This is a multi-center , open-lable clinical trial. 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. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.
The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
Females with age between 18 to 70 years old;
Histologically confirmed triple negative breast cancer;
No more than one-line prior treatment for locally advanced or metastatic breast cancer;
Have at least one measurable lesion as per the RECIST criteria (version 1.1);
Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
Brain metastasis;
Recurrence or metastasis within 6 months after capecitabine withdrawal;
Recurrence or metastasis within 6 months after platinum withdrawal;
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 + Capecitabine
DrugNab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；
Progression free survival (PFS)
Up to disease progression or death due to any cause
PFS rate for 6 cycles
From the date of randomization to the end of 6 cycles
Objective response rate (ORR)
To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
Overall survival (OS)
To evaluate the overall survival of patients with advanced triple-negative breast cancer
Adverse events (AE)
To evaluate the adverse events of patients with advanced triple-negative breast cancer
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Hebei Medical University Fourth Hospital
Lead sponsor
Beijing 302 Hospital
Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator
