Best hope or last hope: access to phase III clinical trials of HER-2/neu for advanced stage breast cancer patients.

Breast cancer is a major public health problem, with a 12% incidence among women. The over-expression of the proto-oncogene HER-2/neu is associated with 30% of breast and ovarian cancers that are very aggressive and do not respond to standard therapeutic regimens. Entrance into clinical trials can represent the best hope and even the last hope for these patients. Entrance, however, is based on satisfying eligibility criteria. In examining advanced stage breast cancer patients' access to phase III clinical trials for HER-2/neu, two specific arguments regarding eligibility will be addressed. First, if research is to provide the utilitarian goal of the 'greatest good to the greatest number', delineation of the population receiving the 'good', rather than a homogeneous sub-set of this population, must be addressed, along with patients' values and goals, very relevant to determining a 'good life', how to achieve it, and whether a treatment is a part of that process. Second, the 'good' being generated should involve realistic, practical values of quality ways of living with advanced breast cancer and not just increased survival, or cure. Arguments for relaxing criteria are based on an accurate versus over-simplified interpretation of utilitarian principles and concepts of human flourishing. Only through addressing these issues can the true 'good' of clinical trials and research be given to the greatest number of people.