Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

Tianjin SinoBiotech Ltd.216 enrolled

Overview

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients. Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.

* 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. * Positive control：recombinant human granulocyte colony-stimulating factor injection. * Targeted patients: breast cancer * Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment. * Number of patients: 216 * Concomitant medicines will be conducted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

216

Conditions

Chemotherapy-induced Neutropenia

Interventions

HSA-GCSF 1.2 mgDRUG

Human Serum Albumin GCSF 1.2mg at day 3 and Day 7

HSA-GCSF 1.5 mgDRUG

Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7

GCSFDRUG

GCSF 5 mcg/kg/day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. * ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency. * 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. * Chronic disease of severe cardiac, kidney and liver. * Other conditions that would be excluded from this study according to doctors'judgment

Locations (1)

Cancer Hospital, Chinese Academy of Medical Scienses

Beijing, China

Outcomes

Primary Outcomes

The mean of duration for class IV neutrophilic granulocytopenia

Time frame: 4 weeks

Secondary Outcomes

The mean of duration for class IV neutrophilic granulocytopenia

Time frame: 8 weeks

The mean of duration for ANC up to 2.0×109/L

Time frame: 8 weeks

ANC

Time frame: 8 weeks

The usage of antibiotics

Time frame: 8 weeks

febrile neutropenia

Time frame: 8 weeks

Data from ClinicalTrials.gov

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