Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT trial).
Amparo Garcia-Tejedor, Carlos Ortega-Exposito, Sira Salinas...
https://pubmed.ncbi.nlm.nih.gov/37621686Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04889924
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
Led by Hospital Universitari de Bellvitge · Updated on 2026-05-19
820
Participants Needed
60
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying breast cancer patients who have positive sentinel lymph nodes after receiving neoadjuvant systemic treatment. The trial aims to compare two approaches: axillary radiotherapy (ART) without lymph node removal and axillary lymph node dissection (ALND) with radiotherapy. This study evaluates whether ART can reduce the risk of lymphedema without worsening cancer outcomes, including recurrences and overall survival, while also assessing quality of life. Participants will be randomly assigned to one of two groups: one receiving axillary radiotherapy targeting levels I and II and additional areas without lymphadenectomy, and the other undergoing axillary lymph node dissection combined with radiotherapy to other lymph node regions. The study plans to enroll 820 patients over five years, including those treated with chemotherapy or hormone therapy as neoadjuvant treatments. An initial pilot phase involved 200 patients, and an interim analysis will be conducted. Throughout the study, participants will be monitored for disease-free survival up to five years, noting the time until cancer recurrence or death. Researchers will also track overall survival over five years and the incidence of lymphedema for up to three years post-surgery. Quality of life and treatment side effects will be evaluated. Patients will undergo imaging with ultrasound or MRI to assess axillary response, and their treatment completion will be recorded. This comprehensive follow-up ensures careful evaluation of safety and efficacy over time.
CONDITIONS
Brief Title
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with breast cancer stages T1-T4 N0 or T0-T4 N1 and eligible for neoadjuvant treatment
- Sentinel lymph node with 2 or fewer macrometastases, micrometastases, or isolated tumor cells after neoadjuvant chemotherapy
- Axillary response confirmed by ultrasound or MRI after neoadjuvant chemotherapy
- Completed at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment
You will not qualify if you...
- Clinical nodal stage cN2
- No evidence of cancer in lymph nodes after treatment (ypN0)
- History of breast surgery for cancer on the same side within the last 10 years
- History of other cancers in the last 5 years, except for squamous carcinoma of the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration consistent with completion of neoadjuvant therapy and subsequent treatment phases
Participants receive either axillary radiotherapy without lymphadenectomy or axillary lymph node dissection followed by radiotherapy to specific lymph node areas.
1 treatment period with multiple visits as per treatment schedule
Follow-up
Duration - Up to 5 years
Participants are monitored for disease-free survival, overall survival, and lymphedema incidence after completion of treatment.
Regular follow-up visits for up to 5 years
Trial Site Locations
Total: 60 locations
1
GenesisCare Mater
Sydney, New South Wales, Australia, 2060
Actively Recruiting
2
GenesisCare North Shore
Sydney, New South Wales, Australia, 2065
Actively Recruiting
3
GenesisCare Frenchs Forest
Sydney, New South Wales, Australia, 2086
Actively Recruiting
4
GenesisCare Norwest
Sydney, New South Wales, Australia, 2153
Actively Recruiting
5
GenesisCare Hurstville
Sydney, New South Wales, Australia, 2220
Actively Recruiting
6
GenesisCare Campbelltown
Sydney, New South Wales, Australia, 2560
Actively Recruiting
7
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
8
Instituto Catalán de Oncología de Badalona
Badalona, Barcelona, Spain, 08916
Actively Recruiting
9
Hospital Comarcal Sant Jaume de Calella
Calella, Barcelona, Spain, 08370
Actively Recruiting
10
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402
Not Yet Recruiting
11
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
Actively Recruiting
12
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
13
Instituto Catalán de Oncología- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
14
Fundación Althaia Manresa
Manresa, Barcelona, Spain, 08243
Actively Recruiting
15
Hospital de Mataró
Mataró, Barcelona, Spain, 08304
Actively Recruiting
16
Hospital Universitario General de Cataluña
Sant Cugat del Vallès, Barcelona, Spain, 08195
Not Yet Recruiting
17
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain, 08221
Actively Recruiting
18
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Actively Recruiting
19
Hospital de Viladecans
Viladecans, Barcelona, Spain, 08840
Actively Recruiting
20
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain, 48903
Actively Recruiting
21
Hospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, Spain, 48960
Actively Recruiting
22
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain, 11009
Not Yet Recruiting
23
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, Spain, 20014
Actively Recruiting
24
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Actively Recruiting
25
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28914
Actively Recruiting
26
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
27
Hospital Universitario Infanta Cristina
Parla, Madrid, Spain, 28981
Actively Recruiting
28
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
29
Hospital Ribera Povisa
Vigo, Pontevedra, Spain, 36211
Actively Recruiting
30
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36213
Actively Recruiting
31
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
Actively Recruiting
32
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Actively Recruiting
33
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
Actively Recruiting
34
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
35
Hospital de la Santa Cruz y San Pablo
Barcelona, Spain, 08025
Actively Recruiting
36
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
37
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
38
Hospital Universitario de Gerona Doctor Josep Trueta
Girona, Spain, 17007
Actively Recruiting
39
Institut Catalán de Oncología de Girona
Girona, Spain, 17007
Actively Recruiting
40
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
41
Hospital Universitario Clínico San Cecilio
Granada, Spain, 18016
Not Yet Recruiting
42
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
43
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
44
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
45
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
46
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
47
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
Madrid, Spain, 28703
Actively Recruiting
48
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Actively Recruiting
49
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
50
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
51
Hospital Montecelo
Pontevedra, Spain, 36071
Actively Recruiting
52
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain, 38010
Actively Recruiting
53
Hospital General de Segovia
Segovia, Spain, 47002
Actively Recruiting
54
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
55
Hospital Universitario de Tarragona Juan XXIII
Tarragona, Spain, 43005
Actively Recruiting
56
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Actively Recruiting
57
Hospital Universitario Doctor Peset
Valencia, Spain, 46017
Actively Recruiting
58
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
59
Hospital Recoletas Campo Grande de Valladolid
Valladolid, Spain, 47007
Actively Recruiting
60
Hospital Universitario de Álava / Txagorritxu
Vitoria-Gasteiz, Álava, Spain, 01009
Actively Recruiting
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Research Team
A
Amparo Garcia-Tejedor, MDPhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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