NCT04975308|Active Not RecruitingPhase 3ResultsFDA Drug

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

EMBER-3

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

Eli Lilly and Company ClinicalTrials.gov

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4 other identifiers

18175J2J-OX-JZLC2021-000079-352023-506786-63-00

Study Type

interventional

Target

874

Locations

21 countries

Sites

240

Timeline

RegisteredJul 2021

StartedOct 2021

CompletionAug 2027

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

874

participants targeted

Target at P75+ for phase_3

Timeline

15mo left

Started Oct 2021

Longer than P75 for phase_3

Geographic Reach

21 countries

240 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.8 years study duration

Study Progress79%

Oct 2021Aug 2027

First Submitted

Initial submission to the registry

July 22, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

July 11, 2025

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

July 22, 2021

Results QC Date

June 23, 2025

Last Update Submit

July 9, 2025

Conditions

Breast Neoplasms Neoplasm Metastasis

Keywords

SERD

Outcome Measures

Primary Outcomes (3)

Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Investigator-assessed PFS (Between Arm C and Arm A)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 26 months)
Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)

Secondary Outcomes (18)

Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B)
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm C and Arm A)
Randomization to the date of first documented progression of disease or death from any cause (up to 25 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm A and Arm B)
Randomization until measured progressive disease (up to 28 months)
Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B)
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm A and Arm B)
Randomization until measured progressive disease (up to 28 months)
+13 more secondary outcomes

Study Arms (3)

Arm A: Imlunestrant

EXPERIMENTAL

Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.

Drug: Imlunestrant

Arm B: Investigator's Choice of Endocrine Therapy

EXPERIMENTAL

Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.

Drug: ExemestaneDrug: Fulvestrant

Arm C: Imlunestrant + Abemaciclib

EXPERIMENTAL

Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.

Drug: ImlunestrantDrug: Abemaciclib

Interventions

ImlunestrantDRUG

Administered orally.

Also known as: LY3484356

Arm A: ImlunestrantArm C: Imlunestrant + Abemaciclib

ExemestaneDRUG

Administered orally.

Arm B: Investigator's Choice of Endocrine Therapy

FulvestrantDRUG

Administered IM.

Arm B: Investigator's Choice of Endocrine Therapy

AbemaciclibDRUG

Administered orally.

Also known as: LY2835219

Arm C: Imlunestrant + Abemaciclib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
\-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
Must be deemed appropriate for treatment with endocrine therapy
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets

You may not qualify if:

Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
Have symptomatic or untreated brain metastasis.
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
Known allergic reaction against any of the components of the study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (243)

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Marin Cancer Care

Greenbrae, California, 94904, United States

Location

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Banner MD Anderson Cancer Center at McKee Medical Center

Loveland, Colorado, 80538, United States

Location

Clermont Oncology Center

Clermont, Florida, 34711, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

IU Health Ball Memorial Hospital, Inc.

Muncie, Indiana, 47303, United States

Location

The University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Care Access - Clifton

Clifton, New Jersey, 07013, United States

Location

Memorial Sloan Kettering - Bergen

Montvale, New Jersey, 07645, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Avera Cancer Institute Sioux Falls

Sioux Falls, South Dakota, 57105, United States

Location

Florida Cancer Specialists

Nashville, Tennessee, 37203, United States

Location

The Mark H Zangmeister Cancer Center

Nashville, Tennessee, 37203, United States

Location

USO - Texas Oncology - Allen

Allen, Texas, 75013, United States

Location

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Willamette Valley Cancer Institute & Research Ctr.

Houston, Texas, 77070, United States

Location

Texas Oncology - Carrollton

Lewisville, Texas, 75056, United States

Location

Texas Oncology - Denison

The Woodlands, Texas, 75020, United States

Location

Texas Oncology - Paris

The Woodlands, Texas, 75460, United States

Location

Blue Ridge Cancer Care