Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607601
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
CARE Initiative Real-world Emulation of the PALOMA-2 Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CARE Initiative Study Real-world Emulation of the PALOMA-2 Comparative Effectiveness Trial of Palbociclib and Letrozole vs Placebo and Letrozole for the First-line Treatment of ERHER2- Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive ERhuman epidermal growth factor receptor 2-negative HER2- advanced breast cancer using real-world electronic health record data The main questions this study aims to answer are
1 Do patients with metastatic ERHER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival rwPFS compared with patients treated with letrozole alone
2 How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial
1 Do patients with metastatic ERHER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival rwPFS compared with patients treated with letrozole alone
2 How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial
Detailed Description:
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation CARE Initiative is a program designed to build an empirical evidence base for the use of real-world data RWD in clinical and regulatory decision-making Using randomized controlled trials RCT as a benchmark for causal effect estimates a series of RCT emulations will be conducted across varying trials real world data sources and study design elements to better understand under what conditions non-interventional studies using data generated during routine clinical care can provide reliable conclusions about drug effectiveness
In this study real-world electronic health record EHR data will be used to emulate the Palbociclib Ongoing Trials in the Management of Breast Cancer PALOMA-2 efficacy trial of palbociclib as first-line therapy in patients with estrogen receptor-positive ERhuman epidermal growth factor receptor 2-negative HER2- advanced breast cancer2 Similarly to the PALOMA-2 trial this study will compare real-world progression-free survival rwPFS between patients who initiate palbociclib and letrozole and those initiating letrozole alone
In this study real-world electronic health record EHR data will be used to emulate the Palbociclib Ongoing Trials in the Management of Breast Cancer PALOMA-2 efficacy trial of palbociclib as first-line therapy in patients with estrogen receptor-positive ERhuman epidermal growth factor receptor 2-negative HER2- advanced breast cancer2 Similarly to the PALOMA-2 trial this study will compare real-world progression-free survival rwPFS between patients who initiate palbociclib and letrozole and those initiating letrozole alone
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