The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.
Recruiting · NCT05634889 · Interventional (participants receive a specific treatment) · Lead sponsor: Region Skane
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion 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.
- Age ≥ 18 years.
- All resection margins are tumor free (no tumor on ink).
- Primary tumor ER-positive, HER2-negative.
Exclusion criteria
- Regional or distant metastases outside the ipsilateral axilla.
- Previous RT towards the planned target area, i.e. the ipsilateral chest/lymph nodes.
- Neoadjuvant systemic therapy.
- Axillary lymph node dissection or other previous axillary surgery on the affected side.
- Prior history of invasive breast cancer.
- Pregnancy.
- Bilateral invasive breast cancer.
- Contraindication for radiotherapy or systemic treatment.
- Inability to absorb or understand the contents of the informed consent form; for example, through disability, inadequate language skills or dementia.
- Other invasive cancer within 5 years prior to breast cancer diagnosis
Where it is running
30 locations listed.
- Bergen - Bergen, Norway
- Bodø - Bodø, Norway
- Region Västragötaland - Borås, Sweden
- Region Sörmland - Eskilstuna, Sweden
- Gjövik - Gjøvik, Norway
- Region Västra Götaland - Gothenburg, Sweden
- Region Gävleborg - Gävle, Sweden
- Region Halland - Halmstad, Sweden
- Helsinki University Hospital - Helsinki, Finland
- Region Jönköping - Jönköping, Sweden
- Region Kalmar län - Kalmar, Sweden
- Region Värmland - Karlstad, Sweden
- Kristiansand - Kristiansand, Norway
- Lahti Hospital - Lahti, Finland
- Region Östergötland - Linköping, Sweden
- Region Skåne - Lund, Sweden
- Oslo - Oslo, Norway
- Region Västragötaland - Skövde, Sweden
- Stavanger - Stavanger, Norway
- Region Stockholm - Stockholm, Sweden
- Region Västernorrland - Sundsvall, Sweden
- Tromsø - Tromsø, Norway
- Trondheim - Trondheim, Norway
- Turku University Hospital - Turku, Finland
- Region Västerbotten - Umeå, Sweden
- Region Uppsala - Uppsala, Sweden
- Region Kronoberg - Vaxjo, Sweden
- Region Västmanland - Västerås, Sweden
- Ålesund - Ålesund, Norway
- Region Örebro - Örebro, Sweden