Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

Study Overview
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Brief Summary
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Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

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. Targeted patients: breast cancer Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy Number of patients: 80

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

Conditions
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Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Drug: rHSA-GCSF 2.4mg
* 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. 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. Antibiotics were treated within 72 hours before chemotherapy. Long-term use of hormones or immunosuppressive agents. Severe mental or neurological disease. 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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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>intervention: rHSA-GCSF 2.4 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（2.4mg）will be injected subcutaneously at at 10 am (±90 min) on the 3th and 7th day of each chemotherapy cycle.After injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration. | Drug: rHSA-GCSF 2.4mg<br>* Human Serum Albumin GCSF 2.4mg at day 3 and day 7<br>* Other names: Human Serum Albumin GCSF;|
| Active Comparator: Positive control group<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 10 am (±90 min) from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. (The minimum of usage was continuous 7 days ,The maximum of usage was continuous 14 days) | Drug: GCSF<br>* GCSF 5 mcg/kg/day<br>* Other names: jisaixin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main curative effect evaluation index | The duration of the degree of Ⅳ neutropenia | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy evaluation index | The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L) | 8 weeks | 
| Secondary efficacy evaluation index-1 | The time required for neutrophil recovery to 2.0x109/L( | 8 weeks | 
| Secondary efficacy evaluation index-2 | ANC | 8 weeks | 
| Secondary efficacy evaluation index-3 | febrile neutropenia | 8 weeks | 
| Secondary efficacy evaluation index-4 | The usage of antibiotics | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Neutropenia, breast cancer