Article Dans Une Revue Future Oncology Année : 2023

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

Nicholas C. Turner
  • Fonction : Auteur
Cynthia Huang-Bartlett
  • Fonction : Auteur
Kevin M. Kalinsky
  • Fonction : Auteur
Massimo Cristofanilli
  • Fonction : Auteur
Giampaolo Bianchini
Stephen K.L. Chia
  • Fonction : Auteur
Hiroji I. Iwata
  • Fonction : Auteur
Wolfgang J. Janni
  • Fonction : Auteur
Cynthia X. Ma
  • Fonction : Auteur
Erica L. Mayer
  • Fonction : Auteur
Yeon-Hee Park
  • Fonction : Auteur
Steven Fox
  • Fonction : Auteur
Xiaochun Liu
  • Fonction : Auteur
Sasha Mcclain
  • Fonction : Auteur

Résumé

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.

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hal-04194824 , version 1 (27-09-2023)

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Nicholas C. Turner, Cynthia Huang-Bartlett, Kevin M. Kalinsky, Massimo Cristofanilli, Giampaolo Bianchini, et al.. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncology, 2023, 19 (8), pp.559-573. ⟨10.2217/fon-2022-1196⟩. ⟨hal-04194824⟩
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