The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.
T-REX
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.
1 other identifier
interventional
1,350
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2023
Longer than P75 for not_applicable breast-cancer
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedStudy Start
First participant enrolled
March 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
November 20, 2024
November 1, 2024
5.8 years
November 18, 2022
November 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence Free Survival
Five years
Secondary Outcomes (8)
Locoregional recurrence
Five years
Regional nodal recurrence
Five years
New contralateral breast cancer
Five years
Distant recurrence free survival
Five years
Overall survival
Five years
- +3 more secondary outcomes
Study Arms (2)
Standard
NO INTERVENTIONRadiotherapy to the remaining breast after breast conserving surgery or chest wall after mastectomy, and regional axillary lymph node levels I-IV. Internal mammary nodes are included in the target volume if the tumor has a central/medial localization in the breast.
Intervention
EXPERIMENTALNo 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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Exact Sciences Corporationcollaborator
Study Sites (26)
Ålesund
Ålesund, Norway
Bergen
Bergen, Norway
Bodø
Bodø, Norway
Gjövik
Gjøvik, Norway
Kristiansand
Kristiansand, Norway
Oslo
Oslo, Norway
Stavanger
Stavanger, Norway
Tromsø
Tromsø, Norway
Trondheim
Trondheim, Norway
Region Västragötaland
Borås, Sweden
Region Gävleborg
Gävle, Sweden
Region Västra Götaland
Gothenburg, Sweden
Region Halland
Halmstad, Sweden
Region Jönköping
Jönköping, Sweden
Region Kalmar län
Kalmar, Sweden
Region Värmland
Karlstad, Sweden
Region Östergötland
Linköping, Sweden
Region Skåne
Lund, Sweden
Region Örebro
Örebro, Sweden
Region Västragötaland
Skövde, Sweden
Region Stockholm
Stockholm, Sweden
Region Västernorrland
Sundsvall, Sweden
Region Västerbotten
Umeå, Sweden
Region Uppsala
Uppsala, Sweden
Region Kronoberg
Vaxjo, Sweden
Region Västmanland
Västerås, Sweden
Related Publications (1)
Alkner S, de Boniface J, Lundstedt D, Mjaaland I, Ryden L, Vikstrom J, Bendahl PO, Holmberg E, Sackey H, Wieslander E, Karlsson P. Protocol for the T-REX-trial: tailored regional external beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases - an open, multicentre, randomised non-inferiority phase 3 trial. BMJ Open. 2023 Sep 26;13(9):e075543. doi: 10.1136/bmjopen-2023-075543.
PMID: 37751948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Alkner, Associate professor
Lunds Universitet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2022
First Posted
December 2, 2022
Study Start
March 17, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2033
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The above information is available. IPD will be shared upon reasonable request after publication of the main endpoint. No end date.
- Access Criteria
- Study protocol, Statistical Analysis Plan, Informed Consent Form and Clinical Study Report will be available to all interested. Deidentified participant data, and access to biological material, could be made available to researchers who provide a methodologically sound proposal with all prepared documents for ethical approval to the T-REX study group / the T-REX biobank group through primary investigator Sara Alkner (sara.alkner@med.lu.se).
Data will be made available upon request by the T-REX study group through primary investigator Sara Alkner (sara.alkner@med.lu.se) as specified below.