Home › Trials › NCT05514054

Comparing Imlunestrant to Standard Hormone Therapy for Early Breast Cancer

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

Phase 3 Interventional Eli Lilly and Company · NCT05514054

This study is testing if a new drug called imlunestrant can better prevent breast cancer from coming back compared to standard hormone therapy in patients who have already had treatment for early-stage ER+ and HER2- breast cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment8000 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionschemotherapy
Locations683 sites (Daphne, Alabama and 682 other locations)
Trial IDNCT05514054 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of imlunestrant compared to standard endocrine therapies in patients with early-stage, estrogen receptor positive (ER+), and human epidermal receptor 2 negative (HER2-) breast cancer. Participants must have previously undergone 2 to 5 years of endocrine therapy and are at a higher risk for cancer recurrence. The study aims to assess how well imlunestrant can prevent cancer from returning over a potential duration of up to 10 years.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with ER+, HER2- early-stage breast cancer who have completed 2 to 5 years of endocrine therapy.

Not a fit: Patients with metastatic disease or those who have not adhered to prior endocrine therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients at high risk of breast cancer recurrence.

How similar studies have performed: Other studies have shown promise in evaluating new endocrine therapies for breast cancer, but the specific use of imlunestrant in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Daphne, Alabama and 682 other locations

+633 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Neoplasms
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.