drugset / Trial / NCT04975308

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

NCT04975308

Phase 3 Active not recruiting 874 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-04
Primary completion
2024-06-24
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 150 mg Oral
Subject Exemestane Small molecule 25 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Imlunestrant Small molecule 400 mg Oral