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HER2 ECD

Human epidermal growth factor receptor 2 (HER2) is a protein that helps regulate cell growth and survival. In some cancers, particularly breast cancer, tumour cells produce excessive amounts of HER2, which can accelerate cancer growth and spread. The extracellular domain of this protein, known as HER2 ECD, can be released from the cell surface into the bloodstream, where it can be measured as a circulating biomarker.

HER2 ECD

Why HER2 ECD matters

Around 15% of breast cancers are HER2-positive. HER2 status is currently determined by examining tumour biopsy samples, but measuring HER2 ECD in the blood may provide additional information to support disease monitoring. HER2 ECD measurement has potential to help monitor disease progression, identify changes in HER2 status as cancer spreads, and support the assessment of patients who may benefit from HER2-targeted therapies. Elevated levels may also occur in conditions such as obesity, diabetes and liver disease, so results require interpretation alongside other clinical findings.

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References


Ardavanis, A. K. (2008). Trastuzumab plus paclitaxel or docetaxel in HER-2-negative/HER-2 ECD-positive anthracycline- and taxane-refractory advanced breast cancer. The Oncologist, 13(4), 361-369. Ardizzoni, A. C. (2001). Study of pretreatment serum levels of HER2/neu oncoprotein as a prognostic and predictive factor in patients with advanced non small cell lung carcinoma. Cancer, 92(7), 1896-1904. Carney, W. P. (2013). Circulating HER2 extracellular domain: a specific and quantitative biomarker of prognostic value in all breast cancer patients? Biomarkers in Cancer, 5, 31-39. Cosentino-Boehm, A. L. (2013). Soluble human epidermal growth factor receptor 2 (sHER2) as a potential risk assessment, screening and diagnostic biomarker of lung adenocarcinoma. Diagnostics, 3(1), 13-32. Fernández-Real, J. M.-N.-M. (2010). Serum HER-2 concentration is associated with insulin resistance and decreases after weight loss. Nutrition & Metabolism, 7(14). Fornier, M. N. (2005). Serum HER2 extracellular domain in metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel: association with HER2 status by immunohistochemistry and fluorescence in situ hybridization and with response rate. Annals of Oncology, 16(2), 234-239. Hu, R. H. (2026). Female serum HER2 expression: its association with metabolic syndrome and treatment drug response. International Journal of Endocrinology, 1910633. Malla, R. R. (2024). HER-2 positive gastric cancer: current targeted treatments. International Journal of Biological Macromolecules, 274(1), 133247. Memon, A. A. (2015). Circulating human epidermal growth factor receptor 2 (HER2) is associated with hyerglycemia and insulin resistance. Journal of DIabetes, 7(3), 369-377. Molina, R. J. (1997). Serum levels of C-erbB-2 (HER-2/neu) in patients with malignant and non-malignant diseases. Tumour Biology, 18(3), 188-196. Motoo, Y. S. (1994). Serum levels of c-erbB-2 protein in digestive diseases. Journal of Gastroenterology, 29(5), 616-620. Osaki, T. M. (1995). Serum level and tissue expression of c-erbB-2 protein in lung adenocarcinoma. Chest, 108(1), 157-162. Oyama, K. F. (2015). Evaluation of serum HER2-ECD levels in patients with gastric cancer. Journal of Gastroenterology, 50(1), 41-45. Peng, Z. L. (2014). Serum HER2 extracellular domain as a potential alternative for tissue HER2 status in metastatic gastric cancer patients. Biomarkers in Medicine, 8(5), 663-670. Perrier, A. G. (2018). The extracellular domain of Her2 in serum as a biomarker of breast cancer. Laboratory Investigation, 98(6), 696-707. Pichon, M. F. (2004). Serum HER-2 extracellular domain (ECD) before the first metastases in 128 breast cancer patients. Clinical Laboratory, 50(3-4), 163-170. Polychronidis, A. C. (2003). Serum levels of c-erbb-2 correlate with advanced stage and liver metastasis in colorectal cancer. Folia Medica, 45(2), 12-16. Saito, M. Y. (2016). Serum HER2 as an adjunct to assess HER2 status for advanced gastric cancer. Acta Oncologica, 55(3), 309-317. Shah, M. A.-P. (2026). Immunotherapy and targeted therapy ofr advanced gastroesophageal cancer: ASCO Living Guideline, version 2026.1.2. Journal of Clinical Oncology. Shamshirian, A. A.-N. (2020). Diagnostic value of serum HER2 levels in breast cancer: a systematic review and meta-analysis. BMC Cancer, 20(1), 1049. Shi, H. Z. (2017). Serum HER2 as a predictive biomarker for tissue HER2 status and prognosis in patients with gastric cancer. World Journal of Gastroenterology, 23(10), 1836-1842. Sjaarda, J. G. (2018). Blood HER2 and uromodulin as causal mediators of CKD. Journal of the American Society of Nephrology, 29(4), 1326-1335. Tsigris, C.