drugset / Trial / NCT02489409

Recombinant Human Endostatin (EndostarTM) Injection in Treatment of Recurrent Metastatic Breast Cancer

NCT02489409

Phase 2 Unknown 120 enrolled Xinjiang Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-10
Primary completion
2018-05
Completion
2018-07

Drugs

EvaluationDrugModalityDoseRoute
Subject EndostarTM Unknown 210 mg Other
Background Capecitabine Small molecule 2000 mg/m2 Oral
Background Gemcitabine Small molecule Intravenous
Background Platinum Small molecule 30 mg/m2 Intravenous
Background Vinorelbine Small molecule 40 mg Intravenous

Indications