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The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bavituximab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives include time to tumor progression, duration of response, overall survival, and safety. | Approximately 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JSC. National Cancer Centre | Lisi Lake | K'alak'i T'bilisi | 0177 | Georgia | ||
| Ltd. Oncological Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C547825 | bavituximab |
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| Batumi |
| 6000 |
| Georgia |
| Ltd. Tbilisi Oncological Dispensary | Tbilisi | 0171 | Georgia |
| Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str | Tbilisi | 0176 | Georgia |
| D017437 |
| Skin and Connective Tissue Diseases |