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

Catalan Institute of Health

Status: Enrolling

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

Treatments: Procedure: Lymphadenectomy; Radiation: Axillary Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04889924

PR148/21

Details and patient eligibility

About

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.

Full description

A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 1660 patients, 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. An interim analysis will also be performed with the first 820 patients.

Enrollment: 1,660 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,660 participants in 2 patient groups

Axillary radiotherapy without lymphadenectomy

Experimental group

Description:

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

Treatment:

Radiation: Axillary Radiotherapy

Axillary lymph node dissection

Active Comparator group

Description:

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

Treatment:

Procedure: Lymphadenectomy