Clinical trial NCT06550063: HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
Official title: HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagus Cancer
Gastric Cancer
HER2-positive Cancer
HER2-low Cancer
Keywords: Esophageal cancer
Gastric cancer
HER2-positive cancer
HER2-low cancer
Targeted treatment
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 2188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a multi-center, retrospective, international cohort study including a population of patients diagnosed with EGA from 2000 to April 2024 across all stages of disease with primary tumour routinely tested for HER2 status.

Brief summary: 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.


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

Primary outcomes:
measure: Geographical variation in HER2 status
timeFrame: 2000 - 2024
Secondary outcomes:
measure: Clinical TNM stage
timeFrame: 2000 - 2024
measure: Overall survival
timeFrame: 2000 - 2024
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity St James Cancer Institute
state: Leinster
Study officials:
affiliation: Trinity St James Cancer Institute
name: John V Reynolds, MBBCh,MD
role: PRINCIPAL_INVESTIGATOR
References: