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Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment.

Nicholas C TurnerCynthia Huang-BartlettKevin KalinskyMassimo CristofanilliGiampaolo BianchiniStephen K L ChiaHiroji IwataWolfgang JanniCynthia X MaErica L MayerJang-Yeon ParkSteven FoxXiaochun LiuSasha McClainFrancois-Clement Bidard
Published in: Future oncology (London, England) (2023)
ESR1 mutation ( ESR1 m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) that in a phase II study significantly improved progression-free survival (PFS) over fulvestrant (also a SERD) in ER+/HER2- ABC. SERENA-6 (NCT04964934) is a randomized, double-blind, phase III study evaluating the efficacy and safety of switching from an AI to camizestrant, while maintaining the same CDK4/6i, upon detection of ESR1 m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat ESR1 m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy. The primary end point is PFS; secondary end points include chemotherapy-free survival, time to second progression event (PFS2), overall survival, patient-reported outcomes and safety.
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