Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619704
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR HER2- Metastatic Breast Cancer Treated With Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A rEtrospectIve Real-world Analysis of earLy responsE ratEs With Ribociclib and Endocrine Therapy and Descriptive aNalysis of HR HER2- Metastatic Breast Cancer Patients Treated With Chemotherapy EILEEN
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
EILEEN was a non-interventionalobservational retrospective multi-center real life cohort study conducted in 14 private and academic oncology clinics in Turkey Group I cohort of the study was based on secondary use of data of postmenopausal hormone receptor-positive HR human epidermal growth factor receptor 2-negative HER2- metastatic breast cancer MBC patients treated with ribociclib in combination with letrozole LET or fulvestrant FUL after June 2020 Group II cohort of the study was a parallel comprehensive chart review for detecting all postmenopausal HR HER2- MBC patients who were eligible for cyclin-dependent kinase inhibitors CDKis but received chemotherapy The study used secondary data which was retrieved from electronic or paper medical records or clinical databases available at the sites Regular follow up with close monitorization was used for the effective management of patients with breast cancer Data sources included information about diagnosis treatment and monitorization of patients at an individual level The study used medical patient records at hospitals eg hospital discharge files primary clinical records and electronic medical records
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: