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 (108) 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
Alabama
Alabama Oncology Princeton
RECRUITING
Birmingham
Arkansas
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
RECRUITING
Hot Springs
Arizona
Ironwood Cancer and Research Centers Chandler Ii
RECRUITING
Chandler
California
Helios Clinical Research the Oncology Institute Fountain Valley
RECRUITING
Fountain Valley
Ventura County Hematology Oncology Specialists
RECRUITING
Oxnard
Florida
Brcr Coral Springs
RECRUITING
Coral Springs
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Florida Clinical Trials Group Plantation
RECRUITING
Plantation
Hematology Oncology Associates of the Treasure Coast
RECRUITING
Port Saint Lucie
Florida Clinical Trials Group Tamarac
RECRUITING
Tamarac
Iowa
Mercy Medical Center
RECRUITING
Cedar Rapids
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Cancer Care Specialists For Illinois
RECRUITING
Ofallon
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
Kentucky
Owensboro Health Mitchell Memorial Cancer Center
RECRUITING
Owensboro
Minnesota
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
RECRUITING
Saint Paul
North Carolina
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 Cancer Specialists
RECRUITING
Omaha
New Jersey
Astera Cancer Care East Brunswick
RECRUITING
East Brunswick
Summit Medical Group
RECRUITING
Florham Park
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
New York Cancer and Blood Specialists
RECRUITING
Shirley
Ohio
Gabrail Cancer Center Research
RECRUITING
Canton
Dayton Physicians Network
RECRUITING
Dayton
Oregon
Oregon Oncology Specialists
RECRUITING
Salem
Pennsylvania
McGlinn Cancer Institute
RECRUITING
West Reading
Tennessee
Ballad Health Cancer Center Kingsport
RECRUITING
Kingsport
Virginia
Virginia Cancer Institute
RECRUITING
Richmond
Washington
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
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
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
RECRUITING
São Paulo
China
The First Peoples Hospital of Changde City
RECRUITING
Changde
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
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
Hainan General Hospital
RECRUITING
Haikou
Nanchang Peoples Hospitalchaoyang Branch
RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital Wuxiang Branch
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
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
Japan
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyoku
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
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
Mie University Hospital
RECRUITING
Tsu
Yokohama City University Medical Center
RECRUITING
Yokohama
Malaysia
Pulau Pinang Hospital
RECRUITING
George Town
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
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
Taiwan
China Medical University Hospital
RECRUITING
Taichung
United Kingdom
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