HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses
giving breast cancer specific immune cells greater opportunity to function while the immune
repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the
chance to test secondary prevention of breast cancer in high risk settings. There is a need
to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in
combination with chemotherapy with or without added trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will be
continued at H. Lee Moffitt Cancer Center and Research Institute.

Inclusion Criteria:

- Women ≥ 18 years.

- HER-2 expressing 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 serum 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.

- Potential participants with MUGA < 50% EF.

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