J2J-MC-JZLH EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501007-28-00

Acronym

J2J-MC-JZLH

Enrollment

2427

Registered

2023-03-06

Start date

2023-04-18

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Breast Neoplasms

Brief summary

Invasive Disease-Free Survival (IDFS)

Detailed description

Distant Recurrence-Free Survival (DRFS), Overall Survival (OS), Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant, Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning, Change from Baseline in the EORTC QLQ-C30 Role Functioning, Change from Baseline in the EORTC QLQ-C30 Global QOL, Proportion of Time on Study Treatment with High Overall Adverse Event Burden

Interventions

DRUGEXEMESTANE

DRUGLETROZOLE

DRUGTAMOXIFEN

DRUG-

DRUGANASTROZOLE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Invasive Disease-Free Survival (IDFS)	—

Secondary

Measure	Time frame
Distant Recurrence-Free Survival (DRFS), Overall Survival (OS), Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant, Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning, Change from Baseline in the EORTC QLQ-C30 Role Functioning, Change from Baseline in the EORTC QLQ-C30 Global QOL, Proportion of Time on Study Treatment with High Overall Adverse Event Burden	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

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