Clinical trial · Observational
The Prognostic Role of TILs and CD8+ T Cells in Operable Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To investigate the long-term prognostic significance of TILs & CD8+ in term of OS
- timeFrame
- Time from study entry to death from any cause, assessed up to 120 months
- description
- Overall Survival (OS)
- measure
- To investigate the long-term prognostic significance of TILs & CD8+ in term of DFS
- timeFrame
- Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 120 months
- description
- Disease-Free Survival (DFS)
- measure
- To investigate the long-term prognostic significance of TILs & CD8+ in term of iBCFS
- timeFrame
- Time from study entry to invasive breast cancer recurrence or death, whichever comes first, assessed up to 120 months
- description
- Invasive Breast Cancer-Free Survival (iBCFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDMahmoud 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
- BACKGROUNDBadve 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
- BACKGROUNDGogas 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
- BACKGROUNDFountzilas 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
- BACKGROUNDLemos 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.