Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma

Roche

Status: Completed

Conditions: Gastric Cancer, Gastroesophageal Junction Cancer

Treatments: Biological: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02731313

ML27940

Details and patient eligibility

About

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+.

Enrollment: 420 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

420 participants in 1 patient group

Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma

Description:

Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned.

Treatment:

Biological: Trastuzumab