Phase 1  | 
Enrolling
 | Investigational Drug

EMBER; NCT04188548

Breast Cancer or Endometrial Cancer

Selective ER Degrader


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*

show modal icon NCT04188548
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: Up to one prior regimen of any kind in the advanced/metastatic setting and no prior CDK4 & 6 inhibitor therapy
    • Part B: 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.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

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.