- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02489409
Recombinant Human Endostatin (EndostarTM) Injection in Treatment of Recurrent Metastatic Breast Cancer
July 12, 2017 updated by: Shun-E Yang, Xinjiang Medical University
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
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shun-E Yang, Professor
- Phone Number: 0991-7819372 15805197983
- Email: 319889719@qq.com
Study Contact Backup
- Name: Wei Liu, Assitant
- Phone Number: 7819371 0991-7819372
- Email: 319889719@qq.com
Study Locations
-
-
Xinjiang
-
Urumchi, Xinjiang, China, 830000
- Recruiting
- Third Affiliated Hospital of Xinjiang Medical University
-
Contact:
- Shun-E Yang, Professor
- Phone Number: 15805197983
- Email: 319889719@qq.com
-
Contact:
- Xun Li, Assistant
- Phone Number: 7819371 0991-7819372
- Email: yangshune@medmail.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14; EndostarTM Injection: 210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h).
|
210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
Other Names:
1.0 m/m2, iv 0.5h, d1, 8
Other Names:
40 mg/d, iv, d1, 8
Other Names:
30 mg/m2, iv 3h, d1-3
Other Names:
2 000 mg/m2, po, d1-14
Other Names:
|
Active Comparator: Control group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14.
|
1.0 m/m2, iv 0.5h, d1, 8
Other Names:
40 mg/d, iv, d1, 8
Other Names:
30 mg/m2, iv 3h, d1-3
Other Names:
2 000 mg/m2, po, d1-14
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response rate
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical benefit rate
Time Frame: 2 years
|
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
|
progression-free survival
Time Frame: 2 years
|
Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died from the start of randomization.
|
2 years
|
median survival time
Time Frame: 2 years
|
median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.
|
2 years
|
overall survival
Time Frame: 2 years
|
overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization
|
2 years
|
adverse responses
Time Frame: 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shun-E Yang, Professor, Third Affiliated Hospital of Xinjiang Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
May 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
July 1, 2015
First Submitted That Met QC Criteria
July 1, 2015
First Posted (Estimate)
July 3, 2015
Study Record Updates
Last Update Posted (Actual)
July 17, 2017
Last Update Submitted That Met QC Criteria
July 12, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Vinorelbine
- Endostatins
Other Study ID Numbers
- XinjiangMU001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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