Breast Cancer Clinical Trial
Official title:
A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
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.
OBJECTIVES:
- 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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