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

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. Participants with
HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with
or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered
NED will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be
manufactured using participants' leukapheresis product, which will be administered in the
Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three booster vaccines will be
administered at 3 month intervals following the initial induction vaccines. Immune analysis
will be done after participant receives all induction vaccines and again after they receive
all booster vaccines.

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 over Age 18 years.

- Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than
or equal to 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, that have completed chemotherapy and/or trastuzumab and are within 1
year from their last treatment and have no evidence of disease.

- Deemed to require anti-estrogen therapy for treatment of their breast cancer can
continue anti-estrogen therapy 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.

- Willing to use birth control if necessary.

- 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 positive HIV or hepatitis C at baseline.

- Patients with coagulopathies, including thrombocytopenia with platelet count less than
75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.

- Major cardiac illness MUGA less than 50% EF.

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