Back to resultsReduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
Primary Purpose
Neutropenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pegfilgrastim
Sponsored by
About this trial
This is an interventional treatment trial for Neutropenia
Eligibility Criteria
Inclusion Criteria:
- female aged 18-69 years
- diagnosed pathologically as early breast cancer
- with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
- received no prior chemotherapy (chemotherapy naïve)
- have Karnofsky performance status ≥ 80,
- baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10^9/L,ANC≥2.0X10^9/L, platelet count ≥100X10^9
- adequate cardiac, hepatic and renal function
Exclusion Criteria:
- enrolled onto or had not yet completed other investigational drug trials
- allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
- pregnant or lactating women;
- previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
Sites / Locations
- Department of Medical Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pegfilgrastim 3mg
pegfilgrastim 6mg
Arm Description
Pegfilgrastim 3mg per chemotherapy cycle
Pegfilgrastim 6mg per chemotherapy cycle
Outcomes
Primary Outcome Measures
timely recovery of ANC
The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Secondary Outcome Measures
febrile neutropenia in cycle1
the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken.
grade 3/4 neutropenia in cycle 1
the incidence of absolute neutrophil count (ANC) <1.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
grade 4 neutropenia in cycle 1
the incidence of absolute neutrophil count (ANC) <0.5×10^9/L before the second chemotherapy cycle. Blood routine test was used.
hospitalization due to neutropenia
the incidence of unplanned hospitalization due to neutropenia
Full Information
NCT ID
NCT05283616
First Posted
March 2, 2022
Last Updated
March 12, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05283616
Brief Title
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
Official Title
A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently.
According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg.
In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.
Detailed Description
All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m^2 (or pirarubicin 60mg/m^2) and cyclophosphamide 600mg/m^2 were administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly.
Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or >60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pegfilgrastim 3mg
Arm Type
Experimental
Arm Description
Pegfilgrastim 3mg per chemotherapy cycle
Arm Title
pegfilgrastim 6mg
Arm Type
Active Comparator
Arm Description
Pegfilgrastim 6mg per chemotherapy cycle
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
Pegfilgrastim 3mg per chemotherapy cycle
Primary Outcome Measure Information:
Title
timely recovery of ANC
Description
The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
febrile neutropenia in cycle1
Description
the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken.
Time Frame
1 month
Title
grade 3/4 neutropenia in cycle 1
Description
the incidence of absolute neutrophil count (ANC) <1.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Time Frame
1 month
Title
grade 4 neutropenia in cycle 1
Description
the incidence of absolute neutrophil count (ANC) <0.5×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Time Frame
1 month
Title
hospitalization due to neutropenia
Description
the incidence of unplanned hospitalization due to neutropenia
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
adverse events
Description
the profile and incidence of adverse events. Symptoms and signs were observed; blood routine test and blood biochemistry tests were performed.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female aged 18-69 years
diagnosed pathologically as early breast cancer
with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
received no prior chemotherapy (chemotherapy naïve)
have Karnofsky performance status ≥ 80,
baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10^9/L,ANC≥2.0X10^9/L, platelet count ≥100X10^9
adequate cardiac, hepatic and renal function
Exclusion Criteria:
enrolled onto or had not yet completed other investigational drug trials
allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
pregnant or lactating women;
previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pin Zhang
Organizational Affiliation
Department of Medical Oncology, Cancer Hospital, CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
We'll reach out to this number within 24 hrs