Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04388384
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-24
First Post:
2020-05-05
Brief Title:
Real-life Pan-HER-blockade With Neratinib
Sponsor:
Pierre Fabre Pharma GmbH
Organization:
Pierre Fabre Pharma GmbH
Study Overview
Official Title:
Neratinib in Patients With HER2 Breast Cancer a Multi-centric Multi-national Prospective Longitudinal Non-interventional Study in Germany Austria and Switzerland
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
ELEANOR
Brief Summary:
So far there is no data available on treatment of patients with early-stage hormone receptor HR positive human epidermal growth factor receptor 2 HER2-overexpressedamplified breast cancer who completed adjuvant trastuzumab-based therapy less than one year ago in the clinical routine setting
ELEANOR - designed as a prospective longitudinal non-interventional study NIS - will investigate real-world use of neratinib and its treatment management in patients with HR-positive HER2-overexpressingamplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting
ELEANOR - designed as a prospective longitudinal non-interventional study NIS - will investigate real-world use of neratinib and its treatment management in patients with HR-positive HER2-overexpressingamplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None