Cancer - Herceptin Response

Herceptin® (trastuzumab) is a therapy for women with metastatic breast cancer whose tumors produce excess amounts of a protein called HER2. The American Cancer Society estimates that 178,000 American women will be diagnosed with breast cancer in 2007, and that 40,000 breast cancer patients will die of their disease. Approximately one third of breast cancer tumors are HER2 positive. Herceptin is approved for first-line use in combination with paclitaxel, or as a single agent for patients who have received one or more chemotherapy regimens. In clinical trials, the addition of weekly doses of Herceptin together with or following chemotherapy was shown to extend overall patient survival. Unfortunately, despite pre-testing for high levels of HER2, only a minority of patients have been shown in clinical trials to respond to Herceptin treatment.

We are conducting a biomarker discovery project to identify an early indicator of response to Herceptin treatment. We believe that a test based on an early response biomarker would benefit both patients and payors by enabling more efficient use of Herceptin treatment. Patients with early evidence of response would be encouraged to continue treatment, while those who did not respond would have the opportunity to switch to other, potentially more effective therapies.