Phase III Study Comparing TQB2102 Injection to Docetaxel Plus Trastuzumab and Pertuzumab for Treating HER2 Positive Recurrent or Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a new drug called TQB2102 for Injection compared to a combination treatment of docetaxel, trastuzumab, and pertuzumab in adults with HER2 positive recurrent or metastatic breast cancer. This Phase III trial involves multiple centers and randomizes participants into two groups to compare these treatments. The study aims to better understand how well TQB2102 works and its safety profile in this patient population. Participants receive treatments through intravenous infusions every 21 days. One group is treated with TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab following specific dosing schedules. Docetaxel is given once every three weeks for six cycles, trastuzumab starts with a loading dose followed by maintenance doses every three weeks, and pertuzumab is administered with an initial loading dose followed by maintenance doses every three weeks with observation after infusions. The study compares these two treatment approaches over the course of the trial. During the study, participants will undergo regular evaluations including imaging to assess tumor response, blood tests to monitor drug levels and immune responses, and tracking of any side effects or adverse events. The primary outcomes measured are the objective response rate and progression-free survival up to about 30 months. Secondary outcomes include overall survival, duration of remission, and detailed safety assessments up to around 52 months. The study also involves monitoring specific antibodies related to the drug and other laboratory markers to understand treatment effects fully.

A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer