Herceptin in the Adjuvant Setting: Phase III Trials Begin

Extract

Herceptin research took a long-expected next step in March with the opening of the first large randomized trial to evaluate the monoclonal antibody as the initial treatment in non-metastatic breast cancer.

The trial will pit chemotherapy with cyclophosphamide, adriamycin, and paclitaxel against the same three drugs plus Herceptin as adjuvant treatment for node-positive tumors. The National Surgical Adjuvant Breast and Bowel Project is conducting the study.

A second phase III trial, an intergroup study led by the North Central Cancer Treatment Group, will follow soon. It will involve the same drugs but will be assessing two different schedules for Herceptin as well as a novel weekly schedule for paclitaxel.

Herceptin won Food and Drug Administration approval in September 1998 for use in metastatic breast tumors that overexpress the HER2 protein. The drug’s success in this arena raised hopes that it would prove at least as effective when tried earlier and up front. Smaller phase II trials and pilot studies are already doing that, but the new trials, with thousands of patients, are the first major phase III studies with Herceptin in the adjuvant setting.