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