Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
315actual
Sites
264
Countries
Australia, Austria, Belgium +20
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-06-30 | actual | When the study began enrolling |
| Primary completion | 2025-06-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-09-01 | estimated | The whole study's end, after follow-up |
| First posted | 2021-07-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- ER-Positive HER2-Negative Breast Cancer
Interventions
- 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
Primary outcome
what the primary-completion date above is the date OFProgression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1)
measured From randomization until the earlier of the progression event or death (approximately 2 years)
Publications
- PMID 42496653 — linked by the registry
- PMID 42442380 — linked by the registry
- PMID 40454637 — linked by the registry
- PMID 37070653 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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