Phase 3  | 
 | Investigational Drug

EMBER-3; NCT04975308

Breast Cancer

Selective ER Degrader

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*

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Key Inclusion Criteria
  • Diagnosis of estrogen-receptor-positive (ER+), HER2-negative locally advanced or metastatic breast cancer
  • Disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a CDK4 & 6 inhibitor
    • Patients 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
  • Response Evaluation Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate renal, hematologic, and hepatic organ function
  • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  • Able to swallow capsules/tablets
Key Exclusion Criteria
  • 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
  • Visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease
  • Symptomatic or untreated brain metastasis
  • Serious preexisting medical conditions
  • Known allergic reaction against any of the components of the study treatment
This clinical trial is being conducted globally.
Imlunestrant is administered PO.
Exemestane is administered PO.
Fulvestrant is administered intramuscularly.
Abemaciclib is administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.