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Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study (BCSC-ADVANCE)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980848
First Posted: December 2, 2016
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Dartmouth College
Kaiser Permanente
University of Vermont
University of North Carolina
University of Illinois at Chicago
Advocate Health Care
Harvard Pilgrim Health Care
Albert Einstein College of Medicine, Inc.
Erasmus Medical Center
Information provided by (Responsible Party):
University of California, Davis
  Purpose
This Beast 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.

Condition Intervention
Breast Cancer Device: Screening digital mammography Device: Screening digital breast tomosynthesis Device: Screening breast magnetic resonance imaging Device: Diagnostic mammography Device: Pre-operative breast magnetic resonance imaging

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Screening Benefits: Rate of early stage invasive cancer detection (Aim 1) [ Time Frame: Within one year after screen ]
    Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens

  • Screening Failures: Interval cancer rate (Aim 1) [ Time Frame: Within one year after screen ]
    Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens

  • Screening Harms: Recall rate (Aim 1) [ Time Frame: Within one year after screen ]
    Number of positive screens divided by total number of screens

  • Screening Harms: False-positive (FP) recall rate (Aim 1) [ Time Frame: Within one year after screen ]
    Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens

  • Screening Harms: FP biopsy recommendation rate (Aim 1) [ Time Frame: Within one year after screen ]
    Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens

  • Screening Harms: Other consequences (Aim 1) [ Time Frame: Within one year after screen ]
    Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade

  • Patient Reported Outcomes (Aim 1) [ Time Frame: Measured within one year post-screening ]
    Patient surveys targeted to determining outcomes of interest to patients

  • Rates of additional breast cancers detected (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    Number of women with an additional breast cancer diagnosed within 6 months of initial diagnosis over total number of women, calculated separately for ipsilateral and contralateral cancers

  • 3-year rate of 2nd breast cancer events (Aim 2) [ Time Frame: 3 years after initial diagnosis ]
    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

  • Patient Reported Outcomes (Aim 2) [ Time Frame: Measured 3-12 months post-diagnosis ]
    Patient surveys targeted to determining outcomes of interest to patients


Secondary Outcome Measures:
  • Performance Measures: Sensitivity (Aim 1) [ Time Frame: Within one year after screen ]
    Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases

  • Performance Measures: Specificity (Aim 1) [ Time Frame: Within one year after screen ]
    Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer

  • Performance Measures: Positive predictive value (Aim 1) [ Time Frame: Within one year after screen ]
    Number of cancer cases within 1 year of positive screen divided by number of positive screens

  • Definitive surgery type (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction

  • Negative predictive value of work-up with MRI (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    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

  • Negative predictive value of work-up without MRI (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    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

  • Core biopsy rates (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies

  • Surgical biopsy rate (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies

  • Benign biopsy rate (Aim 2) [ Time Frame: 6 months after initial diagnosis ]
    Number of initial benign biopsies over number of breast biopsies


Other Outcome Measures:
  • 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 ]
    Breast cancers deaths averted estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

  • 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 ]
    Life-years gained estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

  • 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 ]
    Overdiagnosis estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models


Estimated Enrollment: 1000000
Study Start Date: September 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Screening group
Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
Device: Screening digital mammography
Screening with digital mammography alone
Device: Screening digital breast tomosynthesis
Screening with digital mammography plus digital breast tomosynthesis
Device: Screening breast magnetic resonance imaging
Screening with digital mammography plus breast magnetic resonance imaging
Women with breast cancer
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.
Device: Diagnostic mammography
Pre-operative diagnostic work-up with mammography alone
Device: Pre-operative breast magnetic resonance imaging
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include women age 40-74 undergoing screening mammography (Aim 1) and women age ≥18 with a first breast cancer diagnosis (Aim 2). We will include women in the BCSC cohort with mammography from 2005-2017. BCSC participants are identified from six BCSC breast imaging registries. The BCSC prospectively collects data during routine clinical practice through voluntary partnerships with radiology facilities. Women enter the BCSC cohort when they receive a breast-imaging exam at a participating facility.
Criteria

Aim 1 Clinical Outcomes

Inclusion criteria:

  • Women aged 40-79 undergoing screening mammography from 2010-2017 for comparisons with tomosynthesis and 2005-2017 for comparison with breast MRI at a facility that participates in one of 6 BCSC breast imaging registries
  • Digital mammography exams performed for screening and performed with or without supplemental screening with digital breast tomosynthesis from 2010-2017 or breast MRI from 2005-2017, at a facility that participates in one of 6 BCSC breast imaging registries, and in women who meet inclusion criteria.

Exclusion criteria:

  • Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation.
  • Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
  • Exams without complete cancer capture during the follow-up period

Aim 1 Patient Reported Outcomes

Inclusion criteria:

  • Women aged 40-74 years undergoing screening mammography, with or without supplemental screening with digital breast tomosynthesis or breast MRI, at selected BCSC facilities
  • Women within 12 months of a digital screening mammogram with known breast density and no known breast cancer diagnosis
  • For MRI subgroup, we will include women with a screening MRI within the prior 24 months
  • Within strata defined by BCSC registry, breast density subgroup (dense vs. not dense), and race/ethnicity, women with supplemental screening with digital breast tomosynthesis or breast MRI will be matched to women without supplemental screening

Aim 1 Focus Groups

Inclusion criteria:

  • Women age 40-74 years undergoing screening mammography, with or without supplemental screening (defined as digital breast tomosynthesis or breast MRI)
  • Women within 12 months post-most recent screening examination with known dense breasts from most recent screening mammogram and no known breast cancer diagnosis
  • Women who are able to speak English and can travel to a nearby location for a discussion

Subaim 1

Inclusion criteria:

  • Radiologists interpreting digital mammography and/or tomosynthesis for at least one year from 2010-2017 at a facility that participates in the BCSC
  • Digital mammography exams and digital breast tomosynthesis performed for screening and evaluated by a radiologist meeting inclusion criteria from 2010-2017

Exclusion criteria:

  • Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation
  • Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
  • Exams without complete cancer capture during one year following the screening mammogram

Aim 2 Clinical Outcomes

Inclusion criteria:

  • Women at least 18 years of age with a first breast cancer diagnosis (DCIS or invasive) from 2005-2017 for whom there was a mammogram performed within the year prior to breast cancer diagnosis at one of the participating BCSC registry facilities
  • Women for whom we have pathologically-confirmed breast cancer (DCIS or invasive) with a pathology or biopsy record related to the incident cancer diagnosis in the BCSC data
  • MRI and mammography examinations performed for pre-operative work-up from 2005-2017 at one of the participating BCSC registry facilities in women meeting eligibility criteria

Aim 2 Patient Reported Outcomes

Inclusion criteria:

  • Women at least 18 years of age with a first pathology-confirmed breast cancer diagnosis (DCIS or stage I-III invasive) within 3-12 months
  • Known breast density at the time of breast cancer diagnosis

Aim 2 Focus Groups

Inclusion criteria:

  • Women age ≥18 with a first breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-5 years and after completion of active breast cancer treatment who have undergone mammography or MRI pre-operatively.
  • Women who are able to speak English and can travel to a nearby location for a discussion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980848


Locations
United States, California
San Francisco Mammography Registry
San Francisco, California, United States, 94143
United States, Illinois
Metro Chicago Breast Cancer Registry
Chicago, Illinois, United States, 60607
United States, New Hampshire
New Hampshire Mammography Network
Lebanon, New Hampshire, United States, 03755
United States, North Carolina
Carolina Mammography Registry
Chapel Hill, North Carolina, United States, 27599
United States, Vermont
Vermont Breast Cancer Surveillance System
Burlington, Vermont, United States, 05405
United States, Washington
Group Health Registry
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of California, Davis
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Dartmouth College
Kaiser Permanente
University of Vermont
University of North Carolina
University of Illinois at Chicago
Advocate Health Care
Harvard Pilgrim Health Care
Albert Einstein College of Medicine, Inc.
Erasmus Medical Center
Investigators
Principal Investigator: Diana L Miglioretti, PhD University of California, Davis
  More Information

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02980848     History of Changes
Other Study ID Numbers: 941466
PCS-1504-30370 ( Other Identifier: PCORI )
First Submitted: November 19, 2016
First Posted: December 2, 2016
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Please visit http://www.bcsc-research.org for information about requesting BCSC data.

Keywords provided by University of California, Davis:
digital mammography
digital breast tomosynthesis
breast magnetic resonance imaging
screening
breast density
breast imaging
pre-operative magnetic resonance imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases