<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03251768</url>
  </required_header>
  <id_info>
    <org_study_id>CHS01N-1892</org_study_id>
    <nct_id>NCT03251768</nct_id>
  </id_info>
  <brief_title>Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin SinoBiotech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin SinoBiotech Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the efficacy and safety of recombinant human serum albumin /&#xD;
      granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced&#xD;
      neutropenia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC)&#xD;
           treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or&#xD;
           positive control during the period between two chemotherapy treatments.&#xD;
&#xD;
        -  Targeted patients: breast cancer&#xD;
&#xD;
        -  Subjects were randomly divided into two groups. The test group received recombinant&#xD;
           human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg&#xD;
           treatment. Positive control group received recombinant human granulocyte colony stimuli&#xD;
           Factor injection therapy&#xD;
&#xD;
        -  Number of patients: 80&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2017</start_date>
  <completion_date type="Actual">April 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Main curative effect evaluation index</measure>
    <time_frame>4 weeks</time_frame>
    <description>The duration of the degree of Ⅳ neutropenia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy evaluation index</measure>
    <time_frame>8 weeks</time_frame>
    <description>The duration of the degree of Ⅳ neutropenia(ANC&lt;0.5×109/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy evaluation index-1</measure>
    <time_frame>8 weeks</time_frame>
    <description>The time required for neutrophil recovery to 2.0x109/L(</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy evaluation index-2</measure>
    <time_frame>8 weeks</time_frame>
    <description>ANC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy evaluation index-3</measure>
    <time_frame>8 weeks</time_frame>
    <description>febrile neutropenia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy evaluation index-4</measure>
    <time_frame>8 weeks</time_frame>
    <description>The usage of antibiotics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.&#xD;
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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA-GCSF 2.4mg</intervention_name>
    <description>Human Serum Albumin GCSF 2.4mg at day 3 and day 7</description>
    <arm_group_label>Test group</arm_group_label>
    <other_name>Human Serum Albumin GCSF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GCSF</intervention_name>
    <description>GCSF 5 mcg/kg/day</description>
    <arm_group_label>Positive control group</arm_group_label>
    <other_name>jisaixin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65.&#xD;
&#xD;
          -  Diagnosed breast cancer, suitable for TEC or TE .&#xD;
&#xD;
          -  ECOG performance status 0 or 1.&#xD;
&#xD;
          -  Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior&#xD;
             chemotherapy.&#xD;
&#xD;
          -  No obvious abnormal ecg examination.&#xD;
&#xD;
          -  TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).&#xD;
&#xD;
          -  Cr, BUN≤2.5×ULN.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy within past 4 weeks.&#xD;
&#xD;
          -  Uncontrolled inflammatory disease,axillary temperature≥38℃.&#xD;
&#xD;
          -  Merging other malignant tumor.&#xD;
&#xD;
          -  Pregnancy or nursing status.&#xD;
&#xD;
          -  Participation in another clinical trial with and investigational product within 3&#xD;
             months prior to study entry.&#xD;
&#xD;
          -  Severe diabetes mellitus, or poor blood sugar controller.&#xD;
&#xD;
          -  Allergic disease or allergic constitution. History of protein allergy.&#xD;
&#xD;
          -  History of drug addiction and alcoholism.&#xD;
&#xD;
          -  Hematopoietic stem cell transplantation or organ transplantation.&#xD;
&#xD;
          -  Antibiotics were treated within 72 hours before chemotherapy.&#xD;
&#xD;
          -  Long-term use of hormones or immunosuppressive agents.&#xD;
&#xD;
          -  Severe mental or neurological disease.&#xD;
&#xD;
          -  Chronic disease of severe cardiac, kidney and liver.&#xD;
&#xD;
          -  Other conditions that would be excluded from this study according to doctors'judgment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Binghe XU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chemotherapy</keyword>
  <keyword>Neutropenia</keyword>
  <keyword>breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251768
org study id: CHS01N-1892
nct id: NCT03251768
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of the efficacy and safety of recombinant human serum albumin /
      granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced
      neutropenia
-  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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Main curative effect evaluation index
time frame: 4 weeks
description: The duration of the degree of Ⅳ neutropenia
measure: Secondary efficacy evaluation index
time frame: 8 weeks
description: The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L)
measure: Secondary efficacy evaluation index-1
time frame: 8 weeks
description: The time required for neutrophil recovery to 2.0x109/L(
measure: Secondary efficacy evaluation index-2
time frame: 8 weeks
description: ANC
measure: Secondary efficacy evaluation index-3
time frame: 8 weeks
description: febrile neutropenia
measure: Secondary efficacy evaluation index-4
time frame: 8 weeks
description: The usage of antibiotics
arm group label: Test group
arm group type: Experimental
description: 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.
arm group label: Positive control group
arm group type: Active Comparator
description: 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)
intervention type: Drug
intervention name: rHSA-GCSF 2.4mg
description: Human Serum Albumin GCSF 2.4mg at day 3 and day 7
arm group label: Test group
other name: Human Serum Albumin GCSF
intervention type: Drug
intervention name: GCSF
description: GCSF 5 mcg/kg/day
arm group label: Positive control group
other name: jisaixin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Binghe XU, MD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
facility: 
country: China
responsible party type: Sponsor
mesh term: Neutropenia
mesh term: Lenograstim