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ACTIVE NOT RECRUITING

NCT04188548

PHASE1

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2019-12-10

Completion Date

2027-12

Last Updated

2025-06-04

Healthy Volunteers

Conditions

Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer Endometrial Cancer

Interventions

DRUG

LY3484356

Administered orally

DRUG

Abemaciclib

Administered orally

DRUG

Everolimus

Administered orally

DRUG

Alpelisib

Administered orally

DRUG

Trastuzumab

Administered intravenously

DRUG

Aromatase Inhibitor (AI)

Anastrozole or Exemestane or Letrozole administered orally (physician choice)

DRUG

Pertuzumab

Administered intravenously

Inclusion Criteria: 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 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+ 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 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 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 Exclusion Criteria: * 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 (74)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

University of California, Irvine

Orange, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Lake Nona DDU

Orlando, Florida, United States

Winship Cancer Center Emory University

Atlanta, Georgia, United States

Community Cancer Center North

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Minnesota Oncology/Hematology PA

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering - Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Wilmot Cancer Institute

Rochester, New York, United States

Duke University

Durham, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Asante Rogue Regional Medical Center

Medford, Oregon, United States

UPMC Hillman Cancer Center Harrisburg

Harrisburg, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology Nashville

Nashville, Tennessee, United States

UT Southwestern Med Center

Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Minnesota Oncology/Hematology PA