NCT05634889 The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.
| NCT ID | NCT05634889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,350 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,350 participants in total. It began in 2023-03-17 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sara Alkner, Associate professor
PRINCIPAL INVESTIGATOR
Lunds Universitet
Frequently Asked Questions
Who can join the NCT05634889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05634889 currently recruiting?
Yes, NCT05634889 is actively recruiting participants. Contact the research team at sara.alkner@med.lu.se for enrollment information.
Where is the NCT05634889 trial being conducted?
This trial is being conducted at Helsinki, Finland, Lahti, Finland, Turku, Finland, Ålesund, Norway and 11 additional locations.
Who is sponsoring the NCT05634889 clinical trial?
NCT05634889 is sponsored by Region Skane. The principal investigator is Sara Alkner, Associate professor at Lunds Universitet. The trial plans to enroll 1,350 participants.
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