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.
Study Type
OBSERVATIONAL
Enrollment
1,341,172
Screening with digital mammography alone
Screening with digital mammography plus digital breast tomosynthesis
Screening with digital mammography plus breast magnetic resonance imaging
Pre-operative diagnostic work-up with mammography alone
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
Sacramento Area Breast Imaging Registry
Davis, California, United States
San Francisco Mammography Registry
San Francisco, California, United States
Metro Chicago Breast Cancer Registry
Chicago, Illinois, United States
New Hampshire Mammography Network
Lebanon, New Hampshire, United States
Carolina Mammography Registry
Chapel Hill, North Carolina, United States
Vermont Breast Cancer Surveillance System
Burlington, Vermont, United States
Kaiser Permanente Washington Breast Cancer Surveillance Registry
Seattle, Washington, United States
Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)
Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens
Time frame: Within one year after screen
Screening Failures: Interval or advanced breast cancer rate (Aim 1)
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
Time frame: Within one year after screen
Screening Harms: Recall rate (Aim 1)
Number of positive screens divided by total number of screens
Time frame: Within one year after screen
Screening Harms: False-positive (FP) recall rate (Aim 1)
Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens
Time frame: Within one year after screen
Screening Harms: FP biopsy recommendation rate (Aim 1)
Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens
Time frame: Within one year after screen
Screening Harms: Other consequences (Aim 1)
Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade
Time frame: Within one year after screen
Patient Reported Outcomes (Aim 1)
Patient surveys targeted to determining outcomes of interest to patients
Time frame: Measured within one year post-screening
Rates of additional breast cancers detected (Aim 2)
Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
Time frame: 6 months after initial diagnosis
3-year rate of 2nd breast cancer events (Aim 2)
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
Time frame: 3 years after initial diagnosis
Patient Reported Outcomes (Aim 2)
Patient surveys targeted to determining outcomes of interest to patients
Time frame: Measured 6-18 months post-diagnosis
Performance Measures: Sensitivity (Aim 1)
Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases
Time frame: Within one year after screen
Performance Measures: Specificity (Aim 1)
Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer
Time frame: Within one year after screen
Performance Measures: Positive predictive value (Aim 1)
Number of cancer cases within 1 year of positive screen divided by number of positive screens
Time frame: Within one year after screen
Definitive surgery type (Aim 2)
Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction
Time frame: 6 months after initial diagnosis
Negative predictive value of work-up with MRI (Aim 2)
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
Time frame: 6 months after initial diagnosis
Negative predictive value of work-up without MRI (Aim 2)
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
Time frame: 6 months after initial diagnosis
Core biopsy rates (Aim 2)
Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies
Time frame: 6 months after initial diagnosis
Surgical biopsy rate (Aim 2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies
Time frame: 6 months after initial diagnosis
Benign biopsy rate (Aim 2)
Number of initial benign biopsies over number of breast biopsies
Time frame: 6 months after initial diagnosis