Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients. Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.

Detailed Description
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Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments. Positive control：recombinant human granulocyte colony-stimulating factor injection. Targeted patients: breast cancer Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment. Number of patients: 216 Concomitant medicines will be conducted.

Official Title
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Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients

Conditions
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Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Drug: HSA-GCSF 1.2 mg
* Drug: HSA-GCSF 1.5 mg
* Drug: GCSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65. Diagnosed breast cancer, suitable for TEC or TE . ECOG performance status 0 or 1. Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy. ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency. No obvious abnormal ecg examination. TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases). Cr, BUN≤2.5×ULN. Signed informed consent. Exclusion Criteria: Chemotherapy within past 4 weeks Uncontrolled inflammatory disease,axillary temperature≥38℃. Merging other malignant tumor Pregnancy or nursing status. Participation in another clinical trial with and investigational product within 3 months prior to study entry. Severe diabetes mellitus, or poor blood sugar controller. Allergic disease or allergic constitution. History of protein allergy. History of drug addiction and alcoholism. Hematopoietic stem cell transplantation or organ transplantation. Chronic disease of severe cardiac, kidney and liver. Other conditions that would be excluded from this study according to doctors'judgment

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Intervention: HSA-GCSF 1.2 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（1.2mg）will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration. | Drug: HSA-GCSF 1.2 mg<br>* Human Serum Albumin GCSF 1.2mg at day 3 and Day 7<br>|
| Experimental: Group 2<br>Intervention:HSA-GCSF 1.5 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（1.5mg）will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration. Intervention: Drug: TE or TEC | Drug: HSA-GCSF 1.5 mg<br>* Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7<br>|
| Active Comparator: Group 3<br>Intervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at night o'clock a.m. from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. The maximum of usage was continuous 14 days. Intervention: Drug: TE or TEC | Drug: GCSF<br>* GCSF 5 mcg/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean of duration for class IV neutrophilic granulocytopenia |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean of duration for class IV neutrophilic granulocytopenia |  | 8 weeks | 
| The mean of duration for ANC up to 2.0×109/L |  | 8 weeks | 
| ANC |  | 8 weeks | 
| The usage of antibiotics |  | 8 weeks | 
| febrile neutropenia |  | 8 weeks |