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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805153
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 evaluate 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 Drug: rhG-CSF Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : 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: 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

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 Name: filgrastim




Primary Outcome Measures :
  1. 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 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) [ Time Frame: 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) [ Time Frame: through the next three consecutive cycles chemotherapy,an average of 3 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
  • 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
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Responsible Party: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02805153    
Other Study ID Numbers: CSPC-PGC-IV-01
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs