A NEW CLINICAL TRIAL FOR WOMEN WITH METASTATIC BREAST CANCER

by Hope S. Rugo, MD

UCSF will be one of the sites in the United States participating in a clinical study of anti-VEGF, an antibody to vascular endothelial growth factor (VEGF). VEGF is one of the major growth factors involved in angiogenesis, a process of new blood vessel growth that appears to be essential for cancer cell growth and metastases. In breast cancer, angiogenesis appears to be an important factor in prognosis. Anti-VEGF is a monoclonal antibody that inactivates VEGF, thereby blocking angiogenesis.

Anti-VEGF is given intravenously every two weeks. A Phase II trial in women with metastatic breast cancer showed some reduction in cancer as well as stable cancers in other women. The new study is a Phase III, randomized clinical trial sponsored by Genentech.

Women with metastatic breast cancer not responsive to taxanes (Taxol or Taxotere) or Adriamycin, who have received two or fewer treatments for metastatic disease, are eligible to participate. Patients will be randomized between treatment with Xeloda (capecitabine, a chemotherapy drug given by mouth) or Xeloda and anti-VEGF. Due to concern about bleeding, women with brain metastases are not eligible to participate in this trial.

This randomized study is very important in order to determine if this new treatment will improve responses to a known chemotherapy drug. Anti-VEGF is not available outside of this trial. For more information about this study, please contact Liz Wieland at the Clinical Research Office at (415) 353-7213. The study is expected to open in mid November.