Clinical trial NCT04889924: ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Official title: Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Chemotherapy
Sentinel Lymph Node
Axillary Lymph Nodes Dissection
Radiotherapy Side Effect
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 1660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, multicenter study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 1660 patients, 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. An interim analysis will also be performed with the first 820 patients recruited.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: From date of diagnosis until the date of death from any cause, assessed up to 5 years
measure: Lymphedema Incidence
timeFrame: From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: GenesisCare Mater
state: New South Wales
city: Sydney
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: Sydney
country: Australia
facility: GenesisCare Frenchs Forest
state: New South Wales
city: Sydney
country: Australia
facility: GenesisCare Norwest
state: New South Wales
city: Sydney
country: Australia
facility: GenesisCare Hurstville
state: New South Wales
city: Sydney
country: Australia
facility: GenesisCare Campbelltown
state: New South Wales
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Badalona
country: Spain
facility: Instituto Catalán de Oncología de Badalona
state: Barcelona
city: Calella
country: Spain
facility: Hospital Comarcal Sant Jaume de Calella
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Consorci Sanitari Integral
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Instituto Catalán de Oncología- Hospital Duran i Reynals
state: Barcelona
city: Manresa
country: Spain
facility: Fundación Althaia Manresa
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Universitario General de Cataluña
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mútua Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Viladecans
country: Spain
facility: Hospital de Viladecans
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Bizkaia
city: Galdakao
country: Spain
facility: Hospital Universitario Galdakao-Usansolo
state: Bizkaia
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Cádiz
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Gipuzkoa
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro
state: Madrid
city: Parla
country: Spain
facility: Hospital Universitario Infanta Cristina
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Ribera Povisa
state: Pontevedra
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Reus
country: Spain
facility: Hospital Universitario Sant Joan de Reus
state: Tarragona
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Cruz y San Pablo
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Universitario de Gerona Doctor Josep Trueta
city: Girona
country: Spain
facility: Institut Catalán de Oncología de Girona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Tarragona
country: Spain
facility: Hospital Universitario de Tarragona Juan XXIII
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Recoletas Campo Grande de Valladolid
city: Vitoria
country: Spain
facility: Hospital Universitario de Álava / Txagorritxu
state: Álava
Study officials:
affiliation: Hospital Clínico y Provincial de Barcelona
name: Maria Laplana, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Amparo Garcia-Tejedor, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: