Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity Health Network, Toronto

About this trial

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).

Eligibility criteria

Qualifiers

Age > 18 years

In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)

Tumour <3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components

>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)

Disqualifiers

Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)

Tumour histology limited to lobular carcinoma only

Extensive intraductal component

T4 disease

Trial design

Treatments tested in this trial

  • rPBI

Treatment groups

171 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor

Sunnybrook Health Sciences Centre

Collaborator

Royal Victoria Regional Health Centre

Collaborator

AC Camargo Cancer Center

Collaborator

King Hussein Cancer Center

Collaborator

NYU Langone Health

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Peter MacCallum Cancer Centre, Australia

Collaborator

CHU de Quebec-Universite Laval

Collaborator

Tel-Aviv Sourasky Medical Center

Collaborator

Virginia Commonwealth University

Collaborator

AOU Careggi

Collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Maisonneuve-Rosemont Hospital

Collaborator

Columbia University

Collaborator

Lakeridge Health

Collaborator

London Health Sciences Centre

Collaborator

Clínica IRAM

Collaborator

University Malaysia Medical Centre

Collaborator

Aga Khan University

Collaborator