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

Not Applicable

Recruiting

• Conditions: Sentinel Lymph Node; Axillary Lymph Nodes Dissection; Radiotherapy Side Effect; Breast Cancer; Chemotherapy
• Interventions: Radiation: Axillary Radiotherapy; Procedure: Lymphadenectomy

• Registration Number: NCT04889924
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-17
• Study Start: 2021-06-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1660

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axillary radiotherapy without lymphadenectomy	Axillary Radiotherapy	Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
Axillary lymph node dissection	Lymphadenectomy	Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain

Primary Outcome Measures

Name	Time	Method
Disease-free survival	From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of diagnosis until the date of death from any cause, assessed up to 5 years	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.
Lymphedema Incidence	From date of surgery until the date of first lynphedema apparition, assessed up to 3 years	Volume difference between both arms (cm\^3) above 10%

Trial Locations

Locations (58)

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 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

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, 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; 🇪🇸 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; 🇪🇸 Sevilla, Spain

Hospital Universitario de Tarragona Juan XXIII; 🇪🇸 Tarragona, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Recoletas Campo Grande de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario de Álava / Txagorritxu; 🇪🇸 Vitoria, Álava, Spain