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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Breast Cancer Pathology Samples

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No