Clinical trial NCT02580799: Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples
Official title: Immunohistochemical HER2 Status Evaluation In Breast Cancer Pathology Samples: A Multicenter, Parallel-Design Concordance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast tissue samples from female participants with a breast cancer diagnosis

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)
timeFrame: Up to 70 days
measure: Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples
timeFrame: Up to 70 days
measure: Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)
timeFrame: Up to 70 days
measure: Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples
timeFrame: Up to 70 days
measure: Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)
timeFrame: Up to 70 days
measure: Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples
timeFrame: Up to 70 days
measure: Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)
timeFrame: Up to 70 days
measure: Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples
timeFrame: Up to 70 days
Secondary outcomes:
measure: Percentage of Participants With Diagnosis of Primary Tumor
timeFrame: Up to 70 days
measure: Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision
timeFrame: Up to 70 days
measure: Percentage of Participants With Pathological Score
timeFrame: Up to 70 days
measure: Percentage of Participants With Pathological Grade
timeFrame: Up to 70 days
measure: Percentage of Participants With Different Hormone Receptors
timeFrame: Up to 70 days
measure: Percentage of Participants With Specified Density of Hormone Receptors
timeFrame: Up to 70 days
measure: Percentage of Participants With HER2 Test Form Based on Country
timeFrame: Up to 70 days
measure: Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers
timeFrame: Up to 70 days
measure: Percentage of Participants With HER2 Test Form Based on Antigen Retrieval
timeFrame: Up to 70 days
measure: Percentage of Participants With HER2 Test Form Based on Primary Antibody
timeFrame: Up to 70 days
measure: Percentage of Participants With Different IHC Results
timeFrame: Up to 70 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: