Actively Recruiting
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Led by University Health Network, Toronto · Updated on 2026-04-03
171
Participants Needed
17
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
S
Sunnybrook Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Breast cancer recurrence or new primary (ductal carcinoma in situ or invasive carcinoma) in the breast
- Tumor less than 3.0 cm in greatest diameter on pathology
- More than 5 years since completion of prior whole or partial breast radiation (prior nodal radiation allowed)
- Clinically node negative
- Negative surgical margins with no tumor on ink
- Fully healed surgical incision with no signs of infection
You will not qualify if you...
- Multicentric disease (multifocal cancer in the same quadrant allowed)
- Tumor only of lobular carcinoma type
- Extensive intraductal component
- T4 stage disease
- Node positive or distant metastatic disease
- Serious non-cancer illnesses that prevent radiation treatment
- Currently pregnant or breastfeeding
- Presence of breast implant or pacemaker on the same side
- Unable to start radiation within 16 weeks after surgery or 12 weeks after last chemotherapy cycle
- Unable to clearly identify surgical cavity
- Psychiatric disorders preventing consent or study adherence
- Grade II or higher late skin toxicity from prior radiation with CTCAE v5.0 grading
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
Virgina Community University Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298-0037
Actively Recruiting
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
5
A.C.Camargo Cancer Center
São Paulo, São Paulo, Brazil, 105401
Actively Recruiting
6
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Actively Recruiting
7
London Health Science Centre - Verspeeten Family Cancer Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
8
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
9
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
10
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
11
CHU de Québec-Université Laval
Montreal, Quebec, Canada, G1G 5X1
Actively Recruiting
12
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
13
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
14
Clinica IRAM
Vitacura, Santiago Metropolitan, Chile, 7630370
Actively Recruiting
15
Tel-Aviv Sourasky Medical Centre
Tel Aviv, Israel
Actively Recruiting
16
AOU Careggi - Florence University Hospital
Florence, Italy
Actively Recruiting
17
King Hussein Cancer Centre
Amman, Jordan, Jordan
Actively Recruiting
Research Team
D
Danielle Rodin, MD
CONTACT
A
Anne Koch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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