Single-dose Preoperative Partial Breast Irradiation for Low-risk Breast Cancer Patients

What this Trial Is About

Researchers are evaluating the use of MRI-guided single-dose preoperative partial breast radiotherapy in women aged 50 and older with low-risk breast cancer to study the rate of complete tumor disappearance after treatment. This trial focuses on patients with unifocal cT1N0 breast cancer who are ER positive and HER2 negative, aiming to predict tumor response using MRI scans and markers in blood and tumor tissue. The study is designed to assess how well tumors respond to this radiotherapy approach over an interval of six to twelve months before surgery. Participants receive a single dose of radiotherapy delivering 20Gy to the gross tumor volume and 15Gy to the clinical tumor volume before surgery. Breast conserving surgery is scheduled 12 months after radiotherapy if MRI scans show complete radiologic response. If response is incomplete, surgery occurs at 6 months, or sooner if the tumor progresses. MRI scans are performed every 3 months between radiotherapy and surgery to monitor tumor response. During the study, patients undergo regular MRI scans and tumor marker assessments to track treatment effect. After surgery, follow-up continues for up to 10 years to evaluate cancer outcomes, side effects, cosmetic results, and quality of life. The primary outcome measured is the pathologic complete response 12 months after radiotherapy, reflecting the absence of cancer cells in the tissue removed during surgery.

Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients