Caelyx Adjuvant in Elderly Breast Cancer

Inclusion Criteria: * Histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria). * Age \> 65 years * Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution). * Performance status 0 to 2 (WHO scale) * 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 * Adequate organ function (as defined by neutrophils \> 1.5 x109/L, Platelets \> 100 x 109/L, Hemoglobin \> 10 g/dl, total bilirubin \> 1.5 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. * Patients must be accessible for treatment and follow-up. * 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) * 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. * 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 arrythmias * 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. * Past (less than 5 years) or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix. * Concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry * Concurrent treatment with other experimental drugs. No participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. * Concurrent treatment with any other anti-cancer therapy.