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出境医 / 临床实验 / Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Neutropenia Drug: PEG-rhG-CSF Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : January 18, 2020
Actual Study Completion Date : January 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: PEG-rhG-CSF
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
 Drug: PEG-rhG-CSF
4.5mg per cycle, 24 hours after chemotherapy
Outcome Measures
Primary Outcome Measures :
  1. RDI for each EC chemotherapy [ Time Frame: 60 days after the first chemotherapy ]
    Ratio of actual dose intensity to standard dose intensity

  2. Chemotherapeutic dose adjustment due to neutropenia [ Time Frame: 60 days after the first chemotherapy ]
    percentage of dose decreasing due to neutropenia

  3. overall completion rate of chemotherapy [ Time Frame: 60 days after the first chemotherapy ]
    calculate the overall chemo-completion rate among all patients


Secondary Outcome Measures :
  1. Incidence of febrile neutropenia [ Time Frame: 60 days after the first chemotherapy ]
  2. Incidence of Grade 3/4 ACN reduction [ Time Frame: 60 days after the first chemotherapy ]
    evaluate the incidence of Grade 3/4 absolute neutrophil count

  3. Duration of Grade 3/4 ACN reduction [ Time Frame: 60 days after the first chemotherapy ]
    observe the duration of Grade 3/4 absolute neutrophil count


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Tracking Information
First Submitted Date  ICMJE June 30, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date October 28, 2020
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date January 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • RDI for each EC chemotherapy [ Time Frame: 60 days after the first chemotherapy ]
    Ratio of actual dose intensity to standard dose intensity
  • Chemotherapeutic dose adjustment due to neutropenia [ Time Frame: 60 days after the first chemotherapy ]
    percentage of dose decreasing due to neutropenia
  • overall completion rate of chemotherapy [ Time Frame: 60 days after the first chemotherapy ]
    calculate the overall chemo-completion rate among all patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Incidence of febrile neutropenia [ Time Frame: 60 days after the first chemotherapy ]
  • Incidence of Grade 3/4 ACN reduction [ Time Frame: 60 days after the first chemotherapy ]
    evaluate the incidence of Grade 3/4 absolute neutrophil count
  • Duration of Grade 3/4 ACN reduction [ Time Frame: 60 days after the first chemotherapy ]
    observe the duration of Grade 3/4 absolute neutrophil count
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Cancer
  • Neutropenia
Intervention  ICMJE Drug: PEG-rhG-CSF
4.5mg per cycle, 24 hours after chemotherapy
Study Arms  ICMJE Experimental: PEG-rhG-CSF
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
Intervention: Drug: PEG-rhG-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2020) 		104
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		130
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009941
Other Study ID Numbers  ICMJE BC-P26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tao OUYANG, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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