An Open-Label, Multicenter, Randomized Controlled Phase III Clinical Study of Neoadjuvant Chemotherapy Based on SNF Classification With or Without Precision Medicine Agents for Early-Stage or Locally Advanced HR+/HER2- Breast Cancer
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.
⁃ Eligibility Criteria:
• Female patients aged 18 to 70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed HR-positive/HER2-negative breast cancer (defined as: (1) ER-positive: ≥10% tumor cells positive by immunohistochemistry (IHC).
⁃ (2) PR-positive: ≥10% tumor cells positive by IHC. (3) HR-positive: ER and/or PR positive. (4) HER2-negative: HER2 0-1+ by IHC or HER2 2+ with negative FISH (no amplification).
⁃ 4\. Confirmed SNF2/3/4 subtype based on H\&E staining combined with digital pathology molecular subtyping.
⁃ 5\. Clinical tumor stage: cT1c-T2, cN1-N2 or cT3-T4, cN0-N2. 6. Agreement to undergo breast cancer surgery if meeting the criteria for resection after neoadjuvant therapy.
⁃ 7\. Adequate organ function, meeting the following criteria: Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥75×10⁹/L; Total bilirubin (TBIL) ≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; Serum creatinine (Cr) ≤1×ULN; Creatinine clearance rate (CrCl) \>50 mL/min (calculated by Cockcroft-Gault formula).
⁃ 8\. Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiography or MUGA scan.
⁃ 9\. Negative serum pregnancy test for women of childbearing potential. Contraception requirement: Women of childbearing potential must use medically approved contraception during treatment and for at least 3 months after the last dose of the study drug.
⁃ 10Voluntary participation with signed informed consent, good compliance, and willingness to follow up.