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 (30) 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
Arizona
Ironwood Cancer and Research Centers Chandler Ii
RECRUITING
Chandler
Florida
Brcr Coral Springs
RECRUITING
Coral Springs
Florida Clinical Trials Group Tamarac
RECRUITING
Tamarac
Illinois
Cancer Care Specialists For Illinois
RECRUITING
O'fallon
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
North Carolina
Pardee Cancer Center
RECRUITING
Hendersonville
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Astera Cancer Care East Brunswick
RECRUITING
East Brunswick
Ohio
Gabrail Cancer Center Research
RECRUITING
Canton
Washington
Northwest Medical Specialties
RECRUITING
Tacoma
Other Locations
Australia
Sunshine Coast University Private Hospital
RECRUITING
Birtinya
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
One Clinical Research
RECRUITING
Nedlands
Wollongong Hospital
RECRUITING
Wollongong
Japan
Cancer Institute Hospital of Jfcr
RECRUITING
Kotoku
Tokyo Womens Medical University Hospital
RECRUITING
Shinjukuku
Malaysia
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
RECRUITING
Kota Kinabalu Sabah
Sarawak General Hospital
RECRUITING
Kuching
Republic of Korea
Keimyung University Dongsan Hospital
RECRUITING
Dalseogu
Inje University Haeundae Paik Hospital
RECRUITING
Haeundaegu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasungun
Inha University Hospital
RECRUITING
Junggu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
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
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.