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HER2/neu

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Also known as: ERBB2; c-erbB-2; HER2 Serum
Formal name: HER2/neu Amplification by FISH; HER2 Overexpression by IHC; HER2 Quantitative, Serum

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.

Sources Used in Current Review

(Updated July 2013). Breast Cancer Workup. Medscape reference. Available online at http://emedicine.medscape.com/article/1947145-workup#aw2aab6b5b6 through http://emedicine.medscape.com. Accessed July 2013.

Ithimakin, Suthinee et al. HER2 Drives Luminal Breast Cancer Stem Cells in the Absence of HER2 Amplification: Implications for Efficacy of Adjuvant Trastuzumab. Cancer Research. February 2013. Available online at http://cancerres.aacrjournals.org/content/early/2013/02/14/0008-5472.CAN-12-3349.abstract through http://cancerres.aacrjournals.org. doi: 10.1158/0008-5472.CAN-12-3349 Accessed July 2013.

(Copyright 2012). Breast Cancer and Breast Pathology. John Hopkins University. Available online at http://pathology.jhu.edu/breast/biomarker-testing.php through http://pathology.jhu.edu. Accessed July 2013.

(Updated December 2012) HER2/neu Testing. Quest Diagnostics. Available online at http://www.questdiagnostics.com/testcenter/testguide.action?dc=CF_HER_2 through http://www.questdiagnostics.com. Accessed July 2013.

Markman, M. (2013 February 13, Updated). Breast Cancer and HER2. Emedicine [On-line information]. Available online at http://emedicine.medscape.com/article/1689966-overview through http://emedicine.medscape.com. Accessed July 2013.

Breast Cancer Management Assays. ARUP Consult [On-line information]. Available online at http://www.arupconsult.com/Topics/BreastCancer.html through http://www.arupconsult.com. Accessed July 2013.

(Updated 2013). HER2 Testing: Summary for Breast Cancer Patients. Available online at http://www.nccn.com/about-us/61-symptoms-category.html through http://www.nccn.com. Accessed July 2013.

(©2012). What to Know: ASCO's Guideline on HER2 Testing for Breast Cancer. American Society of Clinical Oncologists. Available online at http://www.cancer.net/publications-and-resources/what-know-ascos-guidelines/what-know-ascos-guideline-her2-testing-breast-cancer through http://www.cancer.net. Accessed July 2013.

(Updated June 2011). Serum HER2 Testing. Atlantic Health System. Available online at https://atlantichealth.dnadirect.com/grc/patient-site/her2-serum/index.html through https://atlantichealth.dnadirect.com. Accessed July 2013.

(November 2008) ARUP Laboratories Technical Bulleting. HER-2/neu Serum For monitoring soluble HER-2/neu protein in patients with metastatic breast cancer. Available online at http://www.aruplab.com/Testing-Information/resources/TechnicalBulletins/HER-2neu%20Serum.pdf through http://www.aruplab.com. Accessed August 2013.

Carney W, et al. Potential Clinical Utility of Serum HER-2/neu Oncoprotein Concentrations in Patients with Breast Cancer. Clinical Chemistry, October 2003 vol. 49 no. 10 1579-1598. Available online at http://www.clinchem.org/content/49/10/1579.short through http://www.clinchem.org. Accessed August 2013.

(October 2013) Wolff A, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. Available online at http://www.asco.org/quality-guidelines/recommendations-human-epidermal-growth-factor-receptor-2-testing-breast-cancer through http://www.asco.org. Accessed October 2013.

Lam L, et al. Challenges in the clinical utility of the serum test for HER2 ECD. Biochim Biophys Acta. 2012 August; 1826(1): 199–208. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3362659/ through http://www.ncbi.nlm.nih.gov. Accessed October 2013.

Gregory J. Tsongalis, PhD, HCLD, CC, Professor of Pathology, Director, Molecular Pathology, Dartmouth Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, Lebanon, NH.

Sources Used in Previous Reviews

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Pagana, Kathleen D. & Pagana, Timothy J. (2001). Mosby's Diagnostic and Laboratory Test Reference 5th Edition: Mosby, Inc., Saint Louis, MO.

Check, W. (2002 February). Making the call on HER2 testing methods. CAP Today, In the News [On-line journal]. Available online at http://www.cap.org/html/publications/feature.html through http://www.cap.org.

Check, W. (2002 February). Serum HER2 testing. CAP Today, In the News [On-line journal]. Available online at http://www.cap.org/html/publications/sidebar1.html through http://www.cap.org.

ASCO (1996). c-erbB-2 as a Marker for Breast Cancer. American Society for Clinical Oncology [On-line guideline]. Available online at http://www.asco.org/prof/pp/html/guide/tumor/m_tumor14.htm through http://www.asco.org.

ACS (2001). Immunotherapy with Trastuzumab (Herceptin). American Cancer Society [On-line information]. Available online through http://www.cancer.org.

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Locke, J. (2001 February). HER2/neu Testing. American Association for Clinical Chemistry, Strategies [Newsletter]. Available through AACC (http://www.aacc.org)

Yazifi, H., and Gown, A. (2002 June). Controversies and guidelines in tissue-based HER-2/neu testing in breast cancer. Medical Laboratory Observer [Journal], Vol. 34 (6), pp 12-16,20. Available through MLO (http://www.mlo-online.com)

MEDCEU (1999). Breast Cancer and HER2. MEDCEU [On-line continuing education]. Available online at http://www.medceu.com/course-no-test.cfm?CID=307 through http://www.medceu.com.

Pagana, K. D. & Pagana, T. J. (© 2007). Mosby's Diagnostic and Laboratory Test Reference 8th Edition: Mosby, Inc., Saint Louis, MO. Pp 200-202.

Wu, A. (© 2006). Tietz Clinical Guide to Laboratory Tests, 4th Edition: Saunders Elsevier, St. Louis, MO. Pp 548-551.

Hicks, D. and Kulkarni, S. (2008 April 14). HER2+ Breast Cancer: Review of Biologic Relevance and Optimal Use of Diagnostic Tools. Medscape from American Journal of Clinical Pathology [On-line information]. Available online at http://www.medscape.com/viewarticle/570732 through http://www.medscape.com. Accessed July 2009.

Markman, M. (2009 June 30, Updated). Breast Cancer and HER2. Emedicine [On-line information]. Available online at http://emedicine.medscape.com/article/1689966-overview through http://emedicine.medscape.com. Accessed July 2009.

(2009 May, Updated). Breast Cancer Management Assays. ARUP Consult [On-line information]. Available online at http://www.arupconsult.com/Topics/OncologicDz/GynecologicalTumors/BreastCancerManagement.html# through http://www.arupconsult.com. Accessed July 2009.

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(2006 December). What to Know: ASCO's Guideline on HER2 Testing for Breast Cancer. American Society of Clinical Oncologists [On-line information]. Available online through http://www.cancer.net. Accessed July 2009.

Esteva, F. et. al. (2005 May 13). Clinical Utility of Serum HER2/neu in Monitoring and Prediction of Progression-Free Survival in Metastatic Breast Cancer Patients Treated With Trastuzumab-Based Therapies. Medscape from Breast Cancer Research [On-line information]. Available online at http://www.medscape.com/viewarticle/503103 through http://www.medscape.com. Accessed July 2009.

Tse, C. et. al. (2005). Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients. Clinical Chemistry. 2005;51:1093-1101 [On-line information]. Available online at http://www.clinchem.org/cgi/reprint/51/7/1093 through http://www.clinchem.org. Accessed July 2009.

Zidan J, Dashkovsky I, Stayerman C, et al. Comparison of HER-2 overexpression in primary breast cancer and metastatic sites and its effect on biological targeting therapy of metastatic disease. Br J Cancer. 2005 Sep 5;93(5):552-6.

Lower EE, Glass E, Blau R, Harman S. HER-2/neu expression in primary and metastatic breast cancer. 1: Breast Cancer Res Treat. 2009 Jan;113(2):301-6. Epub 2008 Feb 14.

Carney WP, Brown-Shimer S, Hamer PJ. Serum HER-2/neu testing can identify HER-2/neu positive patients previously classified as negative by tissue testing. American Association for Clinical Chemistry Annual Meeting Proceedings, 2008. Clin Chem Vol 54(56) Suppl, Pg A130: Abstract No. C-96.

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Serum HER-2/neu and Relative Resistance to TRASTUZUMAB-based Therapy in Patients With Metastatic Breast Cancer. Cancer 2008; 113:1294-1301.