This trial is a single-arm study. The purpose of the trial is to evaluate the efficacy and safety of chidamide and fulvestrant in HR+/HER2- breast cancer that has failed prior adjuvant endocrine therapy with CDK4/6 inhibitors.
The study was a single-center, single-arm, open trial design. Twenty-three patients with advanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6 inhibitors in combination with endocrine therapy were treated with fulvestrant and chidamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
chidamide combined with fulvestrant
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: max 6 months
PFS
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
CBR
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Time frame: max 6 months
DOR
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
Time frame: max 6 months
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