OncRef

Clinical Trial: NCT04964934

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-09-23

Study Overview

Brief Summary

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) 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.

Official Title

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

Conditions

ER-Positive HER2-Negative Breast Cancer

Intervention / Treatment

  • Drug: AZD9833
  • Drug: AZD9833 Placebo
  • Drug: Anastrozole
  • Drug: Anastrozole placebo
  • Drug: Letrozole
  • Drug: Letrozole placebo
  • Drug: Palbociclib
  • Drug: Abemaciclib
  • Drug: Luteinizing hormone-releasing hormone (LHRH) agonist
  • Drug: Ribociclib

Other Study ID Numbers

  • D8534C00001
  • 2023-503990-39-00
  • 2021-000546-17
  • 2023

Start Date (Actual)

2021-06-30

Primary Completion Date (Actual)

2025-06-30

Study Completion Date (Estimated)

2028-09-01

Enrollment (Actual)

315

Study Type

Interventional

Phase

Phase 3