A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
234actual
Sites
59
Countries
Argentina, Austria, Belgium +11
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 | 2016-09-14 | actual | When the study began enrolling |
| Primary completion | 2018-06-15 | 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 | 2016-04-21 | estimated | When this record first appeared on the registry |
| Results posted | 2019-07-12 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Breast Cancer
Interventions
- Drug: Abemaciclib — also filed as LY2835219
- Drug: Tamoxifen
- Drug: Prophylactic Loperamide
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS)
measured Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2019-01-29 · 4.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2016-06-29 · 448 KB · SAP_001.pdf
Publications
- PMID 35829935 — 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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