SMALL Trial 

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

SMALL Trial Logo

Trial Overview and Summary 

Trial Overview 
 Chief Investigator:  Professor Stuart McIntosh
 Sponsor:  University of Birmingham
 Funder:  NIHR HTA 
 Disease Site:  Breast Cancer 
 Trial Type:  Non-IMP  
 Status:    Open to recruitment  
 UKCRN Study ID:   40111
 Open to New Sites?   Yes 
 Recruitment Start Date:   13-Dec-2019
 Anticipated Recruitment End Date:  30-Jun-2025
 CRCTU Trial Management Team:  B Team
  Trial Email Address: 

Trial Summary

The SMALL study will compare open surgery with a minimally invasive technique called vacuum-assisted excision (VAE) for the treatment of small breast cancers found at breast screening. Such small breast cancers have usually been treated with open surgery. The 2012 UK Breast Screening Review showed that breast screening does save lives, but that many women may be having more treatment than is really necessary for their breast cancer.  Also, experts do not currently know how open surgery compares with other safe and effective methods to remove small breast cancers. We want to find out what the best treatment is for women in this group, so that in future we can only operate on those women who really require surgery. We aim to do this by comparing open surgery with VAE. VAE is widely used in the Breast Screening Programme, and has been successfully used instead of an operation to removal small benign tumours in the breast. Based on this, in the SMALL study we would like to find out if VAE (which involves the use of a biopsy needle to remove the cancer) will be as effective as an open operation.

Please note that the trials team cannot give individuals clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Protocol

Please note: Clinical trial protocols are complex technical documents, which should only be used for the treatment of subjects taking part in the trial.  Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to  the CRUK website

To view the Protocol and other trial related documents, please refer to the Investigators Page

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

For the Patient 

Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to  the CRUK website