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Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Sponsor: University Health Network, Toronto
Summary
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).
Official title: Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
Key Details
Gender
FEMALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
171
Start Date
2023-06-27
Completion Date
2027-06-27
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
rPBI
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Locations (17)
NYU Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Virgina Community University Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
A.C.Camargo Cancer Center
São Paulo, São Paulo, Brazil
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
London Health Science Centre - Verspeeten Family Cancer Centre
London, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CHU de Québec-Université Laval
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Clinica IRAM
Vitacura, Santiago Metropolitan, Chile
Tel-Aviv Sourasky Medical Centre
Tel Aviv, Israel
AOU Careggi - Florence University Hospital
Florence, Italy
King Hussein Cancer Centre
Amman, Jordan, Jordan