Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
Study Details
Study Description
Brief Summary
Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
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Targeted patients: breast cancer
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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
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Number of patients: 80
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test group 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
Human Serum Albumin GCSF 2.4mg at day 3 and day 7
Other Names:
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| Active Comparator: Positive control group 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
GCSF 5 mcg/kg/day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Main curative effect evaluation index [4 weeks]
The duration of the degree of Ⅳ neutropenia
Secondary Outcome Measures
- Secondary efficacy evaluation index [8 weeks]
The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L)
- Secondary efficacy evaluation index-1 [8 weeks]
The time required for neutrophil recovery to 2.0x109/L(
- Secondary efficacy evaluation index-2 [8 weeks]
ANC
- Secondary efficacy evaluation index-3 [8 weeks]
febrile neutropenia
- Secondary efficacy evaluation index-4 [8 weeks]
The usage of antibiotics
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-65.
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Diagnosed breast cancer, suitable for TEC or TE .
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ECOG performance status 0 or 1.
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Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
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No obvious abnormal ecg examination.
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TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
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Cr, BUN≤2.5×ULN.
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Signed informed consent.
Exclusion Criteria:
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Chemotherapy within past 4 weeks.
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Uncontrolled inflammatory disease,axillary temperature≥38℃.
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Merging other malignant tumor.
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Pregnancy or nursing status.
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Participation in another clinical trial with and investigational product within 3 months prior to study entry.
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Severe diabetes mellitus, or poor blood sugar controller.
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Allergic disease or allergic constitution. History of protein allergy.
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History of drug addiction and alcoholism.
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Hematopoietic stem cell transplantation or organ transplantation.
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Antibiotics were treated within 72 hours before chemotherapy.
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Long-term use of hormones or immunosuppressive agents.
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Severe mental or neurological disease.
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Chronic disease of severe cardiac, kidney and liver.
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Other conditions that would be excluded from this study according to doctors'judgment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Beijing | China | 100021 |
Sponsors and Collaborators
- Tianjin SinoBiotech Ltd.
Investigators
- Principal Investigator: Binghe XU, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHS01N-1892