Trial details

Trial short name: PRESERVE

Official title: Partial breast re-irradiation using ultra hypofractionation Phase 2 multi- institutional study

Principal Investigator: Dr. Hanbo Chen

Cancer type: Breast
Cancer location: Breast
Disease stage: Early Cancer
Trial phase:
Intervention: Radiation: rPBI

Registration #: NCT05592938

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial description:
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 they can accrue sufficient patient with rPBI who will be treated using 26 Gray(Gy) in 5 daily fractions over 1-week. Planned interim analysis after the 15 recruited patients for early toxicity evaluation with stopping rule for unacceptable toxicity.

Inclusion Criteria: • Age > 18 years • In-breast recurrence confirmed as unicentric • Tumour <3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components • >1 year after completion of prior adjuvant whole or partial breast radiotherapy • Clinically node negative • Negative margins (no tumour on ink) • Recovered from surgery with the incision completely healed and no signs of infection • Negative metastatic work-up (no evidence of distant metastases on bone scan, and computerized tomography (CT) scans of the thorax, abdomen, and pelvis; or using (FDG) Positron emission tomography (PET)-CT). Exclusion Criteria: • Infiltrating Lobular Carcinoma • Multifocal or multicentric disease • 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 (Level I 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