This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.
Voluntarily participate in this study, sign the informed consent form, and have good compliance;
Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival >6 months;
Histologically or cytologically confirmed HER2-positive invasive breast cancer;
Hormone receptor (HR) status confirmed;
Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
Bilateral breast cancer or inflammatory breast cancer;
History of invasive breast cancer or ductal carcinoma in situ;
Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;