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Recruiting NCT05592938

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Trial Parameters

Condition Breast Cancer
Sponsor University Health Network, Toronto
Study Type INTERVENTIONAL
Phase N/A
Enrollment 171
Sex FEMALE
Min Age 18 Years
Max Age 99 Years
Start Date 2023-06-27
Completion 2027-06-27
Interventions
rPBI

Brief 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 Criteria

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 * 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 breas

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