The overall purpose of this proposal is to evaluate the clinical benefits of inhibitors of angiogenesis in regards to improving the care of patients with breast cancer. We are complementing these clinical trials with studies of the quality of life of participating patients, as well as with studies of the cost effectiveness of application of these agents in comparison to standard care. Several possible angiogenic inhibitors are available for study.
Clinical trials directed toward accomplishment of our goals and aims are now nearly complete .
We have completed a Phase II study of thalidomide and reported the preliminary results at a national meeting, and a manuscript describing the final results is being prepared. We are now considering whether our preliminary results justify a Phase III trial in which paclitaxel plus TNP470 will be compared to paclitaxel alone. The following sections will describe our progress to date, as well as problems we have encountered and the actions we have taken to resolve them. As stated, the overall goals of this project are to evaluate the effects of angiogenic inhibitors in prospective clinical trials in patients with breast cancer. I trial that has provided more information regarding our proposal to conduct a randomized trial regarding whether TNP-470 contributes added benefit to the chemotherapeutic agent, paclitaxel.