Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial

The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are: * Analyse the efficacy and safety of disitamab vedotin in combination wit

Trial Details

NCT ID
NCT06278870
Phase
PHASE3
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • disitamab vedotin
  • Pyrotinib
  • trastuzumab
  • Pertuzumab
  • taxane drug
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Adult female patients (age 18-75 years) with metastatic breast cancer confirmed by pathology or imaging;
  • Pathologically confirmed HER2 positive (definition: Immunohistochemistry(IHC) 3+, or IHC 2+ and Fluorescent In Situ Hybridization(FISH) amplificati…
  • No previous chemotherapy regimen for metastatic breast cancer;
  • At least one measurable lesion exists (Response Evaluation Criteria in Solid Tumors(RECIST) 1.1);

For full eligibility, visit ClinicalTrials.gov.

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