Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
NCT04964934 · SERENA-6 Phase 3Active, not recruiting
- Lead sponsor
- AstraZeneca (Industry)
- Enrollment
- 315 (actual)
- Start date
- 30 Jun 2021
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Sep 2028
- Last update posted
- 23 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Triple
- Arms
- 2
Interventions
- 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 Drug
Conditions and primary outcome
- ER-Positive HER2-Negative Breast Cancer
Primary outcome
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1) (From randomization until the earlier of the progression event or death (approximately 2 years))
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
4 on PubMedSERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy.
The oncologist · 2026 Aug 6
PubMed 42496653 (opens in a new tab)DOI 10.1093/oncolo/oyag278 (opens in a new tab)
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.
The Lancet. Oncology · 2026 Aug
PubMed 42442380 (opens in a new tab)DOI 10.1016/S1470-2045(26)00287-1 (opens in a new tab)
First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer.
The New England journal of medicine · 2025 Aug 7
PubMed 40454637 (opens in a new tab)DOI 10.1056/NEJMoa2502929 (opens in a new tab)
Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment.
Future oncology (London, England) · 2023 Mar
PubMed 37070653 (opens in a new tab)DOI 10.2217/fon-2022-1196 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04964934 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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