<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/NCT03800355</url>
  </required_header>
  <id_info>
    <org_study_id>GEICAM/2016-04</org_study_id>
    <nct_id>NCT03800355</nct_id>
  </id_info>
  <brief_title>Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk</brief_title>
  <official_title>An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spanish Breast Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación ADEY</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spanish Breast Cancer Research Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational, Other Designs (OD) post-marketing, multicenter study, which will obtain&#xD;
      retrospective data from male patients diagnosed with invasive breast cancer between 2000 and&#xD;
      2019 in the medical oncology departments of hospitals that are associated with Spanish Breast&#xD;
      Cancer Research Group (GEICAM) (using information obtained from patient medical histories).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the objectives of this project is to ensure representativeness of the cases referred&#xD;
      to. Accordingly, participating sites agree to enroll in the study male patients who were&#xD;
      diagnosed with breast cancer in the period between 2000 and 2019.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>General condition: Age</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>General condition age will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General condition: performance status at diagnosis</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Performance status by Eastern Cooperative Oncology Group (ECOG) Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General condition and history: substance abuse</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With Substance abuse of tobacco and alcohol will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosis of other primary tumors</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Diagnosis of other primary tumors synchronous or metachronous, will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>BMI is a value derived from the mass (weight) and height. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary comorbidities</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Primary comorbidities will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Mutational status of BRCA or other genes of genetic predisposition will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family history of cancer</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Family history of cancer will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: date of diagnosis</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Date of diagnosis will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: histology</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>The histology of the tumor will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: clinical and/or pathological stage</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system of the Union for International Cancer Control (UICC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: hormone-receptor expression</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Hormone-receptor expression will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: histologic grade</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Tumor histologic grade will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: Ki-67</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Tumor Ki-67 proliferation index will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomopathological characteristics of the tumor: lymphovascular invasion</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2017.</time_frame>
    <description>Number of Participants With Presence of lymphovascular invasion will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment data: date of surgery</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Will be collected date of surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment data: type of surgery</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment data: type of chemotherapy</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment data: adjuvant radiotherapy</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With adjuvant radiotherapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment data: adjuvant hormonotherapy</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With hormonotherapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment data: other type of anti-cancer treatment</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With other type of anti-cancer treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follow-up data: relapse type</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With each relapse type: local, regional or distant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follow-up data: site of metastatic disease</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With site of metastatic disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follow-up data: occurrence of other primary tumors</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follow-up data: current condition</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>The date of the last review and current clinical condition will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biological and molecular characteristics analyzed in primary tumors: tumor subtypes</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological and molecular characteristics analyzed in primary tumors: risk groups</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Number of Participants With risk groups on the reference of breast cancer in women, including morphological analyses and description of the clinical profile (e.g., morphological type, differentiation (histologic grade), Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Date and cause of death</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>Date and cause of death, when applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS).</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>DFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-free survival (DMFS).</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>DMFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented distant relapse, second invasive non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS).</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS).</measure>
    <time_frame>From date of patient breast cancer diagnosis until 2019.</time_frame>
    <description>OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">777</enrollment>
  <condition>Breast Cancer, Male</condition>
  <arm_group>
    <arm_group_label>Male breast cancer</arm_group_label>
    <description>The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue and blood samples will be collected and biological and genetic analyses will be&#xD;
      performed.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study target population is all cases of male breast cancer (MBC), diagnosed with&#xD;
        invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology&#xD;
        Departments of participating sites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients diagnosed with primary invasive breast carcinoma between the years&#xD;
             2000-2019, and who have been treated and/or followed up in the Medical Oncology&#xD;
             Departments of participating sites.&#xD;
&#xD;
          -  The enrollment of patients who died is allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male patients who do not wish to participate in the study for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Investigator</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario Ramón y Cajal, Madrid, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chief Medical Investigator</last_name>
    <role>Study Director</role>
    <affiliation>Fundación Onkologikoa, San Sebastián, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Ferrol</name>
      <address>
        <city>Ferrol</city>
        <state>A Coruña</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de los Lirios</name>
      <address>
        <city>Alcoy</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Agustín</name>
      <address>
        <city>Avilés</city>
        <state>Asturias</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Granollers</name>
      <address>
        <city>Granollers</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Catalán de Oncología de L'Hospitalet</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorci Corporació Sànitari Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorci Sanitari de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Basurto</name>
      <address>
        <city>Bilbao</city>
        <state>Bizcaia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospitalario Provincial de Castellón</name>
      <address>
        <city>Castellón De La Plana</city>
        <state>Castellón</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General La Mancha Centro</name>
      <address>
        <city>Alcázar De San Juan</city>
        <state>Ciudad Real</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>Donostia-San Sebastián</city>
        <state>Guipúzcoa</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologikoa</name>
      <address>
        <city>Donostia-San Sebastián</city>
        <state>Guipúzcoa</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Getafe</name>
      <address>
        <city>Getafe</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Severo Ochoa</name>
      <address>
        <city>Leganés</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Móstoles</name>
      <address>
        <city>Móstoles</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quirónsalud Madrid</name>
      <address>
        <city>Pozuelo De Alarcón</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Tortosa Verge de la Cinta</name>
      <address>
        <city>Tortosa</city>
        <state>Tarragona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall D´Hebrón</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IDOC Centre Médic</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Luz</name>
      <address>
        <city>Cuenca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Catalán de Oncología de Girona</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Juan Ramón Jiménez</name>
      <address>
        <city>Huelva</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaén</name>
      <address>
        <city>Jaén</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario Insular-Materno Infantil</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare Madrid Hospital La Milagrosa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central de la Defensa Gómez Ulla</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Zarzuela</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Espases</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Señora De Candelaria</name>
      <address>
        <city>Santa Cruz De Tenerife</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau i Santa Tecla</name>
      <address>
        <city>Tarragona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Toledo</name>
      <address>
        <city>Toledo</city>
        <zip>45007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Río Hortega</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quirón Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Araba</name>
      <address>
        <city>Vitoria-Gasteiz</city>
        <state>Álava</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.geicam.org</url>
    <description>Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer in males</keyword>
  <keyword>Observational</keyword>
  <keyword>Gene Sequencing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03800355
org study id: GEICAM/2016-04
nct id: NCT03800355
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An observational, Other Designs (OD) post-marketing, multicenter study, which will obtain
      retrospective data from male patients diagnosed with invasive breast cancer between 2000 and
      2019 in the medical oncology departments of hospitals that are associated with Spanish Breast
      Cancer Research Group (GEICAM) (using information obtained from patient medical histories).
One of the objectives of this project is to ensure representativeness of the cases referred
      to. Accordingly, participating sites agree to enroll in the study male patients who were
      diagnosed with breast cancer in the period between 2000 and 2019.
observational model: Case-Only
time perspective: Retrospective
measure: General condition: Age
time frame: From date of patient breast cancer diagnosis until 2019.
description: General condition age will be recorded.
measure: General condition: performance status at diagnosis
time frame: From date of patient breast cancer diagnosis until 2019.
description: Performance status by Eastern Cooperative Oncology Group (ECOG) Scale
measure: General condition and history: substance abuse
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With Substance abuse of tobacco and alcohol will be recorded.
measure: Diagnosis of other primary tumors
time frame: From date of patient breast cancer diagnosis until 2019.
description: Diagnosis of other primary tumors synchronous or metachronous, will be recorded.
measure: Body mass index (BMI)
time frame: From date of patient breast cancer diagnosis until 2019.
description: BMI is a value derived from the mass (weight) and height. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
measure: Primary comorbidities
time frame: From date of patient breast cancer diagnosis until 2019.
description: Primary comorbidities will be recorded.
measure: Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition
time frame: From date of patient breast cancer diagnosis until 2019.
description: Mutational status of BRCA or other genes of genetic predisposition will be recorded.
measure: Family history of cancer
time frame: From date of patient breast cancer diagnosis until 2019.
description: Family history of cancer will be recorded.
measure: Anatomopathological characteristics of the tumor: date of diagnosis
time frame: From date of patient breast cancer diagnosis until 2019.
description: Date of diagnosis will be collected.
measure: Anatomopathological characteristics of the tumor: histology
time frame: From date of patient breast cancer diagnosis until 2019.
description: The histology of the tumor will be collected
measure: Anatomopathological characteristics of the tumor: clinical and/or pathological stage
time frame: From date of patient breast cancer diagnosis until 2019.
description: Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system of the Union for International Cancer Control (UICC).
measure: Anatomopathological characteristics of the tumor: hormone-receptor expression
time frame: From date of patient breast cancer diagnosis until 2019.
description: Hormone-receptor expression will be collected
measure: Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression
time frame: From date of patient breast cancer diagnosis until 2019.
description: Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected
measure: Anatomopathological characteristics of the tumor: histologic grade
time frame: From date of patient breast cancer diagnosis until 2019.
description: Tumor histologic grade will be collected
measure: Anatomopathological characteristics of the tumor: Ki-67
time frame: From date of patient breast cancer diagnosis until 2019.
description: Tumor Ki-67 proliferation index will be collected
measure: Anatomopathological characteristics of the tumor: lymphovascular invasion
time frame: From date of patient breast cancer diagnosis until 2017.
description: Number of Participants With Presence of lymphovascular invasion will be collected
measure: Treatment data: date of surgery
time frame: From date of patient breast cancer diagnosis until 2019.
description: Will be collected date of surgery
measure: Treatment data: type of surgery
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected.
measure: Treatment data: type of chemotherapy
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
measure: Treatment data: adjuvant radiotherapy
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With adjuvant radiotherapy
measure: Treatment data: adjuvant hormonotherapy
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With hormonotherapy
measure: Treatment data: other type of anti-cancer treatment
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With other type of anti-cancer treatment.
measure: Follow-up data: relapse type
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With each relapse type: local, regional or distant
measure: Follow-up data: site of metastatic disease
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With site of metastatic disease
measure: Follow-up data: occurrence of other primary tumors
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive).
measure: Follow-up data: current condition
time frame: From date of patient breast cancer diagnosis until 2019.
description: The date of the last review and current clinical condition will be recorded.
measure: Biological and molecular characteristics analyzed in primary tumors: tumor subtypes
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes)
measure: Biological and molecular characteristics analyzed in primary tumors: risk groups
time frame: From date of patient breast cancer diagnosis until 2019.
description: Number of Participants With risk groups on the reference of breast cancer in women, including morphological analyses and description of the clinical profile (e.g., morphological type, differentiation (histologic grade), Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67).
measure: Date and cause of death
time frame: From date of patient breast cancer diagnosis until 2019.
description: Date and cause of death, when applicable.
measure: Disease-free survival (DFS).
time frame: From date of patient breast cancer diagnosis until 2019.
description: DFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
measure: Distant metastasis-free survival (DMFS).
time frame: From date of patient breast cancer diagnosis until 2019.
description: DMFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented distant relapse, second invasive non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
measure: Progression-free survival (PFS).
time frame: From date of patient breast cancer diagnosis until 2019.
description: PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
measure: Overall survival (OS).
time frame: From date of patient breast cancer diagnosis until 2019.
description: OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause.
arm group label: Male breast cancer
description: The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites.
Tumor tissue and blood samples will be collected and biological and genetic analyses will be
      performed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chief Medical Investigator
role: Study Director
affiliation: Hospital Universitario Ramón y Cajal, Madrid, Spain
last name: Chief Medical Investigator
role: Study Director
affiliation: Fundación Onkologikoa, San Sebastián, Spain
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country: Spain
url: http://www.geicam.org
description: Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Neoplasms, Male
sharing ipd: No