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

NCT07545434 | Completed

• 1 other identifier: TRANS_10_7/23
• Study Type: observational
• Target: 3,646
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Breast Cancer

Keywords

TILs; CD8+ T-cells; breast cancer; adjuvant; dose-dense chemotherapy

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Cooperative Oncology Group

Athens, 11526, Greece

Location

Related Publications (5)

• Mahmoud SM, Paish EC, Powe DG, Macmillan RD, Grainge MJ, Lee AH, Ellis IO, Green AR. Tumor-infiltrating CD8+ lymphocytes predict clinical outcome in breast cancer. J Clin Oncol. 2011 May 20;29(15):1949-55. doi: 10.1200/JCO.2010.30.5037. Epub 2011 Apr 11.

  PMID: 21483002 BACKGROUND

• Badve SS, Cho S, Lu X, Cao S, Ghose S, Thike AA, Tan PH, Ocal IT, Generali D, Zanconati F, Harris AL, Ginty F, Gokmen-Polar Y. Tumor Infiltrating Lymphocytes in Multi-National Cohorts of Ductal Carcinoma In Situ (DCIS) of Breast. Cancers (Basel). 2022 Aug 13;14(16):3916. doi: 10.3390/cancers14163916.

  PMID: 36010908 BACKGROUND

• Gogas H, Dafni U, Karina M, Papadimitriou C, Batistatou A, Bobos M, Kalofonos HP, Eleftheraki AG, Timotheadou E, Bafaloukos D, Christodoulou C, Markopoulos C, Briasoulis E, Papakostas P, Samantas E, Kosmidis P, Stathopoulos GP, Karanikiotis C, Pectasides D, Dimopoulos MA, Fountzilas G. Postoperative dose-dense sequential versus concomitant administration of epirubicin and paclitaxel in patients with node-positive breast cancer: 5-year results of the Hellenic Cooperative Oncology Group HE 10/00 phase III Trial. Breast Cancer Res Treat. 2012 Apr;132(2):609-19. doi: 10.1007/s10549-011-1913-4. Epub 2011 Dec 21.

  PMID: 22187126 BACKGROUND

• Fountzilas G, Skarlos D, Dafni U, Gogas H, Briasoulis E, Pectasides D, Papadimitriou C, Markopoulos C, Polychronis A, Kalofonos HP, Siafaka V, Kosmidis P, Timotheadou E, Tsavdaridis D, Bafaloukos D, Papakostas P, Razis E, Makrantonakis P, Aravantinos G, Christodoulou C, Dimopoulos AM. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol. 2005 Nov;16(11):1762-71. doi: 10.1093/annonc/mdi366. Epub 2005 Sep 7.

  PMID: 16148021 BACKGROUND

• Lemos Duarte I, da Silveira Nogueira Lima JP, Passos Lima CS, Deeke Sasse A. Dose-dense chemotherapy versus conventional chemotherapy for early breast cancer: a systematic review with meta-analysis. Breast. 2012 Jun;21(3):343-9. doi: 10.1016/j.breast.2012.02.011. Epub 2012 Mar 15.

  PMID: 22425607 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

FFPEs

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Foteinos-Ioannis Dimitrakopoulos

  Hellenic Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 22, 2026
• Study Start: December 10, 1996
• Primary Completion: September 15, 2023
• Study Completion: March 12, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)