Clinical Trial

The Prognostic Role of TILs and CD8+ T Cells in Operable Breast Cancer

Study acronym: Ν/Α
Completed
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Summary
T cells are a broad class of adaptive immune cells, while CD8⁺ T cells are a specific, specialized subset of T cells, defined by the presence of the CD8 surface receptor. T cells, matured in the thymus, consist of helper, cytotoxic and regulatory functions. This study aimed to evaluate the clinical importance of Tumor Infiltrating Lymphocytes (TILs) as well as CD8⁺ T cells in patients with early-stage breast cancer (eBC) treated with dose-dense sequential chemotherapy. The researchers aim to assess tumor samples for TILs and CD8⁺ T cells from eBC patients using immunohistochemistry (IHC). In particular, we will measure the following parameters: CD8+ T cells found in the tissue around the tumor \[stromal\], CD8+ cells found inside the tumor \[intratumoral\], the total number of CD8⁺ cells as well as stromal TILs \[cells in the surrounding tissue\]. The main point of this study was to better understand the way these immune cells are associated with patients' outcome in a large group of patients with eBC who were treated initially with surgery and then received a dose-intense adjuvant chemotherapy.
Trial Details
NCT Number NCT07545434
Lead Sponsor Hellenic Cooperative Oncology Group
Conditions Early Breast Cancer
Enrollment 3,646 participants
Start Date 1996-12-10
Primary Completion 2023-09-15 (estimated)
Study Completion 2025-03-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-22