PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

June 17, 2016 updated by: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: PEG-rhG-CSF
Other Names:
  • pegfilgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy
Time Frame: up to 30 days after the patient study completion
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
Time Frame: up to 30 days after the patient study completion
up to 30 days after the patient study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
the occurrence rate of III/ IV neutropenia during the whole chemotherapy process
Time Frame: through the study completion,an average of 5 months
through the study completion,an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-PGC-IV-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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