EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy (EMBER-3)

  • STATUS
    Recruiting
  • End date
    Sep 13, 2026
  • participants needed
    800
  • sponsor
    Eli Lilly and Company
Updated on 24 October 2022
cancer
estrogen
measurable disease
breast cancer
growth factor
endocrine therapy
hormone therapy
advanced breast cancer
epidermal growth factor receptor
HER2
EGFR
fulvestrant
erbb2
epidermal growth factor
aromatase inhibitor
estrogen receptor
exemestane

Summary

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Details
Condition Breast Neoplasms, Neoplasm Metastasis
Treatment exemestane, fulvestrant, Abemaciclib, LY3484356, Imlunestrant
Clinical Study IdentifierNCT04975308
SponsorEli Lilly and Company
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
\-- Participants are expected to have received prior treatment with a CDK4/6
inhibitor, if this treatment is approved and can be reimbursed
Must be deemed appropriate for treatment with endocrine therapy
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets

Exclusion Criteria

Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease
Have symptomatic or untreated brain metastasis
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
Known allergic reaction against any of the components of the study treatment
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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