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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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. 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.


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)

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Principal Investigator

Dr. Ellie Guardino MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRSADJ0009

NCT ID:

NCT00477139

Start Date:

January 2009

Completion Date:

September 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317