NCT07225790Completed
Emulation of the MONARCH-3 Trial Using Specialty Oncology Electronic Health Records Databases
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3883 (actual)
- First submitted
- 5 Nov 2025
- Start date
- Nov 2025
- Primary completion date
- Jan 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07225790
What you commit to
- Study type: Observational
- Participants enrolled: 3883
- From Nov 2025 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
Other
- CNS metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.