<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/NCT02250352</url>
  </required_header>
  <id_info>
    <org_study_id>1B-13-2</org_study_id>
    <secondary_id>NCI-2014-01932</secondary_id>
    <secondary_id>HS-13-00342</secondary_id>
    <secondary_id>1B-13-2</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02250352</nct_id>
  </id_info>
  <brief_title>Core Biopsies for Establishing a Breast Tumor Tissue Repository</brief_title>
  <official_title>Core Biopsies of Breast Tumor Tissue Repository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This research trial establishes a breast tumor tissue repository from core biopsies.&#xD;
      Collecting breast tissue from core biopsies may allow doctors to learn more about the biology&#xD;
      of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may&#xD;
      also allow doctors to conduct future studies to help understand how breast cancer grows and&#xD;
      how it responds to different types of therapy. This will help doctors develop better breast&#xD;
      cancer therapies and better tests to help make treatment decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To develop a baseline and serial breast cancer core biopsy repository within the&#xD;
      University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer&#xD;
      Program.&#xD;
&#xD;
      II. To develop and maintain a secure clinical database of relevant demographic, clinical,&#xD;
      pathologic and longitudinal outcome characteristics of the samples to be banked.&#xD;
&#xD;
      III. To have an efficient process for the distribution of de-identified samples from the bank&#xD;
      to researchers with institutional review board (IRB)-approved protocols or exemptions for the&#xD;
      study of breast cancer-related questions. These studies would include analyses of tumor&#xD;
      proteins and nucleic acids, serum/plasma and germline deoxyribonucleic acid (DNA) and immune&#xD;
      cells in relationship to other baseline and follow-up clinical and pathological variables.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 4 cohorts.&#xD;
&#xD;
      COHORT I (PATIENTS WITH NEWLY DIAGNOSED EARLY STAGE BREAST CANCER WHO WILL UNDERGO DEFINITIVE&#xD;
      SURGERY BEFORE ANY SYSTEMIC THERAPY): Patients undergo baseline and, if applicable, follow-up&#xD;
      core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases.&#xD;
      Patients who experience a recurrence or progression after therapy undergo additional core&#xD;
      biopsies at the time of recurrence. Clinical and blood specimens will also be gathered.&#xD;
&#xD;
      COHORT II (PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER WHO WILL RECEIVE STANDARD OF CARE&#xD;
      SYSTEMIC THERAPY BEFORE SURGERY OR PATIENTS WITH ADVANCED UNRESECTABLE DISEASE): Patients&#xD;
      undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also&#xD;
      undergo biopsies at a specific time point following the initiation of standard systemic&#xD;
      therapy.&#xD;
&#xD;
      COHORT III (PATIENTS BEING EVALUATED FOR A SUSPICIOUS BREAST MASS THAT HAS A HIGH LIKELIHOOD&#xD;
      OF BEING CANCER): Patients undergo core biopsy, clinical, and blood sample collection as in&#xD;
      Cohort I. Patients who have Breast Imaging-Reporting and Data System (BIRADS) 4b, 4c, and 5&#xD;
      lesions may undergo up to 6 additional 6 core biopsies.&#xD;
&#xD;
      COHORT IV (PATIENTS WITH BREAST CANCER RECURRENCE OR PROGRESSION [LOCAL, REGIONAL, OR&#xD;
      DISTANT/METASTATIC]): Patients undergo core biopsy, clinical, and blood sample collection as&#xD;
      in Cohort I. Patients may also undergo 1-3 extra core biopsies.&#xD;
&#xD;
      After completion of study, patients are followed up every 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 14, 2013</start_date>
  <completion_date type="Anticipated">November 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 14, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program</measure>
    <time_frame>Up to 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Development and maintenance of a secure clinical database of relevant demographic, clinical, pathologic, and longitudinal outcome characteristics of the samples to be banked</measure>
    <time_frame>Up to 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Development of an efficient process for the distribution of de-identified samples from the bank to researchers with IRB-approved protocols or exemptions for the study of breast cancer-related questions</measure>
    <time_frame>Up to 10 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">1450</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort I (newly diagnosed, surgery before systemic therapy)</arm_group_label>
    <description>Patients undergo baseline and, if applicable, follow-up core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases. Patients who experience a recurrence or progression after therapy undergo additional core biopsies at the time of recurrence. Clinical and blood specimens will also be gathered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort II (newly diagnosed, systemic therapy before surgery)</arm_group_label>
    <description>Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also undergo biopsies at a specific time point following the initiation of standard systemic therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort III (patients with suspicious breast mass)</arm_group_label>
    <description>Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients who have BIRADS 4b, 4c, and 5 lesions may undergo up to 6 additional 6 core biopsies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort IV (breast cancer recurrence or progression)</arm_group_label>
    <description>Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients may also undergo 1-3 extra core biopsies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cytology specimen collection procedure</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Cohort I (newly diagnosed, surgery before systemic therapy)</arm_group_label>
    <arm_group_label>Cohort II (newly diagnosed, systemic therapy before surgery)</arm_group_label>
    <arm_group_label>Cohort III (patients with suspicious breast mass)</arm_group_label>
    <arm_group_label>Cohort IV (breast cancer recurrence or progression)</arm_group_label>
    <other_name>cytologic sampling</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor Tissue Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects seen at USC Norris Comprehensive Cancer Center and LAC+USC Medical Center will be&#xD;
        recruited for this trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Known or suspected breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to sign informed consent&#xD;
&#xD;
          -  Known bleeding disorder&#xD;
&#xD;
          -  Use of anticoagulant medications (heparin, warfarin, etc.) within one week prior to&#xD;
             biopsy&#xD;
&#xD;
          -  Use of antiplatelet medications (aspirin, clopidogrel, etc.) within one week prior to&#xD;
             biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evanthia Roussos-Torres, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zeno Ashai</last_name>
    <phone>323-865-0463</phone>
    <email>zeno.ashai@med.usc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ameria Casillas-Lopez</last_name>
      <phone>323-865-0804</phone>
      <email>America.Casillas-Lopez@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>Julie Lang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 12, 2022</last_update_submitted>
  <last_update_submitted_qc>November 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT02250352
org study id: 1B-13-2
secondary id: NCI-2014-01932
secondary id: HS-13-00342
secondary id: 1B-13-2
secondary id: P30CA014089
nct id: NCT02250352
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research trial establishes a breast tumor tissue repository from core biopsies.
      Collecting breast tissue from core biopsies may allow doctors to learn more about the biology
      of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may
      also allow doctors to conduct future studies to help understand how breast cancer grows and
      how it responds to different types of therapy. This will help doctors develop better breast
      cancer therapies and better tests to help make treatment decisions.
PRIMARY OBJECTIVES:

      I. To develop a baseline and serial breast cancer core biopsy repository within the
      University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer
      Program.

      II. To develop and maintain a secure clinical database of relevant demographic, clinical,
      pathologic and longitudinal outcome characteristics of the samples to be banked.

      III. To have an efficient process for the distribution of de-identified samples from the bank
      to researchers with institutional review board (IRB)-approved protocols or exemptions for the
      study of breast cancer-related questions. These studies would include analyses of tumor
      proteins and nucleic acids, serum/plasma and germline deoxyribonucleic acid (DNA) and immune
      cells in relationship to other baseline and follow-up clinical and pathological variables.

      OUTLINE: Patients are assigned to 1 of 4 cohorts.

      COHORT I (PATIENTS WITH NEWLY DIAGNOSED EARLY STAGE BREAST CANCER WHO WILL UNDERGO DEFINITIVE
      SURGERY BEFORE ANY SYSTEMIC THERAPY): Patients undergo baseline and, if applicable, follow-up
      core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases.
      Patients who experience a recurrence or progression after therapy undergo additional core
      biopsies at the time of recurrence. Clinical and blood specimens will also be gathered.

      COHORT II (PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER WHO WILL RECEIVE STANDARD OF CARE
      SYSTEMIC THERAPY BEFORE SURGERY OR PATIENTS WITH ADVANCED UNRESECTABLE DISEASE): Patients
      undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also
      undergo biopsies at a specific time point following the initiation of standard systemic
      therapy.

      COHORT III (PATIENTS BEING EVALUATED FOR A SUSPICIOUS BREAST MASS THAT HAS A HIGH LIKELIHOOD
      OF BEING CANCER): Patients undergo core biopsy, clinical, and blood sample collection as in
      Cohort I. Patients who have Breast Imaging-Reporting and Data System (BIRADS) 4b, 4c, and 5
      lesions may undergo up to 6 additional 6 core biopsies.

      COHORT IV (PATIENTS WITH BREAST CANCER RECURRENCE OR PROGRESSION [LOCAL, REGIONAL, OR
      DISTANT/METASTATIC]): Patients undergo core biopsy, clinical, and blood sample collection as
      in Cohort I. Patients may also undergo 1-3 extra core biopsies.

      After completion of study, patients are followed up every 6 months.
observational model: Cohort
time perspective: Prospective
measure: Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program
time frame: Up to 10 years
measure: Development and maintenance of a secure clinical database of relevant demographic, clinical, pathologic, and longitudinal outcome characteristics of the samples to be banked
time frame: Up to 10 years
measure: Development of an efficient process for the distribution of de-identified samples from the bank to researchers with IRB-approved protocols or exemptions for the study of breast cancer-related questions
time frame: Up to 10 years
arm group label: Cohort I (newly diagnosed, surgery before systemic therapy)
description: Patients undergo baseline and, if applicable, follow-up core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases. Patients who experience a recurrence or progression after therapy undergo additional core biopsies at the time of recurrence. Clinical and blood specimens will also be gathered.
arm group label: Cohort II (newly diagnosed, systemic therapy before surgery)
description: Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also undergo biopsies at a specific time point following the initiation of standard systemic therapy.
arm group label: Cohort III (patients with suspicious breast mass)
description: Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients who have BIRADS 4b, 4c, and 5 lesions may undergo up to 6 additional 6 core biopsies.
arm group label: Cohort IV (breast cancer recurrence or progression)
description: Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients may also undergo 1-3 extra core biopsies.
intervention type: Other
intervention name: cytology specimen collection procedure
description: Correlative studies
arm group label: Cohort I (newly diagnosed, surgery before systemic therapy)
arm group label: Cohort II (newly diagnosed, systemic therapy before surgery)
arm group label: Cohort III (patients with suspicious breast mass)
arm group label: Cohort IV (breast cancer recurrence or progression)
other name: cytologic sampling
Tumor Tissue Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evanthia Roussos-Torres, M.D.
role: Principal Investigator
affiliation: University of Southern California
last name: Zeno Ashai
phone: 323-865-0463
email: zeno.ashai@med.usc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms