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 BidardPublished 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.
Keyphrases
- estrogen receptor
- phase iii
- free survival
- open label
- phase ii study
- circulating tumor
- placebo controlled
- double blind
- epidermal growth factor receptor
- clinical trial
- patient reported outcomes
- phase ii
- locally advanced
- cell cycle
- tyrosine kinase
- cell free
- artificial intelligence
- endothelial cells
- study protocol
- circulating tumor cells
- advanced non small cell lung cancer
- rectal cancer
- quantum dots
- single molecule
- label free
- induced pluripotent stem cells