NCT02805205

Brief Summary

The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Apr 2013

Status
completed

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

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

June 13, 2016

Last Update Submit

June 17, 2016

Conditions

Breast Cancer

Keywords

PEG-rhG-CSF neutropenia

Outcome Measures

Primary Outcomes (2)

  • the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy

    up to 30 days after the patient study completion

  • the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy

    up to 30 days after the patient study completion

Secondary Outcomes (1)

  • the occurrence rate of III/ IV neutropenia during the whole chemotherapy process

    through the study completion,an average of 5 months

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSFDRUG
Also known as: pegfilgrastim
PEG-rhG-CSF

Eligibility Criteria

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

You may qualify if:

  • Patients with age between 18 and 70 years
  • diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy
  • grade III/IV neutropenia after chemotherapy
  • KPS score≥70
  • life expectancy of at least 3 months
  • Written informed consent are acquired

You may not qualify if:

  • Have accepted any other drug related clinical trial within 4 weeks before anticipated
  • uncontrolled infection
  • pregnancy
  • Other situations that investigators consider as contra-indication for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegylated granulocyte colony-stimulating factorpegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 17, 2016

Study Start

April 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06