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Search / Trial NCT04889924

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

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · May 13, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for patients with breast cancer who have had chemotherapy and still have cancer in their sentinel lymph nodes (the first lymph nodes to which cancer is likely to spread). The trial aims to find out if using axillary radiotherapy (ART), which uses targeted radiation to treat the lymph nodes, is better at reducing the risk of lymphedema (swelling caused by fluid build-up) compared to a more invasive procedure called axillary lymph node dissection (ALND), where the lymph nodes are surgically removed. The researchers are also looking at how these treatments affect cancer recurrence, overall survival rates, and the quality of life for patients.

To be eligible for this trial, participants should be adults aged 65 to 74 who have been diagnosed with breast cancer and have a specific type of lymph node involvement after receiving neoadjuvant treatment (which is chemotherapy given before surgery). They need to have completed most of their chemotherapy and have not had certain previous cancers or breast surgeries in the last few years. If you choose to participate, you can expect to undergo regular assessments and be part of a study that may help improve treatment options for future breast cancer patients.

Gender

ALL

Eligibility criteria

  • 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.

About Hospital Universitari De Bellvitge

Hospital Universitari de Bellvitge is a leading academic medical center located in L'Hospitalet de Llobregat, Spain, affiliated with the University of Barcelona. Renowned for its commitment to advanced patient care, innovative research, and education, the hospital plays a pivotal role in the development and execution of clinical trials across various therapeutic areas. With a multidisciplinary team of healthcare professionals and researchers, Hospital Universitari de Bellvitge strives to enhance medical knowledge and improve treatment outcomes through rigorous scientific inquiry and collaboration. Its state-of-the-art facilities and comprehensive patient care services make it an ideal environment for conducting high-quality clinical research.

Locations

Madrid, , Spain

Barcelona, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

La Laguna, Santa Cruz De Tenerife, Spain

Valencia, , Spain

Terrassa, Barcelona, Spain

Majadahonda, Madrid, Spain

El Palmar, Murcia, Spain

Valladolid, , Spain

Granada, , Spain

Santa Cruz De Tenerife, , Spain

Barcelona, , Spain

Hospitalet De Llobregat, Barcelona, Spain

Sevilla, , Spain

Pontevedra, , Spain

Badalona, Barcelona, Spain

Málaga, , Spain

Mataró, Barcelona, Spain

Cadiz, , Spain

Parla, Madrid, Spain

Málaga, , Spain

Alcalá De Henares, Madrid, Spain

Burgos, , Spain

A Coruña, , Spain

Barcelona, , Spain

Viladecans, Barcelona, Spain

Reus, Tarragona, Spain

Madrid, , Spain

Barakaldo, Bizkaia, Spain

Terrassa, Barcelona, Spain

Donostia, Gipuzkoa, Spain

Granada, , Spain

Vigo, Pontevedra, Spain

Manresa, Barcelona, Spain

L'hospitalet De Llobregat, Barcelona, Spain

Madrid, , Spain

Pamplona, , Spain

Pontevedra, , Spain

Valladolid, , Spain

Segovia, , Spain

Cadiz, Cádiz, Spain

Badalona, Barcelona, Spain

L'hospitalet De Llobregat, Barcelona, Spain

Galdakao, Bizkaia, Spain

Vigo, Pontevedra, Spain

Girona, , Spain

Girona, , Spain

Tarragona, , Spain

Vitoria, álava, Spain

Sant Cugat Del Vallès, Barcelona, Spain

Sydney, New South Wales, Australia

Calella, Barcelona, Spain

Leganés, Madrid, Spain

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Vitoria, , Spain

Patients applied

0 patients applied

Trial Officials

Maria Laplana, MDPhD

Principal Investigator

Hospital Clínico y Provincial de Barcelona

Amparo Garcia-Tejedor, MDPhD

Principal Investigator

Hospital Universitari de Bellvitge

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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