This is a prospective, single center, single arm phase II study designed to explore the efficacy and safety of surufatinib + fulvastrant + chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy.
This is a prospective, single center, single arm phase II study. In the safety lead-in stage, 6 subjects will be recruited and administered with surufatinib 250 mg/d, QD PO; Fulvestrant 500mg, im, Q4W; Chidamide 30mg, PO, BIW, with four weeks as a cycle. DLTs of the 6 subjects will be evaluated in the first cycle to determine the recommended dosage of combinational therapy. Then 57 subjects will be recruited and administered with the triplet regimen to explore the efficacy and safety of combinational treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
surufatinib: 250 mg/d, QD PO; Fulvestrant: 500mg, im, Q4W; Chidamide 30mg, PO, BIW; Q4W
Anyang Tumor Hospital
Anyang, China
RECRUITINGHenan University of Science and Technology First Affiliated Hospital
Luoyang, China
RECRUITINGNanyang Second General Hospital
Nanyang, China
NOT_YET_RECRUITINGPFS
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time frame: up to 3 years
ORR
The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart.
Time frame: up to 3 years
DCR
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD).
Time frame: up to 3 years
OS
The time from recruitment to death due to any cause.
Time frame: up to 3 years
Adverse Events (AEs)
Adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0.
Time frame: up to 3 years
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He'nan Cancer Hospital
Zhengzhou, China
RECRUITINGThe Third People's Hospital of Zhengzhou
Zhengzhou, China
RECRUITING