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ACTIVE NOT RECRUITING

NCT04975308

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

874

Start Date

2021-10-04

Completion Date

2027-08

Last Updated

2025-07-11

Healthy Volunteers

Conditions

Breast Neoplasms Neoplasm Metastasis

Interventions

DRUG

Imlunestrant

Administered orally.

DRUG

Exemestane

Administered orally.

DRUG

Fulvestrant

Administered IM.

DRUG

Abemaciclib

Administered orally.

Locations (243)

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Marin Cancer Care

Greenbrae, California, United States

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Banner MD Anderson Cancer Center at McKee Medical Center

Loveland, Colorado, United States

Clermont Oncology Center

Clermont, Florida, United States

University of Florida College of Medicine

Gainesville, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Florida Cancer Specialists

St. Petersburg, Florida, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

University of Chicago Medical Center

Chicago, Illinois, United States

NorthShore University HealthSystem - Evanston Hospital

Evanston, Illinois, United States

IU Health Ball Memorial Hospital, Inc.

Muncie, Indiana, United States

The University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, United States

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Care Access - Clifton

Clifton, New Jersey, United States

Memorial Sloan Kettering - Bergen

Montvale, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

Avera Cancer Institute Sioux Falls

Sioux Falls, South Dakota, United States

Florida Cancer Specialists

Nashville, Tennessee, United States

The Mark H Zangmeister Cancer Center

Nashville, Tennessee, United States

USO - Texas Oncology - Allen

Allen, Texas, United States

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

Willamette Valley Cancer Institute & Research Ctr.

Houston, Texas, United States

Texas Oncology - Carrollton

Lewisville, Texas, United States

Texas Oncology - Denison