<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/NCT02980848</url>
  </required_header>
  <id_info>
    <org_study_id>941466</org_study_id>
    <secondary_id>PCS-1504-30370</secondary_id>
    <nct_id>NCT02980848</nct_id>
  </id_info>
  <brief_title>Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study</brief_title>
  <acronym>BCSC-ADVANCE</acronym>
  <official_title>Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Pilgrim Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</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 Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational&#xD;
      pragmatic comparative effectiveness research study using high-quality, prospectively&#xD;
      collected data from BCSC registries to generate evidence on how breast density should be&#xD;
      integrated into decision making around breast cancer screening and preoperative diagnostic&#xD;
      work-up. We will augment existing BCSC registry infrastructure with additional prospective&#xD;
      data collection and collection of patient reported outcomes (PROs), CISNET modeling of&#xD;
      long-term screening outcomes, and qualitative data from focus groups with women represented&#xD;
      in two aims.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone&#xD;
      versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI)&#xD;
      by extent of breast density.&#xD;
&#xD;
      Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of&#xD;
      experience, and whether any &quot;learning curve&quot; depends on radiologist specialty (i.e., breast&#xD;
      imaging specialist vs. general radiologist).&#xD;
&#xD;
      Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast&#xD;
      density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive&#xD;
      breast cancer.&#xD;
&#xD;
      Covid-19 Enhancement Aim and Hypotheses:&#xD;
&#xD;
      Develop patient-focused messaging content through focus groups that radiology facilities can&#xD;
      use when scheduling appointments to inform women of the safety to schedule or postpone breast&#xD;
      screening or diagnostic services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</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>3 Years</target_duration>
  <primary_outcome>
    <measure>Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening Failures: Interval or advanced breast cancer rate (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens&#xD;
Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening Harms: Recall rate (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of positive screens divided by total number of screens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening Harms: False-positive (FP) recall rate (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening Harms: FP biopsy recommendation rate (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening Harms: Other consequences (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Outcomes (Aim 1)</measure>
    <time_frame>Measured within one year post-screening</time_frame>
    <description>Patient surveys targeted to determining outcomes of interest to patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of additional breast cancers detected (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-year rate of 2nd breast cancer events (Aim 2)</measure>
    <time_frame>3 years after initial diagnosis</time_frame>
    <description>Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Outcomes (Aim 2)</measure>
    <time_frame>Measured 6-18 months post-diagnosis</time_frame>
    <description>Patient surveys targeted to determining outcomes of interest to patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance Measures: Sensitivity (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance Measures: Specificity (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance Measures: Positive predictive value (Aim 1)</measure>
    <time_frame>Within one year after screen</time_frame>
    <description>Number of cancer cases within 1 year of positive screen divided by number of positive screens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Definitive surgery type (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value of work-up with MRI (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Number of women with a negative pre-operative MRI and no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women with a negative pre-operative MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value of work-up without MRI (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Number of women without a pre-operative MRI with no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women without a pre-operative MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core biopsy rates (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical biopsy rate (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benign biopsy rate (Aim 2)</measure>
    <time_frame>6 months after initial diagnosis</time_frame>
    <description>Number of initial benign biopsies over number of breast biopsies</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Modeled Long-Term Mortality Outcome: Breast cancers deaths averted (Aim 1)</measure>
    <time_frame>From date of first screening examination until the date of death from any cause, up to 100 years of age</time_frame>
    <description>Breast cancers deaths averted estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models</description>
  </other_outcome>
  <other_outcome>
    <measure>Modeled Long-Term Mortality Outcome: Life-years gained (Aim 1)</measure>
    <time_frame>From date of first screening examination until the date of death from any cause, up to 100 years of age</time_frame>
    <description>Life-years gained estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models</description>
  </other_outcome>
  <other_outcome>
    <measure>Modeled Long-Term Mortality Outcome: Overdiagnosis (Aim 1)</measure>
    <time_frame>From date of first screening examination until the date of death from any cause, up to 100 years of age</time_frame>
    <description>Overdiagnosis estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1341172</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Screening group</arm_group_label>
    <description>Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women with breast cancer</arm_group_label>
    <description>Women diagnosed with stage 0-III breast cancer undergoing pre-operative work-up with diagnostic mammography alone or diagnostic mammography plus pre-operative breast magnetic resonance imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening digital mammography</intervention_name>
    <description>Screening with digital mammography alone</description>
    <arm_group_label>Screening group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening digital breast tomosynthesis</intervention_name>
    <description>Screening with digital mammography plus digital breast tomosynthesis</description>
    <arm_group_label>Screening group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening breast magnetic resonance imaging</intervention_name>
    <description>Screening with digital mammography plus breast magnetic resonance imaging</description>
    <arm_group_label>Screening group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic mammography</intervention_name>
    <description>Pre-operative diagnostic work-up with mammography alone</description>
    <arm_group_label>Women with breast cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-operative breast magnetic resonance imaging</intervention_name>
    <description>Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging</description>
    <arm_group_label>Women with breast cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include women age 40-79 undergoing screening mammography (Aim 1) and women&#xD;
        age ≥18 with a first breast cancer diagnosis (Aim 2). We will include women in the BCSC&#xD;
        cohort with mammography from 2005-2017. BCSC participants are identified from seven BCSC&#xD;
        breast imaging registries. The BCSC prospectively collects data during routine clinical&#xD;
        practice through voluntary partnerships with radiology facilities. Women enter the BCSC&#xD;
        cohort when they receive a breast-imaging exam at a participating facility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Aim 1 Clinical Outcomes&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women aged 40-79 undergoing screening mammography from 2010-2017 for comparisons with&#xD;
             tomosynthesis and 2005-2017 for comparison with breast MRI at a facility that&#xD;
             participates in one of six BCSC breast imaging registries&#xD;
&#xD;
          -  Digital mammography exams performed for screening and performed with or without&#xD;
             supplemental screening with digital breast tomosynthesis from 2010-2017 or breast MRI&#xD;
             from 2005-2017, at a facility that participates in one of seven BCSC breast imaging&#xD;
             registries, and in women who meet inclusion criteria.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Exams performed on women with a history of breast cancer, mastectomy, or breast&#xD;
             augmentation.&#xD;
&#xD;
          -  Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to&#xD;
             avoid classifying diagnostic exams as screening&#xD;
&#xD;
          -  Exams without complete cancer capture during the follow-up period&#xD;
&#xD;
        Aim 1 Patient Reported Outcomes&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women aged 40-74 years undergoing screening mammography, with or without supplemental&#xD;
             screening with digital breast tomosynthesis or breast MRI, at selected BCSC facilities&#xD;
&#xD;
          -  Women within 12 months of a digital screening mammogram with known breast density and&#xD;
             no known breast cancer diagnosis&#xD;
&#xD;
          -  For MRI subgroup, we will include women with a screening MRI within the prior 24&#xD;
             months&#xD;
&#xD;
          -  Within strata defined by BCSC registry, breast density subgroup (dense vs. not dense),&#xD;
             and race/ethnicity, women with supplemental screening with digital breast&#xD;
             tomosynthesis or breast MRI will be matched to women without supplemental screening&#xD;
&#xD;
        Aim 1 Focus Groups&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women age 40-74 years undergoing screening mammography, with or without supplemental&#xD;
             screening (defined as digital breast tomosynthesis or breast MRI)&#xD;
&#xD;
          -  Women within 12 months post-most recent screening examination with known dense breasts&#xD;
             from most recent screening mammogram and no known breast cancer diagnosis&#xD;
&#xD;
          -  Women who are able to speak English and can travel to a nearby location for a&#xD;
             discussion&#xD;
&#xD;
        Subaim 1&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Radiologists interpreting digital mammography and/or tomosynthesis for at least one&#xD;
             year from 2010-2017 at a facility that participates in the BCSC&#xD;
&#xD;
          -  Digital mammography exams and digital breast tomosynthesis performed for screening and&#xD;
             evaluated by a radiologist meeting inclusion criteria from 2010-2017&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Exams performed on women with a history of breast cancer, mastectomy, or breast&#xD;
             augmentation&#xD;
&#xD;
          -  Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to&#xD;
             avoid classifying diagnostic exams as screening&#xD;
&#xD;
          -  Exams without complete cancer capture during one year following the screening&#xD;
             mammogram&#xD;
&#xD;
        Aim 2 Clinical Outcomes&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women at least 18 years of age with a first breast cancer diagnosis (DCIS or invasive)&#xD;
             from 2005-2017 for whom there was a mammogram performed within the year prior to&#xD;
             breast cancer diagnosis at one of the participating BCSC registry facilities&#xD;
&#xD;
          -  Women for whom we have pathologically-confirmed breast cancer (DCIS or invasive) with&#xD;
             a pathology or biopsy record related to the incident cancer diagnosis in the BCSC data&#xD;
&#xD;
          -  MRI and mammography examinations performed for pre-operative work-up from 2005-2017 at&#xD;
             one of the participating BCSC registry facilities in women meeting eligibility&#xD;
             criteria&#xD;
&#xD;
        Aim 2 Patient Reported Outcomes&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women at least 18 years of age with a first pathology-confirmed breast cancer&#xD;
             diagnosis (DCIS or stage I-III invasive) within 6-18 months&#xD;
&#xD;
          -  Known breast density at the time of breast cancer diagnosis&#xD;
&#xD;
        Aim 2 Focus Groups&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women age ≥18 with a first breast cancer diagnosis (DCIS or stage I-III invasive&#xD;
             cancer) within 1-5 years and after completion of active breast cancer treatment who&#xD;
             have undergone mammography or MRI pre-operatively.&#xD;
&#xD;
          -  Women who are able to speak English and can travel to a nearby location for a&#xD;
             discussion&#xD;
&#xD;
        COVID-19 Enhancement Focus Groups&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Women age 18-74 who were due for breast imaging services during the COVID pandemic and&#xD;
             have either canceled their appointment, delayed their appointment, or kept their&#xD;
             appointment&#xD;
&#xD;
          -  Women who are able to speak English and can attend calls virtually through Zoom or&#xD;
             over the phone&#xD;
&#xD;
          -  In addition, for focus groups with women who have prior breast cancer:&#xD;
&#xD;
               1. First breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-3&#xD;
                  years prior to March, 2020.&#xD;
&#xD;
               2. Completed active cancer treatment (ongoing endocrine and Herceptin therapy&#xD;
                  acceptable)&#xD;
&#xD;
               3. No evidence of a second breast cancer event in cancer registry or pathology data&#xD;
                  before recruitment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana L Miglioretti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sacramento Area Breast Imaging Registry</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Mammography Registry</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Chicago Breast Cancer Registry</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hampshire Mammography Network</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Mammography Registry</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vermont Breast Cancer Surveillance System</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Washington Breast Cancer Surveillance Registry</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bcsc-research.org/</url>
    <description>Breast Cancer Surveillance Consortium (BCSC)</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>digital mammography</keyword>
  <keyword>digital breast tomosynthesis</keyword>
  <keyword>breast magnetic resonance imaging</keyword>
  <keyword>screening</keyword>
  <keyword>breast density</keyword>
  <keyword>breast imaging</keyword>
  <keyword>pre-operative magnetic resonance imaging</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>Please visit http://www.bcsc-research.org for information about requesting BCSC data.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>February 28, 2022</submitted>
    <submission_canceled>February 28, 2022</submission_canceled>
    <submitted>December 22, 2022</submitted>
    <submission_canceled>January 11, 2023</submission_canceled>
    <submitted>May 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02980848
org study id: 941466
secondary id: PCS-1504-30370
nct id: NCT02980848
lead sponsor: 
collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational
      pragmatic comparative effectiveness research study using high-quality, prospectively
      collected data from BCSC registries to generate evidence on how breast density should be
      integrated into decision making around breast cancer screening and preoperative diagnostic
      work-up. We will augment existing BCSC registry infrastructure with additional prospective
      data collection and collection of patient reported outcomes (PROs), CISNET modeling of
      long-term screening outcomes, and qualitative data from focus groups with women represented
      in two aims.
Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone
      versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI)
      by extent of breast density.

      Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of
      experience, and whether any "learning curve" depends on radiologist specialty (i.e., breast
      imaging specialist vs. general radiologist).

      Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast
      density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive
      breast cancer.

      Covid-19 Enhancement Aim and Hypotheses:

      Develop patient-focused messaging content through focus groups that radiology facilities can
      use when scheduling appointments to inform women of the safety to schedule or postpone breast
      screening or diagnostic services.
observational model: Cohort
time perspective: Prospective
measure: Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)
time frame: Within one year after screen
description: Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens
measure: Screening Failures: Interval or advanced breast cancer rate (Aim 1)
time frame: Within one year after screen
description: Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens
Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens
measure: Screening Harms: Recall rate (Aim 1)
time frame: Within one year after screen
description: Number of positive screens divided by total number of screens
measure: Screening Harms: False-positive (FP) recall rate (Aim 1)
time frame: Within one year after screen
description: Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens
measure: Screening Harms: FP biopsy recommendation rate (Aim 1)
time frame: Within one year after screen
description: Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens
measure: Screening Harms: Other consequences (Aim 1)
time frame: Within one year after screen
description: Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade
measure: Patient Reported Outcomes (Aim 1)
time frame: Measured within one year post-screening
description: Patient surveys targeted to determining outcomes of interest to patients
measure: Rates of additional breast cancers detected (Aim 2)
time frame: 6 months after initial diagnosis
description: Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
measure: 3-year rate of 2nd breast cancer events (Aim 2)
time frame: 3 years after initial diagnosis
description: Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers
measure: Patient Reported Outcomes (Aim 2)
time frame: Measured 6-18 months post-diagnosis
description: Patient surveys targeted to determining outcomes of interest to patients
measure: Performance Measures: Sensitivity (Aim 1)
time frame: Within one year after screen
description: Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases
measure: Performance Measures: Specificity (Aim 1)
time frame: Within one year after screen
description: Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer
measure: Performance Measures: Positive predictive value (Aim 1)
time frame: Within one year after screen
description: Number of cancer cases within 1 year of positive screen divided by number of positive screens
measure: Definitive surgery type (Aim 2)
time frame: 6 months after initial diagnosis
description: Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction
measure: Negative predictive value of work-up with MRI (Aim 2)
time frame: 6 months after initial diagnosis
description: Number of women with a negative pre-operative MRI and no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women with a negative pre-operative MRI
measure: Negative predictive value of work-up without MRI (Aim 2)
time frame: 6 months after initial diagnosis
description: Number of women without a pre-operative MRI with no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women without a pre-operative MRI
measure: Core biopsy rates (Aim 2)
time frame: 6 months after initial diagnosis
description: Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies
measure: Surgical biopsy rate (Aim 2)
time frame: 6 months after initial diagnosis
description: Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies
measure: Benign biopsy rate (Aim 2)
time frame: 6 months after initial diagnosis
description: Number of initial benign biopsies over number of breast biopsies
measure: Modeled Long-Term Mortality Outcome: Breast cancers deaths averted (Aim 1)
time frame: From date of first screening examination until the date of death from any cause, up to 100 years of age
description: Breast cancers deaths averted estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models
measure: Modeled Long-Term Mortality Outcome: Life-years gained (Aim 1)
time frame: From date of first screening examination until the date of death from any cause, up to 100 years of age
description: Life-years gained estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models
measure: Modeled Long-Term Mortality Outcome: Overdiagnosis (Aim 1)
time frame: From date of first screening examination until the date of death from any cause, up to 100 years of age
description: Overdiagnosis estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models
arm group label: Screening group
description: Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
arm group label: Women with breast cancer
description: Women diagnosed with stage 0-III breast cancer undergoing pre-operative work-up with diagnostic mammography alone or diagnostic mammography plus pre-operative breast magnetic resonance imaging.
intervention type: Other
intervention name: Screening digital mammography
description: Screening with digital mammography alone
arm group label: Screening group
intervention type: Other
intervention name: Screening digital breast tomosynthesis
description: Screening with digital mammography plus digital breast tomosynthesis
arm group label: Screening group
intervention type: Other
intervention name: Screening breast magnetic resonance imaging
description: Screening with digital mammography plus breast magnetic resonance imaging
arm group label: Screening group
intervention type: Other
intervention name: Diagnostic mammography
description: Pre-operative diagnostic work-up with mammography alone
arm group label: Women with breast cancer
intervention type: Other
intervention name: Pre-operative breast magnetic resonance imaging
description: Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
arm group label: Women with breast cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Diana L Miglioretti, PhD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
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country: United States
url: https://www.bcsc-research.org/
description: Breast Cancer Surveillance Consortium (BCSC)
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: Please visit http://www.bcsc-research.org for information about requesting BCSC data.
submitted: February 28, 2022
submission canceled: February 28, 2022
submitted: December 22, 2022
submission canceled: January 11, 2023
submitted: May 9, 2023