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/NCT05964504</url>
    </required_header>
    <id_info>
      <org_study_id>237513</org_study_id>
      <nct_id>NCT05964504</nct_id>
    </id_info>
    <brief_title>Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)</brief_title>
    <official_title>Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</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>
        This is a prospective observational registry for patients with invasive lobular carcinoma&#xD;
        (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized&#xD;
        to develop an ILC specific response assessment tool.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Aims:&#xD;
  &#xD;
          1. To evaluate the feasibility of developing a histologic based registry for participants&#xD;
             living with metastatic lobular breast cancer.&#xD;
  &#xD;
          2. To understand the natural history, treatment patterns, and overall survival in patients&#xD;
             with metastatic ILC using modern, real-world data.&#xD;
  &#xD;
        Secondary Aims:&#xD;
  &#xD;
          1. To evaluate the correlation between imaging findings and disease progression.&#xD;
  &#xD;
          2. To evaluate the correlation between ctDNA and disease progression.&#xD;
  &#xD;
          3. To develop an ongoing platform for evaluating new imaging tools, tumor markers, and&#xD;
             participant recruitment for clinical trials.&#xD;
  &#xD;
        Outline:&#xD;
  &#xD;
        Participants will be recruited to participate in the registry during a regularly scheduled&#xD;
        clinic visit with their treating oncologist, and consented to participate at this time. At&#xD;
        each evaluation time point, participants will have a blood draw performed. Participants will&#xD;
        be followed until loss to follow up, death, or withdrawal from the registry.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">February 28, 2034</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2034</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>10 Years</target_duration>
    <primary_outcome>
      <measure>Feasibility of registry</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in &gt;=75% of treating medical oncologists</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients with measurable versus unmeasurable disease</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median Progression Free Survival Rate</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median Overall Survival Rates</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who are currently taking estrogen receptor modulators or degraders</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The overall proportion of participants who are currently taking estrogen receptor modulators or degraders which may interfere with a radiolabeled form of estradiol (FES) in a positron Emission Tomography (PET) versus the participants medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change in Circulating tumor DNA (ctDNA)</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The overall change in quantity of ctDNA mean tumor molecules per mL blood versus medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of novel imaging tools</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The number of novel imaging tools developed during the course of data collection to improve the determination of disease status will be utilized to develop the ILC specific response assessment tool.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of new tumor markers introduced</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The number of participants who have detectable mutations on ctDNA evaluations with are correlated with health outcomes will be utilized to develop the ILC specific response assessment tool.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants enrolled in clinical trials</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The number of participants with metastatic ILC who have enrolled on a clinical trial will be utilized to develop the ILC specific response assessment tool.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Metastatic Breast Cancer</condition>
    <condition>Lobular Breast Carcinoma</condition>
    <arm_group>
      <arm_group_label>Initial Cohort</arm_group_label>
      <description>Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes, for plasma isolation, cell free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within +/- 14 days of whole body imaging studies which will occur when patients are scheduled for standard of care whole body imaging.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Blood Specimen</intervention_name>
      <description>Blood will be drawn via venipuncture</description>
      <arm_group_label>Initial Cohort</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples will be obtained from participants&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Adult participants with histologically proven stage IV invasive lobular carcinoma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Histologically confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is&#xD;
               allowed.&#xD;
  &#xD;
            2. Age &gt;=18 years&#xD;
  &#xD;
            3. Any receptor subtype.&#xD;
  &#xD;
            4. Ability to understand a written informed consent document, and the willingness to sign&#xD;
               it.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Stage I-III breast cancer.&#xD;
  &#xD;
            2. Lack of lobular histology on tumor biopsy.&#xD;
  &#xD;
            3. Other active cancer (prior treated cancer with no current evidence of disease is&#xD;
               allowed).&#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>Rita Mukhtar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Astrid Quirarte</last_name>
      <phone>415-476-8390</phone>
      <email>Astrid.Quirarte@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California, San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94122</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Astrid Quirarte</last_name>
        <phone>415-476-8390</phone>
        <email>Astrid.Quirarte@ucsf.edu</email>
      </contact>
      <investigator>
        <last_name>Rita Mukhtar, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>A. Jo Chien, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>
      <mesh_term>Carcinoma, Lobular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05964504
  org study id: 237513
  nct id: NCT05964504
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective observational registry for patients with invasive lobular carcinoma
        (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized
        to develop an ILC specific response assessment tool.
  Primary Aims:
  
          1. To evaluate the feasibility of developing a histologic based registry for participants
             living with metastatic lobular breast cancer.
  
          2. To understand the natural history, treatment patterns, and overall survival in patients
             with metastatic ILC using modern, real-world data.
  
        Secondary Aims:
  
          1. To evaluate the correlation between imaging findings and disease progression.
  
          2. To evaluate the correlation between ctDNA and disease progression.
  
          3. To develop an ongoing platform for evaluating new imaging tools, tumor markers, and
             participant recruitment for clinical trials.
  
        Outline:
  
        Participants will be recruited to participate in the registry during a regularly scheduled
        clinic visit with their treating oncologist, and consented to participate at this time. At
        each evaluation time point, participants will have a blood draw performed. Participants will
        be followed until loss to follow up, death, or withdrawal from the registry.
  observational model: Cohort
  time perspective: Prospective
  measure: Feasibility of registry
  time frame: Up to 2 years
  description: Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in >=75% of treating medical oncologists
  measure: Proportion of patients with measurable versus unmeasurable disease
  time frame: Up to 10 years
  description: Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist.
  measure: Median Progression Free Survival Rate
  time frame: Up to 10 years
  description: The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
  measure: Median Overall Survival Rates
  time frame: Up to 10 years
  description: The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
  measure: Proportion of participants who are currently taking estrogen receptor modulators or degraders
  time frame: Up to 10 years
  description: The overall proportion of participants who are currently taking estrogen receptor modulators or degraders which may interfere with a radiolabeled form of estradiol (FES) in a positron Emission Tomography (PET) versus the participants medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.
  measure: Mean Change in Circulating tumor DNA (ctDNA)
  time frame: Up to 10 years
  description: The overall change in quantity of ctDNA mean tumor molecules per mL blood versus medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.
  measure: Number of novel imaging tools
  time frame: Up to 10 years
  description: The number of novel imaging tools developed during the course of data collection to improve the determination of disease status will be utilized to develop the ILC specific response assessment tool.
  measure: Number of new tumor markers introduced
  time frame: Up to 10 years
  description: The number of participants who have detectable mutations on ctDNA evaluations with are correlated with health outcomes will be utilized to develop the ILC specific response assessment tool.
  measure: Number of participants enrolled in clinical trials
  time frame: Up to 10 years
  description: The number of participants with metastatic ILC who have enrolled on a clinical trial will be utilized to develop the ILC specific response assessment tool.
  arm group label: Initial Cohort
  description: Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes, for plasma isolation, cell free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within +/- 14 days of whole body imaging studies which will occur when patients are scheduled for standard of care whole body imaging.
  intervention type: Procedure
  intervention name: Blood Specimen
  description: Blood will be drawn via venipuncture
  arm group label: Initial Cohort
  Blood samples will be obtained from participants
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rita Mukhtar, MD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Astrid Quirarte
  phone: 415-476-8390
  email: Astrid.Quirarte@ucsf.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Carcinoma, Lobular
  sharing ipd: No