<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/NCT04477616</url>
  </required_header>
  <id_info>
    <org_study_id>NBC Che001</org_study_id>
    <nct_id>NCT04477616</nct_id>
  </id_info>
  <brief_title>Injection Regimen Trial of PEG-rhG-CSF During Breast Cancer Chemotherapy</brief_title>
  <official_title>Injection Regimen Trial of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (PEG-rhG-CSF) in Preventing Bone Marrow Suppression and/or Febrile Neutropenia (FN) During Breast Cancer Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to try to find a better injection regimen (including time and&#xD;
      dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN&#xD;
      in breast cancer patients who receive chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2021</start_date>
  <completion_date type="Actual">November 6, 2022</completion_date>
  <primary_completion_date type="Actual">October 6, 2022</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>the rates of grade III/IV neutropenia during the first and second chemotherapy cycle</measure>
    <time_frame>up to 9 weeks</time_frame>
    <description>grade III or IV neutropenia (ANC &lt; 1x 10^9/L or 0.5 x 10^9/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the rates of FN during the first and second chemotherapy cycle</measure>
    <time_frame>up to 9 weeks</time_frame>
    <description>the occurrent rate of FN（FN：Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count &lt;500/mcl or neutrophil count &lt;1000/mcl, but expected to drop to &lt;500/ mcl after 48 hours .）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg</measure>
    <time_frame>up to 9 weeks</time_frame>
    <description>If WBC &gt;= 10 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle</measure>
    <time_frame>up to 9 weeks</time_frame>
    <description>Adverse reactions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental: Experimental/PEG-rhG-CSF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC &gt;= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator: Comparator/PEG-rhG-CSF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC &gt;= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Day 7 regimen</intervention_name>
    <description>patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC &gt;= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.</description>
    <arm_group_label>Experimental: Experimental/PEG-rhG-CSF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Day 3 regimen</intervention_name>
    <description>patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC &gt;= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.</description>
    <arm_group_label>Comparator: Comparator/PEG-rhG-CSF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
          1. Female breast cancer aged 18-70 years old, the expected survival period is greater&#xD;
             than 12 months.&#xD;
&#xD;
          2. No previous radiotherapy and chemotherapy.&#xD;
&#xD;
          3. No history of serious systemic disease.&#xD;
&#xD;
          4. KPS≥70.&#xD;
&#xD;
          5. White blood cell count&gt; 3.5 × 10 ^ 9 / L, neutrophil count&gt; 1.8 × 10 ^ 9 / L, platelet&#xD;
             count&gt; 100 × 10 ^ 9 / L, hemoglobin&gt; 9 g / dl.&#xD;
&#xD;
          6. ALT (alanine transaminase) and AST (aspartate transaminase) &lt;1.5 times the upper limit&#xD;
             of normal value, alkaline phosphatase &lt;2.5 times the upper limit of normal value, and&#xD;
             total bilirubin &lt;1.5 times the upper limit of normal value.&#xD;
&#xD;
          7. Serum muscle plasma &lt;1.5 times the upper limit of normal value.&#xD;
&#xD;
          8. No abnormal blood coagulation.&#xD;
&#xD;
          9. Women of childbearing age had a negative serum or urine pregnancy test before the&#xD;
             start of treatment and agreed to contraception during treatment.&#xD;
&#xD;
         10. Cardiac function: two-dimensional echocardiography examination LVEF (left ventricular&#xD;
             ejection fraction) ≥ 55%.&#xD;
&#xD;
         11. Sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy,&#xD;
             and endocrine therapy.&#xD;
&#xD;
          2. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma&#xD;
             and cervical carcinoma in situ).&#xD;
&#xD;
          3. The patient has been enrolled in other clinical trials or used other study drugs 30&#xD;
             days before enrollment in this study.&#xD;
&#xD;
          4. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal&#xD;
             ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue&#xD;
             disease or bone marrow function suppression, and other diseases, can not tolerate&#xD;
             chemotherapy-related treatments.&#xD;
&#xD;
          5. Two-dimensional echocardiography detection LVEF &lt;55%.&#xD;
&#xD;
          6. Severe cardiovascular and cerebrovascular diseases within the first 6 months of&#xD;
             randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension&gt;&#xD;
             150/90 mmHg, myocardial infarction, or cerebrovascular accident).&#xD;
&#xD;
          7. NCI peripheral neurotoxicity grade ≥2.&#xD;
&#xD;
          8. Those taking glucocorticoids.&#xD;
&#xD;
          9. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab, or&#xD;
             pertuzumab.&#xD;
&#xD;
         10. Refuse contraception during treatment and within 8 weeks after completion of treatment&#xD;
             for women of childbearing age.&#xD;
&#xD;
         11. Pregnant and lactating women.&#xD;
&#xD;
         12. After joining the test, a pregnancy test (+) before using the drug.&#xD;
&#xD;
         13. There are mental illness, cognitive impairment, unable to understand the test plan and&#xD;
             side effects, unable to complete the test plan, and follow-up workers (systematic&#xD;
             evaluation is required before the trial is enrolled).&#xD;
&#xD;
         14. No personal freedom and independent civil capacity.&#xD;
&#xD;
         15. The investigator determined that the patient could not obtain long-term follow-up data&#xD;
             (due to unavailability or serious concomitant diseases).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoming Zha, MD</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Jue Wang</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>PEG-rhG-CSF</keyword>
  <keyword>Bone marrow suppression</keyword>
  <keyword>Febrile neutropenia</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 28, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04477616
org study id: NBC Che001
nct id: NCT04477616
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to try to find a better injection regimen (including time and
      dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN
      in breast cancer patients who receive chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the rates of grade III/IV neutropenia during the first and second chemotherapy cycle
time frame: up to 9 weeks
description: grade III or IV neutropenia (ANC < 1x 10^9/L or 0.5 x 10^9/L)
measure: the rates of FN during the first and second chemotherapy cycle
time frame: up to 9 weeks
description: the occurrent rate of FN（FN：Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count <500/mcl or neutrophil count <1000/mcl, but expected to drop to <500/ mcl after 48 hours .）
measure: Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg
time frame: up to 9 weeks
description: If WBC >= 10 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle
measure: Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle
time frame: up to 9 weeks
description: Adverse reactions
arm group label: Experimental: Experimental/PEG-rhG-CSF
arm group type: Experimental
description: patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
arm group label: Comparator: Comparator/PEG-rhG-CSF
arm group type: Active Comparator
description: patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
intervention type: Drug
intervention name: Day 7 regimen
description: patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
arm group label: Experimental: Experimental/PEG-rhG-CSF
intervention type: Drug
intervention name: Day 3 regimen
description: patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
arm group label: Comparator: Comparator/PEG-rhG-CSF
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaoming Zha, MD
role: Study Director
affiliation: The First Affiliated Hospital with Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Jue Wang
investigator title: Prof.
mesh term: Breast Neoplasms
mesh term: Febrile Neutropenia
submitted: August 28, 2023