EligibleTrials
Conditions › Breast Cancer › NCT04889924

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

Recruiting · NCT04889924 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universitari de Bellvitge

View the official record on ClinicalTrials.gov →
Breast Cancer

Interventions studied

Axillary RadiotherapyLymphadenectomy

What this trial is 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.

Who can take part

Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

60 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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