N/A
Completed N=30
Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples
Source: ClinicalTrials.gov NCT02580799 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E) — 16.7; 12.5; 0.0; 8.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E) |
16.7; 12.5; 0.0; 8.3; 4.2; 12.5 | — |
| PRIMARY 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 |
0.171; 0.090; -0.148; -0.124 | =0.137 |
| PRIMARY Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E) |
12.5; 4.2; 0.0; 4.2; 4.2; 12.5 | — |
| PRIMARY 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 |
0.224; 0.000; 0.05 | =0.054 |
| PRIMARY Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E) |
8.3; 4.2; 8.3; 16.7; 4.2; 4.2 | — |
| PRIMARY Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples |
-0.137; 0.259; -0.317 | =0.246 |
| PRIMARY Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E) |
16.7; 13.3; 10.0; 3.3; 6.7; 3.3 | — |
| PRIMARY 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 |
0.002; 0.260; 0.226; -0.063; 0.04 | =0.988 |
| SECONDARY Percentage of Participants With Diagnosis of Primary Tumor |
93.3; 3.3; 3.3 | — |
| SECONDARY Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision |
33.3; 54.2; 8.3; 4.2; 50.0; 16.7 | — |
| SECONDARY Percentage of Participants With Pathological Score |
0.0; 43.3; 56.7; 0.0; 33.3; 66.7 | — |
| SECONDARY Percentage of Participants With Pathological Grade |
0.0; 56.7; 43.3 | — |
| SECONDARY Percentage of Participants With Different Hormone Receptors |
71.3; 42.69 | — |
| SECONDARY Percentage of Participants With Specified Density of Hormone Receptors |
4.0; 8.0; 16.0; 72.0; 12.0; 28.0 | — |
| SECONDARY Percentage of Participants With HER2 Test Form Based on Country |
80.0; 20.0 | — |
| SECONDARY Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers |
20.0; 16.0; 16.0; 48.0 | — |
| SECONDARY Percentage of Participants With HER2 Test Form Based on Antigen Retrieval |
16.0; 32.0; 16.0; 16.0; 20.0 | — |
| SECONDARY Percentage of Participants With HER2 Test Form Based on Primary Antibody |
16.0; 16.0; 16.0; 16.0; 36.0 | — |
| SECONDARY Percentage of Participants With Different IHC Results |
36.7; 20.7; 20.7; 22.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02580799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.