<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/NCT04497285</url>
  </required_header>
  <id_info>
    <org_study_id>SOLTI-1903</org_study_id>
    <nct_id>NCT04497285</nct_id>
  </id_info>
  <brief_title>Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer</brief_title>
  <acronym>HOPE</acronym>
  <official_title>HOPE: Real World Clinical Practice Study to Assess the Impact of Using Comprehensive Genomic Data on the Next Treatment Decision Making Choice in Patients With Locally Advanced or Metastatic Breast Cancer in Spain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SOLTI Breast Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guardant Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SOLTI 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>
      SOLTI 1903 HOPE is a national, real world clinical practice study conducted in patients&#xD;
      diagnosed with metastatic breast cancer who are receiving, have just received or will receive&#xD;
      treatment for its advanced disease. Patients will lead their inclusion, participation and&#xD;
      follow-up in the study through a digital tool, but they are encouraged to include their&#xD;
      physician's in this study. Tissue samples from metastatic (preferred) or primary tumor will&#xD;
      be collected for analyses, together with blood samples. A Molecular Advisory Board (MAB) will&#xD;
      assess and give recommendations according patient's molecular profile.&#xD;
&#xD;
      The primary objective is to assess the real-world clinical practice of integration of&#xD;
      molecular profiling in the Standard of Care (SoC) management of mBC patients connected&#xD;
      through a digital tool.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients are those who are 18 or older, either female or male, confirmed locally&#xD;
      advanced or metastatic breast cancer of any subtype and who have received, are receiving, or&#xD;
      will receive any line of treatment from metastatic disease.&#xD;
&#xD;
      Demographic data, disease characteristics, treatment history, and quality of life data will&#xD;
      be collected through a digital tool by the patient. The data are de-identified and will be&#xD;
      used to advance multiple areas of research into mBC. The study will be complemented by a&#xD;
      patient empowerment program that will include informative workshops and video-tutorials about&#xD;
      precision medicine and the HOPE study itself. Tumor tissue samples must be submitted for&#xD;
      genomic profiling using FoundationOne CDx. Blood samples for circulating tumor DNA (ctDNA)&#xD;
      profiling using Guardant360 also will be collected.&#xD;
&#xD;
      Molecular reports will be reviewed by the Molecular Advisory Board (MAB) and recommendations&#xD;
      according to the molecular profile will be sent to the patients and physicians through the&#xD;
      digital tool to let them know these treatment options and also notified about clinical trials&#xD;
      for which they may be eligible.&#xD;
&#xD;
      The primary objective is to assess the real-world clinical practice of integration of&#xD;
      molecular profiling in the Standard of Care (SoC) management of mBC patients connected&#xD;
      through a digital tool. Secondary objectives include: to describe genetic mutational profile&#xD;
      from both tests, to evaluate if a patient-centric strategy could achieve better enrollment&#xD;
      than the classical approach site-physician-patient, and to assess the efficacy of the program&#xD;
      to allocate patients in clinical trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Metastatic breast cancer management based on tumor molecular profile</measure>
    <time_frame>1 year after end of accrual</time_frame>
    <description>The number of patients assigned to different treatments based on the genomic profile.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the genetic mutational profile in tumor tissue.</measure>
    <time_frame>Ongoing basis during 3 years' patient recruitment</time_frame>
    <description>To describe the genetic mutational profile of the patients using Foundation One CDx.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the genetic mutational profile in blood samples</measure>
    <time_frame>Ongoing basis during 3 years' patient recruitment</time_frame>
    <description>To describe the genetic mutational profile of the patients using liquid biopsy (Guardant360 test).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the enrollment rate of the study</measure>
    <time_frame>Ongoing basis during 3 years' patient recruitment</time_frame>
    <description>To describe the enrollment rate using the HOPE patient centric strategy (videotutorials and user experience of different technologies as the digital tool).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of implementing the program for metastatic breast cancer</measure>
    <time_frame>1 year after end of accrual and subsequently during follow up period of 5 years</time_frame>
    <description>To describe number of patients who are allocated to clinical trials and number of patients allocated on on-label therapies considering tumor genomic profile.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between efficacy endpoints among patients enrolled in clinical trials according to the tumor's genomic profile and among patients receiving SoC.</measure>
    <time_frame>1 year after end of accrual and subsequently during follow up period of 5 years</time_frame>
    <description>To describe of PFS and OS among the patients enrolled in clinical trials according to the tumor's genomic profile, and among the patients receiving SoC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment using EuroQol-5D (EQ-5D) in patients with metastatic breast cancer</measure>
    <time_frame>Ongoing basis during 3 years' patient recruitment</time_frame>
    <description>The EuroQol EQ-5D is designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 5 levels of function (1=no problem, 2=slight problem, 3=moderate problem, 4=severe problem, and 5=unable/extreme). The scores on the 5 descriptors are summarized to create a single summary score. The EQ-5D also includes a visual analog scale (VAS), in which the patients self-rate their overall health status on a scale from 0 (worst imaginable) to 100 (best imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment using Functional Assessment of Cancer Therapy FACT-B in patients with metastatic breast cancer</measure>
    <time_frame>Ongoing basis during 3 years' patient recruitment</time_frame>
    <description>The FACT-B consists of the Functional Assessment of Cancer Therapy-General (FACT-G) (27-items) and a breast-specific module: a 10-item instrument designed to assess patient concernsrelating to BC. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Patients are asked to respond to a Likert scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample collection and collection of tumor tissue block</intervention_name>
    <description>blood sample collection and collection of tumor tissue block</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample collection and collection of tumor tissue block&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Metastatic breas cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female or Male patients.&#xD;
&#xD;
          2. Age ≥18 years.&#xD;
&#xD;
          3. Signed informed consent prior to any screening procedure.&#xD;
&#xD;
          4. Locally advanced or metastatic breast cancer of any subtype confirmed both&#xD;
             pathologically and radiologically (stage IIIb- IV disease).&#xD;
&#xD;
          5. The subjects must be about to receive, or receiving, or will have completed treatment&#xD;
             for their metastatic disease with any line of treatment in either a clinical trial or&#xD;
             the healthcare setting.&#xD;
&#xD;
          6. Availability of one metastatic (preferably), primary tumor sample or blood sample.&#xD;
&#xD;
          7. Measurable or non-measurable disease.&#xD;
&#xD;
          8. Quality of life score according to ECOG scale ≤ 3.&#xD;
&#xD;
          9. Minimal life expectancy of 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to consent or conform to the processes involved in a clinical study.&#xD;
&#xD;
          2. Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the patient or the quality of the data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS)</name>
      <address>
        <city>Barcelona</city>
        <state>Please Select</state>
        <zip>08008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 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>Undecided</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/NCT04497285
org study id: SOLTI-1903
nct id: NCT04497285
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SOLTI 1903 HOPE is a national, real world clinical practice study conducted in patients
      diagnosed with metastatic breast cancer who are receiving, have just received or will receive
      treatment for its advanced disease. Patients will lead their inclusion, participation and
      follow-up in the study through a digital tool, but they are encouraged to include their
      physician's in this study. Tissue samples from metastatic (preferred) or primary tumor will
      be collected for analyses, together with blood samples. A Molecular Advisory Board (MAB) will
      assess and give recommendations according patient's molecular profile.

      The primary objective is to assess the real-world clinical practice of integration of
      molecular profiling in the Standard of Care (SoC) management of mBC patients connected
      through a digital tool.
Eligible patients are those who are 18 or older, either female or male, confirmed locally
      advanced or metastatic breast cancer of any subtype and who have received, are receiving, or
      will receive any line of treatment from metastatic disease.

      Demographic data, disease characteristics, treatment history, and quality of life data will
      be collected through a digital tool by the patient. The data are de-identified and will be
      used to advance multiple areas of research into mBC. The study will be complemented by a
      patient empowerment program that will include informative workshops and video-tutorials about
      precision medicine and the HOPE study itself. Tumor tissue samples must be submitted for
      genomic profiling using FoundationOne CDx. Blood samples for circulating tumor DNA (ctDNA)
      profiling using Guardant360 also will be collected.

      Molecular reports will be reviewed by the Molecular Advisory Board (MAB) and recommendations
      according to the molecular profile will be sent to the patients and physicians through the
      digital tool to let them know these treatment options and also notified about clinical trials
      for which they may be eligible.

      The primary objective is to assess the real-world clinical practice of integration of
      molecular profiling in the Standard of Care (SoC) management of mBC patients connected
      through a digital tool. Secondary objectives include: to describe genetic mutational profile
      from both tests, to evaluate if a patient-centric strategy could achieve better enrollment
      than the classical approach site-physician-patient, and to assess the efficacy of the program
      to allocate patients in clinical trials.
observational model: Other
time perspective: Prospective
measure: Metastatic breast cancer management based on tumor molecular profile
time frame: 1 year after end of accrual
description: The number of patients assigned to different treatments based on the genomic profile.
measure: Description of the genetic mutational profile in tumor tissue.
time frame: Ongoing basis during 3 years' patient recruitment
description: To describe the genetic mutational profile of the patients using Foundation One CDx.
measure: Description of the genetic mutational profile in blood samples
time frame: Ongoing basis during 3 years' patient recruitment
description: To describe the genetic mutational profile of the patients using liquid biopsy (Guardant360 test).
measure: Description of the enrollment rate of the study
time frame: Ongoing basis during 3 years' patient recruitment
description: To describe the enrollment rate using the HOPE patient centric strategy (videotutorials and user experience of different technologies as the digital tool).
measure: Feasibility of implementing the program for metastatic breast cancer
time frame: 1 year after end of accrual and subsequently during follow up period of 5 years
description: To describe number of patients who are allocated to clinical trials and number of patients allocated on on-label therapies considering tumor genomic profile.
measure: Correlation between efficacy endpoints among patients enrolled in clinical trials according to the tumor's genomic profile and among patients receiving SoC.
time frame: 1 year after end of accrual and subsequently during follow up period of 5 years
description: To describe of PFS and OS among the patients enrolled in clinical trials according to the tumor's genomic profile, and among the patients receiving SoC.
measure: Quality of life assessment using EuroQol-5D (EQ-5D) in patients with metastatic breast cancer
time frame: Ongoing basis during 3 years' patient recruitment
description: The EuroQol EQ-5D is designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 5 levels of function (1=no problem, 2=slight problem, 3=moderate problem, 4=severe problem, and 5=unable/extreme). The scores on the 5 descriptors are summarized to create a single summary score. The EQ-5D also includes a visual analog scale (VAS), in which the patients self-rate their overall health status on a scale from 0 (worst imaginable) to 100 (best imaginable).
measure: Quality of life assessment using Functional Assessment of Cancer Therapy FACT-B in patients with metastatic breast cancer
time frame: Ongoing basis during 3 years' patient recruitment
description: The FACT-B consists of the Functional Assessment of Cancer Therapy-General (FACT-G) (27-items) and a breast-specific module: a 10-item instrument designed to assess patient concernsrelating to BC. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Patients are asked to respond to a Likert scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
intervention type: Other
intervention name: blood sample collection and collection of tumor tissue block
description: blood sample collection and collection of tumor tissue block
blood sample collection and collection of tumor tissue block
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided