Clinical trial NCT00477139: A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer
Official title: A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals with HER-2 positive breast cancer.

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.

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.
  * 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Ellie Guardino MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: