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

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

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Neutropenia
• Intervention / Treatment: Drug: rHSA-GCSF 2.4mg; Drug: GCSF

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Chinese Academy of Medical Sciences Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test group; intervention: rHSA-GCSF 2.4 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（2.4mg）will be injected subcutaneously at at 10 am (±90 min) on the 3th and 7th day of each chemotherapy cycle.After injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.	Drug: rHSA-GCSF 2.4mg; Human Serum Albumin GCSF 2.4mg at day 3 and day 7; Other Names: Human Serum Albumin GCSF
ACTIVE_COMPARATOR: Positive control group; intervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at 10 am (±90 min) from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. (The minimum of usage was continuous 7 days ,The maximum of usage was continuous 14 days)	Drug: GCSF; GCSF 5 mcg/kg/day; Other Names: jisaixin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main curative effect evaluation index	The duration of the degree of Ⅳ neutropenia	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy evaluation index	The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L)	8 weeks
Secondary efficacy evaluation index-1	The time required for neutrophil recovery to 2.0x109/L(	8 weeks
Secondary efficacy evaluation index-2	ANC	8 weeks
Secondary efficacy evaluation index-3	febrile neutropenia	8 weeks
Secondary efficacy evaluation index-4	The usage of antibiotics	8 weeks

Collaborators and Investigators

• Sponsor: Tianjin SinoBiotech Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2017
• Primary Completion (ACTUAL): July 23, 2018
• Study Completion (ACTUAL): April 24, 2019

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (ACTUAL): August 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; Chemotherapy; Neutropenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: CHS01N-1892

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No