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NCT Number: NCT04889924

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

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.

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Key information

Conditions

Breast Cancer Axillary Lymph Nodes Dissection Breast Diseases Breast Neoplasms Chemotherapy Neoplasms Neoplasms by Site Radiation Injuries Radiotherapy Side Effect Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GenesisCare Campbelltown, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axillary Radiotherapy

Radiation

Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain

Lymphadenectomy

Procedure

Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain

Primary outcomes

  1. 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

    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 outcomes

  1. Overall survival

    Time frame: 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.

  2. Lymphedema Incidence

    Time frame: 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%

Study contacts

Contact information is provided by the study sponsor or research team.

Amparo Garcia-Tejedor, MDPhD

CONTACT

[email protected]

34 + 932607695 ext. 2812

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Acronym: ADARNAT

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
May 17, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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