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Design of SERENA-6, a Phase III switch trial with camizestrant in ESR1-mutant breast cancer during first-line treatment

Written by Nicholas Turner & Cynthia Huang-Bartlett & Kevin Kalinsky et al

SERENA-6

Future Oncology, our partner journal, has recently published a Clinical Trial Protocol, which details the design of the SERENA-6 breast cancer Phase III trial. Abstract Estrogen receptor 1 gene 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 HR+/HER2– ABC. SERENA-6 (NCT04964934)...

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