SOUND Trial Summary

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Title:
    • Axillary Surgery in Breast Cancer Patients With Negative Axillary Ultrasound: The SOUND Randomized Clinical Trial
  • Published:
    • 2023 in JAMA Oncology
      • ClinicalTrials.gov ID: NCT02167490
  • Location:
    • Italy, Spain, Switzerland, Chile (18 hospitals)
  • Study Objective:
    • To evaluate whether sentinel lymph node biopsy (SLNB):
      • Can be safely omitted in women:
        • With early-stage, clinically node-negative breast cancer with negative axillary ultrasound (AUS), without compromising oncologic outcomes
  • Patient Population:
    • Women with:
      • Unifocal invasive breast cancer:
        • Tumor ≤ 2.0 cm (cT1)
      • Clinically and ultrasound-negative axilla
      • Undergoing breast-conserving surgery
      • No neoadjuvant therapy
    • Tumor types:
      • Majority were hormone receptor-positive, HER2-negative
  • Study Design:
    • Randomized, phase 3, non-inferiority trial
    • Two arms:
      • SLNB group:
        • Underwent sentinel lymph node biopsy
      • Observation group:
        • No axillary surgery
    • Primary endpoint:
      • 5-year distant disease-free survival (DDFS)
    • Secondary endpoints:
      • Overall survival (OS)
      • Disease-free survival (DFS)
      • Axillary recurrence
      • Quality of life
  • Non-inferiority was met for the primary endpoint (DDFS)
  • Clinical Implications:
    • In women with small tumors (≤ 2 cm) and negative axillary ultrasound:
      • SLNB can be omitted without compromising distant disease-free or overall survival
    • Supports a less invasive approach and aligns with the de-escalation of axillary surgery trend in breast cancer care
  • Leads to fewer surgical complications:
    • Lymphedema, seroma, pain
  • Limitations:
    • Results apply only to women with:
      • Negative axillary ultrasound and early-stage, low-risk tumors
    • Not applicable to:
      • Mastectomy patients
      • Multifocal tumors
      • Patients receiving neoadjuvant therapy
  • Conclusion:
    • The SOUND trial confirms that routine sentinel lymph node biopsy can be safely omitted in selected patients with early-stage breast cancer and negative axillary ultrasound:
      • Supporting a shift toward minimally invasive surgical strategies in modern breast cancer management
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Published by Rodrigo Arrangoiz MS, MD, FACS, FSSO

My name is Rodrigo Arrangoiz I am a breast surgeon/ thyroid surgeon / parathyroid surgeon / head and neck surgeon / surgical oncologist that works at Center for Advanced Surgical Oncology in Miami, Florida. I was trained as a surgeon at Michigan State University from (2005 to 2010) where I was a chief resident in 2010. My surgical oncology and head and neck training was performed at the Fox Chase Cancer Center in Philadelphia from 2010 to 2012. At the same time I underwent a masters in science (Clinical research for health professionals) at the University of Drexel. Through the International Federation of Head and Neck Societies / Memorial Sloan Kettering Cancer Center I performed a two year head and neck surgery and oncology / endocrine fellowship that ended in 2016. Mi nombre es Rodrigo Arrangoiz, soy cirujano oncólogo / cirujano de tumores de cabeza y cuello / cirujano endocrino que trabaja Center for Advanced Surgical Oncology en Miami, Florida. Fui entrenado como cirujano en Michigan State University (2005 a 2010 ) donde fui jefe de residentes en 2010. Mi formación en oncología quirúrgica y e n tumores de cabeza y cuello se realizó en el Fox Chase Cancer Center en Filadelfia de 2010 a 2012. Al mismo tiempo, me sometí a una maestría en ciencias (investigación clínica para profesionales de la salud) en la Universidad de Drexel. A través de la Federación Internacional de Sociedades de Cabeza y Cuello / Memorial Sloan Kettering Cancer Center realicé una sub especialidad en cirugía de cabeza y cuello / cirugia endocrina de dos años que terminó en 2016.

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