Sentinel Node Vs Observation After Axillary Ultra-souND

NCT02167490 | Active Not Recruiting

• 1 other identifier: IEO S637/311
• Study Type: interventional
• Target: 1,560
• Locations: 4 countries
• Sites: 18

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.

Conditions

Early Stage Breast Carcinoma

Keywords

BC; conservative surgery; SNB; AD; axillary US imaging

Outcome Measures

Primary Outcomes (1)

• Distant-disease free survival

  6 months

Secondary Outcomes (4)

• Cumulative incidence of distant recurrences

  6 months

• Cumulative incidence of axillary recurrences

  6 months

• Disease free survival (DFS)

  6 months

• Overall survival

  6 months

Study Arms (2)

Arm 1: sentinel node biopsy

ACTIVE COMPARATOR

Sentinel node biopsy policy

Procedure: Arm 1: sentinel node biopsy

Arm 2: observation

NO INTERVENTION

No axillary staging

Interventions

Arm 1: sentinel node biopsy PROCEDURE

Sentinel node biopsy policy

Arm 1: sentinel node biopsy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• patients must be accessible for follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (18)

Instituto Oncologico Fundacion Arturo Lopez Perez

Santiago, Chile

Location

Comprensorio Sanitario

Bolzano, 39100, Italy

Location

Azienda Ospedaliera Spedali Civili

Brescia, 25123, Italy

Location

Ospedale Oncologico Regionale

Cagliari, 09121, Italy

Location

Humanitas Mater Domini

Castellanza, Italy

Location

Ospedale S. Anna

Como, 22100, Italy

Location

Azienda Ospedaliera Carlo Poma

Mantova, 46100, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

AOU Federico II

Napoli, 80131, Italy

Location

Istituto Nazionale Tumori

Napoli, 80131, Italy

Location

Ospedale San Matteo

Pavia, Italy

Location

Ospedale Guglielmo di Saliceto

Piacenza, 29100, Italy

Location

Ospedale Fatebenefratelli

Roma, 00186, Italy

Location

Humanitas Cancer Center

Rozzano, 20089, Italy

Location

Ospedale S. Anna

Torino, 10100, Italy

Location

Health Research Institute Hospital La Fe

Valencia, Spain

Location

Universitätsspital Bern Klinik und Poliklinik für Medizinische Onkologie

Bern, Switzerland

Location

Related Publications (18)

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• Wasif N, Maggard MA, Ko CY, Giuliano AE. Underuse of axillary dissection for the management of sentinel node micrometastases in breast cancer. Arch Surg. 2010 Feb;145(2):161-6. doi: 10.1001/archsurg.2009.269.

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  PMID: 16344321 BACKGROUND

• Veronesi U, Orecchia R, Zurrida S, Galimberti V, Luini A, Veronesi P, Gatti G, D'Aiuto G, Cataliotti L, Paolucci R, Piccolo P, Massaioli N, Sismondi P, Rulli A, Lo Sardo F, Recalcati A, Terribile D, Acerbi A, Rotmensz N, Maisonneuve P. Avoiding axillary dissection in breast cancer surgery: a randomized trial to assess the role of axillary radiotherapy. Ann Oncol. 2005 Mar;16(3):383-8. doi: 10.1093/annonc/mdi089. Epub 2005 Jan 24.

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• Goldhirsch A, Ingle JN, Gelber RD, Coates AS, Thurlimann B, Senn HJ; Panel members. Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann Oncol. 2009 Aug;20(8):1319-29. doi: 10.1093/annonc/mdp322. Epub 2009 Jun 17.

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• Colleoni M, Rotmensz N, Peruzzotti G, Maisonneuve P, Mazzarol G, Pruneri G, Luini A, Intra M, Veronesi P, Galimberti V, Torrisi R, Cardillo A, Goldhirsch A, Viale G. Size of breast cancer metastases in axillary lymph nodes: clinical relevance of minimal lymph node involvement. J Clin Oncol. 2005 Mar 1;23(7):1379-89. doi: 10.1200/JCO.2005.07.094.

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  BACKGROUND

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  BACKGROUND

• Jung SH, Kang SJ, McCall LM, Blumenstein B. Sample size computation for two-sample noninferiority log-rank test. J Biopharm Stat. 2005;15(6):969-79. doi: 10.1080/10543400500265736.

  PMID: 16279355 BACKGROUND

• Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, Luini A, Viale G, Cassano E, Peradze N, Toesca A, Massari G, Sacchini V, Munzone E, Leonardi MC, Cattadori F, Di Micco R, Esposito E, Sgarella A, Cattaneo S, Busani M, Dessena M, Bianchi A, Cretella E, Ripoll Orts F, Mueller M, Tinterri C, Chahuan Manzur BJ, Benedetto C, Veronesi P; SOUND Trial Group. Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1557-1564. doi: 10.1001/jamaoncol.2023.3759.

  PMID: 37733364 DERIVED

Study Officials

• Oreste D Gentilini, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: June 19, 2014
• Study Start: January 1, 2012
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CH (1); IT (15); ES (1); CL (1)