drugset
drugset / Trial / 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

NCT07492641 ↗

Phase 3 Recruiting 1056 enrolled BeOne Medicines
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-22
Primary completion
2029-04
Completion
2037-08-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abemaciclib Small molecule — Oral
Subject BGB-43395 Unknown — Oral
Comparator Palbociclib Small molecule — Oral
Comparator Ribociclib Small molecule — Oral
Background Letrozole Other / unclassified — Oral

Indications

hormone receptor-positive breast cancer