This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer. Participants must have HER2-low and PD-L1 positive (CPS≥1)breast cancer that has been treated before. Participants' cancer: Cannot be removed by an operation Has spread to other parts of the body
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tucidinostat (chidamide),30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w
Progression-free survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
Objective Response Rate(ORR)
Objective Response Rate(ORR)by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR)
Time frame: 2 years
Clinical Benefit Rate (CBR)
the total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months
Time frame: 2 years
Disease Control Rate (DCR)
the total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD)
Time frame: 2 years
Overall survival (OS)
Time from treatment until death from any cause
Time frame: 2 years
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