At a glance
ClinicalIndex Comparison Record- ✓Unifocal or multifocal invasive breast cancer T1-T2
- ✓Clinically N0 status
- ✓Macrometastasis (>2mm) in 1-2 lymph nodes at sentinel node biopsy
- ✓All resection margins tumor-free (no tumor on ink)
- ✕Regional or distant metastases outside ipsilateral axilla
- ✕Previous radiotherapy to planned target area (ipsilateral chest/lymph nodes)
- ✕Neoadjuvant systemic therapy
- ✕Axillary lymph node dissection or other previous axillary surgery on affected side
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The T-REX-Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases; an Open, Multicenter, Randomized Non-inferiority Phase 3-trial.
In Brief
A clinical study evaluating De-escalation for Breast Cancer. Currently recruiting, targeting 1,350 participants across 30 sites in 3 countries.
Signals
Detailed Summary
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 expression analysis for the gene signatures ARTIC, POLAR and OncotypeDX will be performed and related to risk of recurrence and benefit of adjuvant radiotherapy.
Study Details
Timeline
Interventions
No regional radiotherapy. Radiotherapy is given to the remaining breast after breast conserving surgery. Chest wall radiotherapy after mastectomy only in case of wide spread multifocality.