Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Trial Parameters
Brief Summary
The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Eligibility Criteria
Inclusion Criteria: Age: 18-70 years old. Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity. Histologically confirmed HER2-positive invasive breast cancer: Note: HER2 positivity is defined as at least one assessment (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH). Clinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization. Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy): 1. Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L 2. Hemoglobin ≥ 100 g/L 3. Platelet count ≥ 100 × 10⁹/L 4. Total bilirubin \< 1.5 × upper limit of normal (ULN) 5. Serum creatinine \< 1.5 × ULN 6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \< 1.5 × ULN