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news.American BioScience has initiated enrollment in a phase II study of Abraxane in combination with Genentech's Herceptin in first-line treatment of metastatic breast cancer.
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The study will be conducted by International Oncology Network (ION), the US’s largest network of community-based oncologists, and will include 20 ION sites.
The open-label, non-randomized study will include 70 patients with locally advanced or metastatic breast cancer. All patients will receive Abraxane at a dose of 125mg/m2 by a 30-minute IV 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.
Abraxane was launched on February 7, 2005 by Abraxis Oncology, the proprietary division of American Pharmaceutical Partners after having received FDA approval in January. It is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.