Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study

Status: Recruiting
Location: See all (58) locations...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
GenesisCare Campbelltown
RECRUITING
Sydney
GenesisCare Frenchs Forest
RECRUITING
Sydney
GenesisCare Hurstville
RECRUITING
Sydney
GenesisCare Mater
RECRUITING
Sydney
GenesisCare North Shore
RECRUITING
Sydney
GenesisCare Norwest
RECRUITING
Sydney
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Hospital Universitario Príncipe de Asturias
RECRUITING
Alcalá De Henares
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Instituto Catalán de Oncología de Badalona
RECRUITING
Badalona
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital Clínico y Provincial de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Cruz y San Pablo
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Universitario Puerta del Mar
NOT_YET_RECRUITING
Cadiz
Hospital Comarcal Sant Jaume de Calella
RECRUITING
Calella
Hospital Universitario de Donostia
RECRUITING
Donostia / San Sebastian
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital Universitario Galdakao-Usansolo
RECRUITING
Galdakao
Hospital Universitario de Gerona Doctor Josep Trueta
RECRUITING
Girona
Institut Catalán de Oncología de Girona
RECRUITING
Girona
Hospital Universitario Clínico San Cecilio
NOT_YET_RECRUITING
Granada
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Consorci Sanitari Integral
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Instituto Catalán de Oncología- Hospital Duran i Reynals
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Severo Ochoa
RECRUITING
Leganés
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta De Hierro
RECRUITING
Majadahonda
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Fundación Althaia Manresa
RECRUITING
Manresa
Hospital de Mataró
RECRUITING
Mataró
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Infanta Cristina
RECRUITING
Parla
Hospital Montecelo
RECRUITING
Pontevedra
Hospital Universitario Sant Joan de Reus
RECRUITING
Reus
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Universitario General de Cataluña
NOT_YET_RECRUITING
Sant Cugat Del Vallès
Hospital Universitario Nuestra Señora de Candelaria
RECRUITING
Santa Cruz De Tenerife
Hospital General de Segovia
RECRUITING
Segovia
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario de Tarragona Juan XXIII
RECRUITING
Tarragona
Consorci Sanitari de Terrassa
RECRUITING
Terrassa
Hospital Universitario Mútua Terrassa
RECRUITING
Terrassa
Instituto Valenciano de Oncología
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Recoletas Campo Grande de Valladolid
RECRUITING
Valladolid
Hospital Álvaro Cunqueiro
RECRUITING
Vigo
Hospital Ribera Povisa
RECRUITING
Vigo
Hospital de Viladecans
RECRUITING
Viladecans
Hospital Universitario de Álava / Txagorritxu
RECRUITING
Vitoria-gasteiz
Contact Information
Primary
Amparo Garcia-Tejedor, MDPhD
agarciat@bellvitgehospital.cat
34 + 932607695
Time Frame
Start Date: 2021-06-11
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 820
Treatments
Experimental: Axillary radiotherapy without lymphadenectomy
Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
Active_comparator: Axillary lymph node dissection
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari de Bellvitge

This content was sourced from clinicaltrials.gov

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