Breast CancerADARNATNCT04889924
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
A study testing Axillary Radiotherapy and Lymphadenectomy in people with Breast Cancer and Chemotherapy, run by Hospital Universitari de Bellvitge at 61 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Chemotherapy, Sentinel Lymph Node
- What is being tested?
- Axillary Radiotherapy and Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 61 sitesin 2 countries
- Study dates
- 11 Jun 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
61 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 2 countries
Spain55 sites, 55 recruiting
- Recruiting
Hospital Universitario de A Coruña
A Coruña, 15006
Alejandra García-Novoa, mag_1406@hotmail.com
Alejandra García-Novoa
- Recruiting
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
Elena Martinez-Gomez, emartinezgomez@hotmail.com
Elena Martinez-Gomez
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Miguel Ángel Luna-Tomás, maluna.germanstrias@gencat.cat
Miguel Ángel Luna-Tomás
- Recruiting
Instituto Catalán de Oncología de Badalona
Badalona, Barcelona, 08916
Jessica Guadalupe Molina, jgmolinao@iconcologia.net
Jessica Guadalupe Molina
- Recruiting
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Patricia Cobos, pcobo@icloud.com
Patricia Cobos
- Recruiting
Hospital del Mar
Barcelona, 08003
Javier Sanz, jsanz@psmar.cat
Javier Sanz
- Recruiting
Hospital de la Santa Cruz y San Pablo
Barcelona, 08025
Bárbara García-Valdecasas, BGValdecasas@santpau.cat
Bárbara García-Valdecasas
- Recruiting
Hospital Clínico y Provincial de Barcelona
Barcelona, 08036
María Laplana, MDPhD, maria.laplana.torres@gmail.com
Eduard Mensión
- Recruiting
Hospital Universitario de Burgos
Burgos, 09006
Yolanda Ulpiana Pérez-Martínez, yperezma@saludcastillayleon.es
Yolanda Ulpiana Pérez-Martínez
- Not yet recruiting
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, 11009
Lucía García-Berbel, luciagberbel@gmail.com
Lucía García-Berbel
- Recruiting
Hospital Comarcal Sant Jaume de Calella
Calella, Barcelona, 08370
Mireia Recaj, mrecaj@salutms.cat
Mireia Recaj
- Recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, 20014
Marta Fernández-Calleja, marta.fernandezcalleja@osakidetza.eus
Marta Fernández-Calleja
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Antonio Piñero, pineromadrona@gmail.com
Antonio Piñero
- Recruiting
Hospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, 48960
Manuel del Toro, MANUEL.DETOROIGLESIAS@osakidetza.eus
Manuel del Toro
- Recruiting
Hospital Universitario de Gerona Doctor Josep Trueta
Girona, 17007
Eva Artigau Nieto, evaartigau@gmail.com
Eva Artigau Nieto
- Recruiting
Institut Catalán de Oncología de Girona
Girona, 17007
Arantxa Eraso, aeraso@iconcologia.net
Arantxa Eraso
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Rosario Ching, r.ching.lopez@gmail.com
Rosario Ching
- Not yet recruiting
Hospital Universitario Clínico San Cecilio
Granada, 18016
Mari Paz López-García, maripaz.lopgar@gmail.com
Mari Paz López-García
- Recruiting
Hospital General de Granollers
Granollers, Barcelona, 08402
Judith Astor, jastor@fphag.org
Judith Astor
- Recruiting
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, 08906
Carmen Buqueras, carmen.buqueras@sanitatintegral.org
Carmen Buqueras
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Amparo Garcia-Tejedor, MDPhD, 660223417, agarciat@bellvitgehospital.cat
Amparo Garcia-Tejedor, MDPhD
- Recruiting
Instituto Catalán de Oncología- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Evelyn Martínez-Pérez, emperez@iconcologia.net
Evelyn Martínez-Pérez
- Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28914
Ana Luis Siles, ana.luis@salud.madrid.org
Ana Luis Siles
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Karla Ferreres, karla.ferreres@salud.madrid.org
Karla Ferreres
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
María Jesús López-Rodríguez, mariajesus.lopez.rodriguez@salud.madrid.org
María Jesús López-Rodríguez
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Chelo Sanz, piagaia2000@yahoo.es
Chelo Sanz
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Marcos Nicolás Meléndez Gispert, marcosmelendezgispert@gmail.com
Marcos Nicolás Meléndez Gispert
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Ángel Montero, angel.monteroluis@gmail.com
Ángel Montero
- Recruiting
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
Madrid, 28703
Javier Heras, jherasa@gmail.com
Javier Heras
- Recruiting
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, 28222
Cristina de la Fuente, cdelafuentealonso@gmail.com
Cristina de la Fuente
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
Auxiliadora Ferrer, clauxili@hotmail.com
Auxiliadora Ferrer
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Ángel Calvo, angelcaltu@gmail.com
Ángel Calvo
- Recruiting
Fundación Althaia Manresa
Manresa, Barcelona, 08243
Andrés Muñiz-Delgado, AMuniz@CST.CAT
Andrés Muñiz-Delgado
- Recruiting
Hospital de Mataró
Mataró, Barcelona, 08304
Sandra López Gordo, sandra.lopezgordo@gmail.com
Sandra López Gordo
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Cristina Artieda, cartieds@navarra.es
Cristina Artieda
- Recruiting
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981
Xabier Remirez Arriaga, xabier.remirez@salud.madrid.org
Xabier Remirez Arriaga
- Recruiting
Hospital Montecelo
Pontevedra, 36071
Teresa Fernández, terefez@yahoo.es
Teresa Fernández
- Recruiting
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, 43204
Fredy Castaño, manozulo@hotmail.com
Fredy Castaño
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Luis Fernando Otón, lfoton@ull.edu.es
Luis Fernando Otón
- Not yet recruiting
Hospital Universitario General de Cataluña
Sant Cugat del Vallès, Barcelona, 08195
Judith Jurado, jujuseguer@gmail.com
Judith Jurado
- Recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
Ana Armijo, anaarmijo0@gmail.com
Ana Armijo
- Recruiting
Hospital General de Segovia
Segovia, 47002
Ana Isabel Gómez-Calvo, agomezca@saludcastillayleon.es
Ana Isabel Gómez-Calvo
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Carlos Míguez, carlos.miguez.sspa@juntadeandalucia.es
Paola Fernández
- Recruiting
Hospital Universitario de Tarragona Juan XXIII
Tarragona, 43005
Judit Aixalà, JAIXALA91@hotmail.com
Judit Aixalà
- Recruiting
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, 08221
María Jesús Díaz-Ruiz, mjdiaz@mutuaterrassa.cat
María Jesús Díaz-Ruiz
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Esther Rubio, erubio@cst.cat
Esther Rubio
- Recruiting
Instituto Valenciano de Oncología
Valencia, 46009
Carlos Fuster, cfuster@fivo.org
Carlos Fuster
- Recruiting
Hospital Universitario Doctor Peset
Valencia, 46017
Charo Martínez García, charobenlloch@hotmail.com
Charo Martínez García
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Susana Cortés, scortesperez@hotmail.com
Susana Cortés
- Recruiting
Hospital Recoletas Campo Grande de Valladolid
Valladolid, 47007
Zandra Mileny Soto, zandramileny.soto@gruporecoletas.com
Zandra Mileny Soto
- Recruiting
Hospital Ribera Povisa
Vigo, Pontevedra, 36211
Ángela Triñanes, atrinanes@povisa.es
Ángela Triñanes
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
María José Lamas, macolamas@gmail.com
María José Lamas
- Recruiting
Hospital de Viladecans
Viladecans, Barcelona, 08840
Cristina Capó, ccapo.hv@gencat.cat
Cristina Capó
- Not yet recruiting
Consorci Sanitari Alt Penedès-Garraf
Vilafranca del Penedès, Barcelona, 08720
Lourdes Hernández Martínez, lhernandez@csapg.cat
Lourdes Hernández Martínez
- Recruiting
Hospital Universitario de Álava / Txagorritxu
Vitoria-Gasteiz, Álava, 01009
Nagore Zeberio, NAGORE.ZEBERIOGANZARAIN@osakidetza.eus
Nagore Zeberio
Australia6 sites, 6 recruiting
- Recruiting
GenesisCare Mater
Sydney, New South Wales, 2060
Gillian Lamoury, 02 + 9458 8050, Gillian.Lamoury@health.nsw.gov.au
Gillian Lamoury
- Recruiting
GenesisCare North Shore
Sydney, New South Wales, 2065
Gillian Lamoury, 02 + 8037 4100, Gillian.Lamoury@health.nsw.gov.au
Gillian Lamoury
- Recruiting
GenesisCare Frenchs Forest
Sydney, New South Wales, 2086
Gillian Lamoury, 02 + 9470 5300, Gillian.Lamoury@health.nsw.gov.au
Gillian Lamoury
- Recruiting
GenesisCare Norwest
Sydney, New South Wales, 2153
Tim Wang, 02 + 8811 8400, tim.wang@genesiscare.com
Tim Wang
- Recruiting
GenesisCare Hurstville
Sydney, New South Wales, 2220
Gina Hesselberg, 02 + 8568 7600, receptiononcologyhurstville@genesiscare.com
Gina Hesselberg
- Recruiting
GenesisCare Campbelltown
Sydney, New South Wales, 2560
George Papadatos, 02 + 4632 5510, admin.campbelltown@genesiscare.com
George Papadatos
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection, Radiotherapy Side Effect
- Being tested
- Axillary Radiotherapy, Lymphadenectomy
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary RadiotherapyRadiation
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
LymphadenectomyProcedure or surgery
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
| Study group | Role | What they receive |
|---|---|---|
| Axillary radiotherapy without lymphadenectomy | Experimental | Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy Receives: Radiation: Axillary Radiotherapy |
| Axillary lymph node dissection | Active comparator | Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain Receives: Procedure: Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From date of diagnosis until the date of death from any cause, assessed up to 5 years
Lymphedema Incidence
Volume difference between both arms (cm^3) above 10%
Measured: From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start11 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, multicenter study.
- Masking
- None (open label)
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge
- Investigators
- Maria Laplana, MDPhD, Principal investigator, Hospital Clínico y Provincial de BarcelonaAmparo Garcia-Tejedor, MDPhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889924
- Sponsor's protocol ID
- PR148/21
- Acronym
- ADARNAT
- Status last verified
- Sep 2026
- First submitted
- 5 May 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37621686
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
- ClinicalTrials.gov ID
- NCT04889924
- Acronym / sponsor ID
- ADARNAT / PR148/21
- Conditions
- Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized, multicenter study.
| Arm | Type | Receives |
|---|---|---|
| Axillary radiotherapy without lymphadenectomy | Experimental | Radiation: Axillary RadiotherapyAxillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy |
| Axillary lymph node dissection | Active comparator | Procedure: LymphadenectomyAxillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary RadiotherapyAxillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain | Radiation | Axillary radiotherapy without lymphadenectomy |
| LymphadenectomyAxillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain | Procedure or surgery | Axillary lymph node dissection |
Primary outcome
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.
2 secondary outcomes
Overall survival
Time frame: From date of diagnosis until the date of death from any cause, assessed up to 5 years
Lymphedema Incidence
Time frame: From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 37621686Garcia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Laplana, MDPhD principal investigator
Hospital Clínico y Provincial de Barcelona
Amparo Garcia-Tejedor, MDPhD principal investigator
Hospital Universitari de Bellvitge
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Radiotherapy and Lymphadenectomy in people with Breast Cancer and Chemotherapy, run by Hospital Universitari de Bellvitge at 61 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Spain, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amparo Garcia-Tejedor, MDPhD (34 + 932607695 ext. 2812, agarciat@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.