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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

individuals with HER-2 positive breast cancer.

Description

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)

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dr. Ellie Guardino MD/PhD, Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 18, 2007
• First Submitted That Met QC Criteria: May 18, 2007
• First Posted (Estimate): May 22, 2007

Study Record Updates

• Last Update Posted (Estimate): April 13, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BRSADJ0009 (Other Identifier: Stanford University); 97811 (Other Identifier: Stanford University Alternate IRB Approval Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No