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

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02805153
Collaborator
(none)
215
2
34

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
215 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental/PEG-rhG-CSF

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.

Drug: PEG-rhG-CSF
Other Names:
  • pegfilgrastim
  • Active Comparator: Active Comparator/rhG-CSF

    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

    Drug: rhG-CSF
    Other Names:
  • filgrastim
  • Outcome Measures

    Primary Outcome Measures

    1. the occurrence rate of grade IV neutropenia during the first chemotherapy cycle [through first cycle of chemotherapy,an average of 1 month]

    Secondary Outcome Measures

    1. 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) [through the next three consecutive cycles chemotherapy,an average of 3 months]

    2. 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) [through the next three consecutive cycles chemotherapy,an average of 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02805153
    Other Study ID Numbers:
    • CSPC-PGC-IV-01
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Jun 20, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 20, 2016