N/A
N=367
Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma
Gastric Cancer, Gastroesophageal Junction Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02731313 ↗Enrolled (actual)
367
Serious AEs
—
Results posted
Oct 2016
Primary outcome: Primary: Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments — 0.69 kappa coefficient — p=0.7436
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Trastuzumab (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments |
0.69 | 0.7436 |
| SECONDARY Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location |
59.6; 40.4 | — |
| SECONDARY Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed |
29.6; 54.8; 9.6; 0.3; 5.8 | — |
| SECONDARY Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages |
9.8; 8.2; 26.0; 12.6; 43.4; 23.0 | — |
| SECONDARY Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories |
0.64 | — |
Summary
The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.
Eligibility Criteria
Inclusion Criteria
- Tumor samples with histologically confirmed gastric or gastro-esophageal junction (GEJ) adenocarcinoma, any stage
- Samples with sufficient tumor material for centralized analysis
- Samples fixed and embedded in paraffin (formalin-fixed paraffin-embedded tissue [FFPET] samples).
Exclusion Criteria
- Fixatives not allowed: Bouin's solution
Data sourced from ClinicalTrials.gov (NCT02731313). 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.