Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Official Title

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) 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

Summary:

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib or abemaciclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumours (RECIST version 1.1)
Secondary Outcome:
  • Progression-free survival 2 (PFS2)
  • Overall survival (OS)
  • Chemotherapy free survival
  • Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
  • Clinical benefit rate at 24 weeks (CBR24)
  • Change from baseline in EORTC QLQ-C30 scale scores
  • Change from baseline in EORTC QLQ-BR23 scale scores
  • Plasma concentration of AZD9833 at specified timepoints
A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with CDK4/6 inhibitor (palbociclib or abemaciclib) versus aromatase inhibitor (anastrozole or letrozole) in combination with CDK4/6 inhibitor for the treatment of patients with HR-positive, HER2- negative metastatic breast cancer with detectable ESR1 Mutation. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole or letrozole in the context of combination with palbociclib or abemaciclib

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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