A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

Inclusion criteria

• Voluntarily participate in this study and sign informed consent;
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected survival of more than 3 months;
• Histologically confirmed invasive breast cancer, no history of any systemic anti-tumor therapy for breast cancer;
• Confirmed as HER2 positive;
• Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
• Agree to undergo breast cancer surgery when reaching the surgical criteria after neoadjuvant therapy;
• Major organ functions are good, meeting certain criteria;
• Agree to use contraception during the study and within 6 months after the study ends; female patients must have a negative serum pregnancy test within 7 days before enrollment and must be non-lactating.

Exclusion criteria

• IV stage metastatic breast cancer or deemed unable to achieve curative surgical resection through neoadjuvant therapy by other investigators.
• Bilateral invasive breast cancer.
• Coexisting diseases and medical history:

• History of invasive breast cancer.
• Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
• Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
• Unhealed wounds or fractures.
• Ocular diseases deemed clinically significant by the investigator.
• Occurrence of arterial/deep venous thrombotic events within the last 6 months.
• History of substance abuse with inability to quit or individuals with mental disorders.
• ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
• Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
• History of interstitial lung disease/pneumonia requiring intervention with steroid treatment, or current presence, or suspected interstitial lung disease/pneumonia during the screening period that cannot be ruled out by the investigator; individuals with pulmonary diseases deemed unsuitable for participation by the investigator.
• Tumor-related symptoms and treatment:

• Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
• Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
• Radiological evidence of tumor invasion into major vessels or judged by the investigator to be highly likely to invade major vessels during the subsequent study period, leading to fatal hemorrhage.
• Study treatment-related:

• Experienced severe hypersensitivity reactions after using monoclonal antibodies.
• Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
• Allergic to any component or excipient in any study drug.
• Participated in other clinical trials of anti-tumor drugs within 4 weeks before the start of the study.
• Deemed inappropriate for inclusion based on the investigator's judgment.