulcer, unstable diabetes mellitus.
* Past or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix.
* Chronic treatment with steroids unless initiated \> 6 months prior to study entry and at low dose (\< 20 mg methylprednisolone or equivalent)
* Concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry.
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry