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Early Breast CancerΝ/ΑNCT07545434

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

An observational study of Early Breast Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Early Breast Cancer
How many people
3,646 participants
Where
1 siteGreece
Study dates
10 Dec 1996to 12 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Hellenic Cooperative Oncology Group

    Athens, 11526

Other trials in Greece

About this study

Official 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

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.

Read more

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.

Read the 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.

Keywords
TILs, CD8+ T-cells, breast cancer, adjuvant, dose-dense chemotherapy
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Overall Survival (OS)

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

  2. To investigate the long-term prognostic significance of TILs & CD8+ in term of DFS

    Disease-Free Survival (DFS)

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

  3. To investigate the long-term prognostic significance of TILs & CD8+ in term of iBCFS

    Invasive Breast Cancer-Free Survival (iBCFS)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start10 Dec 1996
  3. Primary completion15 Sep 2023
  4. Study completion12 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07545434
Sponsor's protocol ID
TRANS_10_7/23
Acronym
Ν/Α
Status last verified
Apr 2026
First submitted
20 Mar 2026
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21483002

  • 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.

    PubMed 36010908

  • 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.

    PubMed 22187126

  • 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.

    PubMed 16148021

  • 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.

    PubMed 22425607

Questions about this trial

What is this clinical trial studying?

An observational study of Early Breast Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07545434, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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