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New treatment option for Breast Cancer
Official title The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.
ClinicalTrials.gov ID: NCT05634889
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Lahti, Finland
- Turku, Finland
- Ålesund, Norway
- Bergen, Norway
- Bodø, Norway
- Gjøvik, Norway
- Kristiansand, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
- Borås, Sweden
- Eskilstuna, Sweden
- Gävle, Sweden
- Gothenburg, Sweden
- Halmstad, Sweden
- Jönköping, Sweden
- Kalmar, Sweden
- Karlstad, Sweden
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Lahti, Finland; Turku, Finland; Ålesund, Norway; Bergen, Norway; Bodø, Norway and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.