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

Primary Purpose

Breast Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

EndostarTM Injection

Gemcitabine

Navelbine

Platinum

Xeloda Tablets:

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Third Affiliated Hospital of Xinjiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.

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.

median survival time

median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.

overall survival

overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization

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

Full Information

NCT ID

NCT02489409

First Posted

July 1, 2015

Last Updated

July 12, 2017

Sponsor

Xinjiang Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02489409

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinjiang Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

EndostarTM Injection

Other Intervention Name(s)

Endostatin

Intervention Description

210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

GEM

Intervention Description

1.0 m/m2, iv 0.5h, d1, 8

Intervention Type

Drug

Intervention Name(s)

Navelbine

Other Intervention Name(s)

NVB

Intervention Description

40 mg/d, iv, d1, 8

Intervention Type

Drug

Intervention Name(s)

Platinum

Other Intervention Name(s)

DDP

Intervention Description

30 mg/m2, iv 3h, d1-3

Intervention Type

Drug

Intervention Name(s)

Xeloda Tablets:

Other Intervention Name(s)

ECX

Intervention Description

2 000 mg/m2, po, d1-14

Primary Outcome Measure Information:

Title

response rate

Description

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

Secondary Outcome Measure Information:

Title

clinical benefit rate

Description

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

Title

progression-free survival

Description

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

Title

median survival time

Description

median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.

Time Frame

2 years

Title

overall survival

Description

overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization

Time Frame

2 years

Title

adverse responses

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shun-E Yang, Professor

Phone

15805197983

Ext

0991-7819372

319889719@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Liu, Assitant

Phone

0991-7819372

Ext

7819371

319889719@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shun-E Yang, Professor

Organizational Affiliation

Third Affiliated Hospital of Xinjiang Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Third Affiliated Hospital of Xinjiang Medical University

City

Urumchi

State/Province

Xinjiang

ZIP/Postal Code

830000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shun-E Yang, Professor

Phone

15805197983

319889719@qq.com

First Name & Middle Initial & Last Name & Degree

Xun Li, Assistant

Phone

0991-7819372

Ext

7819371

yangshune@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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