To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Paclitaxel for injection (albumin binding)260mg/m2,I.v., d1;carboplatin AUC=5, I.v., d1; 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle,and use the EC protocol in advance or decide the next treatment
Paclitaxel 175mg/m2, I.v., d1; Carboplatin injection AUC 5, I.v., d1; 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle,and use the EC protocol in advance or decide the next treatment protocol by the researcher
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
pathologic complete response(pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)
Time frame: 6 months
Objective Response Rate (ORR)
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time frame: 3 months
Disease-free survival(DFS)
Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.
Time frame: 5 years
Overall survival(OS)
Overall survival is defined as the length of time from random assignment to death or to last contact.
Time frame: 5 years
adverse events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
Time frame: until 28 days after the last study drug administration
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