However, if a large difference is observed between the treatment group and the h istorical controls, then it may give additional impetus for a larger phase II study. B. Projected gender and ethnic distribution The ethnic and gender distribution chart below (Table 5) reflects estimates of race and gender of the population to be included in this study. These esti mates are based on the following general statistics of the population in the Pacific Northwest and the characteristics of the diseases to be studied. The population pool from which subjects will be drawn is 76% Caucasian, 11% Asian American, 5% African Am erican, 1% American Indian or Alaska Native, 6.5% other and 0.6 % Native Hawaiian or other Pacific Islander. The number of Hispanics available for study is 2%. Patients with HER2 positive cancer will be eligible regardless of their ethnic or racial origin. Although men with breast cancer are not excluded from this study, less than 1% of all breast cancers occur in men. Ovarian cancer is found exclusively in women. Children are also excluded from the study as the long term effects of immunity against a self-antigen, HER2, is unknown. Furthermore, the incidence of breast and ovarian cancer in children is < 1%. Table 5 . Projected composition of patient population for Protocol 118 TARGETED/PLANNED ENROLLMENT: Number of Subjects Ethnic Category Sex/G ender Females Males Total Hispanic or Latino 0 0 Not Hispanic or Latino 20 0 20 Ethnic Category Total of All Subjects* 20 0 20 Racial Categories American Indian/Alaska Native 0 0 Asian 0 0 Native Hawaiian or Other Pacific Islander 0 0 Black or African American 1 0 1 White 19 0 19 Racial Categories: Total of All Subjects * 20 0 20 14. Administrative Considerations A.