<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/NCT03785704</url>
  </required_header>
  <id_info>
    <org_study_id>NCC1786</org_study_id>
    <nct_id>NCT03785704</nct_id>
  </id_info>
  <brief_title>Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer</brief_title>
  <official_title>Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Totally 60 subjects will be included in the study. The present study was aimed to observe and&#xD;
      evaluate the effect of Xinmailong injection on reducing cardiovascular toxicity associated&#xD;
      with adjuvant chemotherapy after breast cancer surgery. The primary endpoint was 6 months of&#xD;
      cardiac safety. Secondary endpoints included 3 months of cardiac safety, adverse events (AE),&#xD;
      severe adverse events (SAE), and DFS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing the informed consent, the patients in the control group will receive Epirubicin&#xD;
      45mg/m2 d1, 2 + cyclophosphamide 600mg/ m2 d1, repeated every 14 or 21 days for 4 cycles,&#xD;
      followed by paclitaxel 175 mg/m2 (or docetaxel 75 mg/m2) on day 1, repeated every 21 days for&#xD;
      4 cycles. Patients in the Xinmailong group were given 5 mg/kg of Xinmailong injection every&#xD;
      cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen as those in the control group.&#xD;
      The patients-general condition, vital signs, blood routine, liver and kidney function,&#xD;
      electrocardiogram, myocardial enzymes, troponin, BNP and echocardiography should be examined&#xD;
      every week. Breast ultrasound were performed every week. Chest CT were evaluated after 8&#xD;
      cycles of chemotherapy.&#xD;
&#xD;
      After adjuvant chemotherapy, adjuvant radiotherapy and endocrine therapy were given according&#xD;
      to the situation, and long-term survival was observed.&#xD;
&#xD;
      The patients will be followed up for 5 years, once every 6 months with in 1-3 years, once&#xD;
      every 12 months within 4-5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</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>
    <intervention_model_description>Totally 60 subjects will be included in the study.Random assignment was 1:1 to Xinmailong injection group and control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of no cardiac events during chemotherapy</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) .No cardiac events were defined until all relevant indicators (Electrocardiograph, Echcardiography and myocardial enzyme) were normal during chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>5 years</time_frame>
    <description>The time between the start of a randomized clinical trial and the onset of disease recurrence or death from any cause</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Neoplasms</condition>
  <condition>Cardiac Event</condition>
  <condition>Chemotherapeutic Toxicity</condition>
  <arm_group>
    <arm_group_label>Xinmailong injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>given 5 mg/kg of Xinmailong injection every cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen (EC-T) as those in the control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>receive conventional EC-T regimen chemotherapy (Epirubicin 45mg/m2 d1, 2 + cyclophosphamide 600mg/ m2 d1, repeated every 14 or 21 days for 4 cycles, followed by paclitaxel 175 mg/m2 (or docetaxel 75 mg/m2) on day 1, repeated every 21 days for 4 cycles).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xinmailong Injection</intervention_name>
    <description>Xinmailong injection is extracted, separated, purified and refined from Periplaneta americana. It is the second class of new drugs and the only small molecular bioactive peptide preparation approved by the State Pharmaceutical Administration (P.R.China) for the prevention and treatment of heart failure. Its main constituents include complex nucleoside bases and binding amino acids.</description>
    <arm_group_label>Xinmailong injection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥18 years, female;&#xD;
&#xD;
          2. after radical mastectomy, EC - T adjuvant chemotherapy is planned.&#xD;
&#xD;
          3. No relevant treatment (such as antineoplastic therapy, immunotherapy, etc.) that may&#xD;
             affect the outcome of treatment was received before admission.&#xD;
&#xD;
          4. ECOG PS score: 0-2 points;&#xD;
&#xD;
          5. Laboratory criteria:&#xD;
&#xD;
               -  white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more&#xD;
                  than 1.5 x 109 /L.&#xD;
&#xD;
                    -  platelet (&gt;100 *109/L); hemoglobin (&gt;10g/dL); serum creatinine (&lt;1.5 *normal&#xD;
                       value) upper limit (ULN); aspartate aminotransferase (AST) (&lt;2.5 *ULN);&#xD;
                       alanine aminotransferase (ALT) (&lt;2.5 *ULN); total bilirubin (&lt;1.5 *ULN);&#xD;
                       serum creatinine (&lt;1.5 *ULN); the volunteers voluntarily joined the study,&#xD;
                       signed informed consent, and had good compliance and follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cockroach or xinmailong allergy (including xinmailong test positive).&#xD;
&#xD;
          2. Pregnant or lactation woman&#xD;
&#xD;
          3. severe bleeding tendency;&#xD;
&#xD;
          4. With mental disease&#xD;
&#xD;
          5. With severe infection or active gastrointestinal ulcers&#xD;
&#xD;
          6. allergic to chemotherapeutic agents;&#xD;
&#xD;
          7. Disease-free period of other malignant tumor is less than 5 years(except cured basal&#xD;
             cell skin cancer and cervical carcinoma in situ).&#xD;
&#xD;
          8. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or&#xD;
             diabetes&#xD;
&#xD;
          9. taking part or participating in other clinical trials within one month.&#xD;
&#xD;
         10. previous history of severe cardiovascular disease or cardiovascular disease risk&#xD;
             factors were ≥ 4.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fei Ma, MD</last_name>
      <phone>8610-87788495</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>January 20, 2020</last_update_submitted>
  <last_update_submitted_qc>January 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
    <investigator_full_name>Fei Ma</investigator_full_name>
    <investigator_title>Deputy director of oncology</investigator_title>
  </responsible_party>
  <keyword>Xinmailong injection</keyword>
  <keyword>anthracycline induced cardiac toxicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_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/NCT03785704
org study id: NCC1786
nct id: NCT03785704
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Totally 60 subjects will be included in the study. The present study was aimed to observe and
      evaluate the effect of Xinmailong injection on reducing cardiovascular toxicity associated
      with adjuvant chemotherapy after breast cancer surgery. The primary endpoint was 6 months of
      cardiac safety. Secondary endpoints included 3 months of cardiac safety, adverse events (AE),
      severe adverse events (SAE), and DFS.
After signing the informed consent, the patients in the control group will receive Epirubicin
      45mg/m2 d1, 2 + cyclophosphamide 600mg/ m2 d1, repeated every 14 or 21 days for 4 cycles,
      followed by paclitaxel 175 mg/m2 (or docetaxel 75 mg/m2) on day 1, repeated every 21 days for
      4 cycles. Patients in the Xinmailong group were given 5 mg/kg of Xinmailong injection every
      cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen as those in the control group.
      The patients-general condition, vital signs, blood routine, liver and kidney function,
      electrocardiogram, myocardial enzymes, troponin, BNP and echocardiography should be examined
      every week. Breast ultrasound were performed every week. Chest CT were evaluated after 8
      cycles of chemotherapy.

      After adjuvant chemotherapy, adjuvant radiotherapy and endocrine therapy were given according
      to the situation, and long-term survival was observed.

      The patients will be followed up for 5 years, once every 6 months with in 1-3 years, once
      every 12 months within 4-5 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Totally 60 subjects will be included in the study.Random assignment was 1:1 to Xinmailong injection group and control group.
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of no cardiac events during chemotherapy
time frame: up to 12 months
description: Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) .No cardiac events were defined until all relevant indicators (Electrocardiograph, Echcardiography and myocardial enzyme) were normal during chemotherapy.
measure: Disease-free survival (DFS)
time frame: 5 years
description: The time between the start of a randomized clinical trial and the onset of disease recurrence or death from any cause
arm group label: Xinmailong injection group
arm group type: Experimental
description: given 5 mg/kg of Xinmailong injection every cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen (EC-T) as those in the control group.
arm group label: control group
arm group type: No Intervention
description: receive conventional EC-T regimen chemotherapy (Epirubicin 45mg/m2 d1, 2 + cyclophosphamide 600mg/ m2 d1, repeated every 14 or 21 days for 4 cycles, followed by paclitaxel 175 mg/m2 (or docetaxel 75 mg/m2) on day 1, repeated every 21 days for 4 cycles).
intervention type: Drug
intervention name: Xinmailong Injection
description: Xinmailong injection is extracted, separated, purified and refined from Periplaneta americana. It is the second class of new drugs and the only small molecular bioactive peptide preparation approved by the State Pharmaceutical Administration (P.R.China) for the prevention and treatment of heart failure. Its main constituents include complex nucleoside bases and binding amino acids.
arm group label: Xinmailong injection group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College
investigator full name: Fei Ma
investigator title: Deputy director of oncology
mesh term: Breast Neoplasms
mesh term: Cardiovascular Diseases