Breast Cancer Clinical Trial
Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer
Summary
Anemia can be caused by the chemotherapy treatment that is used to treat metastatic breast cancer. This study will be used to find out if ACE-011 can help treat chemotherapy induced anemia in patients with metastatic breast cancer.
Eligibility Criteria
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
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There is 1 Location for this study
Sedona Arizona, , United States
Hot Springs Arkansas, , United States
Beverly Hills California, , United States
Corona California, , United States
Fountain Valley California, , United States
Montebello California, , United States
Riverside California, , United States
Denver Colorado, , United States
Boynton Beach Florida, , United States
Hinsdale Illinois, , United States
Evansville Indiana, , United States
Wichita Kansas, , United States
Baltimore Maryland, , United States
Grand Rapids Michigan, , United States
Tupelo Mississippi, , United States
Kansas City Missouri, , United States
Nyack New York, , United States
Goldsboro North Carolina, , United States
High Point North Carolina, , United States
Winston-Salem North Carolina, , United States
Bismarck North Dakota, , United States
Middletown Ohio, , United States
Philadelphia Pennsylvania, , United States
Charleston South Carolina, , United States
Austin Texas, , United States
Dallas Texas, , United States
Tyler Texas, , United States
Lacey Washington, , United States
Krasnodar , , Russian Federation
Moscow (1) , , Russian Federation
Moscow (2) , , Russian Federation
Nizhny Novgorod , , Russian Federation
Nizhny Novograd (2) , , Russian Federation
Pyatigorsk , , Russian Federation
St. Petersburg (1) , , Russian Federation
St. Petersburg (2) , , Russian Federation
St. Petersburg (3) , , Russian Federation
St. Petersburg (4) , , Russian Federation
Stavropol , , Russian Federation
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