Study ID: Tailor RT
A randomized trial of regional radiotherapy in biomarker low-risk, node-positive breast cancer
Patients with node-positive breast cancer normally receive endocrine therapy, and some may receive chemotherapy to help prevent the cancer from recurring. Many patients also receive radiotherapy (RT) to the whole breast/chest area and the surrounding lymph glands (called regional RT). Researchers seek to determine if patients with low-risk breast cancer must receive regional RT.
Each patient is grouped into one of four study arms:
- Arm 1A: Receives whole breast irradiation following breast-conserving surgery
- Arm 1B: No radiotherapy following mastectomy
- Arm 2A: Receives whole breast irradiation plus regional RT following breast-conserving surgery
- Arm 2B: Radiotherapy to the chest wall and regional nodes following mastectomy
This is an international, multicenter, randomized, non-inferiority phase III trial evaluating outcomes among certain breast cancer patients treated with regional radiotherapy (RT), that is, RT to regional nodes following breast-conserving surgery (BCS) or RT to the chest wall and regional nodes following mastectomy.
Eligible patients are those who have been diagnosed with ER+ve biomarker low-risk breast cancer, defined as Oncotype DX recurrence score <18, and limited nodal disease. Patients must have had BCS or mastectomy and will receive endocrine therapy for five years.
Patients treated by axillary dissection may have one to three positive axillary nodes (macrometastases, >2 mm) regardless of type of surgery. Patients treated by sentinel lymph node biopsy alone may have one or two positive nodes (macrometastases, >2mm) if treated by BCS or one positive node (macrometastases, >2mm) if treated by mastectomy.
- Must have been diagnosed with biomarker low-risk, node-positive breast cancer and no evidence of metastases
- Must already have been treated with breast-conserving surgery or mastectomy and will receive endocrine therapy for five years
- Must be willing to undergo the treatment protocol as specified for the study arm into which the patient has been randomized