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Comparing axillary radiotherapy and lymphadenectomy in breast cancer patients after neoadjuvant therapy

Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study

Not applicable Interventional Hospital Universitari de Bellvitge · NCT04889924

This study is testing whether using axillary radiotherapy instead of surgery can help breast cancer patients who have had neoadjuvant treatment avoid lymphedema.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment820 (estimated)
Ages18 Years and up
SexAll
SponsorHospital Universitari de Bellvitge Academic / other
Drugs / interventionschemotherapy
Locations60 sites (Sydney, New South Wales and 59 other locations)
Trial IDNCT04889924 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether axillary radiotherapy (ART) can reduce the risk of lymphedema compared to axillary lymph node dissection (ALND) in breast cancer patients who have undergone neoadjuvant systemic treatment and have positive sentinel nodes. The study is a prospective, randomized, open-label, multicenter trial with an estimated sample size of 1660 patients over five years. Participants will be stratified based on their neoadjuvant treatment regimen, and both groups will be monitored for recurrence, overall survival, and quality of life. An interim analysis will be conducted after recruiting the first 820 patients to assess early outcomes.

Who should consider this trial

Good fit: Ideal candidates are breast cancer patients with sentinel node involvement who have received neoadjuvant systemic treatment and meet specific eligibility criteria.

Not a fit: Patients with more advanced nodal involvement (cN2) or those who have had prior breast surgery for ipsilateral cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option that minimizes the risk of lymphedema for breast cancer patients.

How similar studies have performed: Previous studies have shown that omitting axillary lymph node dissection can reduce lymphedema risk, but this specific approach in the context of neoadjuvant therapy is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Sydney, New South Wales and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerChemotherapySentinel Lymph NodeAxillary Lymph Nodes DissectionRadiotherapy Side Effect
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.