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1523-023-00964-8  \nHER2‑Low Breast Cancer—Diagnostic Challenges and Opportunities for Insights from Ongoing Studies: A Podcast  \nAditya Bardia1 · Giuseppe Viale2,3  \nAccepted: 27 March 2023 / Published online: 3 May 2023 © The Author(s) 2023  \nAbstract  \nBreast cancer has been traditionally classified as either human epidermal growth factor receptor 2 (HER2)-positive or HER2-negative based on immunohistochemistry (IHC) scoring and/or gene amplification. HER2-positive breast cancer (defined as IHC 3+ or IHC 2+ and in situ hybridization [ISH]+) is routinely treated with HER2-targeted therapies, while HER2-negative breast cancer (defined as IHC 0, IHC 1+, or IHC 2+/ISH−) was not previously eligible for HER2-targeted therapy. Some tumors traditionally defined as HER2-negative express low levels of HER2 (i.e., HER2-low breast cancer, defined as IHC 1+ or IHC 2+/ISH−) . Recently reported results from the DESTINY-Breast04 trial demonstrated that the HER2-targeted antibody–drug conjugate trastuzumab deruxtecan (T-DXd) improved survival in patients with previously treated advanced or metastatic HER2-low breast cancer, leading to the approval of T-DXd in the US and EU for patients with unresectable or metastatic HER2-low breast cancer after prior chemotherapy in the metastatic setting or disease recurrence within 6 months of adjuvant chemotherapy. As the first HER2-targeted therapy approved for the treatment of HER2-low breast cancer, this represents a change in the clinical landscape and presents new challenges, including identifying patients with HER2-low breast cancer. In this podcast, we discuss the strengths and limitations of current methodologies for classifying HER2 expression and future research that will help refine the identification of patients expected to benefit from HER2-targeted therapy, such as T-DXd or other antibody–drug conjugates. Although current methodologies are not optimized to identify all patients with HER2-low breast cancer who may potentially benefit from HER2-targeted antibody–drug conjugates, they are likely to identify many. Ongoing studies—including the DESTINY-Breast06 trial evaluating T-DXd in patients with HER2-low breast cancer and those with tumors expressing very low levels of HER2 (IHC > 0 to \u003C 1+)—will provide insights that may improve the identification of patient populations expected to benefit from HER2-targeted antibody–drug conjugates.  \nAbbreviations  \nADC Antibody–drug conjugate  \nASCO American Society of Clinical Oncology CAP College of American Pathologists  \nCDK Cyclin-dependent kinase  \nFDA Food and Drug Administration  \nHER2 Human epidermal growth factor receptor 2 IHC Immunohistochemistry  \nISH In situ hybridization  \nThe podcast and transcript can be viewed below the abstract of the online version of the manuscript. Alternatively, the podcast can be downloaded here: [https://doi.org/10.6084/m9.figshare.22339660](https://doi.org/10.6084/m9.figshare.22339660) .  \n* Aditya Bardia [Bardia.Aditya@mgh.harvard.edu](Bardia.Aditya@mgh.harvard.edu)  \n1 Massachusetts General Hospital, Boston, MA, USA  \n2 University of Milan, Milan, Italy  \n3 European Institute of Oncology, IRCCS, Milan, Italy  \nRNA Ribonucleic acid  \nT-DXd Trastuzumab deruxtecan  \n1 Podcast Transcript  \nDr. Bardia: Hello, I’m Aditya Bardia. I’m a breast medical oncologist at Massachusetts General Hospital, Harvard Medical School, Boston. Joining me today is Professor Viale.  \nProf. Viale: Hi, this is Beppe Viale. I’m the Chairman of the Department of Pathology and Laboratory Medicine at the European Institute of Oncology in Milano. And as a pathologist, I have dealt with breast cancer in the last 20 years. And I’m happy to join you today for this podcast.  \nDr. Bardia: We are fortunate to have you today, Professor Viale. So, today we will be discussing HER2-low breast cancer, including the implications of the recent US FDA and EU app","cbCaia237zB2Eht6","https://ap.wps.com/l/cbCaia237zB2Eht6","pdf",770609,"English","# Abstract\n## Breast cancer classification by HER2 status\n## Emergence of HER2-low disease and T-DXd approval\n## Diagnostic challenges and future research\n# Abbreviations\n# Podcast transcript","[{\"question\":\"How is HER2-low breast cancer defined in the document?\",\"answer\":\"HER2-low breast cancer is defined as IHC 1+ or IHC 2+/ISH−.\"},{\"question\":\"What key trial results changed the treatment landscape for HER2-low disease?\",\"answer\":\"DESTINY-Breast04 showed that trastuzumab deruxtecan (T-DXd) improved survival in previously treated advanced or metastatic HER2-low breast cancer.\"},{\"question\":\"Why does patient identification present a new challenge for HER2-targeted therapy?\",\"answer\":\"Current methodologies are not optimized to detect all patients with HER2-low breast cancer, so selection requires more precise definition and evaluation of additional technologies.\"}]","HER2-Low Breast Cancer - Diagnostic Challenges and Opportunities for Insights from Ongoing Studies - A Podcast | PDF",1790561346,18]