Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05827081
Status:
SUSPENDED
Last Update Posted:
2024-04-24
First Post:
2023-04-12
Brief Title:
Phase IIIb Study of Ribociclib ET in Early Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IIIb Study to Characterize the Effectiveness and Safety of Adjuvant Ribociclib in a Wide Patient Population With HR HER2- Early Breast Cancer Adjuvant WIDER
Status:
SUSPENDED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adjuvant WIDER trial paused due to manufacturing adjustments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Adjuvant WIDER
Brief Summary:
An open-label multicenter phase IIIb single-arm study to evaluate the safety and efficacy of the combination of ribociclib and standard adjuvant endocrine therapy ET on invasive breast cancer-free survival iBCFS in a wide patient population with HR-positive HR HER2-negative HER2- Anatomic Stage Group III II subset or I high-risk subset as exploratory cohort early Breast Cancer EBC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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