The Phase II trial of bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients has a Simon two-stage design. In the first stage, 15 patients with advanced breast cancer were enrolled and treated with the combination regimen. Nine of the 14 (64%) evaluable patients in this cohort demonstrated an objective tumor response according to RECIST criteria, exceeding the pre-specified primary efficacy endpoint needed to expand enrollment in the trial. An additional 31 patients were then enrolled to achieve the planned study total of 46 patients overall.

"Completion of patient enrollment in our second Phase II breast cancer study marks another milestone for the bavituximab cancer program, with two of our three ongoing Phase II trials now having completed enrollment," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "We believe the rapid enrollment experienced in all three of these trials is representative of the enthusiasm of our clinical investigators as well as the need for improved cancer therapies. We look forward to reporting further data from these studies in the upcoming months."

Secondary objectives of the study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients in the study are evaluated regularly for tumor response according to RECIST criteria. They may continue to receive bavituximab as monotherapy after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.

Source: peregrineinc