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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• GenesisCare Mater
  Sydney, New South Wales, Australia Recruiting
• GenesisCare North Shore
  Sydney, New South Wales, Australia Recruiting
• GenesisCare Frenchs Forest
  Sydney, New South Wales, Australia Recruiting
• GenesisCare Norwest
  Sydney, New South Wales, Australia Recruiting
• GenesisCare Hurstville
  Sydney, New South Wales, Australia Recruiting
• GenesisCare Campbelltown
  Sydney, New South Wales, Australia Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Maria Laplana, MDPhD — Hospital Clínico y Provincial de Barcelona
• Study coordinator: Amparo Garcia-Tejedor, MDPhD
• Email: agarciat@bellvitgehospital.cat
• Phone: 34 + 932607695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.