PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy

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

The Multi-center, Open-label,Randomized Comparison 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 evaluate 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)

215

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
  • chemotherapy naive
  • Karnofsky Performance Status ≥ 70
  • Written informed consent are acquired

Exclusion Criteria:

  • uncontrolled infection
  • Have accepted radiotherapy within 4 weeks before anticipated the study
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Active Comparator: Active Comparator/rhG-CSF
patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10^9/L was documented after the expected nadir, or for a maximum of 14 days
Drug: rhG-CSF
Other Names:
  • filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
Time Frame: through first cycle of chemotherapy,an average of 1 month
through first cycle of chemotherapy,an average of 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
Time Frame: through the next three consecutive cycles chemotherapy,an average of 3 months
through the next three consecutive cycles chemotherapy,an average of 3 months
the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
Time Frame: through the next three consecutive cycles chemotherapy,an average of 3 months
through the next three consecutive cycles chemotherapy,an average of 3 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-01

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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