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PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PEG-rhG-CSF
rhG-CSF
Sponsored by
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring PEG-rhG-CSF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with age between 18 and 70 years
  • diagnosis of breast cancer patients
  • chemotherapy naive
  • Karnofsky Performance Status ≥ 70
  • Written informed consent are acquired

Exclusion Criteria:

  • uncontrolled infection
  • Have accepted radiotherapy within 4 weeks before anticipated the study
  • pregnancy
  • Other situations that investigators consider as contra-indication for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental/PEG-rhG-CSF

    Active Comparator/rhG-CSF

    Arm Description

    patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.

    patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10^9/L was documented after the expected nadir, or for a maximum of 14 days

    Outcomes

    Primary Outcome Measures

    the occurrence rate of grade IV neutropenia during the first chemotherapy cycle

    Secondary Outcome Measures

    the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
    the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)

    Full Information

    First Posted
    June 13, 2016
    Last Updated
    June 17, 2016
    Sponsor
    CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02805153
    Brief Title
    PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
    Official Title
    The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    PEG-rhG-CSF

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    215 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental/PEG-rhG-CSF
    Arm Type
    Experimental
    Arm Description
    patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
    Arm Title
    Active Comparator/rhG-CSF
    Arm Type
    Active Comparator
    Arm Description
    patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10^9/L was documented after the expected nadir, or for a maximum of 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    PEG-rhG-CSF
    Other Intervention Name(s)
    pegfilgrastim
    Intervention Type
    Drug
    Intervention Name(s)
    rhG-CSF
    Other Intervention Name(s)
    filgrastim
    Primary Outcome Measure Information:
    Title
    the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
    Time Frame
    through first cycle of chemotherapy,an average of 1 month
    Secondary Outcome Measure Information:
    Title
    the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
    Time Frame
    through the next three consecutive cycles chemotherapy,an average of 3 months
    Title
    the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
    Time Frame
    through the next three consecutive cycles chemotherapy,an average of 3 months

    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: Patients with age between 18 and 70 years diagnosis of breast cancer patients chemotherapy naive Karnofsky Performance Status ≥ 70 Written informed consent are acquired Exclusion Criteria: uncontrolled infection Have accepted radiotherapy within 4 weeks before anticipated the study pregnancy Other situations that investigators consider as contra-indication for this study

    12. IPD Sharing Statement

    Learn more about this trial

    PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy

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