The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.
JSC. National Cancer Centre
Lisi Lake, K'alak'i T'bilisi, Georgia
Ltd. Oncological Center
Batumi, Georgia
Ltd. Tbilisi Oncological Dispensary
Tbilisi, Georgia
Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str
Tbilisi, Georgia
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
Time frame: Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year.
Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.
Time frame: Approximately 1 year
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