Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02580799

ML28731

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Breast Cancer Pathology Samples

Description:

Breast cancer pathology samples were evaluated for a period of 70 days.