Status:
ACTIVE_NOT_RECRUITING
Emulation of the PALOMA-2 Trial
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 clin...
Detailed Description
Randomized controlled trials (RCTs) are generally regarded as the gold-standard of evidence for establishing efficacy of medical products. However, real-world data (RWD) are increasingly used to compl...
Eligibility Criteria
Inclusion
- 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 ≥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
- 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)
Key Trial Info
Start Date :
July 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
6097 Patients enrolled
Trial Details
Trial ID
NCT07178743
Start Date
July 14 2025
End Date
October 1 2025
Last Update
September 17 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120