BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
NCT07492641
This study is recruiting at 62 US sites in 29 states, according to its ClinicalTrials.gov record last updated .
Summary
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- HR+/HER2- Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- BeOne Medicines
- Last updated on ClinicalTrials.gov
- September 28, 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
Alabama · 1
- Alabama Oncology Princeton · Birmingham, AL
Alaska · 2
- Alaska Oncology and Hematology, Llc · Anchorage, AK
- Fairbanks Cancer Care Physicians Pc · Fairbanks, AK
Arizona · 2
- Pioneer Research Center · Bullhead City, AZ
- Ironwood Cancer and Research Centers Chandler Ii · Chandler, AZ
Arkansas · 1
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park) · Hot Springs, AR
California · 3
- Helios Clinical Research the Oncology Institute Fountain Valley · Fountain Valley, CA
- California Research Institute · Los Angeles, CA
- Ventura County Hematology Oncology Specialists · Oxnard, CA
Florida · 8
- Brcr Coral Springs · Coral Springs, FL
- Mid Florida Hematology and Oncology Center · Orange City, FL
- Cancer Care Centers of Brevard Palm Bay · Palm Bay, FL
- Florida Clinical Trials Group Plantation · Plantation, FL
- Hematology Oncology Associates of the Treasure Coast · Port Saint Lucie, FL
- The Oncology Institute of Hope and Innovation South Miami · South Miami, FL
- Florida Clinical Trials Group Tamarac · Tamarac, FL
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center · Tampa, FL
Georgia · 2
- University Cancer and Blood Center Athens Comprehensive Cancer Center · Athens, GA
- Central Georgia Cancer Care Macon Office · Macon, GA
Hawaii · 1
- Hawaii Cancer Care · Honolulu, HI
Illinois · 1
- Hope and Healing Cancer Services · Hinsdale, IL
Indiana · 2
- Fort Wayne Medical Oncology and Hematology · Fort Wayne, IN
- Hematology Oncology of Indiana · Indianapolis, IN
Iowa · 1
- Mercy Medical Center · Cedar Rapids, IA
Kentucky · 1
- Owensboro Health Mitchell Memorial Cancer Center · Owensboro, KY
Michigan · 1
- Karmanos Cancer Institute · Detroit, MI
Minnesota · 2
- Aspirus St Lukes Hospital · Duluth, MN
- Metro Minnesota Community Oncology Research Consortium (Mmcorc) · Saint Paul, MN
Missouri · 1
- Oncology Hematology Associates · Springfield, MO
Nebraska · 3
- Nebraska Cancer Specialists St Francis Grand Island · Grand Island, NE
- Cancer Partners of Nebraska April Sampson Cancer Center · Lincoln, NE
- Nebraska Cancer Specialists · Omaha, NE
Nevada · 2
- Comprehensive Cancer Centers of Nevada · Las Vegas, NV
- Renown Regional Medical Center · Reno, NV
New Jersey · 3
- Astera Cancer Care East Brunswick · East Brunswick, NJ
- Summit Medical Group · Florham Park, NJ
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ
New York · 5
- Nyu Langone Health Perlmutter Cancer Center Sunset Park · Brooklyn, NY
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island · Mineola, NY
- Nyu Langone Health Perlmutter Cancer Center 34Th Street · New York, NY
- University of Rochester · Rochester, NY
- New York Cancer and Blood Specialists · Shirley, NY
North Carolina · 2
- Pardee Cancer Center · Hendersonville, NC
- Carolina Cancer Research Center · Wilson, NC
Ohio · 2
- Gabrail Cancer Center Research · Canton, OH
- Dayton Physicians Network · Dayton, OH
Oregon · 2
- Oncology Associates of Oregon Willamette Valley Cancer Center · Eugene, OR
- Oregon Oncology Specialists · Salem, OR
Pennsylvania · 2
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall · Broomall, PA
- McGlinn Cancer Institute · West Reading, PA
Tennessee · 1
- Ballad Health Cancer Center Kingsport · Kingsport, TN
Texas · 1
- Texas Oncology Austin Central · Austin, TX
Utah · 1
- Utah Cancer Specialists Cancer Center · Salt Lake City, UT
Virginia · 3
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research) · Blacksburg, VA
- Virginia Cancer Specialists · Fairfax, VA
- Virginia Cancer Institute · Richmond, VA
Washington · 5
- Vista Oncology East Olympia · Olympia, WA
- Multicare Cancer Institute Deaconess Medical Office Building 1 · Spokane, WA
- Multicare Cancer Institute Tacoma General Hospital · Tacoma, WA
- Northwest Medical Specialties · Tacoma, WA
- Multicare Cancer Institute North Star Lodge · Yakima, WA
Wisconsin · 1
- Gundersen Health System · La Crosse, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.