A Multi-center, Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.0 sites484 target enrollmentApril 2013

ConditionsBreast Cancer

InterventionsPEG-rhG-CSF

DrugsPEG-rhG-CSF

Overview

Phase: Phase 4
Intervention: PEG-rhG-CSF
Conditions: Breast Cancer
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 484
Primary Endpoint: the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

PEG-rhG-CSF

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

Intervention: PEG-rhG-CSF