NCT02980848

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,341,172

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

5.4 years

First QC Date

November 19, 2016

Last Update Submit

November 16, 2021

Conditions

Breast Cancer

Keywords

digital mammographydigital breast tomosynthesisbreast magnetic resonance imagingscreeningbreast densitybreast imagingpre-operative magnetic resonance imaging

Outcome Measures

Primary Outcomes (10)

  • 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

    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

    Within one year after screen

  • Screening Harms: Recall rate (Aim 1)

    Number of positive screens divided by total number of screens

    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

    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

    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

    Within one year after screen

  • Patient Reported Outcomes (Aim 1)

    Patient surveys targeted to determining outcomes of interest to patients

    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

    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

    3 years after initial diagnosis

  • Patient Reported Outcomes (Aim 2)

    Patient surveys targeted to determining outcomes of interest to patients

    Measured 6-18 months post-diagnosis

Secondary Outcomes (9)

  • Performance Measures: Sensitivity (Aim 1)

    Within one year after screen

  • Performance Measures: Specificity (Aim 1)

    Within one year after screen

  • Performance Measures: Positive predictive value (Aim 1)

    Within one year after screen

  • Definitive surgery type (Aim 2)

    6 months after initial diagnosis

  • Negative predictive value of work-up with MRI (Aim 2)

    6 months after initial diagnosis

  • +4 more secondary outcomes

Other Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Screening group

Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.

Other: Screening digital mammographyOther: Screening digital breast tomosynthesisOther: Screening breast magnetic resonance imaging

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.

Other: Diagnostic mammographyOther: Pre-operative breast magnetic resonance imaging

Interventions

Screening digital mammographyOTHER

Screening with digital mammography alone

Screening group
Screening digital breast tomosynthesisOTHER

Screening with digital mammography plus digital breast tomosynthesis

Screening group
Screening breast magnetic resonance imagingOTHER

Screening with digital mammography plus breast magnetic resonance imaging

Screening group
Diagnostic mammographyOTHER

Pre-operative diagnostic work-up with mammography alone

Women with breast cancer
Pre-operative breast magnetic resonance imagingOTHER

Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging

Women with breast cancer

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include women age 40-79 undergoing screening mammography (Aim 1) and women age ≥18 with a first breast cancer diagnosis (Aim 2). We will include women in the BCSC cohort with mammography from 2005-2017. BCSC participants are identified from seven BCSC breast imaging registries. The BCSC prospectively collects data during routine clinical practice through voluntary partnerships with radiology facilities. Women enter the BCSC cohort when they receive a breast-imaging exam at a participating facility.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • Radiologists interpreting digital mammography and/or tomosynthesis for at least one year from 2010-2017 at a facility that participates in the BCSC
  • Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sacramento Area Breast Imaging Registry

Davis, California, 95616, United States

Location

San Francisco Mammography Registry

San Francisco, California, 94143, United States

Location

Metro Chicago Breast Cancer Registry

Chicago, Illinois, 60607, United States

Location

New Hampshire Mammography Network

Lebanon, New Hampshire, 03755, United States

Location

Carolina Mammography Registry

Chapel Hill, North Carolina, 27599, United States

Location

Vermont Breast Cancer Surveillance System

Burlington, Vermont, 05405, United States

Location

Kaiser Permanente Washington Breast Cancer Surveillance Registry

Seattle, Washington, 98101, United States

Location

Related Publications (3)

  • Smith RE, Sprague BL, Henderson LM, Kerlikowske K, Miglioretti DL, Wernli KJ, Onega T, diFlorio-Alexander RM, Tosteson ANA. Breast density knowledge and willingness to delay treatment for pre-operative breast cancer imaging among women with a personal history of breast cancer. Breast Cancer Res. 2024 Apr 29;26(1):73. doi: 10.1186/s13058-024-01820-x.

    PMID: 38685119DERIVED

  • 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.

    PMID: 36356184DERIVED

  • 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.

    PMID: 34686934DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Diana L Miglioretti, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2016

First Posted

December 2, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Please visit http://www.bcsc-research.org for information about requesting BCSC data.

Locations

US(7)