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Study identifier: NCT06486883 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Advanced Breast Cancer · Advanced Breast Carcinoma · Hormone Receptor Positive Breast Carcinoma  ·  Sponsor: MedSIR

PhasePhase 2
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

MEDSIR  ·  + 34 932 214 135  ·  contact.trials@medsir.org

Always discuss trial participation with your own doctor first.

Locations (72)

Kepler Universitäts KlinikumLinz, AustriaRecruiting
Medical University of ViennaVienna, AustriaRecruiting
Algemeen Ziekenhuis KlinaBrasschaat, BelgiumRecruiting
Ghent University HospitalGhent, BelgiumRecruiting
CHU Helora - Hopital de MonsMons, BelgiumRecruiting
Cliniques universitaires Saint-LucWoluwe-Saint-Lambert, BelgiumRecruiting
Centre Francois BaclesseCaen, FranceRecruiting
CHU Lyon SudLyon, FranceRecruiting
Institute Paoli CalmettesMarseille, FranceRecruiting
Institut CurieParis, FranceRecruiting
CHU Saint EtienneSaint-Priest-en-Jarez, FranceRecruiting
MVZ Klinikum AschaffenburgAschaffenburg, GermanyRecruiting

+ 60 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06486883