Tailored radiotherapy for breast cancer patients with limited lymph node involvement

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

The T-REX trial is a randomized multicenter trial aimed at evaluating the safety of omitting regional radiotherapy in clinically node-negative breast cancer patients who have one or two sentinel node macrometastases and an estrogen receptor positive, HER2-negative tumor. Participants will be randomly assigned to receive either standard locoregional radiotherapy or a de-escalated approach that excludes lymph node irradiation. The primary outcome is recurrence-free survival at five years, with secondary outcomes including overall survival and health-related quality of life. Gene expression analysis will also be performed to assess tumor characteristics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Primary unifocal or multifocal invasive breast cancer T1-T2.
2. Clinically N0.
3. Macrometastasis (\>2mm) in 1-2 lymph nodes at sentinel node biopsy.
4. Oral and written consent.
5. Age ≥ 18 years.
6. All resection margins are tumor free (no tumor on ink).
7. Primary tumor ER-positive, HER2-negative.

Exclusion Criteria:

1. Regional or distant metastases outside the ipsilateral axilla.
2. Previous RT towards the planned target area, i.e. the ipsilateral chest/lymph nodes.
3. Neoadjuvant systemic therapy.
4. Axillary lymph node dissection or other previous axillary surgery on the affected side.
5. Prior history of invasive breast cancer.
6. Pregnancy.
7. Bilateral invasive breast cancer.
8. Contraindication for radiotherapy or systemic treatment.
9. Inability to absorb or understand the contents of the informed consent form; for example, through disability, inadequate language skills or dementia.
10. Other invasive cancer within 5 years prior to breast cancer diagnosis

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Ålesund
  Ålesund, Norway Recruiting
• Bergen
  Bergen, Norway Recruiting
• Gjövik
  Gjøvik, Norway Recruiting
• Kristiansand
  Kristiansand, Norway Recruiting
• Oslo
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Sara Alkner, Associate professor — Lunds Universitet
• Study coordinator: Sara Alkner, Associate professor
• Email: sara.alkner@med.lu.se
• Phone: +4646171000

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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.