A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative 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
669actual
Sites
146
Countries
Australia, Belgium, Canada +17
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 | 2014-07-22 | actual | When the study began enrolling |
| Primary completion | 2017-02-14 | 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 | 2014-04-08 | estimated | When this record first appeared on the registry |
| Results posted | 2018-03-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Neoplasms
Interventions
- Drug: Abemaciclib — also filed as LY2835219
- Drug: Fulvestrant
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFProgression-Free Survival (PFS)
measured From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: JPBL 05 Protocol_Redactedposted 2014-04-01 · 3.6 MB · Prot_000.pdf
Study Protocol: JPBL 05 Protocol (a)_Redactedposted 2015-01-12 · 18.6 MB · Prot_001.pdf
Study Protocol: JPBL 05 Protocol (b)_Redactedposted 2015-03-30 · 19.1 MB · Prot_002.pdf
Study Protocol: JPBL 05 Protocol (c)_Redactedposted 2015-10-27 · 997 KB · Prot_003.pdf
Study Protocol: JPBL 05 Protocol (d)_Redactedposted 2016-04-26 · 880 KB · Prot_004.pdf
Study Protocol: JPBL 05 Protocol (g)_Redactedposted 2021-02-17 · 4.3 MB · Prot_007.pdf
Statistical Analysis Plan: version 4posted 2016-07-08 · 638 KB · SAP_005.pdf
Statistical Analysis Plan: Addendum for Overall Survival Analysesposted 2017-08-25 · 328 KB · SAP_006.pdf
Publications
- PMID 34425869 — linked by the registry
- PMID 33797023 — linked by the registry
- PMID 33392835 — linked by the registry
- PMID 31563959 — linked by the registry
- PMID 28580882 — 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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