Selective Elimination of Breast Surgery for Invasive Breast Cancer: A Non-randomized Clinical Trial

Kuerer HM, Valero V, Smith BD, et al. Selective Elimination of Breast Surgery for Invasive Breast Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2025;11(5):529–534. doi:10.1001/jamaoncol.2025.0207

A prospective, single arm clinical study published in JAMA Oncology last year (March 2025) evaluated whether breast surgery could be safely omitted in a highly selected group of patients who achieved an exceptional response to neoadjuvant systemic therapy. The trial enrolled 50 women with either HER2 positive or triple negative invasive breast cancer. Following completion of systemic therapy, all participants underwent image guided vacuum assisted core biopsy of the tumor bed. Only patients with no residual invasive or in situ carcinoma on biopsy were eligible to proceed without surgery.

Instead of breast conserving surgery or mastectomy, patients received whole breast radiotherapy alone. The primary endpoint was ipsilateral breast tumour recurrence, with long term follow up to assess local control and safety.

At a median follow up of 55 months, the study reported 0% ipsilateral breast tumor recurrence, indicating excellent local control in this carefully selected cohort. No unexpected safety signals or patterns of regional or distant relapse were observed. The findings suggest that, for a subset of patients who demonstrate a confirmed complete response on rigorous image guided biopsy, omission of breast surgery may be feasible.

While the results of this study demonstrate efficacy, larger, multi center trials with randomized designs are needed to test effectivness of non surgical management in routine practice. Nonetheless, this study provides early evidence supporting a potential future paradigm in which surgery may be safely avoided for select patients achieving exceptional response to neoadjuvant therapy.

Summary author: Dr Huma Irshad, Locum Consultant Breast Surgeon, Leighton Hospital