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
- Ancona, Bergamo, Genoa, Milan, Monza, Padova, and Rome, ItalySee the 8 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking 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?
Trial 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.