A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Exclusion Criteria20

• Diagnosis of stage IV metastatic breast cancer;
• Bilateral breast cancer;
• Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS);
• Diagnosis of another primary malignancy within 5 years prior to first dose;
• History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
• Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, and frequent and uncontrollable arrhythmias;
• Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Complicated lung disease resulting in severely impaired lung function;
• History of ILD / interstitial pneumonitis requiring steroid hormone therapy, current ILD / interstitial pneumonitis, or suspected of having such a disease, etc;
• Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;
• Severe infection within 4 weeks prior to first dose of study drug; active pulmonary inflammation present at screening;
• Ongoing treatment with \>10 mg/d prednisone systemic corticosteroid therapy or equivalent anti-inflammatory active drug or any form of immunosuppressive therapy within 2 weeks prior to the first dose;
• Known hypersensitivity to the study therapeutic drug or any study drug excipients or other monoclonal antibodies;
• Patients who are not suitable to receive the investigational drug (paclitaxel, patulizumab, trastuzumab);
• Have a history of autologous or allogeneic stem cell transplantation or organ transplantation;
• Suffering from severe neurological or psychiatric disorders;
• Subjects with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to signing the information;
• Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
• Subjects who are scheduled to receive a live vaccine or who have received a live vaccine within 28 days prior to the first dose;
• Presence of other serious physical, laboratory test abnormalities or poor compliance that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.