ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer (ADARNAT)

May 18, 2026 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy.

The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 820 patients (410 patients in neoadjuvant chemotherapy and 410 in neoadjuvant hormone therapy), over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).

A pilot phase of the study was carried out with the first 200 patients (Until 1 May 2023), and an interim analysis will also be performed with these first 200 patients.

Study Type

Interventional

Enrollment (Estimated)

820

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Recruiting
        • Genesiscare North Shore
        • Principal Investigator:
          • Gillian Lamoury
        • Contact:
      • Sydney, New South Wales, Australia, 2060
        • Recruiting
        • GenesisCare Mater
        • Contact:
        • Principal Investigator:
          • Gillian Lamoury
      • Sydney, New South Wales, Australia, 2086
        • Recruiting
        • GenesisCare Frenchs Forest
        • Principal Investigator:
          • Gillian Lamoury
        • Contact:
      • Sydney, New South Wales, Australia, 2153
        • Recruiting
        • GenesisCare Norwest
        • Principal Investigator:
          • Tim Wang
        • Contact:
      • Sydney, New South Wales, Australia, 2220
      • Sydney, New South Wales, Australia, 2560
        • Recruiting
        • GenesisCare Campbelltown
        • Contact:
        • Principal Investigator:
          • George Papadatos
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario de A Coruna
        • Contact:
        • Principal Investigator:
          • Alejandra García-Novoa
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
        • Principal Investigator:
          • Javier Sanz
        • Principal Investigator:
          • Marta Jiménez
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínico y Provincial de Barcelona
        • Principal Investigator:
          • María Laplana, MDPhD
        • Principal Investigator:
          • Eduard Mensión
        • Contact:
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Cruz y San Pablo
        • Contact:
        • Principal Investigator:
          • Bárbara García-Valdecasas
        • Principal Investigator:
          • Josep Isern
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
        • Principal Investigator:
          • Yolanda Ulpiana Pérez-Martínez
        • Principal Investigator:
          • Alba González-Castro
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitario de Gerona Doctor Josep Trueta
        • Contact:
        • Principal Investigator:
          • Eva Artigau Nieto
      • Girona, Spain, 17007
        • Recruiting
        • Institut Catalán de Oncología de Girona
        • Contact:
        • Principal Investigator:
          • Arantxa Eraso
      • Granada, Spain, 18016
        • Not yet recruiting
        • Hospital Universitario Clínico San Cecilio
        • Contact:
        • Principal Investigator:
          • Mari Paz López-García
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de Las Nieves
        • Contact:
        • Principal Investigator:
          • Rosario Ching
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Principal Investigator:
          • María Jesús López-Rodríguez
        • Principal Investigator:
          • Raúl Hernanz
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Chelo Sanz
        • Principal Investigator:
          • María Colmenero
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Marcos Nicolás Meléndez Gispert
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
        • Principal Investigator:
          • Karla Ferreres
        • Principal Investigator:
          • Ana Calín
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
        • Principal Investigator:
          • Ángel Montero
      • Madrid, Spain, 28703
        • Recruiting
        • Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
        • Contact:
        • Principal Investigator:
          • Javier Heras
        • Principal Investigator:
          • Alonso Francisco La Rosa de los Ríos
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Principal Investigator:
          • Ángel Calvo
      • Málaga, Spain, 29010
        • Recruiting
        • HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA
        • Principal Investigator:
          • Auxiliadora Ferrer
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
        • Principal Investigator:
          • Cristina Artieda
        • Principal Investigator:
          • Ana Manterola
      • Pontevedra, Spain, 36071
        • Recruiting
        • Hospital Montecelo
        • Contact:
        • Principal Investigator:
          • Teresa Fernández
      • Santa Cruz de Tenerife, Spain, 38010
        • Recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contact:
        • Principal Investigator:
          • Ana Armijo
      • Segovia, Spain, 47002
        • Recruiting
        • Hospital General de Segovia
        • Contact:
        • Principal Investigator:
          • Ana Isabel Gómez-Calvo
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
        • Principal Investigator:
          • Paola Fernández
        • Principal Investigator:
          • Carlos Míguez
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitario de Tarragona Juan XXIII
        • Contact:
        • Principal Investigator:
          • Judit Aixalà
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
        • Principal Investigator:
          • Carlos Fuster
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Doctor Peset
        • Contact:
        • Principal Investigator:
          • Charo Martínez García
        • Principal Investigator:
          • Miguel Ángel Berenguer
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
        • Principal Investigator:
          • Susana Cortés
        • Principal Investigator:
          • María Luisa del Valle
      • Valladolid, Spain, 47007
        • Recruiting
        • Hospital Recoletas Campo Grande de Valladolid
        • Contact:
        • Principal Investigator:
          • Zandra Mileny Soto
        • Principal Investigator:
          • Rocío Cantalapiedra
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Miguel Ángel Luna-Tomás
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Instituto Catalán de Oncología de Badalona
        • Contact:
        • Principal Investigator:
          • Jessica Guadalupe Molina
      • Calella, Barcelona, Spain, 08370
        • Recruiting
        • Hospital Comarcal Sant Jaume de Calella
        • Contact:
        • Principal Investigator:
          • Mireia Recaj
      • Granollers, Barcelona, Spain, 08402
        • Not yet recruiting
        • Hospital General De Granollers
        • Contact:
        • Principal Investigator:
          • Judith Astor
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Principal Investigator:
          • Amparo Garcia-Tejedor, MDPhD
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08906
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalán de Oncología- Hospital Duran i Reynals
        • Contact:
        • Principal Investigator:
          • Evelyn Martínez-Pérez
      • Manresa, Barcelona, Spain, 08243
        • Recruiting
        • Fundación Althaia Manresa
        • Contact:
        • Principal Investigator:
          • Andrés Muñiz-Delgado
        • Principal Investigator:
          • María Teresa Montes
      • Mataró, Barcelona, Spain, 08304
        • Recruiting
        • Hospital de Mataró
        • Contact:
        • Principal Investigator:
          • Sandra López Gordo
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Not yet recruiting
        • Hospital Universitario General de Cataluña
        • Contact:
        • Principal Investigator:
          • Judith Jurado
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitario Mútua Terrassa
        • Contact:
        • Principal Investigator:
          • María Jesús Díaz-Ruiz
        • Principal Investigator:
          • Marta Torras
      • Terrassa, Barcelona, Spain, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
        • Principal Investigator:
          • Esther Rubio
        • Principal Investigator:
          • Jairo Cortés
      • Viladecans, Barcelona, Spain, 08840
        • Recruiting
        • Hospital de Viladecans
        • Contact:
        • Principal Investigator:
          • Cristina Capó
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Recruiting
        • Hospital Universitario de Cruces
        • Contact:
        • Principal Investigator:
          • Patricia Cobos
      • Galdakao, Bizkaia, Spain, 48960
    • Cádiz
      • Cadiz, Cádiz, Spain, 11009
        • Not yet recruiting
        • Hospital Universitario Puerta del Mar
        • Principal Investigator:
          • Lucía García-Berbel
        • Contact:
        • Principal Investigator:
          • Maria Isabel Villanego
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
        • Contact:
        • Principal Investigator:
          • Marta Fernández-Calleja
        • Principal Investigator:
          • Elena Guimón
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
        • Recruiting
        • Hospital Universitario Príncipe de Asturias
        • Contact:
        • Principal Investigator:
          • Elena Martinez-Gomez
      • Leganés, Madrid, Spain, 28914
        • Recruiting
        • Hospital Universitario Severo Ochoa
        • Contact:
        • Principal Investigator:
          • Ana Luis Siles
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
        • Principal Investigator:
          • Cristina de la Fuente
        • Principal Investigator:
          • Esther Ramírez
      • Parla, Madrid, Spain, 28981
        • Recruiting
        • Hospital Universitario Infanta Cristina
        • Contact:
        • Principal Investigator:
          • Xabier Remirez Arriaga
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Arrixaca
        • Contact:
        • Principal Investigator:
          • Antonio Piñero
        • Principal Investigator:
          • Carmen María Servet Pérez de Lema
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Recruiting
        • Hospital Álvaro Cunqueiro
        • Contact:
        • Principal Investigator:
          • María José Lamas
      • Vigo, Pontevedra, Spain, 36211
        • Recruiting
        • Hospital Ribera Povisa
        • Contact:
        • Principal Investigator:
          • Ángela Triñanes
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
        • Principal Investigator:
          • Luis Fernando Otón
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Recruiting
        • Hospital Universitario Sant Joan de Reus
        • Principal Investigator:
          • Fredy Castaño
        • Principal Investigator:
          • Coia Jordà
        • Contact:
    • Álava
      • Vitoria-Gasteiz, Álava, Spain, 01009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment
  • Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs
  • Post-CT axillary response by ultrasound or MRI
  • Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment.

Exclusion Criteria:

  • cN2
  • ypN0
  • History of breast surgery for ipsilateral cancer in the last 10 years
  • History of other cancer in the last 5 years, except squamous carcinoma of the skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axillary radiotherapy without lymphadenectomy
Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
Radiation: Axillary Radiotherapy
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
Active Comparator: Axillary lymph node dissection
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Procedure: Lymphadenectomy
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years
To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymphedema Incidence
Time Frame: From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Volume difference between both arms (cm^3) above 10%
From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Overall survival
Time Frame: From date of diagnosis until the date of death from any cause, assessed up to 5 years
To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
From date of diagnosis until the date of death from any cause, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Maria Laplana, MDPhD, Hospital Clínico y Provincial de Barcelona
  • Principal Investigator: Amparo Garcia-Tejedor, MDPhD, Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR148/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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