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"American Pharmaceutical Partners has announced the start of enrollment in a 70-patient Phase II study of its anticancer agent Abraxane (paclitaxel albumin-bound particles for injectable suspension), administered weekly in combination with Roche's Herceptin (trastuzumab) as a first-line treatment for metastatic breast cancer.
In the open-label, non-randomized trial, which is being conducted by International Oncology Network, all subjects will be given Abraxane at a dose of 125mg/m2 via a 30-minute intravenous infusion once a week for weeks one-to-three in each four-week cycle of therapy; the HER2-positive patients will also receive Herceptin. The primary endpoint is response rate and secondary endpoints are time to tumor progression, overall survival and toxicities.
Jeffrey Scott, president and national medical director of ION, commented: "Abraxane has demonstrated superiority over Taxol (paclitaxel) in terms of response rate, time to tumor progression and survival. The combination of Abraxane with Herceptin in the absence of steroid pre-medication is an important addition to the armamentarium that oncologists use to treat patients with breast cancer."
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