Status:
COMPLETED
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
Lead Sponsor:
Tianjin SinoBiotech Ltd.
Conditions:
Chemotherapy-induced Neutropenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
Detailed Description
* 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03251768
Start Date
October 19 2017
End Date
April 24 2019
Last Update
September 13 2019
Active Locations (1)
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1
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China, 100021