Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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 Title
-----------------
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

Conditions
-----------------
Breast Cancer, Neutropenia

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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: 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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF. | Drug: PEG-rhG-CSF<br>* 4.5mg per cycle, 24 hours after chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDI for each EC chemotherapy | Ratio of actual dose intensity to standard dose intensity | 60 days after the first chemotherapy | 
| Chemotherapeutic dose adjustment due to neutropenia | percentage of dose decreasing due to neutropenia | 60 days after the first chemotherapy | 
| overall completion rate of chemotherapy | calculate the overall chemo-completion rate among all patients | 60 days after the first chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia |  | 60 days after the first chemotherapy | 
| Incidence of Grade 3/4 ACN reduction | evaluate the incidence of Grade 3/4 absolute neutrophil count | 60 days after the first chemotherapy | 
| Duration of Grade 3/4 ACN reduction | observe the duration of Grade 3/4 absolute neutrophil count | 60 days after the first chemotherapy |