Study of Partial Breast Re-irradiation Using a 1-Week Ultra-Hypofractionated Radiation Schedule After Breast-Conserving Surgery for Recurrent or New Breast Cancer

What this Trial Is About

This research aims to evaluate a shorter, 1-week course of partial breast re-irradiation rPBI after breast-conserving surgery for women with recurrent or new primary breast cancer in a previously irradiated breast. The study focuses on women who have had prior whole breast radiation and now face local recurrence, assessing whether this ultra-hypofractionated radiation approach results in acceptable levels of toxicity at one year. This approach is thought to reduce side effects and improve cosmetic outcomes compared to traditional longer treatments or mastectomy. Participants receive external beam rPBI delivering 26 Gy in 5 daily fractions over one week following a second lumpectomy. This phase 2, single-arm, multi-institutional trial enrolls women with localized recurrence or new cancer in the previously irradiated breast. The treatment aims to be more convenient with fewer sessions while maintaining safety and effectiveness, advancing knowledge on optimal care for this patient group. During the study, participants will undergo regular assessments of radiation-associated toxicity, recurrence risk, survival, and quality of life at multiple time points up to five years post-treatment. Evaluations include physical exams, imaging, and questionnaires on breast satisfaction and financial impact. The primary outcome is grade 3 or higher toxicity during the three-year accrual period. This long-term monitoring ensures safety and gathers data on treatment effects over time.

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)