Safety and Effectiveness of Inetetamab with Pertuzumab or Pyrotinib Plus Chemotherapy as First Treatment for HER2 Positive Metastatic Breast Cancer in Women Aged 18 to 70

What this Trial Is About

Researchers are studying the safety and effectiveness of two combination treatments for women with HER2-positive metastatic or recurrent breast cancer. This trial focuses on first-line treatments using Inetetamab combined either with Pertuzumab or with Pyrotinib plus chemotherapy. The goal is to find better clinical benefits and offer new targeted treatment options for this condition. Participants receive Inetetamab intravenously every three weeks with a loading dose followed by maintenance doses. One group also receives Pertuzumab intravenously every three weeks, while the other group takes Pyrotinib orally daily. Chemotherapy is chosen by the doctor. Treatments continue until disease progression, unacceptable side effects, or study end. The study is randomized and open-label, comparing these two regimens. During the study, participants will have tumor assessments every six weeks to measure overall response and progression-free survival, lasting up to two years. Safety is monitored through adverse event reporting and heart function tests. The trial also tracks overall survival for up to about 48 months. Participants will be followed closely with clinical evaluations, imaging, and laboratory tests throughout their involvement.

The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer