Sentinel Node Vs Observation After Axillary Ultra-souND (SOUND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02167490
Recruitment Status : Recruiting
First Posted : June 19, 2014
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
European Institute of Oncology

Brief Summary:

The hypothesis of this trial are that:

  • avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients
  • pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden.

The aims of this prospective randomized study are:

  • to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared
  • to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status
  • to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.

Condition or disease Intervention/treatment Phase
Early Stage Breast Carcinoma Procedure: Arm 1: sentinel node biopsy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs no Axillary Surgical Staging in Patients With Small Breast Cancer and a Negative Preoperative Axillary Assessment (IEO S637/311)
Study Start Date : January 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Arm 1: sentinel node biopsy
Sentinel node biopsy policy
Procedure: Arm 1: sentinel node biopsy
Sentinel node biopsy policy

No Intervention: Arm 2: observation
No axillary staging

Primary Outcome Measures :
  1. Distant-disease free survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cumulative incidence of distant recurrences [ Time Frame: 6 months ]
  2. Cumulative incidence of axillary recurrences [ Time Frame: 6 months ]
  3. Disease free survival (DFS) [ Time Frame: 6 months ]
  4. Overall survival [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • breast cancer <2 cm, and a clinically negative axilla
  • any age
  • candidates to receive breast conserving surgery + radiotherapy
  • negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found)
  • written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
  • patients must be accessible for follow-up.

Exclusion Criteria:

  • synchronous distant metastases
  • previous malignancy
  • bilateral breast cancer
  • multicentric or multifocal breast cancer
  • previous primary systemic therapy
  • pregnancy or breastfeeding
  • pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
  • pre-operative radiological evidence of multiple involved or suspicious nodes
  • patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02167490

Contact: Nicole Rotmensz, Ms +39 02 57489810
Contact: Claudia Sangalli, Ms +39 02 57489840

Instituto Oncologico Fundacion Arturo Lopez Perez Recruiting
Santiago, Chile
Principal Investigator: Badir J Chauan Manzur, MD         
Comprensorio Sanitario Recruiting
Bolzano, Italy, 39100
Principal Investigator: Claudio Graiff, MD         
Azienda Ospedaliera Spedali Civili Recruiting
Brescia, Italy, 25123
Principal Investigator: Fulvio Ragni, MD         
Ospedale Oncologico Regionale Recruiting
Cagliari, Italy, 09121
Principal Investigator: Giuseppe Murenu, MD         
Humanitas Mater Domini Recruiting
Castellanza, Italy
Contact: Claudio Andreoli, MD         
Ospedale S. Anna Recruiting
Como, Italy, 22100
Principal Investigator: Silvia Cattaneo, MD         
Azienda Ospedaliera Carlo Poma Recruiting
Mantova, Italy, 46100
Principal Investigator: Massimo Busani, MD         
Fondazione IRCCS Istituto Nazionale Tumori Recruiting
Milano, Italy, 20133
Principal Investigator: Roberto Agresti, MD         
European Institute of Oncology Recruiting
Milan, Italy, 20141
Principal Investigator: Paolo Veronesi, MD         
AOU Federico II Recruiting
Napoli, Italy, 80131
Principal Investigator: Gennaro Limite, MD         
Istituto Nazionale Tumori Recruiting
Napoli, Italy, 80131
Principal Investigator: Massimo Rinaldo, MD         
Ospedale San Matteo Recruiting
Pavia, Italy
Contact: Adele Sgarella, MD         
Ospedale Guglielmo di Saliceto Recruiting
Piacenza, Italy, 29100
Principal Investigator: Giorgio Macellari, MD         
Ospedale Fatebenefratelli Recruiting
Roma, Italy, 00186
Principal Investigator: Smeralda De Fazio, MD         
Humanitas Cancer Center Terminated
Rozzano, Italy, 20089
Ospedale S. Anna Recruiting
Torino, Italy, 10100
Principal Investigator: Mauro Porpiglia, MD         
Health Research Institute Hospital La Fe Recruiting
Valencia, Spain
Principal Investigator: Francisco Ripoll Orts, MD         
Universitätsspital Bern Klinik und Poliklinik für Medizinische Onkologie Recruiting
Bern, Switzerland
Contact: Patrizia Sager, MD         
Sponsors and Collaborators
European Institute of Oncology
Principal Investigator: Oreste D Gentilini, MD European Institute of Oncology

Marubini E, Valsecchi MG. Analysing survival data from clinical trials and observational studies. Chichester, England: Wiley; 1995. 331 pp.
Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Statist 1988; 16: 1141-1154

Responsible Party: European Institute of Oncology Identifier: NCT02167490     History of Changes
Other Study ID Numbers: IEO S637/311
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by European Institute of Oncology:
BC; conservative surgery; SNB; AD; axillary US imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases