Triple Negative Breast Cancer
Conditions
Keywords
carboplatin-based NACT regimen, tumor-infiltrating lymphocytes, Programmed cell death-1, Programmed cell death Ligand-1, lymphocyte activation gene-3, Triple-negative breast cancer
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.
Interventions
DRUGcarboplatin
carboplatin use due to its effectiveness in increasing pathological complete remission (pCR) rates and improving survival outcomes
Sponsors
Jinnah Sindh Medical University
Ziauddin University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients who had a history of other malignant tumors * Patients who did not complete NAC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Outcome results
None listed