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

NCT ID: NCT00477139

Last Updated: 2011-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-09-30

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.

Conditions

Breast Cancer

Study Design

• Study Time Perspective: RETROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stanford University School of Medicine

Principal Investigators

Dr. Ellie Guardino MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

97811

Identifier Type: OTHER

Identifier Source: secondary_id

BRSADJ0009

Identifier Type: OTHER

Identifier Source: secondary_id

BRSADJ0009

Identifier Type: -

Identifier Source: org_study_id