ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

Breast Cancer Clinical Trial

— ADARNAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889924
• Other study ID #: PR148/21
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Hospital Universitari de Bellvitge
• Contact: Amparo Garcia-Tejedor, MDPhD
• Phone: 0034.932607695
• Email: agarciat[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1660
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy
• Radiotherapy Side Effect
• Sentinel Lymph Node

Intervention

Radiation:
• Axillary Radiotherapy
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain

Procedure:
• Lymphadenectomy
Axillary Lymph node dissection

Locations

Country	Name	City	State
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Instituto Catalán de Oncología de Badalona	Badalona	Barcelona
Spain	Hospital Universitario de Cruces	Barakaldo	Bizkaia
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Cruz y San Pablo	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario Puerta del Mar	Cadiz	Cádiz
Spain	Hospital Comarcal Sant Jaume de Calella	Calella	Barcelona
Spain	Hospital Universitario de Donostia	Donostia	Gipuzkoa
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Galdakao-Usansolo	Galdakao	Bizkaia
Spain	Hospital Universitario de Gerona Doctor Josep Trueta	Girona
Spain	Institut Catalán de Oncología de Girona	Girona
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Consorci Sanitari Integral	L'Hospitalet De Llobregat	Barcelona
Spain	Instituto Catalán de Oncología- Hospital Duran i Reynals	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta De Hierro	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Fundación Althaia Manresa	Manresa	Barcelona
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Universitario Infanta Cristina	Parla	Madrid
Spain	Hospital Montecelo	Pontevedra
Spain	Hospital Universitario Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario General de Cataluña	Sant Cugat Del Vallès	Barcelona
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario de Tarragona Juan XXIII	Tarragona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitario Mútua Terrassa	Terrassa	Barcelona
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Recoletas Campo Grande de Valladolid	Valladolid
Spain	Hospital Álvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Ribera Povisa	Vigo	Pontevedra
Spain	Hospital de Viladecans	Viladecans	Barcelona
Spain	Hospital Universitario de Álava / Txagorritxu	Vitoria	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.	From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years
Secondary	Overall survival	To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.	From date of diagnosis until the date of death from any cause, assessed up to 5 years
Secondary	Lymphedema Incidence	Volume difference between both arms (cm^3) above 10%	From date of surgery until the date of first lynphedema apparition, assessed up to 3 years