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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Selective Estrogen Receptor Degrader
Imlunestrant
Phase
3
Not Enrolling

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*

Related Resources:
Molecule Overview Trial Enrollment
NCT04975308 show modal icon
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 cyclin-dependent kinase 4 and 6 (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.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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or visit www.clinicaltrials.gov for more information on this trial