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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Shirley Vichy Wang
Study ID
NCT07274709
Status
Completed

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Initiation of ribociclib — DRUG
    Initiation of ribociclib plus letrozole described in electronic health records is used as the exposure
  • Initiation of letrozole — DRUG
    Initiation of letrozole described in electronic health records is used as the reference

Study Details

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.

Key Dates

Start date
Sep 7, 2025
Status verified
Nov 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
2,495 participants (actual)

Arms

  • Arm: Initiation of ribociclib plus letrozole
    Exposure group
  • Arm: Initiation of letrozole
    Reference group

Primary Outcome Measure

Time to all-cause mortality/overall survival (OS) [ Time Frame: From time of initiation of therapy through the earliest of death from any cause (the primary outcome of interest) or end of data availability (depending on specialty oncology registry data provider, end of data ranges from June 2023 to April 2024) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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