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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Selective Estrogen Receptor Degrader
Imlunestrant
Phase
1
Not Enrolling

A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+, Locally Advanced or Metastatic Breast Cancer and Other Select Non-breast Cancers*

Related Resources:
Molecule Overview Trial Enrollment
NCT04188548 show modal icon
Key Inclusion Criteria
  • All study parts:
    • Willing to provide adequate archival tissue sample
    • Willing to use highly effective birth control
    • Adequate organ function
    • Able to swallow capsules
  • Participants must have one of the following (dose escalation):
    • Parts A and B: Estrogen-receptor-positive (ER+), HER2-negative breast cancer with evidence of locally advanced, unresectable or metastatic disease and have had the following:
    • Part A: May have had up to one prior regimen of any kind in the advanced/metastatic setting and no prior cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy
    • Part B: May have had up to two prior regimens; no more than one of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor
    • Cohort E4: No prior everolimus
    • Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (PIK3Cα) mutation as determined by local testing
    • Part C: ER+, HER2-positive breast cancer with evidence of locally advanced, unresectable or metastatic disease who have had at least 2 HER2-directed therapies in any setting
    • Part D: ER+, EEC that has progressed after platinum-containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy
    • Part E: ER+ and HER2-positive breast cancer with evidence of locally advanced, unresectable, or metastatic disease
    • Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen
    • Part E: Participants must not have received more than one HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy
  • Participants with ER+, HER2-negative breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting, or have untreated de novo metastatic breast cancer
Key Exclusion Criteria
  • Uncontrolled infections such as hepatitis, tuberculosis, or HIV
  • Another serious medical condition
  • Unstable cancer of the central nervous system
  • Pregnant or breastfeeding
*
This clinical trial is being conducted globally. 
†
LY3484356 is administered PO QD.
‡
Abemaciclib is administered PO BID.
§
Aromatase inhibitor (AI) is administered PO.
‖
Everolimus is administered PO QD.
Alpelisib is administered PO QD.
#
Trastuzumab is administered intravenously (IV) Q21D.
**
Pertuzumab is administered IV Q21D.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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