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
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona 85224-5665
United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California 92708
United States
Brcr Coral Springs
Coral Springs, Florida 33065
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
Florida Clinical Trials Group Tamarac
Tamarac, Florida 33321
United States
Hope and Healing Cancer Services
Hinsdale, Illinois 60521-0509
United States
Cancer Care Specialists For Illinois
O'Fallon, Illinois 62269
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303
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
Astera Cancer Care East Brunswick
East Brunswick, New Jersey 08816-4096
United States
Summit Medical Group
Florham Park, New Jersey 07932-1049
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
Oregon Oncology Specialists
Salem, Oregon 97301
United States
McGlinn Cancer Institute
West Reading, Pennsylvania 19611-2143
United States
Virginia Cancer Institute
Richmond, Virginia 23229-8605
United States
Northwest Medical Specialties
Tacoma, Washington 98405
United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales NSW 2148
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200000
China
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
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
Mie University Hospital
Tsu, Mie-ken 514-8507
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 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
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, Jeollanam-do 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