xml: <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/NCT06021379</url>
    </required_header>
    <id_info>
      <org_study_id>TRA.ARY.FH.95.IV</org_study_id>
      <nct_id>NCT06021379</nct_id>
    </id_info>
    <brief_title>AryoTrust® (Trastuzumab) Safety Study</brief_title>
    <official_title>Post-marketing Surveillance for Evaluation of AryoTrust Safety in Iranian HER2-positive Breast Cancer Patients Undergoing Adjuvant Chemotherapy Regimens</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AryoGen Pharmed Co.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AryoGen Pharmed Co.</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>
        This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing&#xD;
        surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast&#xD;
        cancer patients undergoing adjuvant chemotherapy regimens.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study is an observational, multicenter, non-interventional, single-arm,&#xD;
        open-label PMS study conducted in Iran. No control groups are included in the study design.&#xD;
  &#xD;
        The objective of this PMS study is to monitor and assess the safety of AryoTrust in patients&#xD;
        with non-metastatic HER2-positive breast cancer in adjuvant setting over a period of 27&#xD;
        weeks.&#xD;
  &#xD;
        Treatment with AryoTrust in this study is defined as the administration of 6mg/kg AryoTrust,&#xD;
        every 3 weeks during the 27 weeks of the study period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 22, 2017</start_date>
    <completion_date type="Actual">August 28, 2022</completion_date>
    <primary_completion_date type="Actual">August 28, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs</measure>
      <time_frame>up to 27 weeks</time_frame>
      <description>Safety assessment, including the incidence of any AEs, laboratory results and assessment of tolerability as evaluated by infusion-related reactions. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">597</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>AryoGen Pharmed Trastuzumab</arm_group_label>
      <description>AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trastuzumab</intervention_name>
      <description>AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.</description>
      <arm_group_label>AryoGen Pharmed Trastuzumab</arm_group_label>
      <other_name>AryoTrust</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A total of 597 Iranian patients diagnosed with HER2-positive breast cancer who underwent&#xD;
          adjuvant chemotherapy regimens with AryoTrust were enrolled in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had received Trastuzumab as part of their therapy or were not candidates&#xD;
               for treatment continuation after adjuvant chemotherapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatemeh Homaee Shandiz, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>5th Azar Hospital</name>
        <address>
          <city>Gorgān</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Milad Hospital</name>
        <address>
          <city>Isfahan</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Mahdieh Clinic</name>
        <address>
          <city>Kermanshah</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hashemi Nezhad Hospital</name>
        <address>
          <city>Mashhad</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Imam Reza Hospital</name>
        <address>
          <city>Mashhad</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Omid Hospital</name>
        <address>
          <city>Mashhad</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Sadra Clinic</name>
        <address>
          <city>Qom</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Vasei Hospital</name>
        <address>
          <city>Sabzevar</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Namazi Hospital</name>
        <address>
          <city>Shiraz</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Valiasr Hospital</name>
        <address>
          <city>Tabriz</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Imam Hussein Hospital</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Mahdiyeh Hospital</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shahid Fayaz-Bakhsh Hospital</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shohadaye Tajrish Hospital</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Omid Hospital</name>
        <address>
          <city>Urmía</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Trastuzumab</keyword>
    <keyword>Safety</keyword>
    <keyword>AryoTrust</keyword>
    <keyword>Breast Cancer</keyword>
    <keyword>Adjuvant Chemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trastuzumab</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021379
  org study id: TRA.ARY.FH.95.IV
  nct id: NCT06021379
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing
        surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast
        cancer patients undergoing adjuvant chemotherapy regimens.
  The present study is an observational, multicenter, non-interventional, single-arm,
        open-label PMS study conducted in Iran. No control groups are included in the study design.
  
        The objective of this PMS study is to monitor and assess the safety of AryoTrust in patients
        with non-metastatic HER2-positive breast cancer in adjuvant setting over a period of 27
        weeks.
  
        Treatment with AryoTrust in this study is defined as the administration of 6mg/kg AryoTrust,
        every 3 weeks during the 27 weeks of the study period.
  observational model: Case-Only
  time perspective: Prospective
  measure: Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs
  time frame: up to 27 weeks
  description: Safety assessment, including the incidence of any AEs, laboratory results and assessment of tolerability as evaluated by infusion-related reactions. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
  arm group label: AryoGen Pharmed Trastuzumab
  description: AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
  intervention type: Drug
  intervention name: Trastuzumab
  description: AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
  arm group label: AryoGen Pharmed Trastuzumab
  other name: AryoTrust
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Fatemeh Homaee Shandiz, Prof.
  role: Principal Investigator
  affiliation: Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences
  facility: 
  facility: 
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  country: Iran, Islamic Republic of
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Trastuzumab