Back to resultsEfficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Primary Purpose
Breast Cancer, Neutropenia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
- ECOG<=1
- Expected survival is greater than 6 months
- Qualified for chemotherapy，WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
- No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
- Liver function, ALT and AST should less than 2.5 times of the upper limit.
- Renal function, Cr and BUN should less than 1.5 times of the upper limit.
- Subjects voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
- Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
- Has received hematopoietic stem cell transplantation or bone marrow transplantation
- Other drugs are currently in clinical trials
- There are currently hard-to-control infections, body temperature is higher than 38 degrees.
- Received PEG-rhG-CSF treatment before enrollment
- Received chemotherapy in 4 weeks before enrollment
- Patients with any visceral metastasis
- Patients with severe heart, kidney, liver or any other important organs chronic diseases
- Patients with severe uncontrolled diabetes
- Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
- Suspected or real drug users, substance abusers, alcoholics
- Pregnant or lactating women
- Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-rhG-CSF
Arm Description
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
Outcomes
Primary Outcome Measures
RDI for each EC chemotherapy
Ratio of actual dose intensity to standard dose intensity
Chemotherapeutic dose adjustment due to neutropenia
percentage of dose decreasing due to neutropenia
overall completion rate of chemotherapy
calculate the overall chemo-completion rate among all patients
Secondary Outcome Measures
Incidence of febrile neutropenia
Incidence of Grade 3/4 ACN reduction
evaluate the incidence of Grade 3/4 absolute neutrophil count
Duration of Grade 3/4 ACN reduction
observe the duration of Grade 3/4 absolute neutrophil count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04009941
Brief Title
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Official Title
Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neutropenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
4.5mg per cycle, 24 hours after chemotherapy
Primary Outcome Measure Information:
Title
RDI for each EC chemotherapy
Description
Ratio of actual dose intensity to standard dose intensity
Time Frame
60 days after the first chemotherapy
Title
Chemotherapeutic dose adjustment due to neutropenia
Description
percentage of dose decreasing due to neutropenia
Time Frame
60 days after the first chemotherapy
Title
overall completion rate of chemotherapy
Description
calculate the overall chemo-completion rate among all patients
Time Frame
60 days after the first chemotherapy
Secondary Outcome Measure Information:
Title
Incidence of febrile neutropenia
Time Frame
60 days after the first chemotherapy
Title
Incidence of Grade 3/4 ACN reduction
Description
evaluate the incidence of Grade 3/4 absolute neutrophil count
Time Frame
60 days after the first chemotherapy
Title
Duration of Grade 3/4 ACN reduction
Description
observe the duration of Grade 3/4 absolute neutrophil count
Time Frame
60 days after the first chemotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
ECOG<=1
Expected survival is greater than 6 months
Qualified for chemotherapy，WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
Liver function, ALT and AST should less than 2.5 times of the upper limit.
Renal function, Cr and BUN should less than 1.5 times of the upper limit.
Subjects voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
Has received hematopoietic stem cell transplantation or bone marrow transplantation
Other drugs are currently in clinical trials
There are currently hard-to-control infections, body temperature is higher than 38 degrees.
Received PEG-rhG-CSF treatment before enrollment
Received chemotherapy in 4 weeks before enrollment
Patients with any visceral metastasis
Patients with severe heart, kidney, liver or any other important organs chronic diseases
Patients with severe uncontrolled diabetes
Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
Suspected or real drug users, substance abusers, alcoholics
Pregnant or lactating women
Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
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