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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00477139

Run by

Stanford University

People needed

4

Starts

2009-01-01

Expected to finish

2010-09-01

Last updated by the study team

2011-04-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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