ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Sponsor: Hospital Universitari de Bellvitge • ClinicalTrials.gov ID: NCT04889924
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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.
Interventions
-
Axillary Radiotherapy
(Radiation)
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
-
Lymphadenectomy
(Procedure)
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Eligibility criteria
Conditions
Locations
- 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
- Hospital General de Granollers — Granollers, 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
- Consorci Sanitari Alt Penedès-Garraf — Vilafranca del Penedès, 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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