A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Stanford University
- Enrollment
- 4
- Locations
- 1
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Detailed Description
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. We will ask up to 10 patients with HER-2(+) breast cancer in stable condition and in reasonable health to participate in this study. The study will establish an immune monitoring for correlative studies done in patients with HER-2(+) breast cancer. The immunologic tests that will be done are ELISpot, lymphocyte proliferation, intracellular cytokine staining, lymphocyte immunophenotyping, and ELISA.
Investigators
Eligibility Criteria
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.
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)
Outcomes
Primary Outcomes
Not specified