Clinical Trials of Anti-HER2 Monoclonal Antibodies

There are at least three Phase III clinical trials going on, using Genentech, Inc.'s anti-HER2 monoclonal antibody (MoAB). Two of them have publicly available protocols:

  • Phase III Randomized, Single-Blind Study of Monoclonal Antibody HER2 in Chemotherapy-Naive Metastatic Breast Cancer That Overexpresses HER2/neu

  • Phase III Randomized Study of Chemotherapy with vs without Monoclonal Antibody HER2 in Women with Metastatic Breast Cancer Overexpressing HER2/neu and Previously Untreated with Cytotoxic Chemotherapy

    There is a third such trial, in which patients can apply once per month to a clinical trials company for entry of their name into a lottery program on a computer; those who win get Genentech's anti-HER2 medicine. The only information available on the World Wide Web about this trial is that which has been posted by the University of Alabama. Oddly, that information says that the "endpoint" (investigational purpose) of the trial is "clinical and laboratory safety" -- a seeming makeweight.

    Actually, there are several trials listed at Alabama, all of which seem to be this same lottery. They are:

  • UAB 9546
  • UAB 9531
  • Annette Friedman page.