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U.S. Department of Health and Human Services, Food and Drug Administration, Oncology Center of Excellence, CDER and CBER (2020) Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Guidance for Industry.
https://www.fda.gov/media/83507/download

has been cited by the following article:

• TITLE: Neoadjuvant Immunotherapy in Triple-Negative Breast Cancer: The Clinical Impact of Immune Checkpoint Inhibitors—A Systematic Review

  AUTHORS: Meharun Nesa Ripa, Nazmus Sakib, Ashraful Hussain, Sultan M. Ajwad Quayyum, Ali Akbar, Muhammad Abdul Wadud, Monoranjon Sarker, A. K. M. Daud

  KEYWORDS: Neoadjuvant Immunotherapy, Checkpoint Inhibitors, Triple Negative Breast Cancer (TNBC)

  JOURNAL NAME: Surgical Science, Vol.16 No.3, March 31, 2025

  ABSTRACT: Background: Neoadjuvant immunotherapy, particularly immune checkpoint inhibitors (ICIs), has emerged as a promising therapeutic strategy in the treatment of Triple-Negative breast cancer (TNBC). This systematic review evaluates the clinical impact of ICIs in combination with neoadjuvant chemotherapy, focusing on their improving pathological complete response (pCR) rates and outcomes. This review was conducted using PRISMA guidelines. A comprehensive literature search was conducted across multiple databases, including PubMed, Google Scholar, and EMBASE, for studies evaluating the use of ICIs in neoadjuvant therapy regimens for early-stage TNBC. Overall, while neoadjuvant ICIs represent a potential breakthrough in TNBC treatment, further clinical trials and long-term data are necessary to better define their role in improving patient outcomes.