This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.
Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.
The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.
The total number of patients to be included in this study is 520 patients.
Females with age between 18 to 70 years old;
Histologically confirmed primary invasive breast cancer;
Histologically confirmed triple negative breast cancer;
Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
Patients with severe systemic infection or other serious diseases;
Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
Parallel
Nab-paclitaxel + Carboplatin
Drugnab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles;
Nab-paclitaxel + Epirubicin
Drugnab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and epirubicin given IV at 75 mg/m\^2 on days 1 every 21 days x 6 cycles；
pCR (pathological complete response)
No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR
Objective response rate (ORR)
Disease free survival（DFS）
Adverse events (AE)
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Hebei Medical University Fourth Hospital
Lead sponsor
Beijing 302 Hospital
Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator
