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

NCT ID: NCT02489409

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-07-31

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

EndostarTM Injection

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Navelbine

Intervention Type: DRUG

40 mg/d, iv, d1, 8

Platinum

Intervention Type: DRUG

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

Xeloda Tablets:

Intervention Type: DRUG

2 000 mg/m2, po, d1-14

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.

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

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

Navelbine

Intervention Type: DRUG

40 mg/d, iv, d1, 8

Platinum

Intervention Type: DRUG

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

Xeloda Tablets:

Intervention Type: DRUG

2 000 mg/m2, po, d1-14

Interventions

EndostarTM Injection

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Navelbine

40 mg/d, iv, d1, 8

Intervention Type: DRUG

Platinum

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

Intervention Type: DRUG

Xeloda Tablets:

2 000 mg/m2, po, d1-14

Intervention Type: DRUG

Other Intervention Names

Endostatin; GEM; NVB; DDP; ECX

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xinjiang Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shun-E Yang

Asistant investiagtor, clinical research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shun-E Yang, Professor

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital of Xinjiang Medical University

Locations

Third Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shun-E Yang, Professor

Role: CONTACT

319889719@qq.com

15805197983 ext. 0991-7819372

Wei Liu, Assitant

Role: CONTACT

319889719@qq.com

0991-7819372 ext. 7819371

Facility Contacts

Shun-E Yang, Professor

Role: primary

319889719@qq.com

15805197983

Xun Li, Assistant

Role: backup

yangshune@medmail.com.cn

0991-7819372 ext. 7819371

Other Identifiers

XinjiangMU001

Identifier Type: -

Identifier Source: org_study_id