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

NCT04889924 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2026-05-19

No results posted yet for this study

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 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.

Conditions

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

Interventions

RADIATION

Axillary Radiotherapy

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

PROCEDURE

Lymphadenectomy

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

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Maria Laplana, MDPhD · Hospital Clínico y Provincial de Barcelona

  • Amparo Garcia-Tejedor, MDPhD · Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2026-06-30
Completion
2028-12-31

Countries

  • Australia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889924 on ClinicalTrials.gov