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The HER-2/neu (HER2) proto-oncogene is amplified and overexpressed in 20-40% of invasive breast cancers. HEP2 over- expression is associated with aggressive disease and is an independent predictor of poor prognosis in several subsets of patients. HER2 may also be related to cancer formation, with overexpression detectable in 50-60% of ductal carcinomas in situ (DCIS).The overall goal for the proposal is to develop the knowledge base necessary to develop vaccine and T cell therapy strategies directed against HEP2. Preliminary studies discovered that some patients with breast cancer have existent CD4+ helper T cell immunity and antibody-mediated immunity to HER2. HER2 is a self protein. Before our studies it was assumed patients would be immunologically tolerant to HER2 and that immunity could not be generated. Our prior studies demonstrated that immunity to HER2 is induced in some individuals by virtue of the presence of growing cancer expressing the antigen and gives credence to the concept that HER2-specific immunity can potentially be used in therapy without destroying normal tissue. This grant is exploring issues important for developing HER2 specific vaccines and T cell therapy. In addition, the demonstration of immunity to HER2 offers the opportunity to explore host-tumor interactions in a well-defined antigen system.