ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
ADARNAT
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
1 other identifier
interventional
820
2 countries
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jun 2021
Longer than P75 for not_applicable breast-cancer
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedStudy Start
First participant enrolled
June 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 24, 2026
April 1, 2026
5.1 years
May 5, 2021
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
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 Outcomes (2)
Overall survival
From date of diagnosis until the date of death from any cause, assessed up to 5 years
Lymphedema Incidence
From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Study Arms (2)
Axillary radiotherapy without lymphadenectomy
EXPERIMENTALAxillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
Axillary lymph node dissection
ACTIVE COMPARATORAxillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Interventions
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
GenesisCare Mater
Sydney, New South Wales, 2060, Australia
GenesisCare North Shore
Sydney, New South Wales, 2065, Australia
GenesisCare Frenchs Forest
Sydney, New South Wales, 2086, Australia
GenesisCare Norwest
Sydney, New South Wales, 2153, Australia
GenesisCare Hurstville
Sydney, New South Wales, 2220, Australia
GenesisCare Campbelltown
Sydney, New South Wales, 2560, Australia
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Instituto Catalán de Oncología de Badalona
Badalona, Barcelona, 08916, Spain
Hospital Comarcal Sant Jaume de Calella
Calella, Barcelona, 08370, Spain
Hospital General de Granollers
Granollers, Barcelona, 08402, Spain
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, 08906, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Instituto Catalán de Oncología- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Fundación Althaia Manresa
Manresa, Barcelona, 08243, Spain
Hospital de Mataró
Mataró, Barcelona, 08304, Spain
Hospital Universitario General de Cataluña
Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, 08221, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Hospital de Viladecans
Viladecans, Barcelona, 08840, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903, Spain
Hospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, 48960, Spain
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, 11009, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28914, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Ribera Povisa
Vigo, Pontevedra, 36211, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital Universitario de A Coruña
A Coruña, 15006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital de la Santa Cruz y San Pablo
Barcelona, 08025, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario de Gerona Doctor Josep Trueta
Girona, 17007, Spain
Institut Catalán de Oncología de Girona
Girona, 17007, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18016, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
Madrid, 28703, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Hospital Montecelo
Pontevedra, 36071, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital General de Segovia
Segovia, 47002, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario de Tarragona Juan XXIII
Tarragona, 43005, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Hospital Recoletas Campo Grande de Valladolid
Valladolid, 47007, Spain
Hospital Universitario de Álava / Txagorritxu
Vitoria-Gasteiz, Álava, 01009, Spain
Related Publications (1)
Garcia-Tejedor A, Ortega-Exposito C, Salinas S, Luzardo-Gonzalez A, Falo C, Martinez-Perez E, Perez-Montero H, Soler-Monso MT, Bajen MT, Benitez A, Ortega R, Petit A, Guma A, Campos M, Pla MJ, Pernas S, Penafiel J, Yeste C, Gil-Gil M, Guedea F, Ponce J, Laplana M. Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT trial). Front Oncol. 2023 Aug 9;13:1184021. doi: 10.3389/fonc.2023.1184021. eCollection 2023.
PMID: 37621686DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Laplana, MDPhD
Hospital Clínico y Provincial de Barcelona
- PRINCIPAL INVESTIGATOR
Amparo Garcia-Tejedor, MDPhD
Hospital Universitari de Bellvitge
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 17, 2021
Study Start
June 11, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share