Breast Screening - Risk Adaptive Imaging for Density (BRAID)

University of Cambridge

Status: Enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: ABB-MRI; Diagnostic Test: CESM; Diagnostic Test: ABUS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04097366

A095053

Details and patient eligibility

About

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.

Full 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 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 (CESM). 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.

Enrollment: 13,200 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13,200 participants in 4 patient groups

Standard of Care

No Intervention group

Description:

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 group

Description:

Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.

Treatment:

Diagnostic Test: ABB-MRI

Automated Breast Ultrasound (ABUS)

Active Comparator group

Description:

Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.

Treatment:

Diagnostic Test: ABUS

Contrast Enhanced Mammography (CESM)

Active Comparator group

Description:

Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.

Treatment:

Diagnostic Test: CESM