Cryoablation in Early-Stage Breast Cancer: A Systematic Review of Efficacy, Safety and Oncologic Outcomes

Background: Cryoablation is a minimally invasive technique that is being investigated as an alternative to surgery for early-stage breast cancer. Its potential advantages include outpatient treatment under local anaesthesia, favourable cosmetic outcomes, and possible immunologic synergy. However, its oncologic efficacy and long-term effectiveness are yet to be determined. Methods: We conducted a systematic review in accordance with PRISMA 2020 and the Cochrane Handbook, registered on PROSPERO (CRD420251137549). Databases searched were PubMed/MEDLINE, Scopus, and CENTRAL, from inception to August 2025. Eligible studies included women with unifocal, node-negative invasive ductal carcinoma ≤ 2 cm treated with percutaneous cryoablation. Outcomes of interest were residual disease, ipsilateral breast tumour recurrence, procedural and late complications, and cosmetic or patient-reported outcomes. Results: From 1074 records, 15 unique studies (17 reports) were included, comprising cryoablation-only studies (n = 7), treat-and-resect studies (n = 6), and comparative studies versus surgery (n = 2). Studies containing overlapping pathology validation and comparative components were classified within a single category to avoid duplication. Across treat-and-resect cohorts, complete tumour necrosis was reported in 88-95% of cases, with residual invasive carcinoma (RIC) ranging from 5% to 12%. In cryoablation-only cohorts, IBTR rates ranged from 0% to 4.3%, with follow-up durations spanning 2 months to 8 years. The largest study (ICE3, n = 194) reported a 5-year recurrence rate of 4.3%. Procedural complications were infrequent and self-limiting, most commonly bruising, oedema, or superficial frostbite. No major adverse events were reported. Validated quality-of-life instruments reported high patient satisfaction, with favourable results in selected comparative domains. Most included studies were of moderate methodological quality. Conclusions: Cryoablation appears technically feasible, safe, and cosmetically favourable in well-selected low-risk early-stage breast cancers. Oncologic outcomes are encouraging, with reported local recurrence rates in carefully selected low-risk populations being low, although direct comparison with breast-conserving surgery remains limited by the small number of comparative studies and substantial heterogeneity across the evidence base. Rigorous multicentre randomised trials with long-term follow-up and validated patient-reported outcomes are needed before cryoablation can be considered for routine clinical adoption.