A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

Inclusion Criteria:

- Women >= 18 years.

- Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not
had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with
positive margins.

- Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS
during vaccinations.

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

- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

- Women of childbearing potential must agree to use a medically acceptable form of birth
control during their participation in the study.

- 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.

- Positive for HIV or hepatitis C at baseline by self-report.

- Potential participants with coagulopathies, including thrombocytopenia with platelet
count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec

- Major cardiac illness MUGA or ECHO <50% EF.

- Pre-existing medical illnesses or medications which might interfere with the study as
determined by Principal Investigator (PI).