Clinical Trial

Emulation of the MONARCH-3 Trial Using Specialty Oncology Electronic Health Records Databases

Completed
View on ClinicalTrials.gov →
Summary
Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-11-06; most recent amendment 2026-05-08.
Status change: Active, Not Recruiting → Completed 2026-02-25
Trial Details
NCT Number NCT07225790
Lead Sponsor Brigham and Women's Hospital
Collaborators: Food and Drug Administration (FDA)
Conditions Advanced Breast Cancer
Enrollment 3,883 participants
Start Date 2025-11-03
Primary Completion 2026-01-31 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-12