NCT06965361

Stromal Tumor-Infiltrating Lymphocyte Levels Are Associated With Immune Checkpoint Proteins In Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Ziauddin University · Academic / Other
• Sex: Female
• Age: 24 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the effects of neoadjuvant chemotherapy (NACT) anthracycline-containing, taxane- (Intervention A +T) and anthracycline/taxane /carboplatin (Intervention A+T+C) treatment in young (age; 24-45 years) Triple Negative Breast Cancer (TNBC) female Patients by evaluating Stromal tumor-infiltrating lymphocytes (TILs) Programmed cell death-1 (PD-1), its ligand (PD-L1) and lymphocyte activation gene-3 (LAG-3) checkpoint proteins within tumor. The main question it aims to answer is: Does TILs are the most reliable immune markers and are significantly associated with PD-1, PD-L1 and LAG-3 in carboplatin based NACT treated (Intervention A+T+C) group of TNBC patients? Participants (TNBC Patients) already taking intervention A+T and A+T+C as part of their regular medical care for TNBC.

Detailed description

Stromal tumor-infiltrating lymphocytes (TILs) are currently being considered as a prognostic factor in triple-negative breast cancer (TNBC) and their association with the tumor immune microenvironment is less clear. To address this knowledge gap, investigators aimed to evaluate the expression and association of Programmed cell death-1 (PD-1), its ligand (PD-L1) and lymphocyte activation gene-3 (LAG-3) checkpoint proteins with TILs in neoadjuvant chemotherapy (NACT) treated TNBC patients. Patients (n=54; aged;24-45 years) were classified into two groups: thirty-nine received anthracycline-containing, taxane- (A+T group) and fifteen received anthracycline/taxane /carboplatin (A+T+C group) in combinations. Immunohistochemistry (IHC) staining was used for the evaluation of PD-1, PD-L1 and LAG-3. However, TIL assessment was done by hematoxylin and eosin (H\&E)-staining in TNBC patient's biopsies who received NACT.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	carboplatin use due to its effectiveness in increasing pathological complete remission (pCR) rates and improving survival outcomes
DEVICE	carboplatin	used in the treatment of triple-negative breast cancer (TNBC) due to its effectiveness in achieving pathological complete response (pCR) and breast-conserving surgery (BCS) rates.

Timeline

• Start date: 2021-01-02
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2025-05-11
• Last updated: 2025-05-16

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study