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

Conditions studied

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

About this study

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.

Interventions

• 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

Primary outcomes

• Disease-free survival (From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years)

Eligibility information

Study locations

• GenesisCare Mater, Sydney, New South Wales 2060 Australia
• GenesisCare North Shore, Sydney, New South Wales 2065 Australia
• GenesisCare Frenchs Forest, Sydney, New South Wales 2086 Australia
• GenesisCare Norwest, Sydney, New South Wales 2153 Australia
• GenesisCare Hurstville, Sydney, New South Wales 2220 Australia
• GenesisCare Campbelltown, Sydney, New South Wales 2560 Australia
• Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona 08916 Spain
• Instituto Catalán de Oncología de Badalona, Badalona, Barcelona 08916 Spain
• Hospital Comarcal Sant Jaume de Calella, Calella, Barcelona 08370 Spain
• Hospital General de Granollers, Granollers, Barcelona 08402 Spain

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