Clinical trial · Observational
Emulation of the PALOMA-2 Trial
NCT07178743CI-TRIAL-00111227completedClinicalTrials.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 palbociclib plus letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Initiation of palbociclib plus letrozole
- description
- Exposure group
- interventionNames
- Drug: Initiation of palbociclib plus letrozole
- label
- Initiation of letrozole
- description
- Reference group
- interventionNames
- Drug: Initiation of letrozole
Primary outcomes (1)
- measure
- Time to all-cause mortality (overall survival)
- timeFrame
- Through the earliest of outcome, censoring, or end of data (April 2024)
- description
- Hazard ratio (95% CI)
Secondary outcomes (1)
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 * Postmenopausal women with ER-positive, HER2-negative locally advanced or metastatic breast cancer who receive treatment without curative intent * The line of therapy for patients in EDB1 and EDB3 is implicitly advanced/metastatic because the line of therapy classification starts after their advanced/metastatic diagnosis in the respective database * In EDB4, patients must explicitly have any evidence of a metastasis prior initiating palbociclib plus letrozole or letrozole alone * Adenocarcinoma histology * No prior systemic treatment for advanced/metastatic disease * ECOG performance status of 0 or 1 Exclusion Criteria: * HER2+ * CNS metastases * Prior treatment with CDK4/6 inhibitor * Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix * Systemic anticancer therapy other than palbocicilib or letrozole * Treatment with non-steroidal aromatase inhibitor (i.e.anastrozole, letrozole)
References
Publications (0)
Data not yet available
No reference posted for this study.