Breast Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTABUS
Automated whole breast ultrasound (ABUS) is undertaken with a large transducer panel placed on the breast in three positions. Resultant images are combined to make a 3D image of the breast.
DIAGNOSTIC_TESTCEM
A high kV and a low kV image is taken in two standard views of each breast following the intravenous injection of an iodinated contrast agent.
DIAGNOSTIC_TESTABB-MRI
ABB-MRI is a shorter version of breast MRI. Standard T1W pre and post contrast images are acquired. A MIP and post-contrast T1 weighted image are read.
Sponsors
Cancer Research UK
GE Healthcare
Queen Mary University of London
Public Health England
University of Cambridge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer detection rate in each arm | 42 months after mammogram at study entry | All cancers (detected or interval) in each arm over a three year period will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of stage II or worse cancers over the period of observation | 42 months after last participant entered | size, lymph node status, metastatic status |
| The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM. | 6 months after mammogram at study entry | Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at prevalent round |
| Reading time of each examination | 1 year | Average time and range for each modality. (Seconds). |
| Automated breast density measurements compared with reader assessment | Baseline | Percentage density. |
| The risk of developing breast cancer as assessed by the BOADICEA model | 72 months After last participant entered | Percentage 5 year risk, percentage lifetime risk. |
Countries
United Kingdom
Outcome results
None listed