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

Chemotherapy-induced Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251768
• Other study ID #: CHS01N-1892
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2017
• Est. completion date: April 24, 2019

Study information

• Verified date: December 2018
• Source: Tianjin SinoBiotech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 24, 2019
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Drug:
• rHSA-GCSF 2.4mg
Human Serum Albumin GCSF 2.4mg at day 3 and day 7
• GCSF
GCSF 5 mcg/kg/day

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin SinoBiotech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main curative effect evaluation index	The duration of the degree of ? neutropenia	4 weeks
Secondary	Secondary efficacy evaluation index	The duration of the degree of ? neutropenia(ANC<0.5×109/L)	8 weeks
Secondary	Secondary efficacy evaluation index-1	The time required for neutrophil recovery to 2.0x109/L(	8 weeks
Secondary	Secondary efficacy evaluation index-2	ANC	8 weeks
Secondary	Secondary efficacy evaluation index-3	febrile neutropenia	8 weeks
Secondary	Secondary efficacy evaluation index-4	The usage of antibiotics	8 weeks