A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
240actual
Sites
85
Countries
Belgium, Canada, France +13
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 | 2020-04-22 | actual | When the study began enrolling |
| Primary completion | 2022-08-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-16 | estimated | The whole study's end, after follow-up |
| First posted | 2020-01-02 | actual | When this record first appeared on the registry |
| Results posted | 2023-12-12 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced ER-Positive HER2-Negative Breast Cancer
Interventions
- Drug: AZD9833
- Drug: Fulvestrant
Primary outcome
what the primary-completion date above is the date OFProgression-free Survival (PFS)
measured From date of randomisation to date of objective disease progression (or last evaluable assessment in the absence of progression) or death (up to data cut-off of 29 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-09-15 · 5.0 MB · Prot_000.pdf
Statistical Analysis Planposted 2019-01-30 · 5.3 MB · SAP_001.pdf
Publications
- PMID 39481395 — linked by the registry
- PMID 38729567 — 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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