ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Axillary Radiotherapy, Lymphadenectomy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
Overview
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.
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 outcome measures
- Disease-free survival [Time frame: From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years]
Secondary outcome measures (2)
- Overall survival [Time frame: From date of diagnosis until the date of death from any cause, assessed up to 5 years]
- Lymphedema Incidence [Time frame: From date of surgery until the date of first lynphedema apparition, assessed up to 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 54 centers
- Hospital Universitari Germans Trias i Pujol — Badalona
- Instituto Catalán de Oncología de Badalona — Badalona
- Hospital Comarcal Sant Jaume de Calella — Calella
- Hospital General de Granollers — Granollers
- Consorci Sanitari Integral — L'Hospitalet de Llobregat
- Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat
- Instituto Catalán de Oncología- Hospital Duran i Reynals — L'Hospitalet de Llobregat
- Fundación Althaia Manresa — Manresa
- … and 46 more centers
Australia · 6 centers
- GenesisCare Mater — Sydney
- GenesisCare North Shore — Sydney
- GenesisCare Frenchs Forest — Sydney
- GenesisCare Norwest — Sydney
- GenesisCare Hurstville — Sydney
- GenesisCare Campbelltown — Sydney
Publications
- Garcia-Tejedor A, Ortega-Exposito C, Salinas S, Luzardo-Gonzalez A, Falo C, Martinez-Perez E, Perez-Montero H, Soler-Monso MT, Bajen MT, Benitez A, Ortega R, Petit A, Guma A, Campos M, Pla MJ, Pernas S, Penafiel J, Yeste C, Gil-Gil M, Guedea F, Ponce J, Laplana M. Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT tri PMID 37621686
Identifiers
NCT: NCT04889924 · PR148/21