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Clinical Trials in Sweden / NCT05634889
Recruiting Not applicable

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

NCT05634889 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Skane
Phase
Not applicable
Started
2023-03-17
Last updated
2026-05-11

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

De-escalation

De-escalation: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence Free Survival — Five years

Trial sites (30)

FacilityCityRegionStatus
Helsinki University Hospital Helsinki Finland Recruiting
Lahti Hospital Lahti Finland Not Yet Recruiting
Turku University Hospital Turku Finland Not Yet Recruiting
Ålesund Ålesund Norway Recruiting
Bergen Bergen Norway Recruiting
Bodø Bodø Norway Not Yet Recruiting
Gjövik Gjøvik Norway Recruiting
Kristiansand Kristiansand Norway Recruiting
Oslo Oslo Norway Recruiting
Stavanger Stavanger Norway Recruiting
Tromsø Tromsø Norway Recruiting
Trondheim Trondheim Norway Recruiting
Region Västragötaland Borås Sweden Recruiting
Region Sörmland Eskilstuna Sweden Recruiting
Region Gävleborg Gävle Sweden Recruiting
Region Västra Götaland Gothenburg Sweden Recruiting
Region Halland Halmstad Sweden Recruiting
Region Jönköping Jönköping Sweden Recruiting
Region Kalmar län Kalmar Sweden Recruiting
Region Värmland Karlstad Sweden Recruiting
Region Östergötland Linköping Sweden Recruiting
Region Skåne Lund Sweden Recruiting
Region Örebro Örebro Sweden Recruiting
Region Västragötaland Skövde Sweden Recruiting
Region Stockholm Stockholm Sweden Recruiting
Region Västernorrland Sundsvall Sweden Recruiting
Region Västerbotten Umeå Sweden Recruiting
Region Uppsala Uppsala Sweden Not Yet Recruiting
Region Kronoberg Vaxjo Sweden Recruiting
Region Västmanland Västerås Sweden Recruiting

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Other trials for the same condition

Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer Recruiting
Autologous vs. Implant-based Breast Reconstruction Recruiting
A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices Recruiting
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05634889 on ClinicalTrials.gov ↗ ← All trials in Sweden