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ACTIVE NOT RECRUITING Phase 3

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

NCT05514054 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Tamoxifen
  • DRUG Anastrozole
  • DRUG Letrozole
  • DRUG Exemestane
  • DRUG Imlunestrant

Study Locations (20)

California

  • UCSF - John Muir Health Cancer Center Berkeley — Berkeley
  • Washington Health — Fremont
  • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine — Irvine
  • Loma Linda University Cancer Center — Loma Linda
  • Pacific Cancer Care — Monterey
  • St. Joseph Hospital — Orange
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange
  • University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento
  • Kaiser Permanente San Diego Mission Road — San Diego
  • Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco

Arizona

  • Banner MD Anderson Cancer Center — Gilbert
  • USO - Arizona Oncology Associates - HAL — Glendale
  • St. Joseph's Hospital and Medical Center — Phoenix
  • Mayo Clinic in Arizona - Phoenix — Phoenix
  • TMC HealthCare — Tucson
  • The University of Arizona Cancer Center - North Campus — Tucson

Alabama

  • USO - Southern Cancer Center — Daphne
  • Clearview Cancer Institute — Huntsville
  • Infirmary Cancer Care — Mobile

Arkansas

  • Highlands Oncology Group — Springdale

Trial Details

FieldValue
Enrollment Target 8,000 participants
Start Date 2022-10-04
Est. Completion 2032-03
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05514054

The ClinicalTrials.gov registry entry for NCT05514054 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 8,000 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 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Tamoxifen 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: NCT05514054 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 NCT05514054 about?

NCT05514054 is a clinical study titled "A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer". 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 ...

What is the current status of trial NCT05514054?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 8,000 participants. The study started on 2022-10-04. Estimated completion is 2032-03.

What conditions does trial NCT05514054 study?

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

What interventions are being tested in trial NCT05514054?

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

Who is sponsoring clinical trial NCT05514054?

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 NCT05514054 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. 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