Emulation of the MONALEESA-2 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

NCT07274709

Run by

Shirley Vichy Wang

People needed

2495

Starts

2025-09-07

Expected to finish

2026-01-01

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…

• Age ≥18 years through 2017 to 2023
• Metastatic breast cancer
• Hormone receptor positive (ER/PR+)
• Untreated with systemic anticancer therapy for advanced disease
• ECOG performance status of 0 or 1
• HER2-negative

You may not qualify if…

• Prior treatment with CDK4/6 inhibitor
• Locally advanced (unresectable) or inflammatory breast cancer
• Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
• Prior adjuvant therapy for breast cancer
• Systemic anticancer therapy other than ribociclib or letrozole

Where it is running

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

Full record on ClinicalTrials.gov

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