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