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

Inclusion Criteria:

- Women over Age 18 years.

- Subjects with estrogen independent (as determined by lack of estrogen receptor
expression on primary or residual tumor) stage I III breast cancer with residual
disease in the breast or axillary nodes post-neoadjuvant chemotherapy.

- Women of childbearing age with a negative pregnancy test documented prior to
enrollment.

- Subjects with ECOG Performance Status Score of 0 or 1. 5. Subjects willing to use
birth control if necessary.

- Subjects who have voluntarily signed a written Informed Consent in accordance with
institutional policies after its contents have been fully explained to them.

Exclusion Criteria

- Pregnant or lactating females (pregnancy testing to be performed within 7 days prior
to administration of first dose of vaccine).

- Subjects with positive HIV or hepatitis C at baseline by selfreport.

- Subjects with coagulopathies, including thrombocytopenia with platelet count 75,000,
INR 1.5 and partial thromboplastin time 50 sec

- Subjects with major cardiac illness or MUGA 50% EF.

- Subjects with pre-existing medical illnesses or medications which might interfere
with the study as determined by PI.

- Subjects with laboratory tests reflecting ¬ grade 1 toxicity by NCI CTC version 3.0
including CBC, liver function tests, urinalysis, EKG if cannot be corrected on repeat
test in 7 days.