Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer

Inclusion Criteria:

Histologically confirmed diagnosis of breast cancer documented by cytology or biopsy
Evidence of metastatic breast cancer with a minimum of one lesion per RECIST criteria
Receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine or vinorelbine
Planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study drug administration
Hemoglobin value between ≥ 6.5 to < 11.0 g/dL
Life expectancy of ≥ 6 months

Exclusion Criteria:

Prior radiation therapy to > 20% of the whole skeleton
> 5 prior chemotherapy treatment regimens for metastatic breast cancer
Untreated CNS metastases (exception: CNS metastases treated with whole brain radiotherapy > 6 months prior to randomization)
Uncontrolled hypertension
History of anemia as a result of inherited hemoglobinopathy
History of autoimmune or hereditary hemolysis or gastrointestinal bleeding
Pregnant or lactating