Kosan initiates Phase II breast cancer trial of alvespimycin

The objective of the Phase II trial is to evaluate the safety and anticancer activity of alvespimycin as a single agent in patients who have not previously received Herceptin for metastatic disease except in an adjuvant setting.

The single-agent trial of alvespimycin will be conducted in eastern Europe and will recruit up to 30 patients in a two-stage trial design. Patients with HER2-positive metastatic disease and no prior trastuzumab treatment except as adjuvant therapy (with the last dose more than 12 months prior to study entry) are eligible to participate in the trial. Alvespimycin will be administered intravenously on a one-hour weekly infusion schedule of 80mg/m2 for three weeks out of four weeks in repeated cycles.