Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study

• Conditions: Breast Cancer
• Interventions: Other: Screening digital mammography; Other: Diagnostic mammography; Other: Pre-operative breast magnetic resonance imaging; Other: Screening digital breast tomosynthesis; Other: Screening breast magnetic resonance imaging

• Registration Number: NCT02980848
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-19
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-17
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1341172

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening group	Screening breast magnetic resonance imaging	Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
Screening group	Screening digital mammography	Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
Women with breast cancer	Pre-operative breast magnetic resonance imaging	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.
Screening group	Screening digital breast tomosynthesis	Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
Women with breast cancer	Diagnostic mammography	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.

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcomes (Aim 1)	Measured within one year post-screening	Patient surveys targeted to determining outcomes of interest to patients
Screening Harms: Recall rate (Aim 1)	Within one year after screen	Number of positive screens 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
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 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 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
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
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
Patient Reported Outcomes (Aim 2)	Measured 6-18 months post-diagnosis	Patient surveys targeted to determining outcomes of interest to patients

Secondary Outcome Measures

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

Trial Locations

Locations (7)

San Francisco Mammography Registry; 🇺🇸 San Francisco, California, United States

Sacramento Area Breast Imaging Registry; 🇺🇸 Davis, California, United States

Metro Chicago Breast Cancer Registry; 🇺🇸 Chicago, Illinois, United States

Carolina Mammography Registry; 🇺🇸 Chapel Hill, North Carolina, United States

Kaiser Permanente Washington Breast Cancer Surveillance Registry; 🇺🇸 Seattle, Washington, United States

Vermont Breast Cancer Surveillance System; 🇺🇸 Burlington, Vermont, United States

New Hampshire Mammography Network; 🇺🇸 Lebanon, New Hampshire, United States