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

Completed

Conditions studied: Advanced Breast Cancer

In brief

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 facts

Study ID

NCT07225790

Run by

Brigham and Women's Hospital

People needed

3883

Starts

2025-11-03

Expected to finish

2026-01-31

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female aged ≥18 years at treatment initiation from 2017 - 2023
• Evidence of metastatic breast cancer (MBC)
• Documentation of Estrogen/Progesterone receptor-positive (ER/PR+)
• Documentation of Human Epidermal Growth Factor Receptor Negative (HER2-)
• ECOG performance status of 0 or 1 within 90 days of index date

You may not qualify if…

• CNS metastases
• Prior treatment with CKD4/6 inhibitor
• Prior or current treatment with chemotherapy or endocrine therapy other than letrozole/anastrozole for systemic anticancer therapy for MBC.
• Prior (neo-)adjuvant endocrine therapy
• Systemic anticancer therapy other than abemaciclib or letrozole/anastrozole
• Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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