ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Recruiting now · Not applicable
Conditions studied: Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection, Radiotherapy Side Effect
In brief
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.
Key facts
- Study ID
- NCT04889924
- Run by
- Hospital Universitari de Bellvitge
- People needed
- 820
- Starts
- 2021-06-11
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hospital Universitario Infanta Cristina — Parla, Madrid, Spain (enrolling)
- GenesisCare Frenchs Forest — Sydney, New South Wales, Australia (enrolling)
- GenesisCare Mater — Sydney, New South Wales, Australia (enrolling)
- Hospital Universitario Puerta De Hierro — Majadahonda, Madrid, Spain (enrolling)
- GenesisCare Campbelltown — Sydney, New South Wales, Australia (enrolling)
- Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain (enrolling)
- GenesisCare Norwest — Sydney, New South Wales, Australia (enrolling)
- Hospital Comarcal Sant Jaume de Calella — Calella, Barcelona, Spain (enrolling)
- GenesisCare Hurstville — Sydney, New South Wales, Australia (enrolling)
- GenesisCare North Shore — Sydney, New South Wales, Australia (enrolling)
- Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
- Instituto Catalán de Oncología- Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
- Fundación Althaia Manresa — Manresa, Barcelona, Spain (enrolling)
- Hospital de Mataró — Mataró, Barcelona, Spain (enrolling)
- Instituto Catalán de Oncología de Badalona — Badalona, Barcelona, Spain (enrolling)
- Hospital Universitario Mútua Terrassa — Terrassa, Barcelona, Spain (enrolling)
- Consorci Sanitari de Terrassa — Terrassa, Barcelona, Spain (enrolling)
- Hospital de Viladecans — Viladecans, Barcelona, Spain (enrolling)
- Hospital Universitario de Cruces — Barakaldo, Bizkaia, Spain (enrolling)
- Hospital Universitario Galdakao-Usansolo — Galdakao, Bizkaia, Spain (enrolling)
- Consorci Sanitari Integral — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
- Hospital Universitario de Donostia — Donostia / San Sebastian, Gipuzkoa, Spain (enrolling)
- Hospital Universitario Príncipe de Asturias — Alcalá de Henares, Madrid, Spain (enrolling)
- Hospital Universitario Severo Ochoa — Leganés, Madrid, Spain (enrolling)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (enrolling)
Full record on ClinicalTrials.gov
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