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

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

Trial Details

NCT ID
NCT05634889
Phase
NA
Sponsor
Region Skane
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • De-escalation
Locations (sample)
  • Ålesund, Norway|62.47225,6.15492
  • Bergen, Norway|60.39299,5.32415
  • Bodø, Norway|67.28267,14.37513
  • Gjøvik, Norway|60.79574,10.69155
  • Kristiansand, Norway|58.14671,7.9956

Key Eligibility Criteria

  • Primary unifocal or multifocal invasive breast cancer T1-T2.
  • Clinically N0.
  • Macrometastasis (\>2mm) in 1-2 lymph nodes at sentinel node biopsy.
  • Oral and written consent.

For full eligibility, visit ClinicalTrials.gov.

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