Impact of Preoperative Stereotactic Partial Breast Irradiation on Treatment Response, Treatment-related Toxicity, and Cosmetic Outcomes in Early-stage Breast Cancer: A Prospective, Phase II Clinical Trial

What this Trial Is About

Researchers are studying early-stage breast cancer treatment by comparing preoperative partial breast irradiation (PBI) to the traditional postoperative PBI. Early breast cancer patients often receive radiotherapy after breast-conserving surgery, with hypofractionated radiotherapy methods gaining attention for their shorter treatment times and fewer side effects. This study aims to evaluate the safety, side effects, and cosmetic outcomes of preoperative PBI, which targets the tumor before surgery, potentially allowing more precise radiation and better cosmetic results. The trial is a phase II study involving a single group receiving preoperative PBI, where a single dose of 21 Gy is given within six weeks of registration. Surgery follows between 8 to 12 weeks after radiation. This approach is being compared to historical data on postoperative PBI to assess if preoperative treatment is not inferior in terms of side effects. The study will enroll up to 47 patients over two years, and follow them for up to one year to monitor outcomes. Participants will undergo evaluations of treatment side effects, surgery outcomes, breast appearance, and quality of life at several points: before radiotherapy, six months after, and one year after. Assessments include questionnaires, breast aesthetics scoring using BCCT software, and measurements of breast tissue firmness. Researchers will also monitor acute and late toxicities, disease status, and survival rates. This comprehensive follow-up aims to capture the overall benefits and challenges of preoperative PBI in early breast cancer care.

Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer