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

Trial Title: 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

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer
radiotherapy
gene expression analysis
adjuvant breast cancer treatment
regional breast cancer treatment

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: De-escalation
Description: No regional radiotherapy. Radiotherapy towards the remaining breast after breast conserving surgery, but no radiotherapy at all after mastectomy.
Arm group label: Intervention

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 in collaboration with Exact Sciences, and related to risk of recurrence and benefit of adjuvant radiotherapy.

Detailed description: In this multicenter, prospective randomized trial clinically node-negative breast cancer patients with 1-2 macrometastases in their sentinel lymph node biopsy, and an estrogen receptor positive, HER2-negative tumor, will be randomly assigned to either receive adjuvant locoregional radiotherapy, or no regional radiotherapy. The main aim is to evaluate whether regional radiotherapy may safely be omitted in patients with limited lymph node metastasis and an estimated low risk of locoregional recurrence. Recurrence free survival after five years is the primary outcome, which for non-inferiority should not worsen more than 4.5 percentage units. Secondary outcomes are locoregional recurrence, regional nodal recurrence, new contralateral BC, distant recurrence free survival, overall survival, non-breast malignancies, cardiac disease, arm morbidity, and health-related quality of life. Target volumes include: Standard arm - The remaining breast/chest wall, axillary lymph node levels I-III, the supraclavicular lymph nodes (level IV), the interpectoral lymph nodes and in patients with a medial/central tumor also the internal mammary lymph nodes. Intervention arm - The remaining breast after breast conserving surgery. No radiotherapy after mastectomy

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Region Västra Götaland

Address:
City: Gothenburg
Country: Sweden

Status: Recruiting

Contact:
Last name: Per Karlsson

Facility:
Name: Region Jönköping

Address:
City: Jönköping
Country: Sweden

Status: Not yet recruiting

Contact:
Last name: Kirsten Björlinger

Facility:
Name: Region Kalmar län

Address:
City: Kalmar
Country: Sweden

Status: Not yet recruiting

Contact:
Last name: Barbara Wysocka

Facility:
Name: Region Skåne

Address:
City: Lund
Country: Sweden

Status: Recruiting

Contact:
Last name: Sara Alkner
Email: sara.alkner@gmail.com

Facility:
Name: Region Stockholm

Address:
City: Stockholm
Country: Sweden

Status: Not yet recruiting

Contact:
Last name: Camilla Wendt

Start date: March 17, 2023

Completion date: December 31, 2033

Lead sponsor:
Agency: Region Skane
Agency class: Other

Collaborator:
Agency: Exact Sciences Corporation
Agency class: Industry

Source: Region Skane

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05634889