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).