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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hellenic Cooperative Oncology Group

Athens, 11526, Greece

About this study

This study examines the prognostic significance of TILs and CD8+ in patients with eBC treated with dds-CT. From a total of 5,320 patients enrolled in seven prospective clinical studies conducted by the HECOG between 1996 and 2022, 3,646 patients were deemed eligible having donated tissue for central assessment and translational analysis. All patients had received adjuvant dds-CT, including taxanes and anthracyclines, as part of relevant protocols. Adjuvant endocrine therapy and radiotherapy were administered as clinically indicated. Tumor samples were assessed for stromal TILs, stromal CD8+ (sCD8+), intratumoral CD8+ (iCD8+), and total CD8+ density using immunohistochemistry on tissue microarray cores. Intrinsic breast cancer subtypes defined by immunohistochemistry (IHC4), a cost-saving surrogate of gene expression analysis, is frequently used to guiding treatment decisions based on the expression of ER (estrogen receptor), PgR (progesterone receptors, HER2, and Ki67. The analysis explores the prognostic value of these immune markers in the overall cohort and across different molecular subtypes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women older than 18 years with high-risk, operable eBC.
Histologically confirmed BC
All treated with adjuvant dose-dense sequential chemotherapy (dds-CT).
Tumor tissue specimen (FFPE) availability.

Exclusion criteria

Lack of FFPE samples.
Bilateral disease.
Distal metastases.
Administration of different chemotherapeutic regimens.
Previous primary cancers.

Treatment and study plan

Primary outcomes

To investigate the long-term prognostic significance of TILs & CD8+ in term of OS

Time frame: Time from study entry to death from any cause, assessed up to 120 months

Overall Survival (OS)
To investigate the long-term prognostic significance of TILs & CD8+ in term of DFS

Time frame: Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 120 months

Disease-Free Survival (DFS)
To investigate the long-term prognostic significance of TILs & CD8+ in term of iBCFS

Time frame: Time from study entry to invasive breast cancer recurrence or death, whichever comes first, assessed up to 120 months

Invasive Breast Cancer-Free Survival (iBCFS)

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

Clinical Significance of Tumor Infiltrating Lymphocytes and CD8⁺ T Cells in Patients With Early-stage Breast Cancer: Pooled-analysis of Individual Data From Patients Treated With Dose-dense Adjuvant Chemotherapy

Acronym: Ν/Α

Important dates

Study start: 1996
Primary completion: 2023
Study completion: 2025
First posted: Apr 22, 2026
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed