NCT02865304

Brief Summary

The purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2 negative metastatic breast cancer (MBC) patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2016

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

May 25, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

May 25, 2016

Last Update Submit

August 11, 2016

Conditions

AngiogenesisBreast Cancer

Keywords

metastatic breast cancerHER-2-negativeendostar

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    one year

Study Arms (1)

endostar; taxane

EXPERIMENTAL

Endostar was administered at 7.5 mg/m2, d1-14, q21d and was continued until progressive disease, unacceptable toxicity, consent withdrawal, or completion of 24 months. In the same time,Taxane-based chemotherapy was continued until progressive disease, unacceptable toxicity, consent withdrawal, or up to 8 cycles.

Drug: endostar

Interventions

endostarDRUG
endostar; taxane

Eligibility Criteria

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

You may qualify if:

  • women with ages between 18-70 years with histologically confirmed MBC documented as HER-2-negative

You may not qualify if:

  • cannot tolerated chemotherapy
  • cardiac insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

endostar protein

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • weiwei huang, doctor

    Department of Medical Oncology, Fujian Provincial Cancer Hospital, The Teaching Hospital of Fujian Medical University, The Teaching Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou 350014, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

weiwei huang, doctor

CONTACT

13763893896huangstudenth@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

August 12, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

August 12, 2016

Record last verified: 2016-08