NCT02944604

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

September 8, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

October 24, 2016

Last Update Submit

January 16, 2019

Conditions

Breastcancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of chemotherapy delay

    60 days after the first chemotherapy

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSFDRUG
PEG-rhG-CSF

Eligibility Criteria

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

You may qualify if:

  • years old, gender no limited.
  • Breast cancer diagnosed by pathology.
  • Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.
  • No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10\^9/L, PLT（Platelet）≥80×10\^9 /L, Hb（hemoglobin）≥75g/L, WBC（White blood cell ）≥3×109/L, and no bleeding tendency.
  • KPS (Karnofsky performance status) score≥70.
  • Expected survival≥3 months.
  • Written informed consent are acquired.

You may not qualify if:

  • Severe or uncontrolled infection.
  • Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
  • Mental or nervous system disorders.
  • Severe heart, lung and central nervous system disorders.
  • Pregnant or lactating women.
  • TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \> 2.5×ULN（upper limit of normal）; if it were caused by liver metastases, TBIL, ALT,AST \>5×ULN.
  • Cr（creatinine） \>1.5×ULN.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor

Study Officials

  • Tao Ouyang, MD

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Breast Center

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

September 8, 2016

Primary Completion

September 29, 2017

Study Completion

September 30, 2017

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

CN(1)