Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
• Age: 18-70 years;
• Clinical T2-T4d, or T1c with axillary lymph node positivity;
• Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay；
• Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
• No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
‣ Neutrophil count absolute value ≧2.0×109/L;
⁃ Hemoglobin ≧ 100g/L;
⁃ Platelet count ≧100×109/L;
⁃ Total bilirubin \<1.5 ULN (upper limit of normal);
⁃ Creatinine \< 1.5×ULN
⁃ AST/ALT \< 1.5×ULN;
• Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
• Reproductive age women, negative serum pregnancy test within 14 days before randomization;
• ECOG score 0 or 1;
• Signature of informed consent.