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Brief Title: Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer
Official Title: A Study to Assess the Efficacy and Safety of Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer
Study ID: NCT05291910
Brief Summary: This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.
Detailed Description: This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.To explore a new concept of anti-HER2 monoclonal antibody combined with immunotherapy in the treatment of recurrent or metastatic breast cancer. The primary end point is progression free survival (PFS). The secondary end points are objective response rate (ORR), Clinical Benefit Rate (CBR) and safety assessment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cancer Hospital Chinese Academy Of Medical Sciences, Beijing, , China
Name: Binghe Xu, MD
Affiliation: Director of Breast Cancer Section
Role: PRINCIPAL_INVESTIGATOR