NCT07492641RecruitingPhase 3
BGB-43395 in Combination with Letrozole versus CDK4/6i with Letrozole for Patients with Previously Untreated Advanced or Metastatic HR+/HER2- Breast Cancer
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: EU CTIS (euclinicaltrials.eu) · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 233 (estimated)
- First submitted
- 17 Apr 2026
- Start date
- 3 Aug 2026
- Lead sponsor
- BeOne Medicines I GmbH
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07492641
- EU CT number
- 2025-523960-19-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 233
- 53 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HELIOS Klinikum Berlin Buch GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Augusta-Kranken-Anstalt gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Knappschaft Kliniken Bottrop GmbH Coordinator of this site? Confirm its status | Bottrop | Germany | Recruiting |
| Kliniken der Stadt Koeln gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Kostara Gyn. Oncology Clinic Research UG (haftungsbeschraenkt) Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Recruiting |
| Centrum für Hämatologie und Onkologie Bethanien Coordinator of this site? Confirm its status | Frankfurt/Main | Germany | Recruiting |
| MVZ Onko Medical GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Institut fuer Versorgungsforschung in der Onkologie GbR Coordinator of this site? Confirm its status | Koblenz | Germany | Recruiting |
| Lübecker Onkologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Universitatsklinikum Munster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Beata María Ana Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | Saint-Herblain Cedex | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Europejskie Centrum Zdrowia Otwock Sp. Z.o.o. Coordinator of this site? Confirm its status | Otwock | Poland | Recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.