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)