Clinical trial · Observational
Emulation of the MONARCH-3 Trial Using Specialty Oncology Electronic Health Records Databases
NCT07225790CI-TRIAL-00111144completedClinicalTrials.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 abemaciclib plus letrozole/anastrozole | Drug | — | UNRESOLVED |
| Initiation of letrozole/anastrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Initiation of abemaciclib plus letrozole/anastrozole
- description
- Any doses and frequency observed in clinical practice will be allowed
- interventionNames
- Drug: Initiation of abemaciclib plus letrozole/anastrozole
- label
- Initiation of letrozole/anastrozole
- description
- Any doses and frequency observed in clinical practice will be allowed
- interventionNames
- Drug: Initiation of letrozole/anastrozole
Primary outcomes (1)
- measure
- Time to all-cause mortality (overall survival)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.