Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）

Exclusion Criteria

• •1. Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test at baseline and do not agree to use effective contraception during the study.
• •2. Patients with a known history of severe allergic reactions to any investigational drug components (NCI-CTCAE Grade \> 3) or with any clearly documented drug allergy.
• •3. Patients with bilateral breast cancer or inflammatory breast cancer.
• •4. Patients with metastatic (stage IV) breast cancer at initial diagnosis.
• •5. Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.
• •6. Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc.
• •7. Current diagnosis of severe liver-related diseases such as acute hepatitis, fulminant hepatitis, coagulation factor synthesis disorders. If HBV surface antigen or HBV core antibody are positive, the peripheral blood HBV DNA titer should be \< 1×10\^3 IU/ml for eligibility.
• •8. Any other serious medical condition or comorbidity that may interfere with participation in the study or may significantly affect the safety of the subject (e.g., active or uncontrolled infections, active or requiring antiviral therapy for liver and bile diseases).
• •9. Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol.
• •10. Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer).
• •11. Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions.
• •12. Patients with non-measurable tumors during treatment.
• •13. Any other condition that the investigator deems unsuitable for the participation of the subject in the study.