Breast Cancer

The Serum HER-2/neu Test and Metastatic Breast Cancer

Breast Cancer

The Siemens HER-2/neu test measures circulating levels of the HER-2/neu oncoprotein in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu is greater than 15 ng/mL. It is the only serum test available in the U.S. to monitor HER-2/neu baseline values and Serum HER-2/neu level changes over the course of the disease. Monitoring Serum HER-2/neu levels yields important information about response to therapy, and may help physicians make more informed decisions when developing and modifying patient treatment regimens.1-3


Benefits of Serum HER-2/neu

  • Enhance patient management with reliable and easily interpreted results
  • Target the HER-2/neu oncoprotein with a minimally invasive procedure
  • Personalize treatment and disease management by monitoring the rise and fall of Serum HER-2/neu levels

Serum HER-2/neu Testing Algorithm for Metastatic Breast Cancer (MBC) 4-8

Serum HER-2/neu Test Utility at a Glance

The Serum HER-2/neu test is used to monitor a patient’s HER-2/neu status once a diagnosis of metastatic breast cancer has been established. The chart above shows how the Serum HER-2/neu test is typically used as a monitoring tool complementary to tissue testing.




1. Schwartz MK, et al. International Journal of Biological Markers 2000;15(4):324.
2. Lipton A, et al. Journal of Clinical Oncology 2002;20(6):1467.
3. Esteva FJ, et al. Journal of Clinical Oncology 2002;20(7):1800.
4. Ali SM, Carney WP, Esteva FJ, et al. Serum HER-2/neu and relative resistance to trastuzumab-based therapy in patients with metastatic breast cancer. Cancer. 2008 Sep 15;113(6):1294-301.
5. Lipton A, Leitzel K, Chaudri-Ross HA, et al. Decrease in serum extracellular domain of HER2 at 4 and 8 weeks is associated with prolonged progression-free survival on lapatinib monotherapy. Proceedings of the 31st Annual CTRC-AACR San Antonio Breast Cancer Symposium, 2008. December: Abstract No. 3140.
6. 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.
7. 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.
8. 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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