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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251768
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Neutropenia Drug: rHSA-GCSF 2.4mg Drug: GCSF Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : April 24, 2019

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Arms and Interventions
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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 Name: 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 Name: jisaixin


Outcome Measures
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Primary Outcome Measures :
  1. Main curative effect evaluation index [ Time Frame: 4 weeks ]
    The duration of the degree of Ⅳ neutropenia


Secondary Outcome Measures :
  1. Secondary efficacy evaluation index [ Time Frame: 8 weeks ]
    The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L)

  2. Secondary efficacy evaluation index-1 [ Time Frame: 8 weeks ]
    The time required for neutrophil recovery to 2.0x109/L(

  3. Secondary efficacy evaluation index-2 [ Time Frame: 8 weeks ]
    ANC

  4. Secondary efficacy evaluation index-3 [ Time Frame: 8 weeks ]
    febrile neutropenia

  5. Secondary efficacy evaluation index-4 [ Time Frame: 8 weeks ]
    The usage of antibiotics


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251768


Locations
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China, Beijing
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Tianjin SinoBiotech Ltd.
Investigators
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Principal Investigator: Binghe XU, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Tianjin SinoBiotech Ltd.
ClinicalTrials.gov Identifier: NCT03251768    
Other Study ID Numbers: CHS01N-1892
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin SinoBiotech Ltd.:
Chemotherapy
Neutropenia
breast cancer
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs