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RECRUITING
NCT05592938
NA

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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

Interventions

RADIATION

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