Elder Kenneth, Coles Charlotte, Dodwell David, Elsberger Beatrix, Foster Jessica, Gaunt Claire, Henderson Julia R, Lyburn Iain, Mabena Claire, Morgan Jenna, Nabi Zohal, Paramasivan Sangeetha, Pinder Sarah, Pirrie Sarah, Potter Shelley, Roberts Tracy, Sharma Nisha, Southgate Elizabeth, Stobart Hilary, Talwalkar Amruta, Taylor-Phillips Sian, Teh William, Turner Elliot, Wallis Matthew G, Rea Dan, McIntosh Stuart
Breast Unit, Western General Hospital, Edinburgh, UK.
Department of Oncology, University of Cambridge, Cambridge, UK.
BMJ Open. 2025 Apr 8;15(4):e099702. doi: 10.1136/bmjopen-2025-099702.
Mammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as 'overdiagnosed' cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL () trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.
SMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.
Ethical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.
ISRCTN12240119.
乳腺钼靶筛查可发现许多患有生物学特征良好的小乳腺癌女性，这些患者预后极佳。其中一些患者若未进行筛查，可能永远不会出现临床症状，通常被称为“过度诊断”的癌症。尽管如此，目前所有经筛查发现癌症的患者均接受手术切除和前哨淋巴结活检，尽管这可能属于过度治疗。因此，需要采用侵入性较小的方法来减轻患者的治疗负担，同时维持目前出色的肿瘤学治疗效果。真空辅助切除术（VAE）可能是一种替代治疗方法，“SMALL（小型乳腺癌手术降阶梯治疗）”试验旨在研究VAE用于此类预后良好的浸润性乳腺癌手术治疗安全降阶梯的效果。
“SMALL”是一项前瞻性、多中心、随机III期试验，对比VAE与手术治疗小的、生物学特征良好的经筛查发现的浸润性乳腺癌患者的疗效。“SMALL”采用创新的混合设计，有共同主要终点。这些终点包括初始治疗后手术再次切除率的随机非劣效性比较，以及VAE后5年局部复发的单臂分析。次要结局包括并发症发生率、总生存率、生活质量和卫生经济学分析。该试验包括一项QuinteT招募干预措施以支持招募工作。
英国所有研究地点均获得北爱尔兰研究伦理办公室的伦理批准。研究结果将提交至同行评审期刊发表，进行报告，并与患者合作伙伴以及相关专业组织分享，以为未来筛查发现乳腺癌的管理指南制定提供参考。
ISRCTN12240119。
