
Opinion|Videos|May 15, 2025
Real-World Experience: The Efficacy and Tolerability of Oral Elacestrant for Patients with ESR1 Mutations
Author(s)Virginia Kaklamani, MD, DSc, Megan Kruse, MD
Panelists discuss how real-world studies have shown improved outcomes with elacestrant compared with the original EMERALD trial data, demonstrating that proper patient selection leads to better treatment responses.
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Episodes in this series

Clinical Brief: Real-World Evidence Supporting Elacestrant Use
Main Discussion Topics:
- Real-world outcomes exceeding clinical trial results (unusual finding)
- GUARDIAN database analysis: 6.4 months median time to treatment failure
- Komoda database: 6.8 months progression-free survival (9.4 months if fulvestrant-naive)
- Expert clinical experience aligning with real-world data
- Importance of appropriate patient selection for optimal outcomes
Key Points for Physicians:
- Real-world PFS (6.4-6.8 months) exceeds EMERALD trial results (3.8 months)
- Fulvestrant-naive patients show particularly strong outcomes (9.4 months)
- Early adopters report better results with refined patient selection
- Confirms benefit of using elacestrant in second-line for appropriate patients
- Real-world data validates subgroup findings from EMERALD
The real-world evidence conclusively demonstrates that proper patient selection based on EMERALD subgroup analyses results in significantly improved clinical outcomes compared with the overall trial population.
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