<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/NCT04436393</url>
  </required_header>
  <id_info>
    <org_study_id>01-BR-003</org_study_id>
    <nct_id>NCT04436393</nct_id>
  </id_info>
  <brief_title>Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer</brief_title>
  <acronym>GRECO-B</acronym>
  <official_title>Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guardant Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guardant Health, Inc.</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>
      The purpose of this study is to observe the routine clinical care of patients who have been&#xD;
      diagnosed with breast cancer and have undergone Guardant360 testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing&#xD;
      will be approached regarding participation in the study. After being informed about the study&#xD;
      and potential risks, all patients providing informed consent and access to their medical&#xD;
      records, will provide a list of their health care providers related to their cancer&#xD;
      treatment. Data related to their routine clinical care will be abstracted from medical&#xD;
      records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">March 17, 2022</completion_date>
  <primary_completion_date type="Actual">March 17, 2022</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>Overall Survival</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up&#xD;
Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Events</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up&#xD;
Progression events (or progression-free survival) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject Lost-to-Follow-Up</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up&#xD;
The length of time from date of study consent to date subject exited study prematurely due being considered lost-to-follow-up (ex. lack of response following consent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of biomarker discovery</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>Assess the rate of biomarker discovery compared to tumor genotyping results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Treatment</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>Assess time to next treatment decision compared to tumor genotyping results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real-world Time to Tumor Progression</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>Documented tumor progression either clinically or radiologically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real-world Overall Survival</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>Date of death per clinical record or secondary sources (e.g. national death registries)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics</measure>
    <time_frame>18 months post Guardant360 testing</time_frame>
    <description>Descriptive statistics of patient demographics</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">109</enrollment>
  <condition>Advanced Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Advanced Breast Cancer</arm_group_label>
    <description>Patients with diagnosis of advanced breast cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Guardant360 test</intervention_name>
    <description>tumor cfDNA testing</description>
    <arm_group_label>Advanced Breast Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects located in the United States that have undergone Guardant360 testing as part of&#xD;
        their routine clinical care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (18 years of age and older) with a diagnosis of breast cancer&#xD;
&#xD;
          2. Guardant360 test results released to the patient's physician no less than 14 days&#xD;
             prior to initial patient contact&#xD;
&#xD;
          3. Patient has previously provided contact information (either email or phone) to&#xD;
             Guardant Health&#xD;
&#xD;
          4. Able and willing to complete the electronic informed consent process&#xD;
&#xD;
          5. Must have access to a computer terminal or personal computing device&#xD;
&#xD;
          6. Willingness to consent to the release of medical records&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Unable to understand English&#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>Victoria M Raymond, M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guardant Health, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guardant Health</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>April 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>
  <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/NCT04436393
org study id: 01-BR-003
nct id: NCT04436393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to observe the routine clinical care of patients who have been
      diagnosed with breast cancer and have undergone Guardant360 testing.
Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing
      will be approached regarding participation in the study. After being informed about the study
      and potential risks, all patients providing informed consent and access to their medical
      records, will provide a list of their health care providers related to their cancer
      treatment. Data related to their routine clinical care will be abstracted from medical
      records.
observational model: Cohort
time perspective: Prospective
measure: Overall Survival
time frame: 18 months post Guardant360 testing
description: The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up
Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
measure: Progression Events
time frame: 18 months post Guardant360 testing
description: The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up
Progression events (or progression-free survival) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
measure: Subject Lost-to-Follow-Up
time frame: 18 months post Guardant360 testing
description: The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up
The length of time from date of study consent to date subject exited study prematurely due being considered lost-to-follow-up (ex. lack of response following consent)
measure: Rate of biomarker discovery
time frame: 18 months post Guardant360 testing
description: Assess the rate of biomarker discovery compared to tumor genotyping results
measure: Time to Next Treatment
time frame: 18 months post Guardant360 testing
description: Assess time to next treatment decision compared to tumor genotyping results
measure: Real-world Time to Tumor Progression
time frame: 18 months post Guardant360 testing
description: Documented tumor progression either clinically or radiologically
measure: Real-world Overall Survival
time frame: 18 months post Guardant360 testing
description: Date of death per clinical record or secondary sources (e.g. national death registries)
measure: Demographics
time frame: 18 months post Guardant360 testing
description: Descriptive statistics of patient demographics
arm group label: Advanced Breast Cancer
description: Patients with diagnosis of advanced breast cancer
intervention type: Diagnostic Test
intervention name: Guardant360 test
description: tumor cfDNA testing
arm group label: Advanced Breast Cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria M Raymond, M.S.
role: Principal Investigator
affiliation: Guardant Health, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No