CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 420 enrolled
Drug / intervention
Trastuzumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02731313
NCT02731313N/ACompleted
CompareCT.gov

Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.

Hoffmann-La Roche·observational·Posted Apr 7, 2016·Updated Oct 28, 2016

In Brief

An observational study evaluating Trastuzumab for Gastric Cancer, Gastroesophageal Junction Cancer. Completed, enrolled 420 participants across 19 sites.

Detailed 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+.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Gastroesophageal Junction Cancer
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2016
Enrollment StartJul 1, 2012
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.2 years ago

Interventions

Trastuzumabbiological

Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.