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Closed (no longer recruiting)Last updated: 2 February 2024

EMBER-3: This phase III study is measuring how well a new hormone therapy (imlunestrant) works compared to standard hormone therapy (exemestane or fulvestrant) and combination therapy (imlunestrant + abemaciclib) in people with ER+/HER2- breast cancerA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of three treatment arms. In Arm 1 (Experimental), participants will receive Imlunestrant alone, administered orally. In Arm 2 (Active Comparator), participants will receive the investigator's choice of either Exemestane (administered orally) or Fulvestrant (administered intramuscularly). In Arm 3 (Experimental), participants will receive Imlunestrant plus Abemaciclib, both administered orally.

Conditions

This trial is treating patients with ER+, HER2- locally advanced or metastatic breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

EMBER-3

More information

Trial Identifiers

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Trial sponsor

Eli Lilly and Company

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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