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Clinical Trials in the USA / NCT04188548
Active, not recruiting Phase 1

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

NCT04188548 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2019-12-10
Last updated
2026-06-22

Condition(s) studied

Breast CancerAdvanced Breast CancerMetastatic Breast CancerEndometrial Cancer

Investigational drug(s) / intervention(s)

LY3484356AbemaciclibEverolimusAlpelisibTrastuzumabAromatase Inhibitor (AI)Pertuzumab

LY3484356: Administered orally

Abemaciclib: Administered orally

Everolimus: Administered orally

Alpelisib: Administered orally

Trastuzumab: Administered intravenously

Aromatase Inhibitor (AI): Anastrozole or Exemestane or Letrozole administered orally (physician choice)

Pertuzumab: Administered intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Mayo Clinic in Arizona - Phoenix Phoenix Arizona
Highlands Oncology Group Springdale Arkansas
Beverly Hills Cancer Center Beverly Hills California
University of California, Irvine Orange California
UCSF Medical Center at Mission Bay San Francisco California
Mayo Clinic in Florida Jacksonville Florida
Lake Nona DDU Orlando Florida
Winship Cancer Center Emory University Atlanta Georgia
Community Cancer Center North Indianapolis Indiana
Johns Hopkins University Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Minnesota Oncology/Hematology PA Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Washington University St Louis Missouri
Memorial Sloan Kettering - Bergen Montvale New Jersey
Memorial Sloan Kettering Cancer Center Commack New York
Memorial Sloan Kettering Cancer Center New York New York
Wilmot Cancer Institute Rochester New York
Duke University Durham North Carolina
Ohio State University Medical Center Columbus Ohio
University of Oklahoma Health Sciences Center, Stephenson Cancer Center Oklahoma City Oklahoma
Asante Rogue Regional Medical Center Medford Oregon
UPMC Hillman Cancer Center Harrisburg Harrisburg Pennsylvania
Rhode Island Hospital Providence Rhode Island
Vanderbilt Health One Hundred Oaks Nashville Tennessee
SCRI Oncology Partners Nashville Tennessee
Tennessee Oncology Nashville Nashville Tennessee
UT Southwestern Med Center Dallas Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
South Texas Accelerated Research Therapeutics (START) San Antonio Texas
Minnesota Oncology/Hematology PA The Woodlands Texas
Oncology and Hematology Associates of Southwest Virginia Inc The Woodlands Texas
Texas Oncology - San Antonio Medical Center The Woodlands Texas
US Oncology The Woodlands Texas
USO-Rocky Mountain Cancer Center The Woodlands Texas
Texas Oncology - Tyler Tyler Texas
The University of Vermont Medical Center Inc. Burlington Vermont

+ 34 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile → 📄 Herceptin (trastuzumab) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04188548 on ClinicalTrials.gov ↗ ← All trials in the USA