<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190504043465N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-18</date_registration>
      <primary_sponsor>Pooyesh Darou</primary_sponsor>
      <public_title>Efficacy and safety of PDlasta® and PDgrastim® in breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of PDlasta® (Pegfilgrastim) &amp; PDgrastim® (Filgrastim) efficacy and safety in increasing absolute neutrophil count in breast cancer patients on adjuvant and neoadjuvant treatment with Dose-dense ac4-t4</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39264</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocation of participants into two arm of treatments, the permuted block randomization was used with quadruple blocks. According to the identified sample size of 80, twenty blocks were produced. Four persons of each group were randomly and equally assigned to treatment A or B  using a toss. In order to apply the concealment in the randomization process, 20 thick pocket were selected randomly by the software (www.sealedenvelope.com). By this method, nobody was aware of allocation sequence of participants to treatment groups, Blinding description: Due to the different protocol of prescribing two drugs and the necessity of monitoring an oncologist, there is no possibility of blinding the patient and the therapist. The results analyst specialist will not be informed about how people are assigned to groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients receive the subcutaneous injection of 6 mg of Pegfilgrastim (PDlasta) in each chemotherapy cycle (on the first day after chemotherapy (24 hours later). Intervention 2: Control group: Patients on the first day after chemotherapy (24 hours later) will use Filgrastim (PDgrastim) for subcutaneous injection of 300 micrograms daily for six consecutive days.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Safa Najjar Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, West Shahid nazari Ave, Aboureyhan St, Enghelab e eslami St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1315685981</zip>
        <telephone>+98 21 6640 4050</telephone>
        <email>Safa3n@yahoo.com</email>
        <affiliation>Breast Cancer Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Safa Najjar Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, West Shahid nazari Ave, Aboureyhan St, Enghelab e eslami St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1315685981</zip>
        <telephone>+98 21 6640 4050</telephone>
        <email>Safa3n@yahoo.com</email>
        <affiliation>Breast Cancer Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Investigator diagnosis of breast cancer candidate of adjuvant and neoadjuvant therapy
Absolute neutrophil count ≥1.5 × 10^9/L
Platelet count ≥100 × 10^9/L
Serum creatinine &lt;1.5 × upper limit of normal
Dose-dense ac4-t4 regimen</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Bilirubin &gt; upper limit of normal; or Aspartate transaminase and/or Alanine transaminase &gt;1.5 × upper limit of normal, concomitant with Alkaline phosphatase &gt;2.5 × upper limit of normal
Radiation therapy within 4 weeks of randomization into this study
Prior bone marrow or stem cell transplantation
Total lifetime exposure to Doxorubicin &gt;240 mg/m2 or Epirubicin &gt;600 mg/m2
Ejection fraction&lt;40%
Liver cirrhosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients receive the subcutaneous injection of 6 mg of Pegfilgrastim (PDlasta) in each chemotherapy cycle (on the first day after chemotherapy (24 hours later).</i_keyword>
      <i_keyword>Control group: Patients on the first day after chemotherapy (24 hours later) will use Filgrastim (PDgrastim) for subcutaneous injection of 300 micrograms daily for six consecutive days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Absolute Neutrophil Count. Timepoint: Before intervention (baseline), 7th day and 14th day after each chemotherapy course. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>White blood cell. Timepoint: Before intervention (baseline), 7th day and 14th day after each chemotherapy course. Method of measurement: Blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Febrile neutropenia. Timepoint: 7th day and 14th day after each chemotherapy course. Method of measurement: Clinical evaluation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Pooyesh Darou</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-16</approval_date>
        <contact_name>Ethics committee of Jahad Daneshgahi breast cancer institute</contact_name>
        <contact_address>No. 45, West Shahid nazari Ave, Aboureyhan St, Enghelab e eslami St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
