HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophagus Cancer, Gastric Cancer, HER2-positive Cancer, HER2-low Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Targeted therapies offer promise to improve oncologic outcomes in esophagogastric adenocarcinoma (EGA). The landmark 'Trastuzumab for gastric cancer (ToGA)' trial established the therapeutic value of Human Epidermal Growth Factor Receptor 2 (HER2) directed therapy in advanced gastric and esophagogastric junction adenocarcinoma, setting a standard of care. Further studies, such as DESTINY-gastric01 and DESTINY-gastric02, have demonstrated the efficacy of antibody-drug conjugates (ADCs) targeting HER2-positive gastric and junctional tumours. The use of HER2-directed therapies in the curative intent setting has more recently been evaluated with favourable outcomes in phase II studies. However, data regarding the prevalence and prognostic significance of HER2 overexpression among patients undergoing treatment with curative intent are limited. Furthermore, few studies have evaluated the clinical significance of intratumoural and tumour-metastatic heterogeneity of HER2 expression, and the finding of HER2-low, in this context, which may have important implications for implementation of neoadjuvant targeted therapies in future. While limited single centre series have evaluated the clinicopathologic significance of HER2 status in EGA, no previous international multicentre study of this nature has been reported. The goal of this international, multi-center, retrospective observational study is to elucidate the prevalence and clinical significance of HER2 expression in patients with EGA across different regions globally. The study also aims to assess the clinical significance of HER2 heterogeneity in a large, international cohort of patients with EGA, and its association with clinicopathological outcomes in patients with advanced and recurrent disease.
Primary outcome measures
- Geographical variation in HER2 status [Time frame: 2000 - 2024]
Secondary outcome measures (2)
- Clinical TNM stage [Time frame: 2000 - 2024]
- Overall survival [Time frame: 2000 - 2024]
Eligibility criteria
Inclusion criteria
- Patients with newly diagnosed EGA from 2000 to April 2024 across all stages of disease
- Primary tumour HER2 status tested as routine in all patients with EGA
- Patients aged 18 years or over
Exclusion criteria
\- Patients with esophageal squamous cell carcinoma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ireland · 1 center
- Trinity St James Cancer Institute — Dublin
Identifiers
NCT: NCT06550063 · HERA001