Pilot Phase I HER-2 Pulsed DC Vaccine To Prevent Recurrence For Patients With HER-2 Driven High Risk Invasive Breast Cancer

Inclusion Criteria:

- Women over Age 18 years.

- Subjects with Invasive Breast Cancer at least Stage IIIA N2 (4 positive nodes) or
have recurrent metastatic breast cancer rendered NED by any means that are classic
HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative verified by the
Department of Pathology at the Hospital of the University of Pennsylvania that have
completed chemotherapy and/or trastuzumab and are within 1 year from there last
treatment and have no evidence of disease. 3. Patients deemed to require
anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen
therapy during vaccinations 4. Women of childbearing age with a negative pregnancy
test documented prior to enrollment. 5. Subjects with ECOG Performance Status Score
of 0 or 1 (Appendix D). 6. Subjects willing to use birth control if necessary 7.
Subjects who have voluntarily signed a written Informed Consent in accordance with
institutional policies after its contents have been fully explained to them.

Key exclusion criteria

1. Pregnant or lactating females. 2. Subjects with positive HIV or hepatitis C at baseline
by report. 3.

Subjects with coagulopathies, including thrombocytopenia with platelet count 75,000, INR
1.5 and partial thromboplastin time 50 sec 4. Subjects with major cardiac illness MUGA 50%
EF. 5. Subjects with pre-existing medical illnesses or medications which might interfere
with the study as determined by PI.