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



Status:Terminated
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:11/19/2017
Start Date:June 1, 2009
End Date:November 18, 2010

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A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer

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.


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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