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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
Sponsor: BeOne Medicines
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.
Official title: An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1056
Start Date
2026-05-22
Completion Date
2037-08-07
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
BGB-43395
Administered orally.
Letrozole
Administered orally.
Abemaciclib
Administered orally.
Palbociclib
Administered orally.
Ribociclib
Administered orally.
Locations (241)
Alabama Oncology Princeton
Birmingham, Alabama, United States
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States
Fairbanks Cancer Care Physicians Pc
Fairbanks, Alaska, United States
Pioneer Research Center
Bullhead City, Arizona, United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, United States
City of Hope Phoenix Cancer Center
Goodyear, Arizona, United States
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, Arkansas, United States
City of Hope National Medical Center
Duarte, California, United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California, United States
California Research Institute
Los Angeles, California, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, United States
Providence Saint Johns Health Center
Santa Monica, California, United States
Wellness Oncology and Hematology
West Hills, California, United States
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Lone Tree, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Brcr Coral Springs
Coral Springs, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Cancer Care Centers of Brevard Palm Bay
Palm Bay, Florida, United States
Florida Clinical Trials Group Plantation
Plantation, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
The Oncology Institute of Hope and Innovation South Miami
South Miami, Florida, United States
Florida Clinical Trials Group Tamarac
Tamarac, Florida, United States
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
Tampa, Florida, United States
University Cancer and Blood Center Athens Comprehensive Cancer Center
Athens, Georgia, United States
Central Georgia Cancer Care Macon Office
Macon, Georgia, United States
Hawaii Cancer Care
Honolulu, Hawaii, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Cancer Care Specialists For Illinois
O'Fallon, Illinois, United States
City of Hope Chicago Cancer Center
Zion, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, United States
Mercy Medical Center
Cedar Rapids, Iowa, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Aspirus St Lukes Hospital
Duluth, Minnesota, United States
Allina Health Cancer Institute Minneapolis
Minneapolis, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
Missouri Cancer Associates Columbia, Mo
Columbia, Missouri, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, United States
Nebraska Hematology Oncology
Lincoln, Nebraska, United States
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Nyu Langone Health Perlmutter Cancer Center Sunset Park
Brooklyn, New York, United States
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
Mineola, New York, United States
Nyu Langone Health Perlmutter Cancer Center 34Th Street
New York, New York, United States
University of Rochester
Rochester, New York, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Pardee Cancer Center
Hendersonville, North Carolina, United States
Carolina Cancer Research Center
Wilson, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Dayton Physicians Network
Dayton, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Oregon Oncology Specialists
Salem, Oregon, United States
Consultants in Medical Oncology and Hematology Cancer Center At Broomall
Broomall, Pennsylvania, United States
McGlinn Cancer Institute
West Reading, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Ballad Health Cancer Center Kingsport
Kingsport, Tennessee, United States
Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
Nashville, Tennessee, United States
Texas Oncology Austin Central
Austin, Texas, United States
Texas Oncology Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States
Baylor Scott and White Medical Center Round Rock
Round Rock, Texas, United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Vista Oncology East Olympia
Olympia, Washington, United States
Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, Washington, United States
Multicare Cancer Institute Tacoma General Hospital
Tacoma, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Multicare Cancer Institute North Star Lodge
Yakima, Washington, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
Hospital Brasilia
Brasília, Brazil
Fundacao Universidade de Caxias Do Sul
Caxias do Sul, Brazil
Ictr Instituto Do Cancer E Transplante de Curitiba
Curitiba, Brazil
Centro Regional Integrado de Oncologia Crio
Fortaleza, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia
Ijuí, Brazil
Liga Norte Riograndene Contra O Cancer
Natal, Brazil
Hospital Sao Lucas Da Pucrs
Porto Alegre, Brazil