Completed
Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
What is being tested
PEG-rhG-CSF
Drug
Who is being recruted
Cytopenia+10
+ Agranulocytosis
+ Breast Diseases
From 18 to 65 Years
+21 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 4
Interventional
Study Start: August 2019
Summary
Principal SponsorPeking University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2019
Actual date on which the first participant was enrolled.This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
Official TitleStudy on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Principal SponsorPeking University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
104 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CytopeniaAgranulocytosisBreast DiseasesBreast NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersLeukopeniaNeoplasmsNeoplasms by SiteNeutropeniaSkin DiseasesSkin and Connective Tissue Diseases
Criteria
8 inclusion criteria required to participate
Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
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.
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13 exclusion criteria prevent from participating
Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center