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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
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
BGB-43395
Administered orally.
Letrozole
Administered orally.
Abemaciclib
Administered orally.
Palbociclib
Administered orally.
Ribociclib
Administered orally.
Locations (62)
Alabama Oncology Princeton
Birmingham, Alabama, United States
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California, United States
Brcr Coral Springs
Coral Springs, Florida, United States
Florida Clinical Trials Group Plantation
Plantation, Florida, United States
Florida Clinical Trials Group Tamarac
Tamarac, Florida, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Cancer Care Specialists For Illinois
O'Fallon, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, 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
McGlinn Cancer Institute
West Reading, Pennsylvania, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Blacktown Cancer and Haematology Centre
Blacktown, 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
One Clinical Research
Nedlands, Western Australia, Australia
Tokai University Hospital
Iseharashi, Kanagawa, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasakishi, Kanagawa, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan
Showa Medical University Hospital
Shinagawaku, Tokyo, Japan
Tokyo Womens Medical University Hospital
Shinjukuku, Tokyo, Japan
Pulau Pinang Hospital
George Town, Malaysia
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
Kota Kinabalu Sabah, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Hospital Picaso
Petaling Jaya, Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, Malaysia
Inje University Haeundae Paik Hospital
HaeundaeGu, Busan Gwang'yeogsi, South Korea
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonansi, Chungcheongnam-do, South Korea
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, South Korea
Korea University Ansan Hospital
DanwonGu AnsanSi, Gyeonggi-do, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, South Korea
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Inha University Hospital
Jemulpogu, Incheon Gwang'yeogsi, South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, South Korea
Chung Ang University Hospital
DongjakGu, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Ehwa Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Ulsan University Hospital
Ulsan, Ulsan Gwang'yeogsi, South Korea
Ajou University Hospital
Suwon, South Korea