NCT03907098

Brief Summary

This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced 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
50

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2016

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

Study Start

First participant enrolled

June 30, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

3.5 years

First QC Date

March 29, 2019

Last Update Submit

April 5, 2019

Conditions

Breast Cancer

Keywords

breast cancerendostar

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS)

    From enrollment to disease progression or death due to any cause

    up to approximately 100 months

Secondary Outcomes (4)

  • Overall Survival (OS)

    up to approximately 100 months

  • Objective Response Rate (ORR）

    up to approximately 100 months

  • Clinical Benefit Rate (CBR)

    up to approximately 100 months

  • Adverse events (AEs)

    from enrollment to 30 days after the last dose administration

Study Arms (1)

endostar + chemotherapy

EXPERIMENTAL

Endostar 15 mg per square of BSA, continuous intravenous infusion 24 hours a day, continuous administration for 7 days, every three weeks. Chemotherapy regimens are selected by physicians based on regular clinical decision.

Drug: EndostarDrug: Chemotherapy

Interventions

EndostarDRUG

an anti-angiogenesis drug

Also known as: Recombinant human endostatin
endostar + chemotherapy
ChemotherapyDRUG

Physician's choice

endostar + chemotherapy

Eligibility Criteria

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

You may qualify if:

  • locoregionally Recurrent or metastatic breast cancer confirmed by histology.
  • HER-2 Negative Breast Cancer.
  • At least one measurable lesion according to RECIST 1.1..
  • Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks.
  • years old.
  • ECOG PS 0～1.
  • Participants must have normal organ and marrow function as defined below: ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
  • life expectancy is not less than 12 weeks.
  • Signed informed consent.

You may not qualify if:

  • Uncontrolled central nervous system metastasis.
  • Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments..
  • History of allergy to biological agents in the past.
  • Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension.
  • Pregnant or lactating women..
  • The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer.
  • The risk of uncontrolled infection, thrombosis and bleeding exists.
  • A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
  • Researchers consider it inappropriate to carry out the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

endostar proteinEndostatinsDrug Therapy

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 FactorsTherapeutics

Central Study Contacts

Xiaojia Wang, PhD

CONTACT

86 13906500190wxiaojia0803@163.com

Yuan Huang, PhD

CONTACT

86 13588747179hy415@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 8, 2019

Study Start

June 30, 2016

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

CN(1)