Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT07243002
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.
Status:
RECRUITING
Status Verified Date:
2025-12
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:
REPOWER
Brief Summary:
This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \[HRQoL\], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.
Detailed Description:
This will be a multi-center, multi-country, observational, non-interventional, hybrid study among HR+/HER2- stage II or III eBC patients treated with ribociclib + ET or abemaciclib + ET, as per local label in routine clinical care settings.
The study will include a retrospective and a prospective part. The hybrid design will combine retrospective data extraction from patients' EHRs and prospective data collection from validated PRO questionnaires, bespoke questions, and qualitative interviews, to provide comprehensive data on the patient population.
The exploratory objectives will assess HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET. No formal comparison between the cohorts will be made
The study will include a retrospective and a prospective part. The hybrid design will combine retrospective data extraction from patients' EHRs and prospective data collection from validated PRO questionnaires, bespoke questions, and qualitative interviews, to provide comprehensive data on the patient population.
The exploratory objectives will assess HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET. No formal comparison between the cohorts will be made
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?: