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Trial Title:
HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
NCT ID:
NCT06550063
Condition:
Esophagus Cancer
Gastric Cancer
HER2-positive Cancer
HER2-low Cancer
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Conditions: Keywords:
Esophageal cancer
Gastric cancer
HER2-positive cancer
HER2-low cancer
Targeted treatment
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Trinity St James Cancer Institute
Address:
City:
Dublin
Zip:
D08 NHY1
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Nicola B Raftery, MBBCh,MSc
Phone:
+353 86 1675454
Email:
rafteryn@tcd.ie
Start date:
August 20, 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
St. James's Hospital, Ireland
Agency class:
Other
Source:
St. James's Hospital, Ireland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550063
