Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
BeOne Medicines (Voir sur ClinicalTrials)
mai 2026
août 2037
27 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Jean ZEGHONDY | 21/10/2026 14:50:03 | Contact (sur clinicalTrials) | ||
Critères
Tous
- 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 Criteria:
- 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, except for prior
investigational or approved SERDs in the adjuvant setting, provided that disease
recurrence occurred more than 12 months after the last dose of endocrine-based
therapy.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain
metastasis.
Note: Other protocol-defined inclusion/exclusion criteria may apply.