Actively Recruiting
The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.
Led by Region Skane · Updated on 2026-05-11
1350
Participants Needed
30
Research Sites
563 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
E
Exact Sciences Corporation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary unifocal or multifocal invasive breast cancer T1-T2
- Clinically node-negative (N0)
- Macrometastasis (>2mm) in 1-2 lymph nodes at sentinel node biopsy
- Oral and written consent given
- Age 18 years or older
- All tumor resection margins are free of tumor
- Primary tumor is estrogen receptor positive and HER2-negative
You will not qualify if you...
- Regional or distant metastases outside the ipsilateral axilla
- Previous radiation therapy to the planned target area (ipsilateral chest/lymph nodes)
- Neoadjuvant systemic therapy received
- Axillary lymph node dissection or other prior axillary surgery on the affected side
- Prior history of invasive breast cancer
- Pregnancy
- Bilateral invasive breast cancer
- Contraindication to radiotherapy or systemic treatment
- Inability to understand or absorb informed consent due to disability, language skills, or dementia
- Other invasive cancer within 5 years prior to breast cancer diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
2
Lahti Hospital
Lahti, Finland
Not Yet Recruiting
3
Turku University Hospital
Turku, Finland
Not Yet Recruiting
4
Ålesund
Ålesund, Norway
Actively Recruiting
5
Bergen
Bergen, Norway
Actively Recruiting
6
Bodø
Bodø, Norway
Not Yet Recruiting
7
Gjövik
Gjøvik, Norway
Actively Recruiting
8
Kristiansand
Kristiansand, Norway
Actively Recruiting
9
Oslo
Oslo, Norway
Actively Recruiting
10
Stavanger
Stavanger, Norway
Actively Recruiting
11
Tromsø
Tromsø, Norway
Actively Recruiting
12
Trondheim
Trondheim, Norway
Actively Recruiting
13
Region Västragötaland
Borås, Sweden
Actively Recruiting
14
Region Sörmland
Eskilstuna, Sweden, 24751
Actively Recruiting
15
Region Gävleborg
Gävle, Sweden
Actively Recruiting
16
Region Västra Götaland
Gothenburg, Sweden
Actively Recruiting
17
Region Halland
Halmstad, Sweden
Actively Recruiting
18
Region Jönköping
Jönköping, Sweden
Actively Recruiting
19
Region Kalmar län
Kalmar, Sweden
Actively Recruiting
20
Region Värmland
Karlstad, Sweden
Actively Recruiting
21
Region Östergötland
Linköping, Sweden
Actively Recruiting
22
Region Skåne
Lund, Sweden
Actively Recruiting
23
Region Örebro
Örebro, Sweden
Actively Recruiting
24
Region Västragötaland
Skövde, Sweden
Actively Recruiting
25
Region Stockholm
Stockholm, Sweden
Actively Recruiting
26
Region Västernorrland
Sundsvall, Sweden
Actively Recruiting
27
Region Västerbotten
Umeå, Sweden
Actively Recruiting
28
Region Uppsala
Uppsala, Sweden
Not Yet Recruiting
29
Region Kronoberg
Vaxjo, Sweden
Actively Recruiting
30
Region Västmanland
Västerås, Sweden
Actively Recruiting
Research Team
S
Sara Alkner, Associate professor
CONTACT
T
T-REX Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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