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SERENA-6: Phase III Trial of ctDNA-Guided Switch to Camizestrant + CDK4/6i vs Continued AI + CDK4/6i Following ESR1 Mutation Emergence in HR+/HER2- Advanced Breast Cancer

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In the randomized phase III SERENA-6 trial, switching from AI + CDK4/6i to camizestrant + continued CDK4/6i upon ctDNA detection of ESR1m during 1L therapy—ahead of clinical progression—significantly improved PFS in patients with HR+/HER2- advanced breast cancer.

Released: June 03, 2025

Expiration: December 02, 2025

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Provided by Clinical Care Options, LLC.

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Supported by educational grants from AstraZeneca, Daiichi Sankyo, Inc, Gilead Sciences, Inc., Lilly, Novartis Pharmaceuticals Corporation, and Stemline Therapeutics, Inc.

AstraZeneca

Daiichi Sankyo, Inc.

Gilead Sciences, Inc.

Lilly

Novartis Pharmaceuticals Corporation

Stemline Therapeutics, Inc.