This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer.
Eribulin: According to the standard dose,1.4mg/m\^2 day1、8,repeated every 3 week. After 6 cycles, the investigator decided whether to continue treatment depending on the patient's tolerance. Sintilimab: 500mg once every three weeks. The patients were treated until disease progression or intolerable side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
1.4mg/m\^2 day1、8,repeated every 3 week.
500mg once every three weeks.
zhejiangCH
Hangzhou, Zhejiang, China
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: up to 24 months
Progression-Free Survival (PFS)
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: up to 24 months
Clinical Benefit Rate (CBR)
Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeksin the ITT analysis set.
Time frame: up to 24 months
Duration of Overall Response(DoR)
ime from first recording to CR or PR to disease progression or all-cause death.
Time frame: up to 24 months
Time to response (TTR)
TR defined as the time from the date of the first dose of study treatment to the first objective tumor response when CR or PR is observed.
Time frame: up to 24 months
Overall survival (OS)
Time to death from any cause from the date of first dose of study treatment
Time frame: up to 24 months
adverse event(AE)
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Evaluation performed using the National Cancer Institute (NCI)- Standard for Common Terminology for Adverse Events (CTCAE)v.5.0.
Time frame: Throughout the experiment, assessed up to 24 months.