T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

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. Identifier: NCT00433407
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : October 4, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Condition or disease Intervention/treatment Phase
Breast Cancer Lung Cancer Ovarian Cancer Prostate Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific Biological: trastuzumab Not Applicable

Detailed Description:


  • Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.

OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.

Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
Study Start Date : August 2005
Actual Primary Completion Date : February 2006

Arm Intervention/treatment
Experimental: trastuzumab
blood sample collected on different days from patients receiving trastuzumab
Biological: trastuzumab

Primary Outcome Measures :
  1. T-cell activation in blood samples [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of solid epithelial tumor, including, but not limited to, the following:

    • Breast cancer
    • Ovarian cancer
    • Lung cancer
    • Uterine cancer
    • Prostate cancer
  • HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  • Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)


  • Absolute neutrophil count > 1,000/mm^3
  • Absolute lymphocyte count > 400/mm^3
  • Platelet count > 90,000/mm^3
  • Hemoglobin > 8 g/dL


  • No other chemotherapy within the past 4 weeks

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 identifier (NCT number): NCT00433407

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Mark D. Pegram, MD Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00433407     History of Changes
Other Study ID Numbers: CDR0000449959
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
male breast cancer
recurrent breast cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage I uterine sarcoma

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents