The SMALL study is a phase 3 clinical trial, receiving over £2.3M in funding from the NIHR HTA, designed to test if radiotherapy-guided surgical removal could be more effective as a treatment option for these women.
The SMALL study will recruit 800 women whose breast cancer is early-stage and has been detected through the NHS screening programme, with 500 of those women assigned to the test treatment.
The trial will test the standard treatment versus the use of radiotherapy-guided ‘minimally invasive vacuum incision’.
You can find more details about this study on the NIHR HTA website – https://www.journalslibrary.nihr.ac.uk/programmes/hta/174232/#/
The development of this study has involved wide collaboration from researchers and clinicians from a wide range of specialities.
The NHS Breast Screening Programme offers regular breast cancer screening for women aged 50-70, and often detects early-stage breast cancers. However, as with all screening programmes, there will be women for whom their detected breast cancers would never have been a problem – those who are ‘overdiagnosed’. The difficulty is that there is no way to tell who those women are, and so those women will be treated in the same way – for them, this will have been ‘overtreatment’.
To tackle this, it is a priority of the NCRI Breast Cancer Clinical Studies Group (CSG) to develop studies that work towards ‘de-escalation’ of treatment – that is, ways to reduce the amount of treatment that women with early-stage breast cancer have, so reducing the treatment also received by those women who have been overdiagnosed.
The benefits of developing less invasive treatment techniques will go beyond those overdiagnosed, benefiting all women with early-stage breast cancer as well as reducing the cost of their treatment to the NHS.
Current treatment in the detection of women with early-stage breast cancer is to have a surgical removal. This treatment involves the use of a general anaesthetic, possibly a hospital stay, and an ‘open’ surgical incision. The SMALL study aims to test a technique that will only require an outpatient appointment and a local anaesthetic, as well as a much smaller, non-open surgical intervention.
The NCRI Breast Cancer CSG was integral to the development and gaining of funding of this study. The CSG helped to bring together experts from a variety of specialities to collaborate in the project. This study has involved researchers and clinicians from so many specialities that there are few ways, other than through the CSG, that they could all have been brought together.
Dr Stuart McIntosh, lead investigator for the SMALL study, said of support by the CSG, “The NCRI Breast Cancer CSG undoubtedly helped to develop the study. The discussions with a range of experts at the CSG mean that we have a better study as a result.”
As well as providing the framework for clinicians and researchers to discuss and collaborate on the development of the study, the SMALL study also greatly benefited from Public and Patient Involvement (PPI), supported by Maggie Wilcox and Hilary Stobart, through the NCRI Consumer Forum and Independent Cancer Patients’ Voice. PPI was integral to the SMALL study from its inception, and, according to a reviewer of the study for funding, was “excellent throughout the process.”
Without PPI support, Hilary Stobart and Maggie Wilcox doubt that the study would be as promising as it is, “The involvement of Consumers in the development of many aspects of the study means that we’re more confident that, if the treatment is successful, it will also be better and more acceptable for patients themselves.”
The SMALL study builds on previous projects supported by the NCRI Breast Cancer CSG into de-escalation of treatments, including the PRIMETIME study.
If successful, this study could change the way that early-stage breast cancer detected through screening is treated within the NHS.
It will mean that the experiences of around 1,100 women treated for early-stage breast cancer every year will change, with them receiving less invasive treatment. The benefit will be greatest for those women who are overdiagnosed.
It will also save the NHS money, reducing the cost of treatment for this type of breast cancer. Mr MacIntosh estimates that for the 500 women in the trial alone, over £9M will be saved.