Study
| Phase 3, randomized, double-blind trial [SERENA-6] |
| ER-positive, HER2-negative advanced breast cancer with emerging ESR1 mutations |
| Camizestrant (n=157) vs Aromatase inhibitor (n=158) with CDK4/6 inhibitor |
Efficacy
| mPFS: 16.0 mos vs 9.2 mos (HR 0.44 [0.31-0.60]) |
| 24-mo PFS: 29.7% vs 5.4% |
Safety
| Grade >=3 AEs: Neutropenia (45.2% vs 34.2%) |
| Photopsia (20.0% vs 7.7%) |
| Bradycardia (5.2% vs Not reported) |
| Serious AEs: 10.3% vs 12.3% |
| Discontinuation due to AEs: 1.3% vs 1.9% |
N Engl J Med. Published online 2024.
Bidard FC,Mayer EL,Park YH First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer
http://doi.org/10.1056/nejmoa2502929
Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025
