Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients

DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy

To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Inclusion Criteria:

• Age 18-75 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
• Histologically- or cytologically- confirmed breast adenocarcinoma
• No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
• No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
• At least 4 weeks interval since prior anticancer treatment
• Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
• Life expectancy > 3 months
• Written informed consent

Exclusion Criteria:

• Pregnancy or nursing
• Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
• Other invasive malignancy except nonmelanoma skin cancer or acute infection.
• Radiation of measurable disease (except brain metastases)
• Progressive brain metastases according to clinical or radiological criteria.
• Brain metastases without prior radiation therapy