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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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