BGB-43395 plus letrozole compared with CDK4/6 inhibitors in untreated advanced breast cancer
Compares BGB-43395 with letrozole against CDK4/6 inhibitors in adults with untreated advanced breast cancer.
Plain-language title generated from the registry record
Registry title: BGB-43395 in Combination with Letrozole versus CDK4/6i with Letrozole for Patients with Previously Untreated Advanced or Metastatic HR+/HER2- Breast Cancer
Key facts
- Where
- Bordeaux, Lyon, Marseille, Montpellier Cedex 5, Rennes Cedex, Saint-Herblain Cedex, and Villejuif, FranceSee the 7 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced or metastatic HR+/HER2- breast cancer who have not yet had systemic treatment for advanced disease.
- Age
- 18 years or older (or the legal age of consent where the study takes place).
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic breast cancer, confirmed by tissue examination, HR+ and HER2-.
- Earlier treatment
- No earlier systemic treatment for advanced or metastatic disease. No earlier treatment with a CDK4 or CDK2 targeting agent, or any other investigational anticancer drug.
- Biomarker or test result
- The cancer must be HR+ and HER2-.
Main reasons for not taking part
- Earlier systemic treatment for advanced or metastatic disease
- Earlier treatment with a CDK4 or CDK2 targeting agent
- Earlier treatment with any other investigational anticancer drug
- Active leptomeningeal disease
- Uncontrolled, untreated brain metastasis
Read by machine on 10 November 2026.
Where in France
- Institut BergonieBordeaux, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Institut Paoli-CalmettesMarseille, FranceTaking people
- Institut Regional Du Cancer De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre De Lutte Contre Le Cancer Eugene MarquisRennes Cedex, FranceTaking people
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BeOne Medicines I GmbH
- Trial code
- NCT07492641EU 2025-523960-19-00
- Record updated
- 9 November 2026
- Original description
To evaluate the progression-free survival (PFS) for treatment with BGB-43395 plus letrozole (Arm A) compared with CDK4/6i plus letrozole (Arm B) in patients with advanced or metastatic HR+/HER2- BC who have not received prior systemic treatment for advanced or metastatic disease.Read full original descriptionShow less
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
To evaluate the progression-free survival (PFS) for treatment with BGB-43395 plus letrozole (Arm A) compared with CDK4/6i plus letrozole (Arm B) in patients with advanced or metastatic HR+/HER2- BC who have not received prior systemic treatment for advanced or metastatic disease.
Inclusion: Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent; Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer; Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1; Adequate organ function.
Exclusion: Participants who have received prior systemic treatment in the advanced or metastatic setting; Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting; Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.