Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

Official Title

EMBER: 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

Keywords

Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer Endometrial Cancer Breast Neoplasms Endometrial Neoplasms Trastuzumab Everolimus Aromatase Inhibitors Abemaciclib Alpelisib Aromatase Inhibitor (AI) Dose Escalation LY3484356

Eligibility

You can join if…

Open to people ages 18 years and up

All study parts:

  • Participants must be willing to provide adequate archival tissue sample
  • Participants must be willing to use highly effective birth control
  • Participants must have adequate organ function
  • Participants must be able to swallow capsules

Dose escalation- Participants must have one of the following:

  • Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following:
  • Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
  • Part B: may have had up to 2 prior regimens, no more than 1 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+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies for advanced disease and prior trastuzumab, pertuzumab, and TDM-1 required in any setting.
  • Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.

Participants with ER+/HER2- 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

You CAN'T join if...

  • Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
  • Participants must not have another serious medical condition
  • Participants must not have cancer of the central nervous system that is unstable
  • Participants must not be pregnant or breastfeeding

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94115 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • Beverly Hills Cancer Center not yet accepting patients
    Beverly Hills California 90211 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer
ID
NCT04188548
Phase
Phase 1
Study Type
Interventional
Last Updated