Single-dose Preoperative Partial Breast Radiotherapy for Women 50 and Older with Low-risk Breast Cancer

What this Trial Is About

This research investigates a treatment approach for low-risk breast cancer in female patients aged 50 and above. The study evaluates the effects of a single-dose preoperative partial breast radiotherapy guided by MRI, aiming to measure the rate of complete tumor disappearance at the time of surgery, which occurs between six and twelve months after radiotherapy. Researchers will also monitor tumor response through MRI scans and blood and tumor tissue markers to predict this outcome. Patients receive a single dose of radiotherapy targeting the tumor area, with doses of 20Gy to the gross tumor volume and 15Gy to the clinical tumor volume. Surgery to conserve the breast is planned around 12 months after radiotherapy if MRI shows a complete response. If MRI indicates an incomplete response or disease progression, surgery may be moved earlier, around six months or sooner. During the months between radiotherapy and surgery, MRI scans occur every three months to monitor tumor response. Participants will be assessed regularly using MRI scans and various blood and tissue tests to follow tumor changes and treatment effects. After surgery, patients will be followed for up to 10 years to evaluate cancer outcomes, side effects, cosmetic results, and quality of life. The primary measure is the complete pathological response at 12 months post-radiotherapy, with secondary measures including radiologic response, adverse events, quality of life, cosmetic outcomes, recurrence rates, survival, and biomarkers related to radiotherapy effects.

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