Breast CancerBRAIDNCT04097366
Breast Screening - Risk Adaptive Imaging for Density
A study testing ABUS, CEM and ABB-MRI in people with Breast Cancer, run by University of Cambridge at 10 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ABUS, CEM and ABB-MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 28 May 2019to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, GL53 7AS
Tayside Health Board, Ninewells Hospital
Dundee, Dundee, DD1 9SY
Greater Glasgow Health Board, Gartnavel Royal Hospital
Glasgow, Glasgow, G12 0XH
The Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
University Hospitals of Leicester, Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
Barts Health NHS Trust, Royal London Hospital
London, London, E1 1FR
Royal Free London NHS Foundation Trust
London, London, NW3 2QG
Manchester University NHS Foundation Trust
Manchester, M23 9LT
Nottingham University Hospitals NHS Trust, City Hospital
Nottingham, Nottinghamshire, NG5 1PB
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- ABUS, CEM, ABB-MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABUSDiagnostic test
Also called Whole Breast Ultrasound, Automated Breast Ultrasound
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.
CEMDiagnostic test
Also called Contrast Enhanced Mammography
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.
ABB-MRIDiagnostic test
Also called Abbreviated Magnetic Resonance Imaging, Abridged MRI, Abbreviated Protocol MRI, Abbreviated Breast MRII
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are. |
| Abbreviated MRI (ABB-MRI) | Active comparator | Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram. Receives: Diagnostic Test: ABB-MRI |
| Automated Breast Ultrasound (ABUS) | Active comparator | Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram. Receives: Diagnostic Test: ABUS |
| Contrast Enhanced Mammography (CEM) | Active comparator | Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram. Receives: Diagnostic Test: CEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer detection rate in each arm
All cancers (detected or interval) in each arm over a three year period will be collected.
Measured: 42 months after mammogram at study entry
Secondary outcomes (7)
Incidence of stage II or worse cancers over the period of observation
size, lymph node status, metastatic status
Measured: 42 months after last participant entered
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
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
Measured: 6 months after mammogram at study entry
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
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
Measured: 21 months after mammogram at study entry
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
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 incident round; Interval cancer rate; Stage of interval cancers; Size of interval cancers
Measured: 42 months after last participant entered
Reading time of each examination
Average time and range for each modality. (Seconds).
Measured: 1 year
Automated breast density measurements compared with reader assessment
Percentage density.
Measured: Baseline
The risk of developing breast cancer as assessed by the BOADICEA model
Percentage 5 year risk, percentage lifetime risk.
Measured: 72 months After last participant entered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start28 May 2019
- Primary completion30 Sep 2024
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, GE Healthcare, Queen Mary University of London, Public Health England
- Responsible party
- Principal investigator, Fiona J Gilbert, University of Cambridge
- Investigators
- Fiona Gilbert, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097366
- Sponsor's protocol ID
- A095053
- Acronym
- BRAID
- Status last verified
- May 2024
- First submitted
- 9 Sep 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilbert FJ, Payne NR, Allajbeu I, Yit L, Vinnicombe S, Lyburn I, Sharma N, Teh W, James J, Seth A, Suaris T, Aggarwal R, Al-Attar M, Savaridas S, Antoniou A, Pharoah P, Duffy S. Comparison of supplemental breast cancer imaging techniques-interim results from the BRAID randomised controlled trial. Lancet. 2025 May 31;405(10493):1935-1944. doi: 10.1016/S0140-6736(25)00582-3. Epub 2025 May 21.
PubMed 40412427
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Screening - Risk Adaptive Imaging for Density
- ClinicalTrials.gov ID
- NCT04097366
- Acronym / sponsor ID
- BRAID / A095053
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cancer Research UK, GE Healthcare, Queen Mary University of London, Public Health England
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are. |
| Abbreviated MRI (ABB-MRI) | Active comparator | Diagnostic Test: ABB-MRISupplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram. |
| Automated Breast Ultrasound (ABUS) | Active comparator | Diagnostic Test: ABUSSupplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram. |
| Contrast Enhanced Mammography (CEM) | Active comparator | Diagnostic Test: CEMSupplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABUSAlso: Whole Breast Ultrasound, Automated Breast UltrasoundAutomated 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 test | Automated Breast Ultrasound (ABUS) |
| CEMAlso: Contrast Enhanced MammographyA 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 test | Contrast Enhanced Mammography (CEM) |
| ABB-MRIAlso: Abbreviated Magnetic Resonance Imaging, Abridged MRI, Abbreviated Protocol MRI, Abbreviated Breast MRIIABB-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. | Diagnostic test | Abbreviated MRI (ABB-MRI) |
Primary outcome
Cancer detection rate in each arm
Time frame: 42 months after mammogram at study entry
All cancers (detected or interval) in each arm over a three year period will be collected.
7 secondary outcomes
Incidence of stage II or worse cancers over the period of observation
Time frame: 42 months after last participant entered
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
Time frame: 6 months after mammogram at study entry
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
Time frame: 21 months after mammogram at study entry
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
Time frame: 42 months after last participant entered
Reading time of each examination
Time frame: 1 year
Automated breast density measurements compared with reader assessment
Time frame: Baseline
The risk of developing breast cancer as assessed by the BOADICEA model
Time frame: 72 months After last participant entered
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 40412427Gilbert FJ, Payne NR, Allajbeu I, Yit L, Vinnicombe S, Lyburn I, Sharma N, Teh W, James J, Seth A, Suaris T, Aggarwal R, Al-Attar M, Savaridas S, Antoniou A, Pharoah P, Duffy S. Comparison of supplemental breast cancer imaging techniques-interim results from the BRAID randomised controlled trial. Lancet. 2025 May 31;405(10493):1935-1944. doi: 10.1016/S0140-6736(25)00582-3. Epub 2025 May 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Gilbert principal investigator
University of Cambridge
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABUS, CEM and ABB-MRI in people with Breast Cancer, run by University of Cambridge at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer detection rate in each arm (time frame: 42 months after mammogram at study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04097366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.