Disitamab Vedotin in Combination With Pyrotinib Versus THP for First-line Treatment of HER2-positive Advanced Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a new combination treatment using disitamab vedotin and pyrotinib compared to the current standard first-line therapy of paclitaxel combined with trastuzumab and pertuzumab for women newly diagnosed with recurrent or metastatic HER2-positive advanced breast cancer. This phase III randomized, double-blind trial also explores how biomarkers might influence treatment outcomes and safety. Participants in the experimental group receive disitamab vedotin intravenously every 14 days at 2 mg/kg combined with daily oral pyrotinib in 28-day cycles for 6 to 8 cycles, followed by maintenance treatment with trastuzumab and pyrotinib. The control group receives a taxane drug (such as docetaxel or paclitaxel) with trastuzumab and pertuzumab every 21 days for 6 to 8 cycles, followed by maintenance therapy with trastuzumab and pertuzumab. Treatment dosing aligns with national guidelines for breast cancer therapy. During the study, participants will have regular assessments including tumor measurements, organ function tests, and quality of life evaluations. Researchers will monitor progression-free survival over about 30 months, along with overall survival, disease control rates, response rates, clinical benefits, adverse events, and biomarker effects. Safety monitoring continues through treatment completion, with the total study duration extending to 8 years for some outcomes.

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