Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）
Trial Parameters
Brief Summary
This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive（ER≥50%），HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent form to participate in the clinical research. 2. Confirmed postmenopausal females diagnosed with invasive breast cancer. 3. Clinical stage T1-3N1M0. 4. Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++) but in situ hybridization (ISH) indicates negative. Strong positive for ER: ER immunohistochemistry test shows 50% or more tumor cells positive. 5. No prior breast cancer-related treatment. 6. No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I). 7. ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction. 8. Within 1 week prior to enrollment, routine blood tests are essentially normal: Absolute neutrophil count (NEUT#) ≥ 1.5×10\^9 /L; White blood cell count (WBC) ≥ 3.0×10\^9 /L; Platelets ≥ 90×10\^9