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Clinical Trial
. 2025 May 1;11(5):529-534.
doi: 10.1001/jamaoncol.2025.0207.

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

Henry M Kuerer  1 , Vicente Valero  2 , Benjamin D Smith  3 , Savitri Krishnamurthy  4 , Emilia J Diego  5 , Helen M Johnson  1 , Heather Lin  6 , Yu Shen  6 , Anthony Lucci  1 , Simona F Shaitelman  3 , Melissa P Mitchell  3 , Judy C Boughey  7 , Richard L White  8 , Kelly K Hunt  1 , Wei T Yang  9 , Gaiane M Rauch  9   10 ; Exceptional Responders Study Group
Collaborators, Affiliations
Clinical Trial

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

Henry M Kuerer et al. JAMA Oncol. .

Abstract

Importance: 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.

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

Design, setting, and participants: 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.

Intervention: 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.

Main outcome measures: The primary outcome was ipsilateral breast tumor recurrence.

Results: 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.

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02945579.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kuerer reported personal fees from the New England Journal of Medicine, UpToDate, McGraw Hill, and Endomagnetics outside the submitted work. Dr Smith reported grants from Artidis, salary support from Varian M, and royalties and equity interest in Oncora Medical outside the submitted work;. Dr Krishnamurthy reported personal fees from AstraZeneca and Daiichi Sankyo outside the submitted work. Dr Johnson reported grants from the National Cancer Institute and National Center for Research Resources during the conduct of the study. Dr Shaitelman reported grants from Artidis and research support from Exact Sciences outside the submitted work. Dr Mitchell reported grants from ARTIDIS during the conduct of the study and being a co–principal investigator for the NRG BR008 trial. Dr Boughey reported institutional support from the MD Anderson Cancer Center during the conduct of the study as well as research support from Eli Lilli rand SimBioSys and data safety monitoring board service for CairnsSurgical outside the submitted work. Dr Hunt reported personal fees from ArmadaHealth and AstraZeneca and grants from Cairn Surgical, Eli Lilly & Co, and Lumicell outside the submitted work. No other disclosures were reported.

Comment in

References

    1. Kuerer HM, Rauch GM, Krishnamurthy S, et al. A clinical feasibility trial for identification of exceptional responders in whom breast cancer surgery can be eliminated following neoadjuvant systemic therapy. Ann Surg. 2018;267(5):946-951. doi: 10.1097/SLA.0000000000002313 - DOI - PMC - PubMed
    1. Tasoulis MK, Lee HB, Yang W, et al. Accuracy of post-neoadjuvant chemotherapy image-guided breast biopsy to predict residual cancer. JAMA Surg. 2020;155(12):e204103. doi: 10.1001/jamasurg.2020.4103 - DOI - PMC - PubMed
    1. Kuerer HM, Smith BD, Krishnamurthy S, et al. ; Exceptional Responders Clinical Trials Group . Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022;23(12):1517-1524. doi: 10.1016/S1470-2045(22)00613-1 - DOI - PubMed
    1. Kuerer HM, Rauch G, Krishnamurthy S, et al. Omission of breast surgery after neoadjuvant systemic therapy for invasive cancer: three-year preplanned primary-endpoint on a phase II multicentre prospective trial. ESMO Congress 2023; October 20, 2023; Madrid, Spain. https://www.annalsofoncology.org/article/S0923-7534(23)01277-2/fulltext
    1. Johnson HM, Lin H, Shen Y, et al. ; Exceptional Responders Study Group . Patient-reported outcomes of omission of breast surgery following neoadjuvant systemic therapy: a nonrandomized clinical trial. JAMA Netw Open. 2023;6(9):e2333933. doi: 10.1001/jamanetworkopen.2023.33933 - DOI - PMC - PubMed

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