Immunotherapy Vaccine and Herceptin in Breast Cancer

Exclusion Criteria

• •Clinical and/or radiographic evidence of residual or persistent breast cancer
• •Receiving immunosuppressive therapy to include methotrexate or steroids (note: the use of prednisone, or equivalent, \<2.0mg/day, is allowed)
• •Tbili \>1.8, creatinin \>2, hemoglobin \<10, platelets \<100,000/mm³, WBC \<2,000
• •Active pulmonary disease requiring medication to include multiple inhalers
• •Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
• •Pregnant or are nursing
• •History of autoimmune disease (patients with vitiligo not excluded)
• •HIV positive
• •Previous or concomitant malignancies at other sites, except effectively treated non- melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured
• •Other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk
• •Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrollment
• •Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance