Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment.
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Date
2023-03-01ICR Author
Author
Turner, N
Huang-Bartlett, C
Kalinsky, K
Cristofanilli, M
Bianchini, G
Chia, S
Iwata, H
Janni, W
Ma, CX
Mayer, EL
Park, YH
Fox, S
Liu, X
McClain, S
Bidard, F-C
Type
Journal Article
Metadata
Show full item recordAbstract
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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Subject
ESR1 mutation
advanced breast cancer
camizestrant
circulating tumor DNA
endocrine therapy resistance
hormone-receptor-positive breast cancer
selective estrogen receptor degrader
Female
Humans
Antineoplastic Combined Chemotherapy Protocols
Aromatase Inhibitors
Breast Neoplasms
Clinical Trials, Phase III as Topic
Fulvestrant
Randomized Controlled Trials as Topic
Receptor, ErbB-2
Receptors, Estrogen
Research team
Molecular Oncology
Language
eng
Date accepted
2023-03-01
License start date
2023-03-01
Citation
Future Oncology, 2023, 19 (8), pp. 559 - 573
Publisher
FUTURE MEDICINE LTD