HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes (HERA)

August 12, 2024 updated by: Nicola Raftery, St. James's Hospital, Ireland

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicola B Raftery, MBBCh,MSc
  • Phone Number: +353 86 1675454
  • Email: rafteryn@tcd.ie

Study Locations

  • Ireland
    • Leinster
      • Dublin, Leinster, Ireland, D08 NHY1
        • Recruiting
        • Trinity St James Cancer Institute
        • Contact:
          • Nicola B Raftery, MBBCh,MSc
          • Phone Number: +353 86 1675454
          • Email: rafteryn@tcd.ie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geographical variation in HER2 status
Time Frame: 2000 - 2024
2000 - 2024

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical TNM stage
Time Frame: 2000 - 2024
2000 - 2024
Overall survival
Time Frame: 2000 - 2024
2000 - 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. James's Hospital, Ireland

Investigators

  • Principal Investigator: John V Reynolds, MBBCh,MD, Trinity St James Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERA001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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