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 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.

Trial Details

NCT ID
NCT06486883
Phase
PHASE2
Sponsor
MedSIR
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Trastuzumab deruxtecan (T-DXd, DS-8201a)
  • CDK4/6i plus ET
Locations (sample)
  • Graz, Austria|47.06733,15.44197
  • Linz, Austria|48.30639,14.28611
  • Vienna, Austria|48.20849,16.37208
  • Brasschaat, Belgium|51.2912,4.49182
  • Ghent, Belgium|51.05,3.71667

Key Eligibility Criteria

  • Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific pro…
  • Female or male patients ≥ 18 years of age at the time of signing ICF.
  • ECOG performance status of 0-1.
  • Minimum life expectancy of ≥ 12 weeks at screening.

For full eligibility, visit ClinicalTrials.gov.

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