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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477139
First Posted: May 22, 2007
Last Update Posted: April 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples Without DNA
Blood

Enrollment: 4
Study Start Date: January 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
individuals with HER-2 positive breast cancer.
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477139


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Ellie Guardino MD/PhD Stanford University
  More Information

Responsible Party: Dr. Ellie Guardino MD/PhD, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00477139     History of Changes
Other Study ID Numbers: BRSADJ0009
97811 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSADJ0009 ( Other Identifier: Stanford University )
First Submitted: May 18, 2007
First Posted: May 22, 2007
Last Update Posted: April 13, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases