Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.

Inclusion criteria

• 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

Exclusion criteria

• metastatic breast cancer
• Patient is pregnant or breast feeding
• Any evidence of sense or motor nerve disorders
• Bilateral Primary Breast Cancer (DCIS in one side not included)
• Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
• Have received chemotherapy because of any malignancy other than breast cancer
• Known severe hypersensitivity to any drugs in this study