A prospective phase II clinical study of Trastuzumab Rezetecan for Injection combined with Iparomlimab and Tuvonralimab Injection versus TAC regimen as neoadjuvant therapy for early or locally advanced HR-positive/HER2-low breast cancer

INTERVENTION: Control group:TAC regimen (Docetaxel + Cyclophosphamide + Epirubicin), one cycle every 3 weeks for 6 cycles. Docetaxel: 75mg/m^2, iv, Q3W; Epirubicin: 90mg/m^2, iv, Q3W; Cyclophosphamide: 500mg/m^2, iv, Q3W;Trial group:Injectable Rakencituzumab combined with Injectable Aparolitovorelizumab injection, one cycle every 3 weeks for 6 cycles. Injectable Rakencituzumab: 4.8mg/kg, iv, Q3W; Injectable Aparolitovorelizumab injection: 5mg/kg, iv, Q3W; CONDITION: Previously untreated early or locally advanced breast cancer with low‐to‐intermediate HR expression and low HER2 expression PRIMARY OUTCOME: Pathological complete response rate (pCR); SECONDARY OUTCOME: Objective response rate (ORR);Event‐free survival (EFS);Incidence of adverse events (AE/SAE); INCLUSION CRITERIA: 1.Age is greater than or equal to 18 and less than or equal to 70; 2.Histologically confirmed invasive breast cancer with no prior systemic anti‐tumor therapy for breast cancer; 3.Patients with breast cancer confirmed by histopathology to have positive HR expression and low HER2 expression (low HER2 expression is defined as IHC 1+ or IHC 2+/ISH‐); 4.Patients with stage II‐III breast cancer (cT2‐cT4 or N+, cM0) whose tumor staging conforms to the 8th edition AJCC Breast Cancer Staging Criteria; patients with supraclavicular lymph node metastasis should be excluded; 5.Having at least one measurable target lesion according to RECIST V1.1; 6.ECOG performance status score: 0–1; 7.The functional status of vital organs must meet the following requirements (no blood products or cell growth factors used for corrective treatment within 14 days prior to the first dose): 1) Bone marrow function: Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelets >= 100×1