Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment.
Loading...
Embargo End Date
ICR Authors
Authors
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
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
Document Type
Journal Article
Date
2023-03-01
Date Accepted
2023-03-01
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.
Citation
Future Oncology, 2023, 19 (8), pp. 559 - 573
Source Title
Future Oncology
Publisher
TAYLOR & FRANCIS LTD
ISSN
1479-6694
eISSN
1744-8301
1744-8301
1744-8301
Collections
Research Team
Molecular Oncology