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Study identifier: NCT07492641 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: HR+/HER2- Breast Cancer  ·  Sponsor: BeOne Medicines

PhasePhase 3
Planned participants1056
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Study Director  ·  877-828-5568  ·  clinicaltrials@beonemed.com

Always discuss trial participation with your own doctor first.

Locations (74)

Alabama Oncology PrincetonBirmingham, Alabama, United StatesRecruiting
Alaska Oncology and Hematology, LlcAnchorage, Alaska, United StatesRecruiting
Ironwood Cancer and Research Centers Chandler IiChandler, Arizona, United StatesRecruiting
Helios Clinical Research the Oncology Institute Fountain ValleyFountain Valley, California, United StatesRecruiting
Brcr Coral SpringsCoral Springs, Florida, United StatesRecruiting
Florida Clinical Trials Group PlantationPlantation, Florida, United StatesRecruiting
Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida, United StatesRecruiting
Florida Clinical Trials Group TamaracTamarac, Florida, United StatesRecruiting
Hope and Healing Cancer ServicesHinsdale, Illinois, United StatesRecruiting
Cancer Care Specialists For IllinoisO'Fallon, Illinois, United StatesRecruiting
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana, United StatesRecruiting
Owensboro Health Mitchell Memorial Cancer CenterOwensboro, Kentucky, United StatesRecruiting

+ 62 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07492641