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
- Berlin, Bochum, Bottrop, Cologne, Dresden, Duesseldorf, Essen, Esslingen am Neckar, Frankfurt/Main, Hamburg, Hanover, Homburg, Hösbach, Kiel, Koblenz, Leipzig, Lübeck, Muenster, Munich, Ravensburg, Velbert, and Westerstede, GermanySee the 24 sites
- Phase
- Phase 3
Where in Germany
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyTaking people
- Augusta-Kranken-Anstalt gGmbHBochum, GermanyTaking people
- Knappschaft Kliniken Bottrop GmbHBottrop, GermanyTaking people
- Kliniken der Stadt Koeln gGmbHCologne, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Kostara Gyn. Oncology Clinic Research UG (haftungsbeschraenkt)Duesseldorf, GermanyTaking people
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Klinikum Esslingen GmbHEsslingen am Neckar, GermanyTaking people
- Centrum für Hämatologie und Onkologie BethanienFrankfurt/Main, GermanyTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, GermanyTaking people
- Mammazentrum Hamburg MVZ GbRHamburg, GermanyTaking people
- MVZ Onko Medical GmbHHanover, GermanyTaking people
- Universitaet Des SaarlandesHomburg, GermanyTaking people
- MVZ am Klinikum Aschaffenburg, Zweigpraxis Hämatologie - OnkologieHösbach, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Institut fuer Versorgungsforschung in der Onkologie GbRKoblenz, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- MVZ für Hämatologie und Onkologie Lübeck GmbHLübeck, GermanyTaking people
- Universitatsklinikum Munster AöRMuenster, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- MVZ fuer Haematologie und Onkologie Ravensburg GmbHRavensburg, GermanyTaking people
- MVZ-Onkologie Velbert GbRVelbert, GermanyTaking people
- Medizinische Studiengesellschaft NORD-WEST GmbHWesterstede, GermanyTaking 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.