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Clinical Trials in the UK / NCT05514054
Active, not recruiting Phase 3

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

NCT05514054 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2022-10-04
Last updated
2026-04-02

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

ImlunestrantTamoxifenAnastrozoleLetrozoleExemestane

Imlunestrant: Administered orally.

Tamoxifen: Administered per local approved label.

Anastrozole: Administered per local approved label.

Letrozole: Administered per local approved label.

Exemestane: Administered per local approved label.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (672)

FacilityCityRegionStatus
USO - Southern Cancer Center Daphne Alabama
Clearview Cancer Institute Huntsville Alabama
Infirmary Cancer Care Mobile Alabama
Banner MD Anderson Cancer Center Gilbert Arizona
USO - Arizona Oncology Associates - HAL Glendale Arizona
St. Joseph's Hospital and Medical Center Phoenix Arizona
Mayo Clinic in Arizona - Phoenix Phoenix Arizona
TMC HealthCare Tucson Arizona
The University of Arizona Cancer Center - North Campus Tucson Arizona
Highlands Oncology Group Springdale Arkansas
UCSF - John Muir Health Cancer Center Berkeley Berkeley California
Washington Health Fremont California
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine Irvine California
Loma Linda University Cancer Center Loma Linda California
Pacific Cancer Care Monterey California
St. Joseph Hospital Orange California
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California
Kaiser Permanente San Diego Mission Road San Diego California
Zuckerberg San Francisco General Hospital and Trauma Center San Francisco California
UCSF Medical Center at Mission Bay San Francisco California
Saint Joseph's Medical Center Stockton California
Anschutz Cancer Pavilion Aurora Colorado
UCHealth Memorial Hospital Colorado Springs Colorado
UCHealth Harmony Fort Collins Colorado
Banner MD Anderson Cancer Center at North Colorado Medical Center Greeley Colorado
USO - Rocky Mountain Cancer Centers Lakewood Colorado
Banner MD Anderson Cancer Center at McKee Medical Center Loveland Colorado
Yale-New Haven Hospital New Haven Connecticut
Georgetown University Medical Center Washington D.C. District of Columbia
MedStar Washington Hospital Center Washington D.C. District of Columbia
AdventHealth Altamonte Springs Altamonte Springs Florida
Memorial Regional Hospital Hollywood Florida
Millennium Oncology Research Clinic Hollywood Florida
Mayo Clinic in Florida Jacksonville Florida
Miami Cancer Institute at Baptist Health, Inc. Miami Florida
USO - Cancer Care Centers of Brevard Palm Bay Florida
USO - Woodlands Medical Specialists Pensacola Florida
Miami Cancer Institute - Plantation Plantation Florida
Tampa General Hospital Tampa Florida

+ 632 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05514054 on ClinicalTrials.gov ↗ ← All trials in the UK