A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

January 5, 2013 updated by: Jiangsu HengRui Medicine Co., Ltd.
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Hospital Affiliated to Academy Military Medical Science

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:

  • Investigator diagnosis of breast cancer
  • Age 18 to 70 years
  • ECOG performance status ≤ 1
  • Chemotherapy naïve
  • Body weight ≥ 45kg
  • Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
  • Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN

Exclusion Criteria:

  • Prior bone marrow or stem cell transplantation
  • Received systemic antibiotics treatment within 72 h of chemotherapy
  • Radiation therapy within 4 weeks of randomization into this study
  • Pregnancy, lactation

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: Pegylated rhG-CSF: 100µg/kg
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
Drug: Drug: Pegylated rhG-CSF: 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Experimental: Pegylated rhG-CSF: 6mg
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg
Drug: Pegylated rhG-CSF: 6mg
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Active Comparator: rhG-CSF 5ug/kg/day
Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day
Drug: rhG-CSF 5ug/kg/day
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate and the duration of grade 3/4 neutropenia in cycle 1
Time Frame: 21 days
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate and the duration of grade 3/4 neutropenia in cycle 2-4
Time Frame: Through cycle 2 to cycle 4
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.
Through cycle 2 to cycle 4
Rate of the febrile neutropenia in cycle 1
Time Frame: Through 4 cycles
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃.
Through 4 cycles

Collaborators and Investigators

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

Sponsor

Jiangsu HengRui Medicine 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

March 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 5, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHPG-19K -III-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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