Featured Clinical Trial:
Chemotherapy-induced anemia in metastatic breast cancer (product/compound: ACE-011)
ClinicAid Locations: Southern California - Fountain Valley, Corona, Riverside
Status: Enrollment closed.
Condition: Chemotherapy-induced Anemia in Metastatic Breast Cancer
Product Name/Compound: ACE-011
Full Study Title: 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
Study 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.
Eligible Participants:
Inclusion (Eligible):
- 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 (Not Eligible):
- Prior radiation therapy to > 20% of the whole skeleton
- > 5 prior chemotherapy treatment regimens for metastatic breast cancer
- Concurrent use of bevacizumab
- 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
Study Phase: Phase IIb (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT00931606
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