Breast Cancer
Conditions
Keywords
digital mammography, digital breast tomosynthesis, breast magnetic resonance imaging, screening, breast density, breast imaging, pre-operative magnetic resonance imaging
Brief summary
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.
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.
Interventions
OTHERScreening digital mammography
Screening with digital mammography alone
OTHERScreening digital breast tomosynthesis
Screening with digital mammography plus digital breast tomosynthesis
OTHERScreening breast magnetic resonance imaging
Screening with digital mammography plus breast magnetic resonance imaging
Pre-operative diagnostic work-up with mammography alone
OTHERPre-operative breast magnetic resonance imaging
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
Sponsors
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
Wake Forest University Health Sciences
Harvard Pilgrim Health Care
Albert Einstein College of Medicine
Erasmus Medical Center
University of California, Davis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year rate of 2nd breast cancer events (Aim 2) | 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 |
| Rates of additional breast cancers detected (Aim 2) | 6 months after initial diagnosis | Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women |
| Screening Benefits: Rate of early stage invasive cancer detection (Aim 1) | 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 or advanced breast cancer rate (Aim 1) | Within one year after screen | 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 |
| Screening Harms: Recall rate (Aim 1) | Within one year after screen | Number of positive screens divided by total number of screens |
| Screening Harms: False-positive (FP) recall rate (Aim 1) | 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) | 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) | 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) | Measured within one year post-screening | Patient surveys targeted to determining outcomes of interest to patients |
| Patient Reported Outcomes (Aim 2) | Measured 6-18 months post-diagnosis | Patient surveys targeted to determining outcomes of interest to patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Benign biopsy rate (Aim 2) | 6 months after initial diagnosis | Number of initial benign biopsies over number of breast biopsies |
| Performance Measures: Sensitivity (Aim 1) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 6 months after initial diagnosis | Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modeled Long-Term Mortality Outcome: Life-years gained (Aim 1) | 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) | 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 |
| Modeled Long-Term Mortality Outcome: Breast cancers deaths averted (Aim 1) | 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 |
Countries
United States
Outcome results
None listed