LY3484356 for Breast Cancer
(EMBER Trial)
Recruiting at121 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Eli Lilly and Company
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
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.
Research Team
C1
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for adults with advanced or metastatic breast or endometrial cancer. They must be able to swallow pills, have good organ function, and provide a tissue sample. Women should not be pregnant and must use effective birth control. Those with ER+/HER2- breast cancer should have seen benefits from prior hormone therapy.Inclusion Criteria
I can swallow pills.
I have ER+/HER2- breast cancer and responded well to hormone therapy, or I have untreated advanced breast cancer.
I am willing to provide samples of my previously collected tissue.
See 2 more
Exclusion Criteria
Participants must not have another serious medical condition
My brain or spinal cord cancer is stable.
I do not have uncontrolled hepatitis, tuberculosis, or HIV.
See 1 more
Treatment Details
Interventions
- Abemaciclib (CDK4/6 Inhibitor)
- Alpelisib (PI3K Inhibitor)
- Aromatase Inhibitor (AI) (Aromatase Inhibitor)
- Everolimus (mTOR Inhibitor)
- LY3484356 (Other)
- Pertuzumab (Monoclonal Antibodies)
- Trastuzumab (Monoclonal Antibodies)
Trial OverviewThe study tests LY3484356 alone or combined with other cancer drugs (Trastuzumab, Aromatase Inhibitor, Pertuzumab, Abemaciclib, Everolimus, Alpelisib) to evaluate safety and effectiveness against advanced breast or endometrial cancers.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Part E: Dose Expansion: LY3484356 + Trastuzumab + PertuzumabExperimental Treatment3 Interventions
LY3484356 administered orally in combination with trastuzumab and pertuzumab administered intravenously.
Group II: Part D: Dose Expansion: LY3484356 +/- AbemaciclibExperimental Treatment2 Interventions
LY3484356 and Abemaciclib given orally with trastuzumab administered intravenously.
Group III: Part C:Dose Expansion: LY3484356 + Trastuzumab +/- AbemaciclibExperimental Treatment3 Interventions
LY3484356 administered orally in combination with trastuzumab intravenously with or without Abemaciclib.
Group IV: Part B: Dose Expansion: Cohort E5: LY3484356 + AlpelisibExperimental Treatment2 Interventions
LY3484356 and alpelisib given orally.
Group V: Part B: Dose Expansion: Cohort E4: LY3484356 + EverolimusExperimental Treatment2 Interventions
LY3484356 and everolimus given orally.
Group VI: Part B: Dose Expansion: Cohort E3: LY3484356Experimental Treatment1 Intervention
LY3484356 given orally.
Group VII: Part A: Dose Expansion: LY3484356 + Abemaciclib +/- AIExperimental Treatment3 Interventions
LY3484356 and abemaciclib given orally in combination with or without Aromatase Inhibitor (AI) of physician's choice (Anastrozole, Exemestane, or Letrozole) administered orally.
Group VIII: Dose Escalation LY3484356Experimental Treatment1 Intervention
LY3484356 given orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
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