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

Running, not enrolling · Phase 3

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT05514054

Run by

Eli Lilly and Company

People needed

8000

Starts

2022-10-04

Expected to finish

2032-03-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
• Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
• Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
• Must have an increased risk of disease recurrence based on clinical-pathological risk features.
• Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
• Have adequate organ function.

You may not qualify if…

• Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
• Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
• Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
• Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
• Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
• Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
• Participants with a history of any other cancer.
• Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Where it is running

• University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange, California, United States
• University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento, California, United States
• Kaiser Permanente San Diego Mission Road — San Diego, California, United States
• USO - Southern Cancer Center — Daphne, Alabama, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States
• Infirmary Cancer Care — Mobile, Alabama, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• USO - Arizona Oncology Associates - HAL — Glendale, Arizona, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States
• TMC HealthCare — Tucson, Arizona, United States
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• UCSF - John Muir Health Cancer Center Berkeley — Berkeley, California, United States
• Washington Health — Fremont, California, United States
• Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine — Irvine, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Pacific Cancer Care — Monterey, California, United States
• St. Joseph Hospital — Orange, California, United States
• Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States
• UCSF Medical Center at Mission Bay — San Francisco, California, United States
• Saint Joseph's Medical Center — Stockton, California, United States
• Anschutz Cancer Pavilion — Aurora, Colorado, United States
• UCHealth Memorial Hospital — Colorado Springs, Colorado, United States
• CHUAC-Hospital Teresa Herrera — A Coruña, Spain

Full record on ClinicalTrials.gov

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