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ALND vs ART in Positive Senti...

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

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, randomized, multicenter study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axillary radiotherapy without lymphadenectomy

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

Group Type EXPERIMENTAL

Axillary Radiotherapy

Intervention Type RADIATION

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

Axillary lymph node dissection

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

Group Type ACTIVE_COMPARATOR

Lymphadenectomy

Intervention Type PROCEDURE

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

Interventions

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Axillary Radiotherapy

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

Intervention Type RADIATION

Lymphadenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Amparo Garcia-Tejedor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Laplana, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico y Provincial de Barcelona

Amparo Garcia-Tejedor, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

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