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; expectedsurvival of more than 3 months;

• Histologically confirmed invasive breast cancer, no history of any systemicanti-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 afterneoadjuvant therapy;

• Major organ functions are good, meeting certain criteria;

• Agree to use contraception during the study and within 6 months after the studyends; female patients must have a negative serum pregnancy test within 7 days beforeenrollment and must be non-lactating.

Exclusion Criteria:

• IV stage metastatic breast cancer or deemed unable to achieve curative surgicalresection through neoadjuvant therapy by other investigators.

• Bilateral invasive breast cancer.

• Coexisting diseases and medical history:

1. History of invasive breast cancer.

2. Occurrence of any other malignant tumors within the last 3 years or currentsimultaneous presence.

3. Underwent significant surgical treatment, incisional biopsy, or significanttrauma within 28 days before the start of the study.

4. Unhealed wounds or fractures.

5. Ocular diseases deemed clinically significant by the investigator.

6. Occurrence of arterial/deep venous thrombotic events within the last 6 months.

7. History of substance abuse with inability to quit or individuals with mentaldisorders.

8. ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2congestive heart failure.

9. Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of thestudy.

10. History of interstitial lung disease/pneumonia requiring intervention withsteroid treatment, or current presence, or suspected interstitial lungdisease/pneumonia during the screening period that cannot be ruled out by theinvestigator; individuals with pulmonary diseases deemed unsuitable forparticipation by the investigator.

• Tumor-related symptoms and treatment:

1. Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapywithin 4 weeks before the start of the study.

2. Received traditional Chinese medicine treatment with indications for anti-tumoreffects within 2 weeks before the start of the study.

3. Radiological evidence of tumor invasion into major vessels or judged by theinvestigator to be highly likely to invade major vessels during the subsequentstudy period, leading to fatal hemorrhage.

• Study treatment-related:

1. Experienced severe hypersensitivity reactions after using monoclonalantibodies.

2. Developed uncontrollable active autoimmune diseases within 2 weeks before thestart of the study.

3. Allergic to any component or excipient in any study drug.

• Participated in other clinical trials of anti-tumor drugs within 4 weeks before thestart of the study.

• Deemed inappropriate for inclusion based on the investigator's judgment.