Back to resultsA Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
Primary Purpose
Breast Cancer, Neutropenia, Febrile Neutropenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Drug: Pegylated rhG-CSF: 100µg/kg
Pegylated rhG-CSF: 6mg
rhG-CSF 5ug/kg/day
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, neutropenia, febrile neutropenia
Eligibility Criteria
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
Sites / Locations
- Hospital Affiliated to Academy Military Medical Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Pegylated rhG-CSF: 100µg/kg
Pegylated rhG-CSF: 6mg
rhG-CSF 5ug/kg/day
Arm Description
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg
Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day
Outcomes
Primary Outcome Measures
Rate and the duration of grade 3/4 neutropenia in cycle 1
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.
Secondary Outcome Measures
Rate and the duration of grade 3/4 neutropenia in cycle 2-4
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.
Rate of the febrile neutropenia in cycle 1
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃.
Full Information
NCT ID
NCT01611051
First Posted
May 31, 2012
Last Updated
January 5, 2013
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01611051
Brief Title
A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neutropenia, Febrile Neutropenia
Keywords
breast cancer, neutropenia, febrile neutropenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pegylated rhG-CSF: 100µg/kg
Arm Type
Experimental
Arm Description
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
Arm Title
Pegylated rhG-CSF: 6mg
Arm Type
Experimental
Arm Description
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg
Arm Title
rhG-CSF 5ug/kg/day
Arm Type
Active Comparator
Arm Description
Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day
Intervention Type
Drug
Intervention Name(s)
Drug: Pegylated rhG-CSF: 100µg/kg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Pegylated rhG-CSF: 6mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
rhG-CSF 5ug/kg/day
Intervention Description
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).
Primary Outcome Measure Information:
Title
Rate and the duration of grade 3/4 neutropenia in cycle 1
Description
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Rate and the duration of grade 3/4 neutropenia in cycle 2-4
Description
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.
Time Frame
Through cycle 2 to cycle 4
Title
Rate of the febrile neutropenia in cycle 1
Description
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃.
Time Frame
Through 4 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Affiliated to Academy Military Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
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