SMALL Trial Version 1.0, 10-May-2019
Research type
Research Study
Full title
SMALL: Open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer – a phase III randomised multi-centre trial
IRAS ID
254829
Contact name
Jessica Foster
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
10 years, 4 months, 30 days
Research summary
In the NHS Breast Screening Programme, there has been concern about overdiagnosis (the diagnosis of cancers which would never have been seen if a woman had not had a screening mammogram). It’s estimated that for every breast cancer death prevented by screening, around three cancers are overdiagnosed, and therefore potentially overtreated. These cancers have always been treated with an operation, under general anaesthetic. This research will look at a new way of removing small, early-stage breast cancers found by screening, to try and reduce overtreatment. The research will use a method called vacuum-assisted excision (VAE), under ultrasound guidance and local anaesthetic, to remove the cancer. Afterwards, a mammogram is done to make sure that the cancer is completely removed.
Women with small breast cancers will be assigned at random to have their cancer removed either with a standard surgical operation under general anaesthetic, or else using the new vacuum-assisted needle method to remove the breast tumour only. After standard surgery, up to 1 in 5 women need a follow-up operation, because when the cancer is removed and examined in the lab, cancer cells are still present at the edge of the tissue removed. Using VAE, we need to make sure that a larger number of women won’t need a follow-up operation if the mammogram shows the cancer is not fully removed. In the research, we will compare the rate of women requiring a follow-up operation in both groups. We also know that after breast cancer surgery there is a low risk of the cancer coming back in the breast - about 1 in 100 women (after 5 years) - this can be treated with another operation. We will be following women up to make sure that this doesn’t happen more often in women having VAE compared with standard surgery.
REC name
HSC REC A
REC reference
19/NI/0126
Date of REC Opinion
7 Aug 2019
REC opinion
Further Information Favourable Opinion