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A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

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Trial Profile

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Camizestrant (Primary) ; Abemaciclib; Anastrozole; Letrozole; LHRH receptor agonists; Palbociclib; Ribociclib
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms SERENA-6
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 02 Jun 2025 According to an AstraZeneca media release, results from this trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and were published in The New England Journal of Medicine.
  • 01 Jun 2025 According to an AstraZeneca media release, based on the results of the SERENA-6 Phase III trial, camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) has been granted Breakthrough Therapy Designation (BTD) in the US by the Food and Drug Administration for the treatment of adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer upon emergence of ESR1 mutation during first-line endocrine-based therapy.
  • 01 Jun 2025 According to an AstraZeneca media release, Nicholas Turner is co-principal investigator for the trial.

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