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A Study of Imlunestrant, Inve...

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

Last Updated: 2025-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

874 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms Neoplasm Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Imlunestrant

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.

Group Type EXPERIMENTAL

Imlunestrant

Intervention Type DRUG

Administered orally.

Arm B: Investigator's Choice of Endocrine Therapy

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.

Group Type EXPERIMENTAL

Exemestane

Intervention Type DRUG

Administered orally.

Fulvestrant

Intervention Type DRUG

Administered IM.

Arm C: Imlunestrant + Abemaciclib

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.

Group Type EXPERIMENTAL

Imlunestrant

Intervention Type DRUG

Administered orally.

Abemaciclib

Intervention Type DRUG

Administered orally.

Interventions

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Imlunestrant

Administered orally.

Intervention Type DRUG

Exemestane

Administered orally.

Intervention Type DRUG

Fulvestrant

Administered IM.

Intervention Type DRUG

Abemaciclib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3484356 LY2835219

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Marin Cancer Care

Greenbrae, California, United States

Site Status

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

Banner MD Anderson Cancer Center at McKee Medical Center

Loveland, Colorado, United States

Site Status

Clermont Oncology Center

Clermont, Florida, United States

Site Status

University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Florida Cancer Specialists

St. Petersburg, Florida, United States

Site Status

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

NorthShore University HealthSystem - Evanston Hospital

Evanston, Illinois, United States

Site Status

IU Health Ball Memorial Hospital, Inc.

Muncie, Indiana, United States

Site Status

The University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

Care Access - Clifton

Clifton, New Jersey, United States

Site Status

Memorial Sloan Kettering - Bergen

Montvale, New Jersey, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Site Status

Aultman Hospital

Canton, Ohio, United States

Site Status

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

Site Status

Avera Cancer Institute Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

Florida Cancer Specialists

Nashville, Tennessee, United States

Site Status

The Mark H Zangmeister Cancer Center

Nashville, Tennessee, United States

Site Status

USO - Texas Oncology - Allen

Allen, Texas, United States

Site Status

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

Site Status

Willamette Valley Cancer Institute & Research Ctr.

Houston, Texas, United States

Site Status