A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
Trial Parameters
Brief Summary
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.
Eligibility Criteria
Inclusion Criteria: * Subjects voluntarily enrolled in this study with good compliance * Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1 * HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology * Defined hormone receptor (HR) status * Has not received systemic anti-tumor therapy during the recurrence/metastasis stage (acceptable ≤ first-line endocrine therapy) * If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence/metastasis be greater than 12 months * Have at least one measurable lesion according to RECIST 1.1 criteria; * Good major organ function Exclusion Criteria: * It is known that there is spinal cord compression or active central nervous system metastasis; * Subjects with only skin and/or brain lesions as target lesions * Combined diseases and medical history 1