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

Study identifier:D8534C00001

ClinicalTrials.gov identifier:NCT04964934

EudraCT identifier:2021-000546-17

CTIS identifier:N/A

Recruiting

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

Medical condition

ER-Positive HER2-Negative Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Estimated Enrollment

300

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 30 Jun 2021
Estimated Primary Completion Date: 10 Jan 2025
Estimated Study Completion Date: 26 Nov 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria