J2J-OX-JZLC: EMBER-3: A Phase 3, Randomized, Open-label Study of Imlunestrant, Investigator’s Choice of Endocrine Therapy, and Imlunestrant plus Abemaciclib in Patients with Estrogen receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with endocrine Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506786-63-00

Acronym

J2J-OX-JZLC

Enrollment

263

Registered

2024-03-27

Start date

2021-09-30

Completion date

Unknown

Last updated

2025-12-11

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

Conditions

Breast Cancer

Brief summary

Investigator-assessed PFS (between Arm A and Arm B) in the ITT population, Investigator-assessed PFS (between Arm A and Arm B) in the ESR1-mutation detected population, Investigator-assessed PFS(between Arm C and Arm A) in the ITT population

Interventions

DRUGFULVESTRANT

DRUGEXEMESTANE

DRUGABEMACICLIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Investigator-assessed PFS (between Arm A and Arm B) in the ITT population, Investigator-assessed PFS (between Arm A and Arm B) in the ESR1-mutation detected population, Investigator-assessed PFS(between Arm C and Arm A) in the ITT population	—

Countries

Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain

Outcome results

None listed

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