Axillary Lymph Node Dissection vs Axillary Radiotherapy in Positive Sentinel Node After Neoadjuvant Therapy (ADARNAT)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    1666
  • sponsor
    Hospital Universitari de Bellvitge
Updated on 11 May 2022
chemotherapy regimen
axillary lymph node dissection
sentinel node

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 of this study is to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in recurrences and overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.

Description

A prospective, randomized, open-label, parallel-assigned, multicenter, phase III study. The estimated sample size is 1.666 patients, over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).

Details
Condition Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection, Radiotherapy Side Effect
Treatment Lymphadenectomy, axillary radiotherapy
Clinical Study IdentifierNCT04889924
SponsorHospital Universitari de Bellvitge
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

T1-T4b N0-1 at diagnosis and subsidiary of neoadjuvant treatment
Post-CT SLN with ≤2 macrometastasis
If N + pre-neoadjuvant treatment also include micrometastases
Post-CT axillary ultrasound, BEDI <4 in all visualized nodes
Complete at least 3 months of neoadjuvant chemotherapy and 6 months of endocrine treatment

Exclusion Criteria

Inflammatory carcinoma or cN2
ypN0
History of breast surgery for ipsilateral cancer
History of other cancer in the last 5 years, except squamous carcinoma of the skin
Clear my responses

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