SERENA-6

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

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

Phase

Phase 3

Status

Active not recruiting

Conditions

ER-Positive HER2-Negative Breast Cancer

Interventions

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

Arms

• AZD9833 + palbociclib, abemaciclib or ribociclib · Experimental
• Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib · Active comparator

Enrollment

315

Primary outcomes

• Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1)

Sponsor

AstraZeneca

Start

Jun 30, 2021

Primary completion

Jun 30, 2025

Results posted

No

Registry record

NCT04964934 · updated Sep 23, 2026

• Brufsky A, Park YH, Bidard FC, Mayer EL, Janni W, Ma C, Cristofanilli M, Bianchini G, Iwata H, Fasching PA, Nowecki Z, Pascual J, Chen SC, Moreau L, Ruiz-Borrego M, Shai A, Karadurmus N, Jung KH, Kikawa Y, Baird RD, Habash R, Sugarman R, Fox S, Selvi Miralles M, Huang Bartlett C, Turner N. SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy. Oncologist. 2026 Aug 6;31(9):oyag278. doi: 10.1093/oncolo/oyag278. PubMed 42496653
• Turner NC, Mayer EL, Park YH, Janni W, Ma C, Cristofanilli M, Bianchini G, Kalinsky K, Iwata H, Chia S, Brufsky AM, Fasching PA, Nowecki Z, Pascual J, Karadurmus N, Gal-Yam E, Chung WP, Im SA, Zambelli A, Dalenc F, Oliveira M, Ishiguro H, Huang CS, Klinowska T, Fox S, Morrow C, Robert L, Huang-Bartlett C, Bidard FC. Switching to camizestrant at ESR1 mutation emergence before disease progression during first-line treatment of hormone receptor-positive advanced breast cancer (SERENA-6): extended analysis of a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):941-958. doi: 10.1016/S1470-2045(26)00287-1. Epub 2026 Jul 13. PubMed 42442380
• Bidard FC, Mayer EL, Park YH, Janni W, Ma C, Cristofanilli M, Bianchini G, Kalinsky K, Iwata H, Chia S, Fasching PA, Brufsky A, Nowecki Z, Pascual J, Moreau L, Chen SC, Karadurmus N, Gal-Yam EN, Jung KH, Pernas S, McClain S, He W, Klinowska T, Huang-Bartlett C, Turner NC; SERENA-6 Study Group. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Aug 7;393(6):569-580. doi: 10.1056/NEJMoa2502929. Epub 2025 Jun 1. PubMed 40454637
• Turner N, Huang-Bartlett C, Kalinsky K, Cristofanilli M, Bianchini G, Chia S, Iwata H, Janni W, Ma CX, Mayer EL, Park YH, Fox S, Liu X, McClain S, Bidard FC. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol. 2023 Mar;19(8):559-573. doi: 10.2217/fon-2022-1196. Epub 2023 Apr 18. PubMed 37070653