A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)

Inclusion Criteria:

• Female, aged >=18 years.
• Subject must have histologic diagnosis of breast carcinoma.
• Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging.
• Subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy.
• Subject must have ECOG performance status 0, 1, or 2.
• Subject must have life expectancy > 6 months
• Subject must have left ventricular ejection fraction >=55% as determined by MUGA scan.

• Subject must have normal organ function, except if abnormal due to tumor involvement:

  • Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=90 g/L, Neutrophils >=1.5 X 10^9/L)
  • Adequate renal function (serum creatinine < 2 X the upper limit of normal (ULN)
  • Adequate liver function (bilirubin < 2 times ULN, AST or ALT < 2 times ULN in the absence of liver metastasis, AST or ALT < 5 times ULN in the presence of liver metastasis.
• Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
• Subject must be able to understand and give informed consent.

Exclusion Criteria:

• Age > 75 years old.
• Subject who is pregnant or breastfeeding or is unwilling to use adequate contraception.
• Subject who has had a previous chemotherapy for metastatic disease.
• Subject who has history of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure.
• Subject who has clinically significant hepatic disease in regard to Hepatitis B, Hepatitis C, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer.
• Subject who has uncontrolled bacterial, viral, or fungal infection.
• Subject who exhibits confusion or disorientation.
• Subject with any condition which would prevent adequate follow-up.
• Subject who has received radiotherapy in the last 4 weeks.
• Subject with any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
• Subject who has brain metastasis.
• Subject who is not able to give informed consent.