To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Eribulin Mesylate,1.4mg/m2,Intravenous infusion,d1,d8,3-week cycle
Sintilimab Injection,Intravenous infusion,200mg,3-week cycle
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression Free Survival,PFS
The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Number of participants with Adverse Events
Adverse Events are monitored throughout the trial and for 30 days after discontinuation of treatment (90 days for serious adverse events) and graded according to the Common Terminology Criteria for Adverse Events, version 4.0, of the National Cancer Institute.
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
the correlation between the expression of PD-L1 of circulating tumor cells and prognosis
To detect the differences of the expression of PD-L1 in patients with different curative effects and prognosis,including the number of circulating tumor cells,and PD-L1 expression or others.
Time frame: From one week before treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
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