OncRef

Clinical Trial: NCT04975308

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-07-22

Study Overview

Brief Summary

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Official Title

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

Conditions

Breast Neoplasms, Neoplasm Metastasis

Intervention / Treatment

  • Drug: Imlunestrant
  • Drug: Exemestane
  • Drug: Fulvestrant
  • Drug: Abemaciclib

Other Study ID Numbers

  • 18175
  • J2J-OX-JZLC
  • 2021-000079-35
  • 2023-506786-63-00
  • 2023

Start Date (Actual)

2021-10-04

Primary Completion Date (Actual)

2024-06-24

Study Completion Date (Estimated)

2027-08

Enrollment (Actual)

874

Study Type

Interventional

Phase

Phase 3