eMonarcHER: A Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node Positive, HR+, HER2+ Breast Cancer.

eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004035-24-DE

Enrollment

115

Registered

2021-04-22

Start date

2021-06-14

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

High-Risk, Node-Positive, HR+, HER2+ Breast Cancer MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006199 Term: Breast cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Verzenios Product Name: Abemaciclib Product Code: LY2835219 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LY2835219 Other descriptive name: ABEMACICLIB Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Enrollment to the study stopped on 03 FEB 2022. As of amendment (d) all patients enrolled into the study will be unblinded. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Enrollment to the study stopped on 03 FEB 2022. As of amendment (d) all patients enrolled into the study will be unblinded.

Design outcomes

Primary

Measure	Time frame
Main Objective: To monitor the safety of abemaciclib plus physician's choice ET in the study population.;Secondary Objective: ;Primary end point(s): AEs and SAEs per CTCAE v5.0;Timepoint(s) of evaluation of this end point: Upon approval of amendment (d), the sponsor will not evaluate the statistical hypothesis as originally planned, thus Section 9.4.2 is no longer applicable	—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At the end of trial.	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Romania, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026