Peregrine completes enrollment in Phase II breast cancer trial

The planned 46 patients have been enrolled and are currently undergoing treatment and follow-up. The primary objective of the multi-center, open-label Phase II study is to assess the overall response rate to bavituximab and docetaxel.

In this trial’s Simon two-stage design, 15 patients with advanced breast cancer were enrolled in the trial’s first cohort. Approximately 10 of the 14 evaluable patients in this cohort demonstrated an objective tumor response according to response evaluation criteria in solid tumors (RECIST) criteria.

According to Peregrine, these results compare favorably with historical response rates for docetaxel as solo therapy in advanced breast cancer patients and exceeded 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.

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. Patients may continue to receive bavituximab as monotherapy after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.

Steven King, president and CEO of Peregrine, said: “Completion of patient enrollment in this Phase II study in advanced breast cancer patients represents a milestone for Peregrine’s bavituximab cancer program, as this is the first of our three ongoing Phase II cancer trials to complete patient enrollment.”