Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Sep;13(3):547-575.
doi: 10.1007/s40487-025-00346-2. Epub 2025 May 26.

Immunotherapy in Triple-Negative Breast Cancer

Elisa Tiberi  1 , Alessandro Parisi  2 , Mirco Pistelli  3 , Agnese Savini  3 , Federica Galassi  4 , Chiara Reschini  4 , Debora Quintavalle  4 , Riccardo Napoleoni  4 , Carlo Ferrari  4 , Rossana Berardi  3
Affiliations
Review

Immunotherapy in Triple-Negative Breast Cancer

Elisa Tiberi et al. Oncol Ther. 2025 Sep.

Abstract

Currently, immunotherapy has led to a paradigmatic shift in the treatment of many cancer types, including triple-negative breast cancer. Immunotherapy increases the efficacy of the immune system in treating cancer, with a durable effect due to immunologic memory. The PD-1 inhibitor, pembrolizumab, combined with neoadjuvant chemotherapy, improved event-free survival and is a new standard of care for patients with high-risk, early stage triple-negative breast cancer (TNBC), regardless of tumor PD-L1 expression. For metastatic TNBC, pembrolizumab combined with chemotherapy is a new standard of care for first-line therapy for PD-L1+ metastatic TNBC, and it improves overall survival. The PD-L1 inhibitor, atezolizumab, combined with nab-paclitaxel, is also approved for first-line treatment of metastatic PD-L1+ TNBC. The aim of this review is to examine the existing evidence and ongoing studies on immunotherapy in patients with early stage and metastatic triple-negative breast cancer (TNBC), including new combination strategies with several drugs, such as chemotherapy, targeted therapy, or radiation and to discuss immune checkpoint inhibitor (ICI) applications and the possibility of emerging strategies in different TNBC stages.

Keywords: Early breast cancer; Immunotherapy; Metastatic breast cancer; Triple-negative breast cancer.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflicts of Interest: Alessandro Parisi received consultant/advisory board fees from AstraZeneca and Amgen and travel support from Merck, Daiichi-Sankio, and Accord. Elisa Tiberi received consultant/advisory board fees from Bayer and travel support from MSD and Merk. Agnese Savini received consultant/advisory board fees from AstraZeneca, Lilly, GSK, Gilead, Seagen, Genetic oncology, Roche, and Istituto Gentili. Mirco Pistelli received consultant/advisory board fees from AstraZeneca, Lilly, Gilead, Novartis, Pfizer, and Daiichi Sankyo and travel support from Roch and Msd. Federica Galassi, Chiara Reschini, Debora Quintavalle, Riccardo Napoleoni, and Carlo Ferrari declare no conflicts of interest. Rossana Berardi is an Editor-in-Chief of Oncology and Therapy. Rossana Berardi was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Ethical Approval: This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

References

    1. O’Meara TA, Tolaney SM. Tumor mutational burden as a predictor of immunotherapy response in breast cancer. Oncotarget. 2021;12(5):394–400. 10.18632/oncotarget.27877. - PMC - PubMed
    1. Buchbinder EI, Desai A. CTLA-4 and PD-1 pathways: similarities, differences, and implications of their inhibition. Am J Clin Oncol. 2016;39(1):98–106. 10.1097/COC.0000000000000239. - PMC - PubMed
    1. Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. AnnuRevImmunol. 2008;26:677–704. 10.1146/annurev.immunol.26.021607.090331. - PMC - PubMed
    1. Fallarino F, Fields PE, Gajewski TF. B7–1 engagement of cytotoxic T lymphocyte antigen 4 inhibits T-cell activation in the absence of CD28. J Exp Med. 1998;188(1):205–10. 10.1084/jem.188.1.205. - PMC - PubMed
    1. Diana A, Carlino F, Franzese E, Oikonomidou O, Criscitiello C, De Vita F, Ciardiello F, Orditura M. Early triple negative breast cancer: conventional treatment and emerging therapeutic landscapes. Cancers (Basel). 2020;12(4):819. 10.3390/cancers12040819. - PMC - PubMed

LinkOut - more resources