The development of predictive biomarkers and immunologic markers for breast cancer: current status and future perspectives.

Abstract

Breast cancer is the leading cause of cancer-related mortality among women worldwide. The development of predictive biomarkers and immunologic markers has revolutionized breast cancer diagnosis and treatment, enabling personalized medicine approaches. This study aims to review the current status, challenges, and future directions of predictive and immunologic biomarkers in breast cancer. Predictive biomarkers such as HER2/neu expression, estrogen receptor (ER)/progesterone receptor (PR) status, and genomic signatures play a crucial role in treatment decisions, particularly for hormone receptor-positive and HER2-positive tumors. Immunologic markers, including PD-L1 expression, microsatellite instability (MSI), tumor mutational burden (TMB), and tumor-infiltrating lymphocytes (TILs), are essential for predicting responses to immunotherapy, especially in aggressive subtypes like triple-negative breast cancer (TNBC). However, challenges such as tumor heterogeneity, therapy resistance, and standardization of biomarker testing remain significant barriers. This study also explores emerging technologies like artificial intelligence (AI), genomic profiling, and liquid biopsy, which are expected to enhance precision medicine, improve early diagnosis, and optimize treatment strategies. The integration of these advanced molecular approaches holds great promise for improving patient outcomes and overcoming existing limitations in breast cancer management.