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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby powyżej 18 roku życia lub w wieku zgody prawnej.
- •Potwierdzony histopatologicznie zaawansowany lub rozsiany rak piersi HR+/HER2-.
- •Dobry ogólny stan zdrowia (nie więcej niż 1 dzień niesprawności w skali ECOG).
- •Odpowiednia czynność narządów wewnętrznych.
✗ Disqualifies
- •Osoby, które były już leczone systemowo z powodu zaawansowanego lub rozsianego raka piersi.
- •Osoby leczone wcześniej lekami ukierunkowanymi na CDK4 lub CDK2, lub innymi lekami eksperymentalnymi.
- •Osoby z aktywną chorobą opon mózgowych lub nieleczonymi przerzutami do mózgu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 19, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (108)
Alabama Oncology Princeton
Birmingham, United States
Alaska Oncology and Hematology, Llc
Anchorage, United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, United States
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, United States
Ventura County Hematology Oncology Specialists
Oxnard, United States
Brcr Coral Springs
Coral Springs, United States
Mid Florida Hematology and Oncology Center
Orange City, United States
Florida Clinical Trials Group Plantation
Plantation, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, United States
Florida Clinical Trials Group Tamarac
Tamarac, United States
Hope and Healing Cancer Services
Hinsdale, United States
Cancer Care Specialists For Illinois
OFallon, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, United States
Mercy Medical Center
Cedar Rapids, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, United States
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, United States
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, United States
Nebraska Cancer Specialists
Omaha, United States
Renown Regional Medical Center
Reno, United States
Astera Cancer Care East Brunswick
East Brunswick, United States
Summit Medical Group
Florham Park, United States
New York Cancer and Blood Specialists
Shirley, United States
Pardee Cancer Center
Hendersonville, United States
Carolina Cancer Research Center
Wilson, United States
Gabrail Cancer Center Research
Canton, United States
Dayton Physicians Network
Dayton, United States
Oregon Oncology Specialists
Salem, United States
McGlinn Cancer Institute
West Reading, United States
Ballad Health Cancer Center Kingsport
Kingsport, United States
Virginia Cancer Institute
Richmond, United States
Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, United States
Multicare Cancer Institute Tacoma General Hospital
Tacoma, United States
Northwest Medical Specialties
Tacoma, United States
Multicare Cancer Institute North Star Lodge
Yakima, United States
Blacktown Cancer and Haematology Centre
Blacktown, Australia
Liverpool Hospital
Liverpool, Australia
Wollongong Hospital
Wollongong, Australia
Sunshine Coast University Private Hospital
Birtinya, Australia
Townsville University Hospital
Douglas, Australia
Peter Maccallum Cancer Centre
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
One Clinical Research
Nedlands, Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, China
Cancer Hospital of Shantou University Medical College
Shantou, China
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, China
Hainan General Hospital
Haikou, China
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
Wuhan, China
The First Peoples Hospital of Changde City
Changde, China
Nanchang Peoples Hospitalchaoyang Branch
Nanchang, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Fudan University Shanghai Cancer Center
Shanghai, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China
Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Japan Community Healthcare Organization Kurume General Hospital
Kurumeshi, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Japan
Hyogo Medical University Hospital
Nishinomiyashi, Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, Japan
Tokai University Hospital
Iseharashi, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasakishi, Japan
Yokohama City University Medical Center
Yokohama, Japan
Mie University Hospital
Tsu, Japan
National Hospital Organization Osaka National Hospital
Osakashi, Japan
The University of Osaka Hospital
Suitashi, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Japan
Showa Medical University Hospital
Shinagawaku, Japan
Tokyo Womens Medical University Hospital
Shinjukuku, 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
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Hospital Picaso
Petaling Jaya, Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, Malaysia
Brcr Global Puerto Rico Hato Rey
San Juan, Puerto Rico
Inje University Haeundae Paik Hospital
HaeundaeGu, South Korea
Dong A University Hospital
Seogu, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonansi, South Korea
Keimyung University Dongsan Hospital
Dalseogu, South Korea
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, South Korea
Korea University Ansan Hospital
DanwonGu AnsanSi, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, South Korea
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Inha University Hospital
Jemulpogu, South Korea
Gachon University Gil Medical Center
NamdongGu, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, South Korea
Chung Ang University Hospital
DongjakGu, South Korea
Samsung Medical Center
GangnamGu, South Korea
Korea University Guro Hospital
GuroGu, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, South Korea
Korea University Anam Hospital
SeongbukGu, South Korea
Seoul National University Hospital
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Ehwa Womans University Mokdong Hospital
Seoul, South Korea
Asan Medical Center
SongpaGu, South Korea
Ulsan University Hospital
Ulsan, South Korea
Ajou University Hospital
Suwon, South Korea
China Medical University Hospital
Taichung, Taiwan
Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
Maidstone, United Kingdom
Trial contact
Study Director
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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