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

NCT07225790 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3883

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Initiation of abemaciclib plus letrozole/anastrozole

Any doses and frequency observed in clinical practice will be allowed

DRUG

Initiation of letrozole/anastrozole

Any doses and frequency observed in clinical practice will be allowed

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shirley Wang, PhD, ScM · Brigham and Women's Hospital

  • Denys Shay, MD · Brigham and Women's Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225790 on ClinicalTrials.gov