This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.
This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases. This study will be divided into two stages. Phase one, 120 cases of local advanced breast cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS. Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSurgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
pCR(pathologic complete response)
Time frame: up to 96 months
Time as a measure from randomization to disease recurrence or patients died due to disease progression.
DFS(Disease-free survival)
Time frame: up to 96 months
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