A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced 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 · None · Treatment
Enrollment
874actual
Sites
243
Countries
Argentina, Australia, Austria +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 | 2021-10-04 | actual | When the study began enrolling |
| Primary completion | 2024-06-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-07-23 | actual | When this record first appeared on the registry |
| Results posted | 2025-07-11 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Neoplasms
- Neoplasm Metastasis
Interventions
- Drug: Imlunestrant — also filed as LY3484356
- Drug: Exemestane
- Drug: Fulvestrant
- Drug: Abemaciclib — also filed as LY2835219
Primary outcomes
what the primary-completion date above is the date OFInvestigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
measured Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Investigator-assessed PFS (Between Arm C and Arm A)
measured Randomization to the date of first documented progression of disease or death from any cause (up to 26 months)
Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B)
measured Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-07-31 · 1.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-08-24 · 878 KB · SAP_001.pdf
Publications
- PMID 39660834 — 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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