Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT04975308 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Exemestane
  • DRUG Fulvestrant
  • DRUG Abemaciclib
  • DRUG Imlunestrant

Study Locations (20)

Florida

  • Clermont Oncology Center — Clermont
  • University of Florida College of Medicine — Gainesville
  • Mid Florida Hematology and Oncology Center — Orange City
  • Florida Cancer Specialists — Sarasota
  • Florida Cancer Specialists — St. Petersburg

California

  • Marin Cancer Care — Greenbrae
  • University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento
  • Sharp Memorial Hospital — San Diego

Arizona

  • Ironwood Cancer & Research Centers — Chandler
  • Banner MD Anderson Cancer Center — Gilbert

Illinois

  • University of Chicago Medical Center — Chicago
  • NorthShore University HealthSystem - Evanston Hospital — Evanston

New Jersey

  • Care Access - Clifton — Clifton
  • Memorial Sloan Kettering - Bergen — Montvale

Colorado

  • Banner MD Anderson Cancer Center at McKee Medical Center — Loveland

Hawaii

  • Kaiser Permanente Moanalua Medical Center — Honolulu

Indiana

  • IU Health Ball Memorial Hospital, Inc. — Muncie

Trial Details

FieldValue
Enrollment Target 874 participants
Start Date 2021-10-04
Est. Completion 2027-08
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04975308

The ClinicalTrials.gov registry entry for NCT04975308 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 874 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Exemestane is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04975308 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04975308 about?

NCT04975308 is a clinical study titled "A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer". 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 ...

What is the current status of trial NCT04975308?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 874 participants. The study started on 2021-10-04. Estimated completion is 2027-08.

What conditions does trial NCT04975308 study?

This clinical trial studies the following conditions: Breast Neoplasms, Neoplasm Metastasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04975308?

The interventions under investigation include: Exemestane (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG), Imlunestrant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04975308?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04975308 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial