MedTrace Logo

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

NCT04975308 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 874

Last updated 2025-07-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

Imlunestrant

Administered orally.

DRUG

Exemestane

Administered orally.

DRUG

Fulvestrant

Administered IM.

DRUG

Abemaciclib

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2024-06-24
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04975308 on ClinicalTrials.gov