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

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Doxorubicin; Epirubicin; Liposomal doxorubicin

Criteria

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