Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125314
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-11-06
Brief Title:
HER2 TREAT Study Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable andor Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Non-Interventional Retrospective Study Aims to Estimate the Prevalence and Describe the Clinical Manifestations of HER2-Low Breast Cancer Reported in Unresectable andor Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2- Negative From Patient Medical Records in The Gulf Council Cooperation Region
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HER2-low Breast cancer BC has emerged as a new subtype of BC with distinct clinical pathological and prognostic features Little is known about the prevalence of the HER2-low subtype in HER2-negative patients and previous reports showed variations in the criteria used to define the HER2-low subtype Besides data on the clinical features and prognosis of HER2-low patients are limited and it is still unclear whether HER2-low BC has a prognostic value Identifying the prevalence and clinical features of HER2-low BC can help establish a more accurate and reproducible definition of HER2-low BC In the Gulf Cooperation Council GCC region BC is the most common malignancy in women and still poses a significant burden on healthcare resource utilization moreover there is only one record for reimbursed HER2 IHC status categorized as HER2-positive and HER2-negative It is important to understand the prevalence clinical features and outcomes of HER2-low in BC patients from the GCC In this retrospective non-interventional multicenter study the aim to describe the prevalence of HER2-low BC among the current HER2-negative BC population using rescored HER2 IHC samples The local treatment patterns and the outcomes will be analyzed using the information abstracted from the corresponding medical chart review The study will cover the GCC region countries United Arab Emirates UAE Saudi Arabia Qatar Kuwait and Oman
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