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

• Status: Terminated
• Trial end date: 2010-11-18
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

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