Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer – a phase III randomised multi-centre trial

Trial summary:

SMALL is a prospective, multi-centre, randomised (1:2) phase III trial of surgery versus minimally invasive VAE of patients with small, biologically favourable screen-detected breast cancer. It incorporates an 18 month Internal Pilot Study with a QuinteT Recruitment Intervention (Information Study) to optimise recruitment, and is designed to determine whether:

•             The extent of surgical treatment can be reduced in the context of standard adjuvant radiotherapy and endocrine therapy.

•             VAE is non-inferior to conventional surgery in terms of the requirement for a second operation to achieve complete resection of the cancer.

•             There is an acceptable local recurrence risk in the VAE arm with long-term follow up.

Patients will be recruited over a 4-year period and will be followed-up for 5 years from randomisation. Long-term follow-up information will be obtained via data linkage.

RT QA summary:

All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss

QA ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case
Planning Benchmark CaseOnly if change in technique noted
Dummy RunIf a centre is doing partial breast and did not take part in the IMPORT trial
During AccrualIndividual Case ReviewProspective review for the first patient randomised to axillary treatment
Data collectionProspective review for the first partial breast patient randomised to the VAE arm of the study

RTTQA contact:

Chief investigator: Mr Stuart McIntosh, The Patrick G Johnston Centre for Cancer Research

RT Lead: Professor Charlotte Coles, University of Cambridge

Sponsor: University of Birmingham

Funder: National Institute for Health Research (NIHR) Health Technology Assessment Programme (project reference 17/42/32).