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I3Y-MC-JPCF: monarchE: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509671-17-00
Acronym
I3Y-MC-JPCF
Enrollment
1790
Registered
2024-01-26
Start date
2017-07-12
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Interventions

DRUGLETROZOLE
DRUGTAMOXIFEN
DRUGANASTROZOLE
DRUGEXEMESTANE
DRUGVerzenios 50 mg film-coated tablets

Sponsors

Eli Lilly & Co.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026