This study was a single-arm, open-label, phase II study of breast cancer patients with brain metastases. Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.
The natural survival time of breast cancer patients with brain metastases is short and the prognosis is poor. Although the treatment is progressing, but it is still limited. The current domestic guidelines still recommend local therapy as a priority treatment strategy. At the same time, about 80% of patients with brain metastasis will progress to extracranial metastasis, so superior systemic treatment is particularly important, but very lacking.Therefore, new systematic therapeutic drugs are urgently needed .Eutiderone is a new generation of epirubicin anti-tumor drug with good efficacy and safety. In pre-clinical studies, it has been shown that the drug concentration in most tissues is higher than that in plasma, and the concentration of eutiderone in brain tissue is higher, indicating that the drug is easy to cross the blood-brain barrier.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.MRI of the brain with contrast enhancement was performed at baseline and every 6 weeks after enrollment; thereafter, patients with stable disease or a response could be assessed at a reduced frequency to every 9 weeks; central nervous system and noncentral nervous system lesions were assessed according to RANO-BM criteria and RECIST v1.1 criteria until disease progression, respectively.
Yehui Shi
Tianjin, Tianjin Municipality, China
RECRUITINGCNS Objective response rate (CNS-ORR)
The proportion of patients with complete response (CR) and partial response (PR) evaluated as the best response observed from enrollment to progression of all CNS target lesions assessed according to RANO-BM criteria among the total number of patients who could be evaluated.
Time frame: 12 months
CNS Clinical benefit rate(CNS-CBR)
Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) in all CNS target lesions assessed by RANO-BM criteria within 12 weeks.
Time frame: 3 months
CNS Progression-free survival (CNS-PFS)
Time from enrollment to the first radiographic documented disease progression (PD) of all CNS target lesions (RANO-BM criteria) or death from any cause without progression was recorded.
Time frame: 36 months
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Time frame: 12 months
Progression-free survival(PFS)
Time from enrollment to the first radiographically confirmed disease progression (PD) (RECIST 1.1 criteria) or death from any cause without documented progression
Time frame: 36 months
Overall survival (OS)
Time from the enrollment to death of any cause
Time frame: 36 months
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