drugset / Trial / NCT05514054

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

NCT05514054

Phase 3 Active not recruiting 8000 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 in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

Timeline

Start
2022-10-04
Primary completion
2027-10
Completion
2032-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified
Comparator Exemestane Small molecule
Subject Imlunestrant Small molecule Oral
Comparator Letrozole Other / unclassified
Comparator Tamoxifen Small molecule

Indications