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The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.

RecruitingNAAges 18 Years - anyAllRegion Skane
NCT05634889 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

T-REX is a randomized multicenter, non-inferiority trial. Aim: To evaluate whether regional radiotherapy may safely be omitted in clinically node negative breast cancer patients with one or two sentinel node macrometastases and an estrogen receptor positive, HER2-negative tumor. Leading to an improved quality of life and reduced side effects, without worsening recurrence free survival at five years. Intervention: Patients will be randomized to locoregional radiotherapy towards the breast/chestwall and regional lymph nodes vs. to a de-escalated radiotherapy. In the intervention arm no lymph node irradiation will be given. Radiotherapy is still given to the remaining breast after breast conserving surgery, but no radiotherapy is given after mastectomy. Sample size: 1350 patients Primary end-point: Recurrence free survival at five years. Gene expression analysis: For all patients gene

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📋 Eligibility rules (as published)
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
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What it tests

  • De-escalation
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Where

30 sites
Helsinki University Hospital
Helsinki, Finland
Lahti Hospital
Lahti, Finland
Turku University Hospital
Turku, Finland
Ålesund
Ålesund, Norway
Bergen
Bergen, Norway
Bodø
Bodø, Norway
Gjövik
Gjøvik, Norway
Kristiansand
Kristiansand, Norway

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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