Research Summary

Can Breast Surgery Be Safely Omitted After Neoadjuvant Therapy in Select Patients?

Anthony Calabro, MA

Key Highlights

  • The study results showed 0% ipsilateral breast tumor recurrence at a median 55.4-month follow-up among patients treated with radiotherapy alone.
  • Patients who avoided surgery after neoadjuvant systemic therapy were 100% disease-free.
  • The findings support further trials investigating surgical de-escalation in breast cancer management.

In an inaugural nonrandomized clinical trial, researchers investigated whether breast surgery could be safely omitted in women with early-stage, ERBB2-positive or triple-negative invasive breast cancer who demonstrated an exceptional response to neoadjuvant systemic therapy (NST). The study found a 0% rate of ipsilateral breast tumor recurrence at a median follow-up of more than 4.5 years, suggesting the feasibility of this de-escalation approach in carefully selected patients.

Neoadjuvant systemic therapy has been shown to yield pathologic complete responses (pCR) in up to 60% of breast cancers, particularly in biologically aggressive subtypes such as ERBB2-positive and triple-negative disease. These high response rates raise an important question: Is surgery always necessary after a confirmed complete response to systemic therapy?

The prospective, single-arm, phase 2 clinical trial sought to evaluate whether radiotherapy alone could provide equivalent local control in patients with biopsy-proven pCR. The study was conducted at seven US centers and enrolled women aged 40 years or older with clinical stage T1-2N0-1M0 breast cancer.

Eligible patients had ERBB2-positive or triple-negative invasive disease and post-NST residual breast lesions smaller than 2 cm on imaging. Following standard NST, all patients underwent image-guided vacuum-assisted biopsy (VAB) of the tumor bed using a 9-gauge probe with at least 12 cores. Those without residual cancer on VAB received whole-breast radiotherapy with a boost, omitting breast and axillary surgery. Patients initially presenting with nodal metastases but with breast pCR on VAB underwent targeted axillary dissection. Clinical follow-up included physical examination and mammography every 6 months.

Among 50 enrolled patients (median age, 62 years), 29 had ERBB2-positive and 21 had triple-negative disease. Breast pCR confirmed on post-NST VAB occurred in 31 patients (62%; 95% CI, 47.2%-75.3%). All 8 patients with nodal metastases at diagnosis and pCR on breast VAB achieved axillary pCR on targeted dissection. After a median of 55.4 months (IQR, 44.0-63.5), there were no ipsilateral breast tumor recurrences. Disease-free and overall survival were 100% among patients who avoided surgery.

“The results of this nonrandomized clinical trial that reported preplanned 5-year outcomes suggest that omission of breast surgery in select patients after NST may be feasible, with no recurrences seen,” the authors concluded. “More confirmatory studies are necessary before this new approach alters surgical practice.”

Reference:
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