Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Recruiting · NCT05592938 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
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
Where it is running
19 locations listed across 2 US states.
- 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
- AOU Careggi - Florence University Hospital - Florence, Italy
- Universitiy Malaya Medical Centre - Kuala Lumpur, Malaysia
- The Aga Khan University - Nairobi, Kenya
- Tel-Aviv Sourasky Medical Centre - Tel Aviv, Israel
- King Hussein Cancer Centre - Amman, Jordan, Jordan
- 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
- A.C.Camargo Cancer Center - São Paulo, São Paulo, Brazil
- Peter MacCallum Cancer Centre - Melbourne, Victoria, Australia