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

Active, not recruiting · Phase 3 · NCT05514054

Conditions: Breast Neoplasms

At a glance

Research payments reported, 2025
$16.6M
U.S. investigators named
128
Sites paid
134
Planned or actual enrollment
8,000

About the trial

Sponsor
Eli Lilly and Company
Tested
Imlunestrant (drug), Tamoxifen (drug), Anastrozole (drug), Letrozole (drug), Exemestane (drug)
Dates
Started 2022-10-04; completion 2032-03
Results posted
Not yet

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.

From ClinicalTrials.gov, last updated 2026-04-02. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Eli Lilly and Company reported $16.6M in research payments for this study in 2025 (275 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.