N/A
N=30
Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02580799 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Feb 2016
Primary outcome: 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 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2014
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 | — |
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.
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.