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

NCT06965361 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Jinnah Sindh Medical University

    collaborator OTHER

  • Ziauddin University

    lead OTHER

Principal Investigators

  • Shamim Mushtaq, PhD · Ziauddin University

Eligibility

Min Age
24 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-02
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Pakistan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965361 on ClinicalTrials.gov