Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

NCT05592938 NA RECRUITING

Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).

Details

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	RECRUITING
Enrolment	171
Start date	Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sun Jun 27 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Breast Cancer
• Breast Cancer Recurrent

Interventions

• rPBI

Countries

Italy, Jordan, Chile, Israel, Canada, Australia, United States, Brazil