Clinical trial NCT03251768: Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Neutropenia
Keywords: Chemotherapy
Neutropenia
breast cancer
Lead sponsor: Tianjin SinoBiotech Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility 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.

Primary outcomes:
measure: Main curative effect evaluation index
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary efficacy evaluation index
timeFrame: 8 weeks
measure: Secondary efficacy evaluation index-1
timeFrame: 8 weeks
measure: Secondary efficacy evaluation index-2
timeFrame: 8 weeks
measure: Secondary efficacy evaluation index-3
timeFrame: 8 weeks
measure: Secondary efficacy evaluation index-4
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Cancer Hospital
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe XU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z.