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A phase 3 trial testing BGB-43395 in HR-positive / HER2-negative breast cancer, now 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 is a phase 3 interventional study registered as NCT07492641, led by BeOne Medicines, and recruiting on the registry. Official title: An Open-Label, Randomised, 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. Planned enrolment is 1056 participants (estimated). The study started in 2026-05-22 and primary completion is expected in 2029-04. No results have been posted on ClinicalTrials.gov.