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

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.

Eligibility Criteria:
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 six 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 seven 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 6-18 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

COVID-19 Enhancement Focus Groups

Inclusion criteria:

* Women age 18-74 who were due for breast imaging services during the COVID pandemic and have either canceled their appointment, delayed their appointment, or kept their appointment
* Women who are able to speak English and can attend calls virtually through Zoom or over the phone
* In addition, for focus groups with women who have prior breast cancer:

  1. First breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-3 years prior to March, 2020.
  2. Completed active cancer treatment (ongoing endocrine and Herceptin therapy acceptable)
  3. No evidence of a second breast cancer event in cancer registry or pathology data before recruitment.