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BGB-43395 plus letrozole versus CDK4/6 inhibitor plus letrozole in previously untreated advanced or metastatic HR-positive/HER2-negative breast cancer
2025-523960-19-00Phase 3Authorised
- Sponsor
- BeOne Medicines
- Start
- Aug 2026
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
- Countries
- 15
01
Overview
Phase 3, randomised, open-label trial in breast cancer comparing BGB-43395 plus letrozole with CDK4/6 inhibitor plus letrozole (2 arms). Primary endpoint: Progression-free survival by blinded independent central review. Planned start Aug 2026; status: authorised.
02
Drugs
bgb-43395letrozole
03
Conditions
breast cancer
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