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
Start Date
5/22/2026
Completion Date
8/7/2037
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 Criteria
Age Range: 18 years to No maximum
Interventions
BGB-43395
Letrozole
Abemaciclib
Palbociclib
Ribociclib
Conditions
Locations
Alabama Oncology Princeton
Birmingham, Alabama 35211
United States
Alaska Oncology and Hematology, Llc
Anchorage, Alaska 99508-2974
United States
Fairbanks Cancer Care Physicians Pc
Fairbanks, Alaska 99701
United States
Pioneer Research Center
Bullhead City, Arizona 86442
United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona 85224-5665
United States
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, Arkansas 71913
United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California 92708
United States
California Research Institute
Los Angeles, California 90027
United States
Ventura County Hematology Oncology Specialists
Oxnard, California 93030
United States
Brcr Coral Springs
Coral Springs, Florida 33065
United States
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763-8316
United States
Cancer Care Centers of Brevard Palm Bay
Palm Bay, Florida 32901
United States
Florida Clinical Trials Group Plantation
Plantation, Florida 33322
United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida 34952-7596
United States
The Oncology Institute of Hope and Innovation South Miami
South Miami, Florida 33143
United States
Florida Clinical Trials Group Tamarac
Tamarac, Florida 33321
United States
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
Tampa, Florida 33612
United States
University Cancer and Blood Center Athens Comprehensive Cancer Center
Athens, Georgia 30607
United States
Central Georgia Cancer Care Macon Office
Macon, Georgia 31210
United States
Hawaii Cancer Care
Honolulu, Hawaii 96813
United States
Hope and Healing Cancer Services
Hinsdale, Illinois 60521-0509
United States
Cancer Care Specialists For Illinois
OFallon, Illinois 62269
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States
Hematology Oncology of Indiana
Indianapolis, Indiana 46260
United States
Mercy Medical Center
Cedar Rapids, Iowa 52403
United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303
United States
Karmanos Cancer Institute
Detroit, Michigan 48201-2013
United States
Aspirus St Lukes Hospital
Duluth, Minnesota 55805
United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota 55101-2502
United States
Oncology Hematology Associates
Springfield, Missouri 65807-5288
United States
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska 68803
United States
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska 68516
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130-2042
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169-3321
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey 08816-4096
United States
Summit Medical Group
Florham Park, New Jersey 07932-1049
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901-1914
United States
Nyu Langone Health Perlmutter Cancer Center Sunset Park
Brooklyn, New York 11220
United States
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
Mineola, New York 11501
United States
Nyu Langone Health Perlmutter Cancer Center 34Th Street
New York, New York 10016
United States
University of Rochester
Rochester, New York 14642-0001
United States
New York Cancer and Blood Specialists
Shirley, New York 11967
United States
Pardee Cancer Center
Hendersonville, North Carolina 28739
United States
Carolina Cancer Research Center
Wilson, North Carolina 27896
United States
Gabrail Cancer Center Research
Canton, Ohio 44718-2566
United States
Dayton Physicians Network
Dayton, Ohio 45409
United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon 97401
United States
Oregon Oncology Specialists
Salem, Oregon 97301
United States
Consultants in Medical Oncology and Hematology Cancer Center At Broomall
Broomall, Pennsylvania 19008
United States
McGlinn Cancer Institute
West Reading, Pennsylvania 19611-2143
United States
Ballad Health Cancer Center Kingsport
Kingsport, Tennessee 37660
United States
Texas Oncology Austin Central
Austin, Texas 78731-4214
United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah 84107
United States
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia 24060-6325
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031-2171
United States
Virginia Cancer Institute
Richmond, Virginia 23229-8605
United States
Vista Oncology East Olympia
Olympia, Washington 98506
United States
Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, Washington 99204
United States
Multicare Cancer Institute Tacoma General Hospital
Tacoma, Washington 98405
United States
Northwest Medical Specialties
Tacoma, Washington 98405
United States
Multicare Cancer Institute North Star Lodge
Yakima, Washington 98902
United States
Gundersen Health System
La Crosse, Wisconsin 54601-5467
United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales NSW 2148
Australia
Liverpool Hospital
Liverpool, New South Wales NSW 2170
Australia
Wollongong Hospital
Wollongong, New South Wales NSW 2500
Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland QLD 4575
Australia
Townsville University Hospital
Douglas, Queensland QLD 4814
Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria VIC 3000
Australia
Fiona Stanley Hospital
Murdoch, Western Australia WA 6150
Australia
One Clinical Research
Nedlands, Western Australia WA 6009
Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400
Brazil
Hospital Brasilia
Brasília, 71681-603
Brazil
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul, 95070-560
Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia
Ijuí, 98700-000
Brazil
Liga Norte Riograndene Contra O Cancer
Natal, 59062-000
Brazil
Hospital Sao Lucas Da Pucrs
Porto Alegre, 90610-000
Brazil
Instituto Sul Mineiro de Oncologia Ltda
Pouso Alegre, 37554-238
Brazil
Hospital Do Cancer de Pernambuco
Recife, 50040-000
Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20560-120
Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000
Brazil
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui 233004
China
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality 630014
China
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
China
The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian 350009
China
Fujian Cancer Hospital
Fuzhou, Fujian 350014
China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong 510245
China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong 515031
China
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi 530201
China
Hainan General Hospital
Haikou, Hainan 570206
China
Affiliated Hospital of Hebei University(North Branch)
Baoding, Hebei 71000
China
The Fourth Hospital of Hebei Medical University East Branch
Shijiazhuang, Hebei 050035
China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
China
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
Wuhan, Hubei 430048
China
Hubei Cancer Hospital
Wuhan, Hubei 430079
China
The First Peoples Hospital of Changde City
Changde, Hunan 415000
China
Xiangya Hospital of Central South University
Changsha, Hunan 410008
China
Jiangsu Province Hospital Longjiang Branch
Nanjing, Jiangsu 210036
China
Affiliated Hospital of Nantong University
Nantong, Jiangsu 201203
China
Nanchang Peoples Hospitalchaoyang Branch
Nanchang, Jiangxi 330025
China
Jiangxi Cancer Hospital
Nanchang, Jiangxi 330029
China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi 710004
China
Weifang Peoples Hospital
Weifang, Shandong 261000
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200000
China
Yuncheng Central Hospital West Branch
Yuncheng, Shanxi 44099
China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan 610071
China
Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality 300453
China
Yunnan Cancer Hospital
Kunming, Yunnan 650100
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
France
Icm Val Daurelle
Montpellier, 34090
France
Centre Eugene Marquis
Rennes, 35043
France
Institut Gustave Roussy
Villejuif, 94800
France
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, 56068
Germany
Istituto Europeo Di Oncologia
Milan, 20141
Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Italy
Japan Community Healthcare Organization Kurume General Hospital
Kurumeshi, Fukuoka 830-0013
Japan
Gunma Prefectural Cancer Center
Otashi, Gunma 373-8550
Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima 730-8518
Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
Japan
Hyogo Medical University Hospital
Nishinomiyashi, Hyōgo 663-8501
Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, Kagoshima-ken 892-0833
Japan
Tokai University Hospital
Iseharashi, Kanagawa 259-1193
Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasakishi, Kanagawa 211-8533
Japan
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
Mie University Hospital
Tsu, Mie-ken 514-8507
Japan
National Hospital Organization Osaka National Hospital
Osakashi, Osaka 540-0006
Japan
The University of Osaka Hospital
Suitashi, Osaka 565-0871
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo 113-8677
Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo 135-8550
Japan
Showa Medical University Hospital
Shinagawaku, Tokyo 142-8666
Japan
Tokyo Womens Medical University Hospital
Shinjukuku, Tokyo 162-8666
Japan
Pulau Pinang Hospital
George Town, 10450
Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450
Malaysia
Hospital Raja Perempuan Zainab Ii
Johor Bahru, 15586
Malaysia
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
Kota Kinabalu Sabah, 88996
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100
Malaysia
Sarawak General Hospital
Kuching, 93586
Malaysia
Hospital Picaso
Petaling Jaya, 46300
Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, 62250
Malaysia
Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
Bialystok, 15-027
Poland
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519
Poland
Pratia McM Krakow
Krakow, 30-727
Poland
Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
Krakow, 31-826
Poland
Opolskie Centrum Onkologii
Opole, 45-061
Poland
Brcr Global Puerto Rico Hato Rey
San Juan, 00917
Puerto Rico
Inje University Haeundae Paik Hospital
HaeundaeGu, Busan Gwang'Yeogsi 48108
South Korea
Dong A University Hospital
Seogu, Busan Gwang'Yeogsi 49201
South Korea
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo 28644
South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonansi, Chungcheongnam-do 31151
South Korea
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'Yeogsi 42601
South Korea
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do 13496
South Korea
Korea University Ansan Hospital
DanwonGu AnsanSi, Gyeonggi-do 15355
South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do 10408
South Korea
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do 16247
South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Inha University Hospital
Jemulpogu, Incheon Gwang'Yeogsi 22332
South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'Yeogsi 21565
South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeonnam-Gwangju S.M. City 58128
South Korea
Chung Ang University Hospital
DongjakGu, Seoul Teugbyeolsi 06973
South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
South Korea
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi 08308
South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi 06591
South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi 03722
South Korea
Korea University Anam Hospital
SeongbukGu, Seoul Teugbyeolsi 02841
South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi 06273
South Korea
Ehwa Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi 07985
South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi 05505
South Korea
Ulsan University Hospital
Ulsan, Ulsan Gwang'Yeogsi 44033
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
Hospital General Universitario de Elche
Elcheelx, 03203
Spain
Hospital Universitario Clinico San Cecilio
Granada, 18016
Spain
Iob Institute of Oncology Madrid
Madrid, 28007
Spain
Complejo Hospitalario Univ de Santiago (Chus)
Santiago de Compostela, 15706
Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013
Spain
Taipei Veterans General Hospital
Beitou Dist, 11217
Taiwan
China Medical University Hospital
Taichung, 40447
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Zhongzheng Dist, 100225
Taiwan
Adana City Education and Research Hospital
Adana, 01060
Turkey (Türkiye)
Hacettepe University
Ankara, 6100
Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
Turkey (Türkiye)
Royal Surrey County Hospital
Guildford, GU27XX
United Kingdom
Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
Maidstone, ME16 9QQ
United Kingdom