Phase III Study Comparing BL-M07D1 Plus Pertuzumab With Docetaxel, Trastuzumab, and Pertuzumab in First-Line Treatment of HER2-Positive Recurrent or Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of BL-M07D1 combined with Pertuzumab compared to the combination of Docetaxel, Trastuzumab, and Pertuzumab in women with first-line HER2-positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter study aims to provide important data on treatment options for this type of breast cancer. In this trial, participants are randomly assigned to one of two groups. One group receives BL-M07D1 and Pertuzumab administered intravenously every 3 weeks in treatment cycles. The other group receives Docetaxel, Trastuzumab, and Pertuzumab, also given by intravenous infusion every 3 weeks. Participants showing clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons require stopping. Participants will be monitored for up to approximately 24 months to assess progression-free survival as the primary outcome. Researchers will also evaluate overall survival, response rates, duration of response, disease control, clinical benefit, treatment-related adverse events, and development of anti-drug antibodies. Safety assessments and tumor tissue analysis are included. The study involves regular visits for treatment administration, evaluations, and follow-up over the study period.

A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer