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Clinical Trials in Australia / NCT05592938
Recruiting Not applicable

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

NCT05592938 · tracked via the Priya Life Science Australia tracker
Sponsor
University Health Network, Toronto
Phase
Not applicable
Started
2023-06-27
Last updated
2026-07-17

Condition(s) studied

Breast CancerBreast Cancer Recurrent

Investigational drug(s) / intervention(s)

rPBI

rPBI: External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week

Study 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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible) * Tumour histology limited to lobular carcinoma only * 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 * Current or prior diagnosis of bilateral breast cancer

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
NYU Langone Health New York New York Recruiting
Columbia University Medical Center New York New York Recruiting
Virgina Community University Massey Comprehensive Cancer Center Richmond Virginia Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
A.C.Camargo Cancer Center São Paulo São Paulo Recruiting
Royal Victoria Regional Health Centre Barrie Ontario Recruiting
London Health Science Centre - Verspeeten Family Cancer Centre London Ontario Recruiting
Lakeridge Health Oshawa Ontario Recruiting
Odette Cancer Centre Toronto Ontario Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
CHU de Québec-Université Laval Montreal Quebec Recruiting
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal Montreal Quebec Recruiting
Centre hospitalier de l'Université de Montréal Montreal Quebec Recruiting
Clinica IRAM Vitacura Santiago Metropolitan Recruiting
Tel-Aviv Sourasky Medical Centre Tel Aviv Israel Recruiting
AOU Careggi - Florence University Hospital Florence Italy Recruiting
King Hussein Cancer Centre Amman Jordan Recruiting
The Aga Khan University Nairobi Kenya Recruiting
Universitiy Malaya Medical Centre Kuala Lumpur Malaysia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05592938 on ClinicalTrials.gov ↗ ← All trials in Australia