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

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ClinicalTrials.gov Identifier: NCT02805205
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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 Name: pegfilgrastim




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. the occurrence rate of III/ IV neutropenia during the whole chemotherapy process [ Time Frame: through the study completion,an average of 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02805205     History of Changes
Other Study ID Numbers: CSPC-PGC-IV-02
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Keywords provided by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.:
PEG-rhG-CSF neutropenia
Additional relevant MeSH terms:
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Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases