A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women 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
493actual
Sites
155
Countries
Australia, Austria, Belgium +19
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 | 2014-11-06 | actual | When the study began enrolling |
| Primary completion | 2017-01-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2014-09-23 | estimated | When this record first appeared on the registry |
| Results posted | 2018-03-23 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-03 | 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
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS)
measured Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: JPBM Protocol (a)posted 2015-11-13 · 3.1 MB · Prot_000.pdf
Study Protocol: JPBM Protocol (b)posted 2016-12-16 · 3.3 MB · Prot_003.pdf
Study Protocol: JPBM Protocolposted 2014-09-03 · 2.6 MB · Prot_004.pdf
Statistical Analysis Plan: SAP V5 Addendumposted 2017-09-18 · 387 KB · SAP_001.pdf
Statistical Analysis Plan: SAP V5posted 2017-04-14 · 1.1 MB · SAP_002.pdf
Publications
- PMID 28968163 — reports results
- PMID 30675515 — reports results
- PMID 38470447 — linked by the registry
- PMID 36861085 — linked by the registry
- PMID 34661821 — linked by the registry
- PMID 33392835 — 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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