About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Nab-paclitaxel + Carboplatin
- Nab-paclitaxel + Epirubicin
Treatment groups
Locations
1Sponsors and collaborators
Hebei Medical University Fourth Hospital
Lead sponsor
Beijing 302 Hospital
Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator