- Female, aged >=18 years.
- Subject must have histologic diagnosis of breast carcinoma.
- Subject must have documented measurable metastatic breast cancer by appropriate
- 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
- 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
- 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.
- Age > 75 years old.
- Subject who is pregnant or breastfeeding or is unwilling to use adequate
- 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.