Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of California, Davis
- Enrollment
- 1341172
- Locations
- 7
- Primary Endpoint
- Patient Reported Outcomes (Aim 1)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Patient Reported Outcomes (Aim 1)
Time Frame: Measured within one year post-screening
Patient surveys targeted to determining outcomes of interest to patients
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: 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
Screening Failures: Interval or advanced breast 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 Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens
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 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
Rates of additional breast cancers detected (Aim 2)
Time Frame: 6 months after initial diagnosis
Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
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 6-18 months post-diagnosis
Patient surveys targeted to determining outcomes of interest to patients
Secondary Outcomes
- Negative predictive value of work-up without MRI (Aim 2)(6 months after initial diagnosis)
- Performance Measures: Positive predictive value (Aim 1)(Within one year after screen)
- Performance Measures: Specificity (Aim 1)(Within one year after screen)
- Definitive surgery type (Aim 2)(6 months after initial diagnosis)
- Surgical biopsy rate (Aim 2)(6 months after initial diagnosis)
- Benign biopsy rate (Aim 2)(6 months after initial diagnosis)
- Performance Measures: Sensitivity (Aim 1)(Within one year after screen)
- Core biopsy rates (Aim 2)(6 months after initial diagnosis)
- Negative predictive value of work-up with MRI (Aim 2)(6 months after initial diagnosis)