American Pharmaceutical Partners Initiate Clinical Study of Abraxane

American Pharmaceutical Partners has announced that American BioScience initiated enrollment in a Phase II study of Abraxane administered weekly in combination with Herceptin in first-line treatment of metastatic breast cancer.

The study will be conducted by International Oncology Network (ION), the nation's premier, and largest, network of community-based oncologists and will include 20 ION sites. The open-label, nonrandomized study will include 70 patients with locally advanced or metastatic breast cancer.

All patients will receive Abraxane at a dose of 125 mg/m2 by a 30-minute intravenous infusion once a week for Weeks 1-3 in each four-week cycle of treatment; the HER2-positive patients will, in addition, receive Herceptin, which is regularly used in the treatment of these patients.

The primary study endpoint is response rate, and the secondary study endpoints are time to tumor progression, overall survival and toxicities.