Clinical trial · Observational
Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases
NCT07274709CI-TRIAL-00111204completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Initiation of letrozole | Drug | — | UNRESOLVED |
| Initiation of ribociclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Initiation of ribociclib plus letrozole
- description
- Exposure group
- interventionNames
- Drug: Initiation of ribociclib
- label
- Initiation of letrozole
- description
- Reference group
- interventionNames
- Drug: Initiation of ribociclib
- Drug: Initiation of letrozole
Primary outcomes (1)
- measure
- Time to all-cause mortality/overall survival (OS)
- timeFrame
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.