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New study could spare breast cancer patients from underarm surgery

NCT ID NCT04889924

Symptom relief Sponsor: Hospital Universitari de Bellvitge Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study compares two approaches for breast cancer patients who still have cancer in their sentinel lymph node after chemotherapy: removing the underarm lymph nodes (surgery) or treating them with radiation. The goal is to see if radiation can reduce the risk of arm swelling (lymphedema) without affecting cancer survival. About 820 participants will be randomly assigned to one of the two treatments and followed for disease-free survival and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Axillary radiotherapy
What this could lead to
If successful, this could offer a less invasive option for breast cancer patients after chemotherapy, reducing the risk of arm swelling (lymphedema) while maintaining similar cancer control.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The radiotherapy might not be as effective as surgery in preventing cancer recurrence, and individual outcomes may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 820 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm radiation injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axillary lymph nodes dissection Breast cancer Chemotherapy Radiotherapy side effect Sentinel lymph node

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    61 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Consorci Sanitari Alt Penedès-Garraf

    NOT_YET_RECRUITING

    Vilafranca del Penedès, Barcelona, 08720, Spain

  • Consorci Sanitari Integral

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08906, Spain

  • Consorci Sanitari de Terrassa

    RECRUITING

    Terrassa, Barcelona, 08227, Spain

  • Fundación Althaia Manresa

    RECRUITING

    Manresa, Barcelona, 08243, Spain

  • GenesisCare Campbelltown

    RECRUITING

    Sydney, New South Wales, 2560, Australia

  • GenesisCare Frenchs Forest

    RECRUITING

    Sydney, New South Wales, 2086, Australia

  • GenesisCare Hurstville

    RECRUITING

    Sydney, New South Wales, 2220, Australia

    Contact Email: •••••@•••••

  • GenesisCare Mater

    RECRUITING

    Sydney, New South Wales, 2060, Australia

  • GenesisCare North Shore

    RECRUITING

    Sydney, New South Wales, 2065, Australia

  • GenesisCare Norwest

    RECRUITING

    Sydney, New South Wales, 2153, Australia

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Hospital Clínico y Provincial de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Comarcal Sant Jaume de Calella

    RECRUITING

    Calella, Barcelona, 08370, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Hospital General de Granollers

    RECRUITING

    Granollers, Barcelona, 08402, Spain

  • Hospital General de Segovia

    RECRUITING

    Segovia, 47002, Spain

  • Hospital Montecelo

    RECRUITING

    Pontevedra, 36071, Spain

  • Hospital Recoletas Campo Grande de Valladolid

    RECRUITING

    Valladolid, 47007, Spain

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Ribera Povisa

    RECRUITING

    Vigo, Pontevedra, 36211, Spain

  • Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    NOT_YET_RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario Doctor Peset

    RECRUITING

    Valencia, 46017, Spain

  • Hospital Universitario Galdakao-Usansolo

    RECRUITING

    Galdakao, Bizkaia, 48960, Spain

  • Hospital Universitario General de Cataluña

    NOT_YET_RECRUITING

    Sant Cugat del Vallès, Barcelona, 08195, Spain

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Infanta Cristina

    RECRUITING

    Parla, Madrid, 28981, Spain

  • Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía

    RECRUITING

    Madrid, 28703, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Mútua Terrassa

    RECRUITING

    Terrassa, Barcelona, 08221, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    RECRUITING

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Príncipe de Asturias

    RECRUITING

    Alcalá de Henares, Madrid, 28805, Spain

  • Hospital Universitario Puerta De Hierro

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Puerta del Mar

    NOT_YET_RECRUITING

    Cadiz, Cádiz, 11009, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Sant Joan de Reus

    RECRUITING

    Reus, Tarragona, 43204, Spain

  • Hospital Universitario Severo Ochoa

    RECRUITING

    Leganés, Madrid, 28914, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hospital Universitario de A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, 09006, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, Bizkaia, 48903, Spain

  • Hospital Universitario de Donostia

    RECRUITING

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Hospital Universitario de Gerona Doctor Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital Universitario de Tarragona Juan XXIII

    RECRUITING

    Tarragona, 43005, Spain

  • Hospital Universitario de Álava / Txagorritxu

    RECRUITING

    Vitoria-Gasteiz, Álava, 01009, Spain

  • Hospital de Mataró

    RECRUITING

    Mataró, Barcelona, 08304, Spain

  • Hospital de Viladecans

    RECRUITING

    Viladecans, Barcelona, 08840, Spain

  • Hospital de la Santa Cruz y San Pablo

    RECRUITING

    Barcelona, 08025, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Hospital Álvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra, 36213, Spain

  • Institut Catalán de Oncología de Girona

    RECRUITING

    Girona, 17007, Spain

  • Instituto Catalán de Oncología de Badalona

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Instituto Catalán de Oncología- Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Instituto Valenciano de Oncología

    RECRUITING

    Valencia, 46009, Spain

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Other studies related to the condition(s) this trial covers.