# Selective Elimination of Breast Surgery for Invasive Breast Cancer: A Nonrandomized Clinical Trial

**Autores:** Henry M Kuerer, Vicente Valero, Benjamin D Smith et al.
**Revista:** JAMA Oncol (2025)
**PMID:** 40152443 | **PMCID:** PMC11953967
**DOI:** [10.1001/jamaoncol.2025.0207](https://doi.org/10.1001/jamaoncol.2025.0207)
**Fuente:** PubMed Central (open access full-text)

## Relevancia
Ensayo fase II no aleatorizado de 50 pacientes HER2+ o TN con respuesta excelente al NAC, evaluadas con biopsia asistida por vacío (VAB) guiada por imagen. En 31 pacientes (62%) con pCR mamario y 8/8 cN+ con pCR axilar tras TAD, recurrencia ipsilateral 0% a 55 meses. Marca el siguiente paso conceptual: omisión completa de cirugía mamaria en respondedoras excelentes.

## Abstract
Neoadjuvant systemic therapy (NST) has been associated with pathologic complete response (pCR) in up to 60% of breast cancers (BCs). The findings of this trial question the necessity of surgery.

To report preplanned 5-year efficacy outcomes evaluating radiotherapy alone without breast surgery in patients selected with image-guided vacuum assisted biopsy (VAB).

This single-arm, prospective, phase 2 nonrandomized clinical trial was conducted at 7 US medical centers and included women 40 years or older with cT1-2N0-1M0 ERBB2-positive (formerly HER2-positive) or triple-negative invasive BC who showed residual breast lesions after NST of less than 2 cm on imaging. Enrollment was from March 6, 2017, to November 9, 2021. Data analysis was from October to December 2024.

Image-guided VAB of the tumor bed (9G with a minimum of 12 cores) was performed after standard NST. Patients with clinically node-negative disease at diagnosis and no residual cancer in the breast on post-NST VAB underwent whole-breast radiotherapy with a boost without breast or axillary surgery. Patients with initial documented nodal disease and a breast pCR on VAB underwent targeted axillary dissection, while those with residual cancer when undergoing VAB had standard breast and axillary surgery. Patients were monitored with physical examinations and mammography every 6 months.

The primary outcome was ipsilateral breast tumor recurrence.

Fifty patients (median [IQR] age, 62 [55-77] years) were enrolled and underwent post-NST VAB. Twenty-nine (58%) and 21 (42%) patients had ERBB2-positive and triple-negative invasive BC, respectively. Breast pCR on VAB was identified in 31 patients (62%; 95% CI, 47.2%-75.34%), and axillary pCR was identified among all 8 patients with initial nodal metastases and breast pCR on VAB who underwent targeted axillary dissection. At a median follow-up of 55.4 (IQR, 44.0-63.5) months, the ipsilateral breast tumor recurrence rate was 0%, and disease-free and overall survival rates were 100% for patients without breast 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. More confirmatory studies are necessary before this new approach alters surgical practice.

ClinicalTrials.gov Identifier: NCT02945579.

## Texto completo
Texto completo disponible en PMC: [PMC11953967](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953967/). El ensayo de Kuerer presenta el resultado a 5 años de la estrategia de omisión completa de cirugía mamaria en pacientes seleccionadas (HER2+ o TN) con pCR en biopsia guiada por imagen tras NAC. En el subgrupo cN+ con pCR mamaria (n=8), todas alcanzaron pCR axilar tras TAD, confirmando que la combinación TAD + ausencia de cirugía mamaria es una estrategia conceptual avanzada de de-escalación. Recurrencia local 0%, OS 100% a 55 meses.

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*Datos de PubMed. Citar: doi 10.1001/jamaoncol.2025.0207*
