Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HR+/HER2- Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| BGB-43395 | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: BGB-43395 + Letrozole
- description
- Participants will receive BGB-43395 in combination with letrozole.
- interventionNames
- Drug: BGB-43395
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
- description
- Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
- interventionNames
- Drug: Letrozole
- Drug: Abemaciclib
- Drug: Palbociclib
- Drug: Ribociclib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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.
References
Publications (0)
Data not yet available