Myocet Plus Endoxan for Older Patients With Breast Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic breast adenocarcinoma
• No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
• Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
• Performance status (WHO) 0-2
• Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
• Adequate renal function (serum creatinine <1.5 times the upper normal limit)
• Adequate cardiac function (LVEF within normal limits)
• Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
• No radiation of measurable disease (except brain metastases)
• No progressive brain metastases according to clinical or radiological criteria
• No brain metastases without prior radiation therapy
• Written informed consent

Exclusion Criteria:

• Active infection
• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
• Other invasive malignancy except non-melanoma skin cancer
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women