Objective to evaluate the efficacy and safety of neoadjuvant therapy with Chidamide combined with chemotherapy for stage II - III triple-negative breast cancer,and to compare the efficacy and safety of chemotherapy with Chidamide and chemotherapy alone in the neoadjuvant treatment of stage II - III triple-negative breast cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Chidamide, orally,20mg at day 0,4,7,11,21,every 3 weeks; in combination with Docetaxel 75mg/m2,intravenous infusion,at day1 every 3 weeks,and Epirubicin 75mg/m2, intravenous infusion,at day1 every 3 weeks
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGEfficacy Outcome: pathologic complete response(pCR) rate(ypT0/is ypN0)
pCR defined as no invasive tumour residuals in breast and no invasive and no non-invasive tumour residuals in axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy
Time frame: 1years
Objective Response Rate (ORR) by RECIST v1.1
Objective Response Rate (ORR) by RECIST v1.1
Time frame: 12 months
pCR by other definitions
response by other pCR definitions(ypT0 ypN0; ypT0 ypN0/+;ypT0/is ypN0/+; ypT\[any\] ypN0)
Time frame: 12 months
Breast conserving surgery rate
Breast conserving surgery rate
Time frame: 12 months
Event-free survival
Event-free survival
Time frame: 60 months
Overall survival
Overall survival
Time frame: 72 months
Incidence of Adverse Events (AEs)
Incidence of Adverse Events (AEs)
Time frame: 12 months
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