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
Status: Recruiting
Location: See all (241) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
• Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
• Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
• Adequate organ function.
Locations
United States
Alaska
Alaska Oncology and Hematology, Llc
RECRUITING
Anchorage
Fairbanks Cancer Care Physicians Pc
RECRUITING
Fairbanks
Alabama
Alabama Oncology Princeton
RECRUITING
Birmingham
Arkansas
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
RECRUITING
Hot Springs
Arizona
Pioneer Research Center
RECRUITING
Bullhead City
Ironwood Cancer and Research Centers Chandler Ii
RECRUITING
Chandler
City of Hope Phoenix Cancer Center
RECRUITING
Goodyear
California
City of Hope National Medical Center
RECRUITING
Duarte
Helios Clinical Research the Oncology Institute Fountain Valley
RECRUITING
Fountain Valley
California Research Institute
RECRUITING
Los Angeles
Ventura County Hematology Oncology Specialists
RECRUITING
Oxnard
Kaiser Permanente San Marcos Medical Offices
RECRUITING
San Marcos
Providence Saint Johns Health Center
RECRUITING
Santa Monica
Wellness Oncology and Hematology
RECRUITING
West Hills
Colorado
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
RECRUITING
Lone Tree
Connecticut
Danbury Hospital
RECRUITING
Danbury
Florida
Brcr Coral Springs
RECRUITING
Coral Springs
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Cancer Care Centers of Brevard Palm Bay
RECRUITING
Palm Bay
Florida Clinical Trials Group Plantation
RECRUITING
Plantation
Hematology Oncology Associates of the Treasure Coast
RECRUITING
Port Saint Lucie
The Oncology Institute of Hope and Innovation South Miami
RECRUITING
South Miami
Florida Clinical Trials Group Tamarac
RECRUITING
Tamarac
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
RECRUITING
Tampa
Georgia
University Cancer and Blood Center Athens Comprehensive Cancer Center
RECRUITING
Athens
Central Georgia Cancer Care Macon Office
RECRUITING
Macon
Hawaii
Hawaii Cancer Care
RECRUITING
Honolulu
Iowa
Mercy Medical Center
RECRUITING
Cedar Rapids
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Cancer Care Specialists For Illinois
RECRUITING
O'fallon
City of Hope Chicago Cancer Center
RECRUITING
Zion
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
Hematology Oncology of Indiana
RECRUITING
Indianapolis
Kentucky
Owensboro Health Mitchell Memorial Cancer Center
RECRUITING
Owensboro
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Aspirus St Lukes Hospital
RECRUITING
Duluth
Allina Health Cancer Institute Minneapolis
RECRUITING
Minneapolis
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
RECRUITING
Saint Paul
Missouri
Missouri Cancer Associates Columbia, Mo
RECRUITING
Columbia
Oncology Hematology Associates
RECRUITING
Springfield
Mississippi
Hattiesburg Hematology and Oncology Clinic
RECRUITING
Hattiesburg
North Carolina
University of North Carolina At Chapel Hill
RECRUITING
Chapel Hill
Pardee Cancer Center
RECRUITING
Hendersonville
Carolina Cancer Research Center
RECRUITING
Wilson
Nebraska
Nebraska Cancer Specialists St Francis Grand Island
RECRUITING
Grand Island
Cancer Partners of Nebraska April Sampson Cancer Center
RECRUITING
Lincoln
Nebraska Hematology Oncology
RECRUITING
Lincoln
Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Astera Cancer Care East Brunswick
RECRUITING
East Brunswick
Summit Medical Group
RECRUITING
Florham Park
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Renown Regional Medical Center
RECRUITING
Reno
New York
Nyu Langone Health Perlmutter Cancer Center Sunset Park
RECRUITING
Brooklyn
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
RECRUITING
Mineola
Nyu Langone Health Perlmutter Cancer Center 34Th Street
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
New York Cancer and Blood Specialists
RECRUITING
Shirley
Stony Brook Cancer Center
RECRUITING
Stony Brook
Ohio
Gabrail Cancer Center Research
RECRUITING
Canton
Dayton Physicians Network
RECRUITING
Dayton
Oregon
Oncology Associates of Oregon Willamette Valley Cancer Center
RECRUITING
Eugene
Oregon Oncology Specialists
RECRUITING
Salem
Pennsylvania
Consultants in Medical Oncology and Hematology Cancer Center At Broomall
RECRUITING
Broomall
McGlinn Cancer Institute
RECRUITING
West Reading
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
Ballad Health Cancer Center Kingsport
RECRUITING
Kingsport
Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
RECRUITING
Nashville
Texas
Texas Oncology Austin Central
RECRUITING
Austin
Texas Oncology Baylor Charles A Sammons Cancer Center
RECRUITING
Dallas
Baylor Scott and White Medical Center Round Rock
RECRUITING
Round Rock
Utah
Utah Cancer Specialists Cancer Center
RECRUITING
Salt Lake City
Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
RECRUITING
Blacksburg
University of Virginia
RECRUITING
Charlottesville
Virginia Cancer Specialists
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Virginia Cancer Institute
RECRUITING
Richmond
Washington
Vista Oncology East Olympia
RECRUITING
Olympia
Multicare Cancer Institute Deaconess Medical Office Building 1
RECRUITING
Spokane
Multicare Cancer Institute Tacoma General Hospital
RECRUITING
Tacoma
Northwest Medical Specialties
RECRUITING
Tacoma
Multicare Cancer Institute North Star Lodge
RECRUITING
Yakima
Wisconsin
Gundersen Health System
RECRUITING
La Crosse
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Sunshine Coast University Private Hospital
RECRUITING
Birtinya
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Townsville University Hospital
RECRUITING
Douglas
Liverpool Hospital
RECRUITING
Liverpool
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
One Clinical Research
RECRUITING
Nedlands
Wollongong Hospital
RECRUITING
Wollongong
Brazil
Fundacao Pio Xii Hospital de Amor de Barretos
RECRUITING
Barretos
Hospital Brasilia
RECRUITING
Brasília
Fundacao Universidade de Caxias Do Sul
RECRUITING
Caxias Do Sul
Ictr Instituto Do Cancer E Transplante de Curitiba
RECRUITING
Curitiba
Centro Regional Integrado de Oncologia Crio
RECRUITING
Fortaleza
Oncosite Centro de Pesquisa Clinica Em Oncologia
RECRUITING
Ijuí
Liga Norte Riograndene Contra O Cancer
RECRUITING
Natal
Hospital Sao Lucas Da Pucrs
RECRUITING
Porto Alegre
Instituto Sul Mineiro de Oncologia Ltda
RECRUITING
Pouso Alegre
Hospital Do Cancer de Pernambuco
RECRUITING
Recife
Instituto Nacional de Cancer
RECRUITING
Rio De Janeiro
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
RECRUITING
São Paulo
Hospital Santa Rita de Cassia Afecc
RECRUITING
Vitória
China
Affiliated Hospital of Hebei University(North Branch)
RECRUITING
Baoding
Beijing Cancer Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
RECRUITING
Bengbu
The First Peoples Hospital of Changde City
RECRUITING
Changde
Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
RECRUITING
Fuzhou
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
RECRUITING
Guangzhou
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Provincial Hospital
RECRUITING
Hefei
Yunnan Cancer Hospital
RECRUITING
Kunming
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Nanchang Peoples Hospitalchaoyang Branch
RECRUITING
Nanchang
Jiangsu Province Hospital Longjiang Branch
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital Wuxiang Branch
RECRUITING
Nanning
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
The Fourth Hospital of Hebei Medical University East Branch
RECRUITING
Shijiazhuang
Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Weifang Peoples Hospital
RECRUITING
Weifang
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Hubei Cancer Hospital
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
RECRUITING
Wuhan
The Second Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Yuncheng Central Hospital West Branch
RECRUITING
Yuncheng
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Centre de Lutte Contre Le Cancer Institut Bergonie
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
Institut Paoli Calmettes
RECRUITING
Marseille
Icm Val Daurelle
RECRUITING
Montpellier
Centre Eugene Marquis
RECRUITING
Rennes
Ico Site Rene Gauducheau
RECRUITING
Saintherblain
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Helios Klinikum Berlin Buch Brustzentrum
RECRUITING
Berlin
Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
RECRUITING
Esslingen Am Neckar
Centrum Fur Haematologie Und Onkologie Bethanien
RECRUITING
Frankfurt Am Main
Invo Institut Fur Versorgungsforschung in Der Onkologie
RECRUITING
Koblenz
Italy
Asst Papa Giovanni Xxiii
RECRUITING
Bergamo
Istituto Europeo Di Oncologia
RECRUITING
Milan
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
RECRUITING
Monza
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Japan
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyoku
Hiroshima City Hiroshima Citizens Hospital
RECRUITING
Hiroshima
Tokai University Hospital
RECRUITING
Iseharashi
Social Medical Corporation Hakuaikai Sagara Hospital
RECRUITING
Kagoshima
Nippon Medical School Musashi Kosugi Hospital
RECRUITING
Kawasakishi
Cancer Institute Hospital of Jfcr
RECRUITING
Kotoku
Japan Community Healthcare Organization Kurume General Hospital
RECRUITING
Kurumeshi
Hyogo Medical University Hospital
RECRUITING
Nishinomiyashi
National Hospital Organization Osaka National Hospital
RECRUITING
Osakashi
Osaka International Cancer Institute
RECRUITING
Osakashi
Gunma Prefectural Cancer Center
RECRUITING
Otashi
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
Showa Medical University Hospital
RECRUITING
Shinagawaku
Tokyo Womens Medical University Hospital
RECRUITING
Shinjukuku
The University of Osaka Hospital
RECRUITING
Suitashi
Shizuoka Cancer Center
RECRUITING
Suntogun
Mie University Hospital
RECRUITING
Tsu
Kanagawa Cancer Center
RECRUITING
Yokohama
Yokohama City University Medical Center
RECRUITING
Yokohama
Malaysia
Pulau Pinang Hospital
RECRUITING
George Town
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Raja Perempuan Zainab Ii
RECRUITING
Johor Bahru
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
RECRUITING
Kota Kinabalu Sabah
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Sarawak General Hospital
RECRUITING
Kuching
Hospital Picaso
RECRUITING
Petaling Jaya
National Cancer Institute (Institut Kanser Negara)
RECRUITING
Putrajaya
Poland
Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
RECRUITING
Bialystok
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
RECRUITING
Gdynia
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
RECRUITING
Kielce
Pratia McM Krakow
RECRUITING
Krakow
Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
RECRUITING
Krakow
Opolskie Centrum Onkologii
RECRUITING
Opole
Europejskie Centrum Zdrowia Otwock
RECRUITING
Otwock
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
RECRUITING
Warsaw
Puerto Rico
Brcr Global Puerto Rico Hato Rey
RECRUITING
San Juan
Republic of Korea
Cha Bundang Medical Center, Cha University
RECRUITING
Bundanggu Seongnamsi
Soon Chun Hyang University Cheonan Hospital
RECRUITING
Cheonansi
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital
RECRUITING
Dalseogu
Korea University Ansan Hospital
RECRUITING
Danwongu Ansansi
Chung Ang University Hospital
RECRUITING
Dongjakgu
Samsung Medical Center
RECRUITING
Gangnamgu
Korea University Guro Hospital
RECRUITING
Gurogu
Inje University Haeundae Paik Hospital
RECRUITING
Haeundaegu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasungun
National Cancer Center (Korea)
RECRUITING
Ilsandonggu Goyangsi
Inha University Hospital
RECRUITING
Jemulpogu
Gachon University Gil Medical Center
RECRUITING
Namdonggu
The Catholic University of Korea, St Vincents Hospital
RECRUITING
Paldalgu Suwonsi
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Dong A University Hospital
RECRUITING
Seogu
Korea University Anam Hospital
RECRUITING
Seongbukgu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Ehwa Womans University Mokdong Hospital
RECRUITING
Seoul
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
Ajou University Hospital
RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Spain
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Vall D Hebron Institute of Oncology Vhio
RECRUITING
Barcelona
Hospital Universitario Donostia
RECRUITING
Donostiasan Sebastian
Hospital General Universitario de Elche
RECRUITING
Elcheelx
Hospital Universitario Clinico San Cecilio
RECRUITING
Granada
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Iob Institute of Oncology Madrid
RECRUITING
Madrid
Complejo Hospitalario Univ de Santiago (Chus)
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Taiwan
Taipei Veterans General Hospital
RECRUITING
Beitou Dist
China Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Zhongzheng Dist
Turkey
Adana City Education and Research Hospital
RECRUITING
Adana
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
RECRUITING
Ankara
Hacettepe University
RECRUITING
Ankara
Ankara City Hospital
RECRUITING
Ankara City Hospital
Marmara University Pendik Research and Training Hospital
RECRUITING
Istanbul
Ege University Medical Faculty
RECRUITING
Izmir
Kocaeli Universitesi Tip Fakultesi
RECRUITING
Kocaeli
Mersin City Hospital
RECRUITING
Mersin City Hospital
United Kingdom
Royal Surrey County Hospital
RECRUITING
Guildford
Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
RECRUITING
Maidstone
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
877-828-5568
Time Frame
Start Date: 2026-05-22
Estimated Completion Date: 2037-08-07
Participants
Target number of participants: 1056
Treatments
Experimental: Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole.
Active_comparator: Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines