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.