Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

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

Summary: This Beast 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.

Eligibility: 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 6 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 6 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
  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 one year following the screening mammogram
  Aim 2 Clinical Outcomes
  Inclusion criteria:
  -  Women at least 18 years of age with a first breast cancer diagnosis (DCIS or invasive) from 2005-2017 for whom there was a mammogram performed within the year prior to breast cancer diagnosis at one of the participating BCSC registry facilities
  -  Women for whom we have pathologically-confirmed breast cancer (DCIS or invasive) with a pathology or biopsy record related to the incident cancer diagnosis in the BCSC data
  -  MRI and mammography examinations performed for pre-operative work-up from 2005-2017 at one of the participating BCSC registry facilities in women meeting eligibility criteria
  Aim 2 Patient Reported Outcomes
  Inclusion criteria:
  -  Women at least 18 years of age with a first pathology-confirmed breast cancer diagnosis (DCIS or stage I-III invasive) within 3-12 months
  -  Known breast density at the time of breast cancer diagnosis
  Aim 2 Focus Groups
  Inclusion criteria:
  -  Women age ≥18 with a first breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-5 years and after completion of active breast cancer treatment who have undergone mammography or MRI pre-operatively.
  -  Women who are able to speak English and can travel to a nearby location for a discussion

Relevance to patient case: not relevant