Clinical trial NCT04097366: Breast Screening - Risk Adaptive Imaging for Density
Official title: Breast Screening - Risk Adaptive Imaging for Density
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: GE Healthcare
name: Queen Mary University of London
name: Public Health England
First posted: 2019-09-20
Enrollment: 9000
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.

Detailed description: Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.

The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (\<15mm). This is partly due to masking of cancers by dense breast tissue.

This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CEM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give written informed consent
* Willing and able to comply with the scheduled study visits, tests and other procedures
* Female
* Screening mammogram that is either normal or being recalled for assessment
* Increased breast density identified on current screening mammogram examination (BIRADS C or D)

  * If BIRADS C the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant
  * All BIRADS D will be eligible
* Aged 50-70 and eligible for 3-yearly NHS breast screening

Exclusion Criteria:

* Known BRCA carrier or ≥50% risk of being a carrier
* Unable to give informed consent
* Breast implant(s)
* Unable to be followed-up for the study duration
* Current participation in another interventional breast screening trial (Including but not limited to MyPeBS)
* Participated in part A of the BRAID study
* Pregnant or breast feeding

Primary outcomes:
measure: Cancer detection rate in each arm
timeFrame: 42 months after mammogram at study entry
Secondary outcomes:
measure: Incidence of stage II or worse cancers over the period of observation
timeFrame: 42 months after last participant entered
measure: The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
timeFrame: 6 months after mammogram at study entry
measure: The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
timeFrame: 21 months after mammogram at study entry
measure: The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
timeFrame: 42 months after last participant entered
measure: Reading time of each examination
timeFrame: 1 year
measure: Automated breast density measurements compared with reader assessment
timeFrame: Baseline
measure: The risk of developing breast cancer as assessed by the BOADICEA model
timeFrame: 72 months After last participant entered
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester, Leicester Royal Infirmary
state: Leicestershire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, City Hospital
state: Nottinghamshire
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: Tayside Health Board, Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Greater Glasgow Health Board, Gartnavel Royal Hospital
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust, Royal London Hospital
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: University of Cambridge
name: Fiona Gilbert
role: PRINCIPAL_INVESTIGATOR
References: