Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer：a Multicenter Randomized Controlled Trial
Recent clinical studies showed that breast cancer patients especially for those with lymph node metastasis may benefit from dose-dense chemotherapy, like adriamycin and cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd) regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative breast cancer patients. In our study, a prospective, randomized, open-label, multi-center clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy regimen (dd epirubicin/cyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional chemotherapy (epirubicin/cyclophosphamide (EC) followed by docetaxel (T)) as preoperative neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese population.
• Female aged 18-70 years old;
• Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable), clinical stage IIA-IIIA;
• Definite reports on ER/PR/HER2 receptor showing all HER2 negative (HER2 is 0\
⁃ 1+ or 2+ but determined negative via fluorescence in situ hybridization (FISH) or chemiluminescent in situ hybridization (CISH) detected (no amplification) is defined as HER2 negative);
• According to RECIST 1.1, there is at least one measurable objective focus, tumor size \> 2cm;
• Eastern Cooperative Oncology Group (ECOG) performance score is 0 or 1;
• Cardiac function: left ventricular ejection fraction (LVEF)≥55%;
• Normal bone marrow function: White blood cell count \> 4 × 10\^9/l, neutrophil count \> 1.5 × 10\^9/l, platelet count \> 100 × 10\^9/l and hemoglobin 9g/dl;
• Normal liver and renal function: aspartate aminotransferase (AST) and ALT ≤2.5 folds of the upper limit of normal values, total bilirubin ≤1.5 folds of the upper limit of normal values; Serum creatinine ≤1.5 folds of the upper limit of normal value.
• Informed consent form signed.