Stromal Tumor-Infiltrating Lymphocyte Levels Are Associated With Immune Checkpoint Proteins In Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
- Registration Number
- NCT06965361
- Lead Sponsor
- Ziauddin University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
- Female (aged 24-45 years) TNBC patients
- Diagnosed TNBC Patients with immunohistochemistry (IHC) negative test for estrogen receptor (ER), progesterone receptor (PR), and HER-2
- Patients with and without metastases
- Patients who had a history of other malignant tumors
- Patients who did not complete NAC.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A+T group and A+T+C group carboplatin All TNBC patients included in the study received at least four cycles of NACT regimens and were classified into two groups: anthracycline-containing, taxane- (A+T group) and anthracycline/taxane/carboplatin (A+T+C group) combinations
- Primary Outcome Measures
Name Time Method Stromal tumor-infiltrating lymphocyte levels are associated with immune checkpoint proteins in triple negative breast cancer patients receiving neoadjuvant chemotherapy From enrollment to the end of treatment received at least four cycles of NACT regimens. One cycle last for 21 days. The TILs levels were evaluated on Hematoxylin-eosin-stained (H\&E) tissue sections as percentages and three predefined categories were used: Low TIL scores of 0-10%, intermediate 11-40% and high TIL \> 40%.
- Secondary Outcome Measures
Name Time Method Evaluation of PD-1, PD-L1 and LAG-3 in triple negative breast cancer patients receiving neoadjuvant chemotherapy From enrollment to the end of treatment received at least four cycles of NACT regimens. One cycle last for 21 days. 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.
Trial Locations
- Locations (1)
Shamim
🇵🇰Karachi, Sindh, Pakistan