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

NCT02489409 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-07-17

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

EndostarTM Injection

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

DRUG

Gemcitabine

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

DRUG

Navelbine

40 mg/d, iv, d1, 8

DRUG

Platinum

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

DRUG

Xeloda Tablets:

2 000 mg/m2, po, d1-14

Sponsors & Collaborators

  • Xinjiang Medical University

    lead OTHER

Principal Investigators

  • Shun-E Yang, Professor · Third Affiliated Hospital of Xinjiang Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-05-31
Completion
2018-07-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489409 on ClinicalTrials.gov