Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
368actual
Sites
138
Countries
Argentina, Belgium, Czechia +14
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 | 2022-03-11 | actual | When the study began enrolling |
| Primary completion | 2024-02-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-12-27 | actual | When this record first appeared on the registry |
| Results posted | 2025-02-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Neoplasm
- Neoplasm Metastasis
Interventions
- Drug: Abemaciclib
- Drug: Fulvestrant
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFProgression-Free Survival (PFS)
measured Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-10-04 · 7.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-09-22 · 465 KB · SAP_001.pdf
Publications
- PMID 40141282 — linked by the registry
- PMID 39693591 — 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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