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

Running, not enrolling · Phase 3

Conditions studied: Breast Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT04975308

Run by

Eli Lilly and Company

People needed

874

Starts

2021-10-04

Expected to finish

2027-08-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Ironwood Cancer & Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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