A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer

Inclusion Criteria:

Age >= 18 years of age
Histologically documented breast cancer (hormone receptor (ER/PR) status may be either positive or negative) with or without metastatic disease.

HER-2(+) as determined by one of the following measurements. NOTE: HER-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions

Immunohistochemistry (IHC) 3+, or
FISH + (HER-2 gene signal to centromere 17 signal >2)
No transfusion dependent patients and no transfusion within 30 days of leukopheresis

Documented labs within 7 days of donation consisting of:

WBC > 4.0 K/ul & < 11.0 K/ul
platelet count > 150,000/mm3
hemoglobin > 11.0 g/dl.
Hematocrit > 33 %
Weight > 110 lbs
No blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable)
Patients must not have active or unresolved infection.
No cold or flu sympton at time of donation
No prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)
All patients must give signed written informed consent.
ECOG Performance Score of 0 or 1.
Women of childbearing potential must have a negative serum or urine pregnancy test

Exclusion Criteria:

The presence of another active malignancy
Pregnant, lactating, or nursing
Patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)