Education and Training

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

This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.

Stanford is currently not accepting patients for this trial.

Eligibility


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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Chen
6507238686
Not Recruiting