NCT07492641

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

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: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,056 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HR+/HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	BGB-43395	Administered orally.
DRUG	Letrozole	Administered orally.
DRUG	Abemaciclib	Administered orally.
DRUG	Palbociclib	Administered orally.
DRUG	Ribociclib	Administered orally.

Timeline

• Start date: 2026-05-11
• Primary completion: 2029-04-01
• Completion: 2037-08-07
• First posted: 2026-03-25
• Last updated: 2026-03-25

Regulatory

• FDA-regulated drug study