SERENA-6

NCT04964934 📎

Regimen

Experimental
Switch AI to camizestrant 75 mg daily oral SERD, continuing the same CDK4/6 inhibitor.
Control
Continue the AI plus CDK4/6 inhibitor until clinical/radiographic progression.

Population

Men and postmenopausal women with HR+/HER2- advanced breast cancer on a 1L AI plus CDK4/6 inhibitor, without disease progression, whose ctDNA monitoring detected a new emerging ESR1 mutation.

Key finding

SERENA-6 was the first phase 3 trial to validate ctDNA-guided pre-emptive switching: detecting emergent ESR1 mutations during 1L AI + CDK4/6 and switching the AI to camizestrant nearly doubled PFS without waiting for radiographic progression. Sets the template for ctDNA-based adaptive endocrine strategy.

Source: PMID 40454637

Timeline

  • Publication: 2025 Aug 7

Guideline citations

  • NCCN BREAST