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

Nicholas Turner, Cynthia Huang-Bartlett, Kevin Kalinsky, Massimo Cristofanilli, Giampaolo Bianchini, Stephen Chia, Hiroji Iwata, Wolfgang Janni, Cynthia X. Ma, Erica L. Mayer, Yeon Hee Park, Steven Fox, Xiaochun Liu, Sasha Mcclain, Francois Clement Bidard

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

ESR1 mutation (ESR1m) 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 ESR1m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat ESR1m 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.

Original languageEnglish
Pages (from-to)559-573
Number of pages15
JournalFuture Oncology
Volume19
Issue number8
DOIs
StatePublished - Mar 1 2023

Keywords

  • ESR1 mutation
  • advanced breast cancer
  • camizestrant
  • circulating tumor DNA
  • endocrine therapy resistance
  • hormone-receptor-positive breast cancer
  • selective estrogen receptor degrader

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