NCT04889924

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 820 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 820 patients (410 patients in neoadjuvant chemotherapy and 410 in neoadjuvant hormone therapy), 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 (Until 1 May 2023), and an interim analysis will also be performed with these first 200 patients.

Conditions

• Breast Cancer
• Chemotherapy
• Sentinel Lymph Node
• Axillary Lymph Nodes Dissection
• Radiotherapy Side Effect

Interventions

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

Timeline

• Start date: 2021-06-11
• Primary completion: 2026-06-30
• Completion: 2028-12-31
• First posted: 2021-05-17
• Last updated: 2026-04-17

Locations

60 sites across 2 countries: Australia, Spain