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PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PEG-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 neutropenia

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 who need to receive multi-cycle chemotherapy
  • grade III/IV neutropenia after chemotherapy
  • KPS score≥70
  • life expectancy of at least 3 months
  • Written informed consent are acquired

Exclusion Criteria:

  • Have accepted any other drug related clinical trial within 4 weeks before anticipated
  • uncontrolled infection
  • pregnancy
  • Other situations that investigators consider as contra-indication for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PEG-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

    Outcomes

    Primary Outcome Measures

    the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy
    the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy

    Secondary Outcome Measures

    the occurrence rate of III/ IV neutropenia during the whole chemotherapy process

    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
    NCT02805205
    Brief Title
    PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
    Official Title
    A Multi-center, Open-label,Single Arm 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

    5. Study Description

    Brief Summary
    The purpose of this study is to estimate 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 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
    484 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    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
    Intervention Type
    Drug
    Intervention Name(s)
    PEG-rhG-CSF
    Other Intervention Name(s)
    pegfilgrastim
    Primary Outcome Measure Information:
    Title
    the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy
    Time Frame
    up to 30 days after the patient study completion
    Title
    the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy
    Time Frame
    up to 30 days after the patient study completion
    Secondary Outcome Measure Information:
    Title
    the occurrence rate of III/ IV neutropenia during the whole chemotherapy process
    Time Frame
    through the study completion,an average of 5 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 who need to receive multi-cycle chemotherapy grade III/IV neutropenia after chemotherapy KPS score≥70 life expectancy of at least 3 months Written informed consent are acquired Exclusion Criteria: Have accepted any other drug related clinical trial within 4 weeks before anticipated uncontrolled infection pregnancy Other situations that investigators consider as contra-indication for this study

    12. IPD Sharing Statement

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    PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

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