NCT07274709Completed
Emulation of the MONALEESA-2 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
- 2495 (actual)
- First submitted
- 20 Nov 2025
- Start date
- 7 Sept 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Shirley Vichy Wang
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07274709
What you commit to
- Study type: Observational
- Participants enrolled: 2495
- From 7 Sept 2025 to the primary completion date, 1 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 CDK4/6 inhibitor
- Prior adjuvant therapy for breast cancer
- Systemic anticancer therapy other than ribociclib or letrozole
Other illness
- Locally advanced (unresectable) or inflammatory breast cancer
- Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
Who the study is looking for
- 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
Criteria the registry did not label
- Study Period:
- ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024 ENCORE database 3 (EDB3): Follow-up information through June 2023 (there is no specific time period restrictions for patient eligibility) ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
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.