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

Study 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.

Conditions

ER-Positive HER2-Negative Breast Cancer

Interventions / Drugs

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

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment315 participants

Primary Completion—

Lead SponsorAstraZeneca

Data Retrieved2026-04-11 02:55:19.910902+00:00

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