The Prognostic Role of TILs and CD8+ T Cells in Operable Breast Cancer (Ν/Α)

April 21, 2026 updated by: Hellenic Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

3646

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11526
        • Hellenic Cooperative Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Caucasian women, with high-risk early breast cancer.The majority of patients were of Greek origin and had intermediate- to high-risk eBC. Furthermore, this study includes long-term survival data with more than 10 years of follow-up.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time from study entry to death from any cause, assessed up to 120 months
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)
Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 120 months
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)
Time from study entry to invasive breast cancer recurrence or death, whichever comes first, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Investigators

  • Principal Investigator: Foteinos-Ioannis Dimitrakopoulos, Hellenic Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 1996

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRANS_10_7/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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