> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-imlunestrant-versus-standard-endocrine-therapy-in-1fbe3844-7d64-40a8-8560-9100ec0b3d0f > Record changed: 2026-10-13 # A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer NCT05514054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) Participants 8,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) Start date 2022-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) Number of sites 672 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Acronym** EMBER-4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Short title** A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Official title** EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Dates **Completion date** 2032-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **First posted** 2022-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Registry last updated** 2026-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Primary completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Start date** 2022-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Size and sites **Participants** 8,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Planned participants** 8,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Number of sites** 672 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Identifiers **Registry ID** NCT05514054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **ClinicalTrials.gov ID** NCT05514054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Outcomes ### Primary outcomes 1. Invasive Disease-Free Survival (IDFS) Timeframe: Randomization to recurrence or death from any cause (up to 10 years) IDFS excluding second non-breast primary invasive cancers ### Secondary outcomes 1. Distant Recurrence-Free Survival (DRFS) Timeframe: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) DRFS 2. Overall Survival (OS) Timeframe: Randomization to Death from Any Cause (up to 10 Years) OS 3. Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant Timeframe: Year 1, Month 2 to Month 4 PK: steady state plasma concentrations of imlunestrant 4. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Timeframe: Visit 1 Day 1 up to end of Year 5 The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess multidimensional quality of life (QOL) in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Physical functioning was measured by items 1 to 5\. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better). 5. Change from Baseline in the EORTC QLQ-C30 Role Functioning Timeframe: Visit 1 Day 1 up to end of Year 5 The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Role functioning was measured by items 6 and 7\. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better). 6. Change from Baseline in the EORTC QLQ-C30 Global QOL Timeframe: Visit 1 Day 1 up to end of Year 5 The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Global QOL was measured by items 29 and 30\. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better). 7. Proportion of Time on Study Treatment with High Overall Adverse Event Burden Timeframe: Visit 1 Day 1 up to end of Year 5 FACT GP5 = Functional Assessment of Cancer Therapy - General Physical Well-being Item 5 (FACT GP5). High overall adverse event burden is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Sites - USO - Southern Cancer CenterDaphne, United States - Clearview Cancer InstituteHuntsville, United States - Infirmary Cancer CareMobile, United States - Banner MD Anderson Cancer CenterGilbert, United States - USO - Arizona Oncology Associates - HALGlendale, United States - St. Joseph's Hospital and Medical CenterPhoenix, United States - Mayo Clinic in Arizona - PhoenixPhoenix, United States - TMC HealthCareTucson, United States - The University of Arizona Cancer Center - North CampusTucson, United States - Highlands Oncology GroupSpringdale, United States - UCSF - John Muir Health Cancer Center BerkeleyBerkeley, United States - Washington HealthFremont, United States - Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - IrvineIrvine, United States - Loma Linda University Cancer CenterLoma Linda, United States - Pacific Cancer CareMonterey, United States - St. Joseph HospitalOrange, United States - University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, United States - University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United States - Kaiser Permanente San Diego Mission RoadSan Diego, United States - Zuckerberg San Francisco General Hospital and Trauma CenterSan Francisco, United States - UCSF Medical Center at Mission BaySan Francisco, United States - Saint Joseph's Medical CenterStockton, United States - Anschutz Cancer PavilionAurora, United States - UCHealth Memorial HospitalColorado Springs, United States - UCHealth HarmonyFort Collins, United States And 647 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/356295) ### Other registry identifiers (2) - 2022-501007-28 - J2J-MC-JZLH Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Related records ### Drugs (5) - [Anastrozole](https://trialight.com/data/asset/anastrozole-327e05a9-e5b7-41d1-a335-bd8a46453b55.md) - [Exemestane](https://trialight.com/data/asset/exemestane-367c47e6-e892-496e-bbb5-5b4926a3c31a.md) - [Imlunestrant](https://trialight.com/data/asset/imlunestrant-a53f4bdf-2b09-4370-9990-71ac2d706245.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Tamoxifen citrate](https://trialight.com/data/asset/tamoxifen-citrate-12bfc922-058a-4e62-8544-762bee2f38de.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (2) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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