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

Breast Neoplasms Clinical Trial

Official title:

EndostarTM Injection Combined With Gemcitabine+Platinum (GP)/Navelbine+Platinum (NP)/Gemcitabine+Xeloda (GX)/Navelbine+Xeloda (NX) in Treatment of Recurrent Metastatic Breast Cancer: A Randomized, Opened and Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489409
• Other study ID #: XinjiangMU001
• Status: Recruiting
• Phase: Phase 2
• First received: July 1, 2015
• Last updated: July 12, 2017
• Start date: October 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2017
• Source: Xinjiang Medical University
• Contact: Shun-E Yang, Professor
• Phone: 15805197983
• Email: 319889719[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18~70 years old;

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1 score;

• All patients were diagnosed as recurrent metastatic breast cancer retreatment by histopathology and computed tomography (CT) examination;

• The measurable nidus=1: Patients whose nidus diameter = 20 mm by normal CT or magnetic resonance image (MRI) scanning, and = 10 mm by spiral CT scanning;

• Patients whose blood routine, hepatorenal function, electrolyte and cardiac function were basically normal without dysfunction of primary organs. White blood cell count (WBC) =4.0×109/L, neutrophile granulocyte count =1.5×109/L, platelet (PLT) count =100×109/L, hemoglobin (HGB) =95 g/L, serum bilirubin (BIL) =1.5-fold upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) =2-fold upper limit of normal value, and serum creatinine (Scr) =1.5mg/dl;

• The expected survival time >3 months;

• Patients who could understand this study status and had signed the informed consent forms.

Exclusion Criteria:

• Patients who had history of allergic responses to biological agents;

• Patients who were receiving other anti-tumor therapies;

• Patients without measureable nidus;

• Others, including one of the following conditions: patients with uncontrolled central nervous system (CNS) metastatic nidi, with dysfunction of important organs and severe cardiac diseases (congestive heart failure, uncontrollable arrhythmia, and angina pectoris, valvular heart disease, myocardial infarction and refractory hypertension that required long-term drug administration), with chronic infectious wound and with history of uncontrollable psychosis, and women in pregnant or lactation period.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• EndostarTM Injection
210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
• Gemcitabine
1.0 m/m2, iv 0.5h, d1, 8
• Navelbine
40 mg/d, iv, d1, 8
• Platinum
30 mg/m2, iv 3h, d1-3
• Xeloda Tablets:
2 000 mg/m2, po, d1-14

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Xinjiang Medical University	Urumchi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response 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%.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	median survival time	median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.	2 years
Secondary	overall survival	overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization	2 years
Secondary	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	2 years