NCT02489409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

July 1, 2015

Last Update Submit

July 12, 2017

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • clinical benefit rate

    2 years

  • progression-free survival

    2 years

  • median survival time

    2 years

  • overall survival

    2 years

  • adverse responses

    2 years

Study Arms (2)

Experimental group

EXPERIMENTAL

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).

Drug: EndostarTM InjectionDrug: GemcitabineDrug: NavelbineDrug: PlatinumDrug: Xeloda Tablets:

Control group

ACTIVE COMPARATOR

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.

Drug: GemcitabineDrug: NavelbineDrug: PlatinumDrug: Xeloda Tablets:

Interventions

EndostarTM InjectionDRUG

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

Also known as: Endostatin
Experimental group
GemcitabineDRUG

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

Also known as: GEM
Control groupExperimental group
NavelbineDRUG

40 mg/d, iv, d1, 8

Also known as: NVB
Control groupExperimental group
PlatinumDRUG

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

Also known as: DDP
Control groupExperimental group
Xeloda Tablets:DRUG

2 000 mg/m2, po, d1-14

Also known as: ECX
Control groupExperimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EndostatinsGemcitabineVinorelbinePlatinumCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological FactorsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Shun-E Yang, Professor

    Third Affiliated Hospital of Xinjiang Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shun-E Yang, Professor

CONTACT

15805197983319889719@qq.com

Wei Liu, Assitant

CONTACT

0991-7819372319889719@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant investiagtor, clinical research

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 3, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)