Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples
Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples
A multi-center non-interventional, in-vitro trial for evaluation of concordance of the
 results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the
 Immunohistochemical (IHC) method in pathological samples collected from participants with
 breast cancer.
For accurate selection of participants who will be treated with anti-HER2, primary crucial
 thing to do is the right identification of HER2 in breast tumor cells. The advantages and
 disadvantages of IHC and In-Situ Hybridization (ISH) for the detection of HER2 status is
 still disputable. It is generally agreed on that HER2 study should be applied on all invasive
 breast cancer participants. It can be used together with IHC which measures HER2 protein
 expression or ISH which assesses HER2 gene amplification. With regard to IHC, the
 inconsistency of sensitivity and specificity of marketed antibodies, differences in
 interpretation and technical artifacts cause problems in diagnosis on occasion. There is not
 enough study on reasons which cause the consistence and discrepancies between laboratories in
 HER2 detection with IHC method.
Inclusion Criteria:

 Samples that fulfill all of the criteria will be evaluated for the study.

 -  Samples of women aged greater than or equal to (>/=) 18 and less than (<) 75 years

 -  Tumor samples already diagnosed based on the IHC score of 0 to +3

 -  Samples of primary lesions excluding lymph nodes

 -  10 percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples

 Exclusion Criteria:

 Samples that fulfill any of the criteria below will not be included in the study.

 -  Non-invasive ductal carcinoma (NOS) samples

 -  Tru-cut biopsies

 -  Non-breast cancer pathological samples