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
Recruiting · NCT07492641 · Interventional (participants receive a specific treatment) · Lead sponsor: BeOne Medicines
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Participants who have received prior systemic treatment in the advanced or metastatic setting.
- Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
60 locations listed across 22 US states.
- 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
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park) - Hot Springs, Arkansas, United States
- Helios Clinical Research the Oncology Institute Fountain Valley - Fountain Valley, California, United States
- Ventura County Hematology Oncology Specialists - Oxnard, California, United States
- Brcr Coral Springs - Coral Springs, Florida, United States
- Mid Florida Hematology and Oncology Center - Orange City, Florida, United States
- Florida Clinical Trials Group Plantation - Plantation, Florida, United States
- Hematology Oncology Associates of the Treasure Coast - Port Saint Lucie, 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 - OFallon, Illinois, United States
- Fort Wayne Medical Oncology and Hematology - Fort Wayne, Indiana, United States
- Mercy Medical Center - Cedar Rapids, Iowa, United States
- Owensboro Health Mitchell Memorial Cancer Center - Owensboro, Kentucky, United States
- Metro Minnesota Community Oncology Research Consortium (Mmcorc) - Saint Paul, Minnesota, United States
- Nebraska Cancer Specialists St Francis Grand Island - Grand Island, Nebraska, United States
- Cancer Partners of Nebraska April Sampson Cancer Center - Lincoln, Nebraska, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Astera Cancer Care East Brunswick - East Brunswick, New Jersey, United States
- Summit Medical Group - Florham Park, New Jersey, United States
- New York Cancer and Blood Specialists - Shirley, New York, 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
- Oregon Oncology Specialists - Salem, Oregon, United States
- McGlinn Cancer Institute - West Reading, Pennsylvania, United States
- Ballad Health Cancer Center Kingsport - Kingsport, Tennessee, United States
- Virginia Cancer Institute - Richmond, Virginia, United States
- Multicare Cancer Institute Deaconess Medical Office Building 1 - Spokane, Washington, United States
- Multicare Cancer Institute Tacoma General Hospital - Tacoma, Washington, United States
- Northwest Medical Specialties - Tacoma, Washington, United States
- Multicare Cancer Institute North Star Lodge - Yakima, Washington, United States
- Fundacao Pio Xii Hospital de Amor de Barretos - Barretos, Brazil
- 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
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital - Maidstone, United Kingdom
- Hospital Picaso - Petaling Jaya, Malaysia
- National Cancer Institute (Institut Kanser Negara) - Putrajaya, Malaysia
- Brcr Global Puerto Rico Hato Rey - San Juan, Puerto Rico
- Ajou University Hospital - Suwon, South Korea
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira - São Paulo, Brazil
- China Medical University Hospital - Taichung, Taiwan
- Inje University Haeundae Paik Hospital - HaeundaeGu, Busan Gwang'Yeogsi, South Korea
- Dong A University Hospital - Seogu, Busan Gwang'Yeogsi, South Korea
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- 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
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine - Fuzhou, Fujian, China
- Japan Community Healthcare Organization Kurume General Hospital - Kurumeshi, Fukuoka, Japan
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) - Guangzhou, Guangdong, China
- Cancer Hospital of Shantou University Medical College - Shantou, Guangdong, China
- Guangxi Medical University Cancer Hospital Wuxiang Branch - Nanning, Guangxi, China
Showing 60 of 108 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →