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 metastaticbreast 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 <2.5times the upper normal limit in the absence of demonstrable liver metastases, or <5times 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) duringthe 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