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/NCT05988112</url>
    </required_header>
    <id_info>
      <org_study_id>Amira Ali</org_study_id>
      <nct_id>NCT05988112</nct_id>
    </id_info>
    <brief_title>Locoregional Recurrence of Breast Cancer</brief_title>
    <official_title>Locoregional Recurrence After Radiotherapy in Breast Cancer Patients Based on Molecular Subtypes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <brief_summary>
      <textblock>
        our study will be retrospective on breast cancer patients to detect relation between the&#xD;
        locoregional recurrence of breast cancer after radiotherapy and the molecular subtypes&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Having replaced lung cancer as the most common cancer globally, breast cancer today represent&#xD;
        1 in 8 cancer cases and a total of 2.3 million new cases in both sexes .&#xD;
  &#xD;
        It Represents a quarter of all cancer cases in females, and it was the most commonly&#xD;
        diagnosed cancer in women in 2020 , its burden has been growing in many parts of the world,&#xD;
        particularly in transitioning countries . An estimated 685,000 women died from breast cancer&#xD;
        in 2020, corresponding to 16% or 1 in every 6 cancer deaths in women.&#xD;
  &#xD;
        In Egypt, it constitutes 33% of female cancer cases and more than 22,000 new cases diagnosed&#xD;
        each year .&#xD;
  &#xD;
        Treatment Strategies include Surgery, Chemotherapy ,Radiotherapy, Endocrinal (Hormonal)&#xD;
        Therapy &amp; Biological Therapy , according to stages and molecular subtypes&#xD;
  &#xD;
        A majority of breast cancer patients undergoing surgical excision will receive radiotherapy&#xD;
        as a local treatment, which will reduce local and regional recurrence (LRR), further&#xD;
        elevating survival.&#xD;
  &#xD;
        Slightly over 50% of women with early-stage breast cancer remain disease free for at least 10&#xD;
        years, but recurrences continue to occur long after primary diagnosis.&#xD;
  &#xD;
        Several multigene molecular assays are currently under investigation to accurately identify&#xD;
        patients with unfavorable prognosis .However, considering the lack of cost-effectiveness of&#xD;
        these detection approaches, they are not easily applied on a large scale, especially in less&#xD;
        developed countries. In contrast, immunohistochemical (IHC) staining profile is a&#xD;
        cost-effective and popular surrogate.Based on IHC staining profiles, St Gallen International&#xD;
        Breast Cancer Conference in 2013 classified breast cancer into four subtypes: Luminal A,&#xD;
        Luminal B, HER2-positive, and triple-negative breast cancer (TNBC). This classification&#xD;
        system has been widely used in clinical decision-making for the systemic management of breast&#xD;
        cancer.&#xD;
  &#xD;
        This classification depend on presence or absence of estrogen receptor (ER), progesterone&#xD;
        receptor (PR), human epidermal growth factor (Her2) and Ki 67 as luminal A is positive for ER&#xD;
        &amp;PR, negative for Her2 with low Ki67, luminal B is ER positive, PR &amp; Her2 may be positive or&#xD;
        negative but with high Ki67, Her2 is ER &amp;PR negative with Her2 positive, Triple negative (TN)&#xD;
        is ER &amp; PR &amp; Her2 negative with high Ki67, with no benefit of hormonal or anti Her2 therapy.&#xD;
  &#xD;
        Few studies done showed that Luminal A and B subtypes are generally associated with lower&#xD;
        risks of regional nodal involvement at diagnosis and tend to have a more indolent evolution&#xD;
        as compared with the other subtypes. Several retrospective studies have shown lower rates of&#xD;
        LRR in luminal A as compared with the other subtypes, among whom luminal B is considered as&#xD;
        intermediate risk with rates ranging between 1.5 and 8.7% and peak incidence during the first&#xD;
        5 years .&#xD;
  &#xD;
        For HER2-positive patients, there are two distinct periods. In studies in which patients were&#xD;
        not treated with HER2-targeted therapy, LRR rates ranged between 4 and 15% .&#xD;
  &#xD;
        More recently, trastuzumab have positively modified the natural course of this BC subtype.&#xD;
        patients with HER2-positive tumors who underwent surgery and received trastuzumab had LRR&#xD;
        rate of 1.7%. This finding was supported by many studies, who also showed that trastuzumab&#xD;
        treatment resulted in a decrease in LRR by 50%. This has also been observed in small tumors&#xD;
        HER2-positive BC study after trastuzumab .&#xD;
  &#xD;
        The TNG subtype was associated with increased LRR rates, after breast conservation and&#xD;
        mastectomy (3-17%). Moreover, after the diagnosis of an LRR, the TNG subtype is associated&#xD;
        with a high incidence of distant metastases .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Determine Local &amp; regional recurrence according to different molecular subtypes.</measure>
      <time_frame>within 5 years from diagnosis</time_frame>
      <description>radiologically or with re biopsy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>- 5-year free survival</measure>
      <time_frame>within 5 years from diagnosis</time_frame>
      <description>radiologically</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Metastasis-Free Survival</measure>
      <time_frame>within 5 years from diagnosis</time_frame>
      <description>radiologically</description>
    </secondary_outcome>
    <enrollment type="Anticipated">265</enrollment>
    <condition>Locoregional Recurrence</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients diagnosed with breast cancer in clinical oncology department , Assuit university&#xD;
          hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Histological proven breast cancer (IDC / ILC)&#xD;
  &#xD;
            -  with known receptor status&#xD;
  &#xD;
            -  Patient did mastectomy or breast conservative surgery +/- lymph node dissection .&#xD;
  &#xD;
            -  received radiotherapy&#xD;
  &#xD;
            -  on regular follow up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metastatic from the start (stage 4)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Amira Ali Fekry, master</last_name>
      <phone>01099824589</phone>
      <email>aliamera825@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Amira Ali Fekry Mohamed</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Recurrence</mesh_term>
    </condition_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/NCT05988112
  org study id: Amira Ali
  nct id: NCT05988112
  lead sponsor: 
  our study will be retrospective on breast cancer patients to detect relation between the
        locoregional recurrence of breast cancer after radiotherapy and the molecular subtypes
  Having replaced lung cancer as the most common cancer globally, breast cancer today represent
        1 in 8 cancer cases and a total of 2.3 million new cases in both sexes .
  
        It Represents a quarter of all cancer cases in females, and it was the most commonly
        diagnosed cancer in women in 2020 , its burden has been growing in many parts of the world,
        particularly in transitioning countries . An estimated 685,000 women died from breast cancer
        in 2020, corresponding to 16% or 1 in every 6 cancer deaths in women.
  
        In Egypt, it constitutes 33% of female cancer cases and more than 22,000 new cases diagnosed
        each year .
  
        Treatment Strategies include Surgery, Chemotherapy ,Radiotherapy, Endocrinal (Hormonal)
        Therapy & Biological Therapy , according to stages and molecular subtypes
  
        A majority of breast cancer patients undergoing surgical excision will receive radiotherapy
        as a local treatment, which will reduce local and regional recurrence (LRR), further
        elevating survival.
  
        Slightly over 50% of women with early-stage breast cancer remain disease free for at least 10
        years, but recurrences continue to occur long after primary diagnosis.
  
        Several multigene molecular assays are currently under investigation to accurately identify
        patients with unfavorable prognosis .However, considering the lack of cost-effectiveness of
        these detection approaches, they are not easily applied on a large scale, especially in less
        developed countries. In contrast, immunohistochemical (IHC) staining profile is a
        cost-effective and popular surrogate.Based on IHC staining profiles, St Gallen International
        Breast Cancer Conference in 2013 classified breast cancer into four subtypes: Luminal A,
        Luminal B, HER2-positive, and triple-negative breast cancer (TNBC). This classification
        system has been widely used in clinical decision-making for the systemic management of breast
        cancer.
  
        This classification depend on presence or absence of estrogen receptor (ER), progesterone
        receptor (PR), human epidermal growth factor (Her2) and Ki 67 as luminal A is positive for ER
        &PR, negative for Her2 with low Ki67, luminal B is ER positive, PR & Her2 may be positive or
        negative but with high Ki67, Her2 is ER &PR negative with Her2 positive, Triple negative (TN)
        is ER & PR & Her2 negative with high Ki67, with no benefit of hormonal or anti Her2 therapy.
  
        Few studies done showed that Luminal A and B subtypes are generally associated with lower
        risks of regional nodal involvement at diagnosis and tend to have a more indolent evolution
        as compared with the other subtypes. Several retrospective studies have shown lower rates of
        LRR in luminal A as compared with the other subtypes, among whom luminal B is considered as
        intermediate risk with rates ranging between 1.5 and 8.7% and peak incidence during the first
        5 years .
  
        For HER2-positive patients, there are two distinct periods. In studies in which patients were
        not treated with HER2-targeted therapy, LRR rates ranged between 4 and 15% .
  
        More recently, trastuzumab have positively modified the natural course of this BC subtype.
        patients with HER2-positive tumors who underwent surgery and received trastuzumab had LRR
        rate of 1.7%. This finding was supported by many studies, who also showed that trastuzumab
        treatment resulted in a decrease in LRR by 50%. This has also been observed in small tumors
        HER2-positive BC study after trastuzumab .
  
        The TNG subtype was associated with increased LRR rates, after breast conservation and
        mastectomy (3-17%). Moreover, after the diagnosis of an LRR, the TNG subtype is associated
        with a high incidence of distant metastases .
  observational model: Cohort
  time perspective: Retrospective
  measure: Determine Local & regional recurrence according to different molecular subtypes.
  time frame: within 5 years from diagnosis
  description: radiologically or with re biopsy
  measure: - 5-year free survival
  time frame: within 5 years from diagnosis
  description: radiologically
  measure: Metastasis-Free Survival
  time frame: within 5 years from diagnosis
  description: radiologically
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Amira Ali Fekry, master
  phone: 01099824589
  email: aliamera825@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Amira Ali Fekry Mohamed
  investigator title: Assistant lecturer
  mesh term: Recurrence