Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal subtype.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent musi rozumieć cel badania i podpisać świadomą zgodę przed rozpoczęciem
- •Wiek co najmniej 18 lat w momencie podpisania zgody
- •Dobry stan ogólny (ECOG 0-1)
- •Spodziewana długość życia co najmniej 12 tygodni
- •Rak piersi z niską ekspresją białka HER2 lub ultraniską (potwierdzone badaniem laboratoryjnym)
- •Nieoperacyjny, zaawansowany rak piersi z przerzutami potwierdzonymi tomografią
- •Brak wcześniejszego leczenia systemowego zaawansowanego nowotworu
- •Pacjenci leczeni inhibitorami CDK4/6 w przeszłości mogą być włączeni, jeśli od końca leczenia minęło co najmniej 12 miesięcy
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (72)
Kepler Universitäts Klinikum
Linz, Austria
Medical University of Vienna
Vienna, Austria
Algemeen Ziekenhuis Klina
Brasschaat, Belgium
Ghent University Hospital
Ghent, Belgium
CHU Helora - Hopital de Mons
Mons, Belgium
Cliniques universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Centre Francois Baclesse
Caen, France
CHU Lyon Sud
Lyon, France
Institute Paoli Calmettes
Marseille, France
Institut Curie
Paris, France
CHU Saint Etienne
Saint-Priest-en-Jarez, France
MVZ Klinikum Aschaffenburg
Aschaffenburg, Germany
Kliniken Essen Mitte
Essen, Germany
Klinikum Worms - Frauenklinik
Worms, Germany
A.O.U. Ospedali Riuniti di Ancona
Ancona, Italy
Centro di Riferimento Oncologico di Aviano
Aviano, Italy
AOU Careggi
Florence, Italy
Ospedale Policlinico San Martino
Genova, Italy
Instituto Europeo di Oncologia
Milan, Italy
Ospedale San Gerardo
Monza, Italy
Federico II Napoli
Naples, Italy
Istituto Nazionale Tumori Irccs "Fondazione G Pascale"
Naples, Italy
Ospedale Sacro Cuore Don Calabria Negrar
Negrar, Italy
Azienda Ospedaliero- Universitaria Maggiore Della Carita
Novara, Italy
Istituto Oncologico Veneto
Padova, Italy
Oncologia medica AUSL Piacenza
Piacenza, Italy
Ospedale di Macerata
Province of Macerata, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Medtrials Sp. z o.o.
Krakow, Poland
Unidade Local de Saúde de Trás-os-Montes e Alto Douro
Lordelo, Portugal
Hospital de Cascais
Alcabideche, Portugal
Unidade Local de Saúde Amadora/Sintra - Hospital Fernando da Fonseca
Amadora, Portugal
Unidade Local de Saúde da Região de Aveiro
Aveiro, Portugal
Unidade Local de Saúde do Alto Ave
Braga, Portugal
Unidade Local de Saúde de Santa Maria
Lisbon, Portugal
Hospital Da Luz Lisboa
Lisbon, Portugal
Hospital Beatriz Ângelo
Loures, Portugal
Instituto Portugues Oncologia de Porto (IPO)
Porto, Portugal
Unidade Local de Saúde de Santo António
Porto, Portugal
Hospital Quirónsalud Sagrado Corazón
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Institut Català d' Oncologia Girona (ICO)
Girona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitari Sant Joan de Reus
Reus, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Centro Oncológico de Galicia
A Coruña, Spain
Hospital Universitario San Juan de Alicante
Alicante, Spain
Institut Català d' Oncologia Badalona (ICO)
Badalona, Spain
UOMI Cancer Center
Barcelona, Spain
Hospital Universitari Dexeus
Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Spain
Hospital Beata María Ana
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital QuirónSalud Zaragoza
Zaragoza, Spain
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
The Christie NHS Foundation Trust
Lancaster, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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