Peregrine completes enrollment for Phase II breast cancer trial

As part of this two-stage design, 15 patients with locally advanced or metastatic breast cancer have been enrolled initially. The primary objective of the multi-center, open-label study is to assess overall tumor response rate to the combination of bavituximab with docetaxel.

The study may be expanded to include up to an additional 31 subjects if promising results are seen in the first 15 patients. Patients enrolled in the trial will remain in the study until disease progression.

Secondary objectives of the Phase II study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. Tumor response in this study will be evaluated using response evaluation criteria in solid tumors (RECIST) parameters.