Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
NCT ID: NCT04009941
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2019-08-01
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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PEG-rhG-CSF
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
PEG-rhG-CSF
4.5mg per cycle, 24 hours after chemotherapy
Interventions
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PEG-rhG-CSF
4.5mg per cycle, 24 hours after chemotherapy
Eligibility Criteria
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Inclusion Criteria
* ECOG\<=1
* Expected survival is greater than 6 months
* Qualified for chemotherapy，WBC\>=3\*109/L, ANC\>=1.5\*109/L, Hb\>=80g/L, PLT\>=80\*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
* No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
* Liver function, ALT and AST should less than 2.5 times of the upper limit.
* Renal function, Cr and BUN should less than 1.5 times of the upper limit.
* Subjects voluntarily participate in this study and sign informed consent.
Exclusion Criteria
* Has received hematopoietic stem cell transplantation or bone marrow transplantation
* Other drugs are currently in clinical trials
* There are currently hard-to-control infections, body temperature is higher than 38 degrees.
* Received PEG-rhG-CSF treatment before enrollment
* Received chemotherapy in 4 weeks before enrollment
* Patients with any visceral metastasis
* Patients with severe heart, kidney, liver or any other important organs chronic diseases
* Patients with severe uncontrolled diabetes
* Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
* Suspected or real drug users, substance abusers, alcoholics
* Pregnant or lactating women
* Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
18 Years
65 Years
FEMALE
No
Sponsors
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Peking University
OTHER
Responsible Party
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Tao OUYANG
chief of breast surgery
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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BC-P26
Identifier Type: -
Identifier Source: org_study_id