A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer

This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient’s own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers.

This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient’s own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers.The vaccine in this trial has not previously been administered to humans, and therefore the induction of the desired immune responses in humans remains to be established. Patients will receive 6 intramuscular vaccinations over a 14 week period, with 9 clinic visits and 3 follow up visits. In addition, patients are asked to revisit the study physician once a year for 5 years after the study ends to evaluate any long-term effects.Condition:- Breast CancerStudy Type: InterventionalStudy Design: Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety StudyEligibilityAges Eligible for Study: 40 Years – 70 Years, Genders Eligible for Study: BothCriteriaInclusion criteria: * Provide written informed consent. * Previous diagnosis of HER2/neu-positive breast cancer. * Stage II with 4 or more positive nodes, or Stage III in remission. * Have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment with or without local-regional breast irradiation. * Free of recurrent breast cancer disease. * Current chest X-ray showing no evidence of disease. * Completed at least one course of standard adjuvant treatment within 2 years of study entry. * Life expectancy of at least 12 months.Exclusion criteria: * Surgery or chemotherapy treatment within 8 weeks of study enrollment. * Radiotherapy within 12 weeks of study enrollment. * Use of other experimental agents during study. * Use of investigational or commercial agents or therapies intended to treat the malignancy during the study or within 1 month prior to first study vaccination. * Patients younger than 40 years of age must be sterile or incapable of childbearing. * Heart problems or uncontrolled hypertension, bleeding or coagulation disorders, auto-immune disorders, or psychiatric illness or addictive disorders. * Known to be HIV positive. * Past or current treatment with drug Herceptin. * Pregnant or breastfeeding. * Any uncontrolled illness that would preclude the study.[1] East Melbourne, Victoria, VIC 3002, Australia; Not yet recruitingStudy Coordinator 011-61 96561111 [2] Footscray, Victoria, VIC 3011, Australia; Not yet recruitingStudy Coordinator 011-61996252081 [3] Parkville, Victoria, VIC 3050, Australia; Not yet recruitingStudy Coordinator 011-61393427000 [4] Heidelberg, Victoria, VIC 3084, Australia; Not yet recruitingStudy Coordinator 011- 61 94963460