Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

What this study 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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)
• Clinically node negative
• Negative margins (no tumour on ink)
• Recovered from surgery with the incision completely healed and no signs of infection

🚫 You may not be able to join if…

• 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
• Node positive or distant metastatic disease
• Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
• Currently pregnant or lactating
• Presence of an ipsilateral breast implant or pacemaker
• Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
• Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
• Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
• Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0

Where this trial is running

• 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

+ 7 more sites.

Who to contact

Danielle Rodin, MD · (416) 946-6513 · danielle.rodin@uhn.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05592938.