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

NCT04975308

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Breast Neoplasms, Neoplasm Metastasis

Interventions: Imlunestrant, Exemestane, Fulvestrant, Abemaciclib

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, China, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (243)

Chandler, Arizona, United States
Gilbert, Arizona, United States
Greenbrae, California, United States
Sacramento, California, United States
San Diego, California, United States
Loveland, Colorado, United States
Clermont, Florida, United States
Gainesville, Florida, United States
Orange City, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Muncie, Indiana, United States
Louisville, Kentucky, United States
Jackson, Mississippi, United States
Clifton, New Jersey, United States
Montvale, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Canton, Ohio, United States
Toledo, Ohio, United States
Sioux Falls, South Dakota, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Allen, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Lewisville, Texas, United States
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