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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477139
• Other study ID #: BRSADJ0009
• Secondary ID: 97811BRSADJ0009
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: April 11, 2011
• Start date: January 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States,