This Phase Ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced HR-positive, HER2-negative breast cancer patients after the failure of CDK4/6 inhibitor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
chidamide,30mg,po. biw fulvestrant ,500mg, im., d1(c1d15), q4w angiogenesis inhibitors , according to the doctor's advice
Affiliated Tumor Hospital of Shantou University Medical College
Shantou, China
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
Progression-free survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
Disease Control Rate (DCR)
he total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD)
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
Overall survival (OS)
Time from treatment until death from any cause
Time frame: 2 years
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