evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+ABC
This trial is a single-arm study. Designed to evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+/HER2- advanced breast cancer that has failed previous CDK4/6 inhibitor combined with aromatase inhibitor therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
chidamide combined with fulvestrant
Progression Free Survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Time frame: 2 years
Objective Response Rate (ORR)
The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
Time frame: 2 years
clinical benefit rate(CBR)
Defined as the percentage of patients who achieved complete remission (CR), partial remission (PR) and stable disease (SD) for ≥24 weeks as a percentage of the total number of patients in the analysis set.
Time frame: 2 years
The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Time frame: 2 years
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