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A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

NCT07174336

This study is recruiting at 73 US sites in 29 states, according to its ClinicalTrials.gov record last updated .

Summary

The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Breast Neoplasms
  • Neoplasm Metastasis

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Eli Lilly and Company
Last updated on ClinicalTrials.gov
November 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alaska · 1

  • Alaska Oncology and Hematology · Anchorage, AK

Arizona · 2

  • Ironwood Cancer & Research Centers · Chandler, AZ
  • The University of Arizona Cancer Center - North Campus · Tucson, AZ

Arkansas · 1

  • Highlands Oncology Group · Springdale, AR

California · 9

  • Community Cancer Institute · Clovis, CA
  • City of Hope · Duarte, CA
  • Epic Care - Emeryville · Emeryville, CA
  • Marin Cancer Care · Greenbrae, CA
  • City of Hope Orange County Lennar Foundation Cancer Center · Irvine, CA
  • USC/Norris Comprehensive Cancer Center · Los Angeles, CA
  • Profound Research LLC · Oceanside, CA
  • Stanford Cancer Center · Palo Alto, CA
  • Providence Medical Foundation · Santa Rosa, CA

District of Columbia · 1

  • MedStar Washington Hospital Center · Washington D.C., DC

Florida · 4

  • Clermont Oncology Center · Clermont, FL
  • Florida Oncology & Hematology · Fort Myers, FL
  • Mid Florida Hematology and Oncology Center · Orange City, FL
  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center · Tampa, FL

Georgia · 3

  • Central Georgia Cancer Care · Macon, GA
  • City of Hope National Medical Center, Atlanta Cancer Center · Newnan, GA
  • Summit Cancer Care, PC · Savannah, GA

Hawaii · 1

  • Kaiser Permanente Moanalua Medical Center · Honolulu, HI

Illinois · 3

  • City of Hope, Chicago · Chicago, IL
  • University of Illinois at Chicago · Chicago, IL
  • Accellacare of Duly · Lisle, IL

Indiana · 2

  • Indiana University Health University Hospital · Indianapolis, IN
  • Deaconess GI Specialty Center · Newburgh, IN

Kentucky · 1

  • Saint Elizabeth Medical Center Edgewood · Edgewood, KY

Maine · 1

  • New England Cancer Specialists · Westbrook, ME

Maryland · 2

  • American Oncology Partners, PA · Bethesda, MD
  • James M Stockman Cancer Institute · Frederick, MD

Minnesota · 1

  • Metro-Minnesota Community Clinical Oncology · Saint Louis Park, MN

Mississippi · 1

  • North Mississippi Hematology and Oncology Associates · Tupelo, MS

Missouri · 1

  • Oncology Hematology Associates · Springfield, MO

New Hampshire · 1

  • Dartmouth-Hitchcock Medical Center · Lebanon, NH

New Jersey · 3

  • Jefferson Health - Cherry Hill · Cherry Hill, NJ
  • Sidney Kimmel Cancer Center - Washington Township · Sewell, NJ
  • Atlantic Health System Overlook Medical Center · Summit, NJ

North Carolina · 4

  • Messino Cancer Centers · Asheville, NC
  • WakeMed Cancer Care - Waverly Hematology & Medical Oncology · Cary, NC
  • University of North Carolina Medical Center · Chapel Hill, NC
  • Carolina Cancer Research Center · Wilson, NC

Ohio · 2

  • Gabrail Cancer Center · Canton, OH
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T · Columbus, OH

Oregon · 3

  • Good Samaritan Regional Medical Center · Corvallis, OR
  • Oncology Associates of Oregon · Eugene, OR
  • Oregon Health and Science University · Portland, OR

Pennsylvania · 4

  • St. Luke's University Health Network · Bethlehem, PA
  • Jefferson Hospital Northeast · Philadelphia, PA
  • Thomas Jefferson University - Clinical Research Institute · Philadelphia, PA
  • Asplundh Cancer Pavilion · Willow Grove, PA

South Dakota · 1

  • Sanford Cancer Center · Sioux Falls, SD

Tennessee · 2

  • Nashville General Hospital · Nashville, TN
  • Sarah Cannon Research Institute SCRI · Nashville, TN

Texas · 10

  • Hendrick Medical Center · Abilene, TX
  • World Research Link · Baytown, TX
  • USO - Texas Oncology · Dallas, TX
  • UT Southwestern Medical Center · Dallas, TX
  • Texas Oncology - West Texas · El Paso, TX
  • Oncology Consultants P.A. · Houston, TX
  • Nova Oncology · McAllen, TX
  • Texas Oncology - San Antonio Medical Center · San Antonio, TX
  • US Oncology Research Network · The Woodlands, TX
  • Tranquility Research · Webster, TX

Utah · 1

  • Utah Cancer Specialists · Salt Lake City, UT

Virginia · 1

  • Virginia Cancer Specialists · Fairfax, VA

Washington · 6

  • Providence Regional Cancer Partnership · Everett, WA
  • UW Medicine Valley Medical Center · Renton, WA
  • Deaconess Hospital · Spokane, WA
  • Cancer Care Northwest - Vercler · Spokane Valley, WA
  • MultiCare Health System · Tacoma, WA
  • North Star Lodge · Yakima, WA

Wisconsin · 1

  • ThedaCare Physicians - Appleton North · Appleton, WI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.