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

April 5, 2024 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 1660 patients, 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. An interim analysis will also be performed with the first 820 patients recruited.

Study Type

Interventional

Enrollment (Estimated)

1660

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

  • 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:
          • Luis Miguel Alonso
      • 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 Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • María Jesús López-Rodríguez
        • Principal Investigator:
          • Raúl Hernanz
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
        • Principal Investigator:
          • Karla Ferreres
        • Principal Investigator:
          • Ana Calín
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Marcos Nicolás Meléndez Gispert
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
        • Principal Investigator:
          • Chelo Sanz
        • Principal Investigator:
          • María Colmenero
      • 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:
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Principal Investigator:
          • Ángel Calvo
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Contact:
        • Principal Investigator:
          • Ismael Herruzo
        • Principal Investigator:
          • Auxiliadora Ferrer
      • 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
      • Sevilla, 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
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico 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
      • 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 Mataro
        • 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, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
        • Principal Investigator:
          • Esther Rubio
        • Principal Investigator:
          • Jairo Cortés
      • Terrassa, Barcelona, Spain, 08221
        • Not yet recruiting
        • Hospital Universitario Mutua Terrassa
        • Contact:
        • Principal Investigator:
          • María Jesús Díaz-Ruiz
        • Principal Investigator:
          • Marta Torras
      • 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, Gipuzkoa, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
        • Contact:
        • Principal Investigator:
          • Marta Fernández-Calleja
        • Principal Investigator:
          • Elena Guimón
    • Madrid
      • 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
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Recruiting
        • Hospital Álvaro Cunqueiro
        • Contact:
        • Principal Investigator:
          • María José Lamas
      • Vigo, Pontevedra, Spain, 36211
        • Not yet recruiting
        • Hospital Ribera Povisa
        • Contact:
        • Principal Investigator:
          • Ángela Triñares
    • Santa Cruz De Tenerife
      • 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, Álava, Spain, 01009
        • Recruiting
        • Hospital Universitario de Álava / Txagorritxu
        • Contact:
        • Principal Investigator:
          • Amanda Flaquer
        • Principal Investigator:
          • Nagore Zeberio

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

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

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 1, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2026

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)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

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

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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