Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors. Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC). However, the research about the efficacy of Endostatin on breast cancer has just started. Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy. Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations. So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad. To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Large amounts of studies have proved that the development of tumor vessels mainly depend on the activation, proliferation, adhesion and maturity of vascular endothelial cells, which may also become the targets of vascular inhibitors. At present, Avastin, an anti-angiogenesis drug, has been marketed in Euopean and American countries, and another 30 kinds of vascular inhibitors are still in trails. Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors. Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC). However, the research about the efficacy of Endostatin on breast cancer has just started. Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy. Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations. So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad. To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
1.0 m/m2, iv 0.5h, d1, 8
40 mg/d, iv, d1, 8
30 mg/m2, iv 3h, d1-3
2 000 mg/m2, po, d1-14
Third Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
RECRUITINGresponse rate
response rate that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment. ORR=(CR+ CRu+ PR)cases/total cases×100%.
Time frame: 2 years
clinical benefit rate
clinical benefit rate that defined as the total ratio of study subjects with complete response,partial response and stable disease more than 24 months after treatment.
Time frame: 2 years
progression-free survival
Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died from the start of randomization.
Time frame: 2 years
median survival time
median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.
Time frame: 2 years
overall survival
overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization
Time frame: 2 years
adverse responses
adverse responses that defined as the evaluated by rates of all adverse reactions caused by Recombinant Human Endostatin and the changes of all indexes before and after treatment
Time frame: 2 years
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