Table 1

SMALL trial inclusion/exclusion criteria

Inclusion criteriaExclusion criteria
Screen detected breast cancerAssociated malignant microcalcification outwith the lesion
Age over 47 yearsBilateral breast cancer
Radiological unifocal diseaseInvasive lobular cancer
Maximum tumour size of 15 mm on mammography/ultrasoundNot strongly ER/PR positive or HER2 positive
Grade 1 tumourInability to provide informed consent
Strongly ER/PR positive disease (Allred score≥7 or >66% staining)Unable or unwilling to undergo standard surgical treatment
HER2 negative (0/1+on immunohistochemistry or 2+ with negative in situ hybridisation).Contra-indications to standard adjuvant therapies (radiotherapy or endocrine therapy)
Normal axillary US or radiologically equivocal axillary ultrasound with benign pathology on subsequent FNA or core biopsyPrevious ipsilateral invasive breast cancer or DCIS
No previous diagnosis of ipsilateral breast cancer (in situ or invasive)—contralateral disease permitted if surgically treated>5 years previously and disease freeOther invasive malignancy unless

  • Disease free for≥5 years or

  • Previous basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer

  • SMALL - Open Surgery versus minimally invasive-vacuum assisted excision for small screen-detected breast cancer

  • DCIS, ductal carcinoma in situ; ER, oestrogen receptor; FNA, fine needle aspiration; HER2, human epidermal growth factor receptor type 2; PR, progesterone receptor; US, ultrasound.