Clinical Trial

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

Study acronym: KANDELA-302
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 changes
notable Trial sites expanded: 74 -> 90 locations 2026-08-07
notable Trial sites expanded: 62 -> 74 locations 2026-07-25
notable Trial sites expanded: 30 -> 62 locations 2026-07-11
notable Trial sites expanded: 13 -> 30 locations 2026-06-19
notable Trial sites expanded: 4 -> 13 locations 2026-06-04
critical Recruitment opened 2026-05-23
notable Trial sites expanded: 0 -> 4 locations 2026-05-23
Trial Details
NCT Number NCT07492641
Lead Sponsor BeOne Medicines
Conditions HR+/HER2- Breast Cancer
Enrollment 1,056 participants
Start Date 2026-05-22
Primary Completion 2029-04 (estimated)
Study Completion 2037-08-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-06