Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550063
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patients Clinicopathological Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patients Clinicopathological Outcomes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERA
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None