医学
乳腺癌
突变体
癌症
内科学
肿瘤科
直线(几何图形)
癌症研究
遗传学
生物
基因
数学
几何学
作者
Nicholas C. Turner,Cynthia Huang Bartlett,Kevin Kalinsky,Massimo Cristofanilli,Giampaolo Bianchini,Stephen Chia,Hiroji Iwata,Wolfgang Janni,X. Cynthia,Erica L. Mayer,Yeon Hee Park,Stephen B. Fox,Xiaochun Liu,Sasha McClain,François‐Clément Bidard
出处
期刊:Future Oncology
[Future Medicine]
日期:2023-03-01
卷期号:19 (8): 559-573
被引量:63
标识
DOI:10.2217/fon-2022-1196
摘要
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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