A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Women of childbearing potential must have a negative serum or urine pregnancy test
排除标准
- •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)