MedTrace Logo

Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases

NCT07274709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2495

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 ribociclib

Initiation of ribociclib plus letrozole described in electronic health records is used as the exposure

DRUG

Initiation of letrozole

Initiation of letrozole described in electronic health records is used as the reference

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Shirley Vichy Wang

    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
2025-09-07
Primary Completion
2026-01-01
Completion
2026-01-01
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 NCT07274709 on ClinicalTrials.gov