Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .
• Women aged ≥18 years and ≤70 years
• Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
• Not received treatment for breast cancer before operation
• Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 \>20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged \<35 years
• HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
• Performance status (PS) 0-1
• Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit
• No obvious main organs dysfunction