A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer
← catalyst calendarSponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
463actual
Sites
45
Countries
Brazil, China, India +1
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 | 2016-12-05 | actual | When the study began enrolling |
| Primary completion | 2019-03-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2016-05-05 | estimated | When this record first appeared on the registry |
| Results posted | 2020-03-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: Abemaciclib — also filed as LY2835219
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Placebo
- Drug: Fulvestrant
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)
measured Randomization to Measured Progressive Disease or Death (up to 26 Months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2019-05-14 · 1.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2019-04-25 · 4.5 MB · SAP_001.pdf
Publications
- PMID 39385327 — linked by the registry
- PMID 33149768 — 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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