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ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Sponsor: Hospital Universitari de Bellvitge
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.
Official title: Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
820
Start Date
2021-06-11
Completion Date
2028-12-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Axillary Radiotherapy
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
Lymphadenectomy
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Locations (59)
GenesisCare Mater
Sydney, New South Wales, Australia
GenesisCare North Shore
Sydney, New South Wales, Australia
GenesisCare Frenchs Forest
Sydney, New South Wales, Australia
GenesisCare Norwest
Sydney, New South Wales, Australia
GenesisCare Hurstville
Sydney, New South Wales, Australia
GenesisCare Campbelltown
Sydney, New South Wales, Australia
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Instituto Catalán de Oncología de Badalona
Badalona, Barcelona, Spain
Hospital Comarcal Sant Jaume de Calella
Calella, Barcelona, Spain
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Instituto Catalán de Oncología- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Fundación Althaia Manresa
Manresa, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Universitario General de Cataluña
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital de Viladecans
Viladecans, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, Spain
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Infanta Cristina
Parla, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Ribera Povisa
Vigo, Pontevedra, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Universitario de A Coruña
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
Hospital de la Santa Cruz y San Pablo
Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario de Gerona Doctor Josep Trueta
Girona, Spain
Institut Catalán de Oncología de Girona
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Montecelo
Pontevedra, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario de Tarragona Juan XXIII
Tarragona, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Hospital Universitario Doctor Peset
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Recoletas Campo Grande de Valladolid
Valladolid, Spain
Hospital Universitario de Álava / Txagorritxu
Vitoria-Gasteiz, Álava, Spain