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

• Status: Completed
• Trial end date: 2019-04-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin SinoBiotech Ltd.
• Treatments: Lenograstim

Criteria

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.