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

Plain-language summary

This study evaluates tailoring and reducing (de-escalating) regional external beam radiotherapy in people with breast cancer that appears clinically node-negative in the armpit but shows macrometastasis in 1-2 nodes on sentinel node biopsy. Patients aged 18 and older with T1-T2 invasive, hormone-receptor-positive, HER2-negative breast cancer and clear surgical margins may take part. It is a non-phase study and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Region Skane

Intervention

De-escalation

Start date

3/17/2023

Estimated completion

12/31/2033

Countries

Norway, Sweden

Related genes

Locations

• Ålesund, Norway
• Bergen, Norway
• Bodø, Norway
• Gjøvik, Norway
• Kristiansand, Norway
• Oslo, Norway
• Stavanger, Norway
• Tromsø, Norway
• Trondheim, Norway
• Borås, Sweden
• Gävle, Sweden
• Gothenburg, Sweden
• Halmstad, Sweden
• Jönköping, Sweden
• Kalmar, Sweden
• Karlstad, Sweden
• Linköping, Sweden
• Lund, Sweden
• Örebro, Sweden
• Skövde, Sweden
• Stockholm, Sweden
• Sundsvall, Sweden
• Umeå, Sweden
• Uppsala, Sweden
• Vaxjo, Sweden
• Västerås, Sweden

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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