- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02980848
Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study (BCSC-ADVANCE)
Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density
Study Overview
Status
Conditions
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.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Davis, California, United States, 95616
- Sacramento Area Breast Imaging Registry
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San Francisco, California, United States, 94143
- San Francisco Mammography Registry
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Illinois
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Chicago, Illinois, United States, 60607
- Metro Chicago Breast Cancer Registry
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New Hampshire
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Lebanon, New Hampshire, United States, 03755
- New Hampshire Mammography Network
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Carolina Mammography Registry
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Vermont
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Burlington, Vermont, United States, 05405
- Vermont Breast Cancer Surveillance System
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Washington
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Seattle, Washington, United States, 98101
- Kaiser Permanente Washington Breast Cancer Surveillance Registry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 six 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 seven 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 6-18 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
COVID-19 Enhancement Focus Groups
Inclusion criteria:
- Women age 18-74 who were due for breast imaging services during the COVID pandemic and have either canceled their appointment, delayed their appointment, or kept their appointment
- Women who are able to speak English and can attend calls virtually through Zoom or over the phone
In addition, for focus groups with women who have prior breast cancer:
- First breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-3 years prior to March, 2020.
- Completed active cancer treatment (ongoing endocrine and Herceptin therapy acceptable)
- No evidence of a second breast cancer event in cancer registry or pathology data before recruitment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Screening group
Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
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Screening with digital mammography alone
Screening with digital mammography plus digital breast tomosynthesis
Screening with digital mammography plus breast magnetic resonance imaging
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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.
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Pre-operative diagnostic work-up with mammography alone
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)
Time Frame: Within one year after screen
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Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens
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Within one year after screen
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Screening Failures: Interval or advanced breast cancer rate (Aim 1)
Time Frame: Within one year after screen
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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 |
Within one year after screen
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Screening Harms: Recall rate (Aim 1)
Time Frame: Within one year after screen
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Number of positive screens divided by total number of screens
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Within one year after screen
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Screening Harms: False-positive (FP) recall rate (Aim 1)
Time Frame: Within one year after screen
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Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens
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Within one year after screen
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Screening Harms: FP biopsy recommendation rate (Aim 1)
Time Frame: Within one year after screen
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Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens
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Within one year after screen
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Screening Harms: Other consequences (Aim 1)
Time Frame: Within one year after screen
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Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade
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Within one year after screen
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Patient Reported Outcomes (Aim 1)
Time Frame: Measured within one year post-screening
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Patient surveys targeted to determining outcomes of interest to patients
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Measured within one year post-screening
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Rates of additional breast cancers detected (Aim 2)
Time Frame: 6 months after initial diagnosis
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Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
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6 months after initial diagnosis
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3-year rate of 2nd breast cancer events (Aim 2)
Time Frame: 3 years after initial diagnosis
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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
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3 years after initial diagnosis
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Patient Reported Outcomes (Aim 2)
Time Frame: Measured 6-18 months post-diagnosis
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Patient surveys targeted to determining outcomes of interest to patients
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Measured 6-18 months post-diagnosis
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance Measures: Sensitivity (Aim 1)
Time Frame: Within one year after screen
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Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases
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Within one year after screen
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Performance Measures: Specificity (Aim 1)
Time Frame: Within one year after screen
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Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer
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Within one year after screen
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Performance Measures: Positive predictive value (Aim 1)
Time Frame: Within one year after screen
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Number of cancer cases within 1 year of positive screen divided by number of positive screens
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Within one year after screen
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Definitive surgery type (Aim 2)
Time Frame: 6 months after initial diagnosis
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Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction
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6 months after initial diagnosis
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Negative predictive value of work-up with MRI (Aim 2)
Time Frame: 6 months after initial diagnosis
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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
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6 months after initial diagnosis
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Negative predictive value of work-up without MRI (Aim 2)
Time Frame: 6 months after initial diagnosis
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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
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6 months after initial diagnosis
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Core biopsy rates (Aim 2)
Time Frame: 6 months after initial diagnosis
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Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies
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6 months after initial diagnosis
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Surgical biopsy rate (Aim 2)
Time Frame: 6 months after initial diagnosis
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Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies
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6 months after initial diagnosis
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Benign biopsy rate (Aim 2)
Time Frame: 6 months after initial diagnosis
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Number of initial benign biopsies over number of breast biopsies
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6 months after initial diagnosis
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Breast cancers deaths averted estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models
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From date of first screening examination until the date of death from any cause, up to 100 years of age
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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
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Life-years gained estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models
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From date of first screening examination until the date of death from any cause, up to 100 years of age
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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
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Overdiagnosis estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models
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From date of first screening examination until the date of death from any cause, up to 100 years of age
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diana L Miglioretti, PhD, University of California, Davis
Publications and helpful links
General Publications
- Tosteson ANA, Schifferdecker KE, Smith RE, Wernli KJ, Zhao W, Kaplan CP, Buist DSM, Henderson LM, Sprague BL, Onega T, Budesky J, Jackson-Nefertiti G, Johnson D, Miglioretti DL, Kerlikowske K. Women's Breast Cancer Screening Confidence by Screening Modality and Breast Density: A Breast Cancer Surveillance Consortium Survey Study. J Womens Health (Larchmt). 2022 Nov;31(11):1547-1556. doi: 10.1089/jwh.2021.0649.
- Onega T, Zhu W, Kerlikowske K, Miglioretti DL, Lee CI, Henderson LM, Tosteson ANA, Wernli KJ, diFlorio R, Weaver DL, Buist DSM. Preoperative MRI in breast cancer: effect of breast density on biopsy rate and yield. Breast Cancer Res Treat. 2022 Jan;191(1):177-190. doi: 10.1007/s10549-021-06418-x. Epub 2021 Oct 22.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 941466
- PCS-1504-30370 (OTHER: PCORI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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